Consolidated Document number 6/VBHN-BYT on In vitro Fertilization Techniques for Childbirth and Conditions for Surrogacy for Humanitarian Purposes

MINISTRY OF HEALTH -------	SOCIALIST REPUBLIC OF VIET NAM Independence - Freedom - Happiness ---------------
Number: 6/VBHN-BYT	Hanoi, March 16, 2021

CIRCULAR

REGULATIONS ON GOOD DISTRIBUTION PRACTICES FOR MEDICINES AND ACTIVE PHARMACEUTICAL INGREDIENTS

Circular No. 03/2018/TT-BYT dated February 9, 2018 on Good Distribution Practices for Medicines and Active Pharmaceutical Ingredients, effective from March 26, 2018, was amended and supplemented by:

Circular No. 29/2020/TT-BYT dated December 31, 2020 amending and supplementing and abolishing certain legal normative documents issued by the Minister of Health, jointly issued, effective from January 1, 2021.

Pursuant to Law No. 105/2016/QH13 dated April 6, 2016 on pharmaceuticals;

Pursuant to the Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing some provisions and measures for implementing the Medicine Law;

Pursuant to the Government's Decree No. 75/2017/NĐ-CP dated June 20, 2017 stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Drug Administration Department,

The Minister of Health issues this Circular to regulate Good Distribution Practices for Medicines and Active Pharmaceutical Ingredients.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates the publication of application and evaluation of compliance with Good Distribution Practices for Medicines and Active Pharmaceutical Ingredients.

Article 2. Interpretation of Terms

In this Circular, the following terms are understood as follows:

1. Distribution of medicines means the activity of dividing and moving, storing medicines during the process of moving from the warehouse of a medicine manufacturing facility, imported medicine warehouse, or distribution facility to the end user or to distribution points or between distribution points using different transportation means.

2. Distribution of active pharmaceutical ingredients means the activity of dividing and moving, storing active pharmaceutical ingredients during the process of moving from the warehouse of an active pharmaceutical ingredient manufacturing facility, imported active pharmaceutical ingredient warehouse to a finished medicine manufacturing facility or to storage points of a distribution facility or between distribution points using different transportation means.

3. Good Distribution Practices for Medicines and Active Pharmaceutical Ingredients means a set of principles and standards for the distribution of medicines and active pharmaceutical ingredients aimed at ensuring the quality of medicines and active pharmaceutical ingredients through full control of activities during the distribution process and preventing the infiltration of unapproved medicines and active pharmaceutical ingredients into the distribution system.

4. Distribution facility is a facility that carries out the activity of distributing medicines and active pharmaceutical ingredients, wholesale medicine and active pharmaceutical ingredient facilities, vaccine distribution facilities in the National Expanded Immunization Program at provincial and district levels, and other facilities engaged in the distribution of medicines and active pharmaceutical ingredients not for commercial purposes.

5. Non-compliance Deviation

6. WHO is the abbreviation for the English term "World Health Organization," which translates to World Health Organization in Vietnamese.

7. GDP GDP

Chapter II

is the abbreviation for the English term "Good Distribution Practices," which translates to Good Distribution Practices in Vietnamese.

Article 3. Principles and Standards of Good Distribution Practices for Medicines and Active Pharmaceutical Ingredients

1. Publish the application of the principles and standards of Good Distribution Practices for Medicines as prescribed in Appendix I attached to this Circular and updated materials as stipulated in Clause 3 of this Article.

2. Publish the application of the principles and standards of Good Distribution Practices for Active Pharmaceutical Ingredients as prescribed in Appendix II attached to this Circular and updated materials as stipulated in Clause 3 of this Article.

3. In case the World Health Organization amends and supplements the principles and standards of Good Distribution Practices for Medicines and Active Pharmaceutical Ingredients prescribed in Appendices I and II attached to this Circular, the Drug Administration of Vietnam shall organize the translation and publish the amended and supplemented contents on the Ministry of Health's Electronic Information Portal and the Drug Administration of Vietnam's Electronic Information Portal for relevant parties to search, update, and apply.

Article 4. Subjects to which the principles and standards of Good Distribution Practice (GDP) for drug distribution and drug raw material distribution apply.

1. Drug distributors shall implement and comply with GDP as prescribed in Appendix I attached to this Circular and updated information published on the Ministry of Health's Electronic Information Portal and the Drug Administration Department's Electronic Information Website.

2. Drug raw material distributors shall implement GDP as prescribed in Appendix II attached to this Circular and updated information published on the Ministry of Health's Electronic Information Portal and the Drug Administration Department's Electronic Information Website.

3. Vaccine distributors under the National Expanded Immunization Program at provincial and district levels shall implement GDP as prescribed in Appendix I attached to this Circular (excluding Points 5.3, 5.5, 5.6, 5.9, 6.3, 6.4, 7.5, 7.6, 8.1, 8.2, 8.3, 8.4, 8.5, 8.8, 8.12, 9.6, 9.11, 10.3, 12.1, 13.8, 13.9, 15.1, 15.2, 15.3, 15.4, 20.1, 20.2, 20.3, 20.4, 20.5, 20.6, 20.7, and 20.8) and updated information published on the Ministry of Health's Electronic Information Portal and the Drug Administration Department's Electronic Information Website. Such distributors are not required to submit applications for evaluation as stipulated in Chapters III and IV of this Circular.

4. Distributors applying updated GDP documentation must do so within a period of twelve months for cases requiring changes to storage facilities or equipment for drug distribution, or six months for other updates, counted from the date the updated documentation is published on the Ministry of Health's Electronic Information Portal or the Drug Administration Department's Electronic Information Website.

Chapter III

EVALUATION OF COMPLIANCE WITH GOOD DISTRIBUTION PRACTICE FOR DRUGS AND DRUG RAW MATERIALS

Article 5. Documents serving as the basis for evaluating compliance with Good Distribution Practice (GDP) for drugs and drug raw materials.

1. The application for issuance of the Certificate of Compliance with Conditions for Operating a Pharmaceutical Business (submitted when requesting such certificate, the distributor does not need to submit additional documents) as prescribed in Article 38 of the Pharmacy Law and Article 32 of Decree No. 54/2017/ND-CP dated May 8, 2017 of the Government detailing certain provisions and measures to implement the Pharmacy Law (hereinafter referred to as Decree No. 54/2017/ND-CP) serves as the basis for evaluating GDP compliance for distributors. In cases where special control is required for drug distributors, they must follow the provisions of Article 38 of the Pharmacy Law and Article 49 of Decree No. 54/2017/ND-CP.

Technical documents about the distributor presented according to the overall dossier template as prescribed in Model No. 05 of Appendix IV attached to this Circular or an updated overall dossier in case of expanded scope of activities.

2. Documents serving as the basis for evaluating GDP compliance for non-commercial distributors include:

a) Application for GDP compliance assessment according to Model No. 02 prescribed in Appendix IV attached to this Circular;

b) Technical documents about the distributor presented according to the overall dossier template as prescribed in Model No. 05 of Appendix IV attached to this Circular.

3. In cases where a distributor requests issuance of both the GDP Certificate and the Certificate of Compliance with Conditions for Operating a Pharmaceutical Business, the distributor must clearly state this in the application for issuance of the Certificate of Compliance with Conditions for Operating a Pharmaceutical Business.

Article 6. Procedure for Evaluating Compliance with Good Distribution Practices for Medicines and Active Pharmaceutical Ingredients

1. Receiving documents:

The distribution entity shall submit one set of documents in accordance with Article 5 of this Circular along with the assessment fee as prescribed by the Minister of Finance regarding the assessment fee for standards and conditions for distributing medicines and active pharmaceutical ingredients to the Department of Health.

2. The procedure for receiving and assessing the application shall be carried out in accordance with the provisions stipulated at:

a) Clauses 2, 3, 4, 5, and 6 of Article 50 of Decree No. 54/2017/ND-CP for distribution entities that engage in selling combined medicines containing addictive drugs, combined medicines containing psychotropic substances, and combined medicines containing precursors.

b) Clauses 2, 3, 4, and 5 of Article 51 of Decree No. 54/2017/ND-CP for distribution entities that engage in selling toxic medicines and toxic raw materials for medicines; medicines and drug substances listed in the catalog of prohibited substances for certain industries and fields.

c) Clauses 2, 4, and 5 of Article 33 of Decree No. 54/2017/ND-CP for drug business entities not covered by the cases specified in points a and b of this Clause.

3. Within five days from the date of receipt of a valid application, the Department of Health shall establish an Evaluation Team, notify the distribution entity about the Evaluation Team and the anticipated time for on-site evaluation. Within fifteen days from the date of notification, the Evaluation Team shall conduct the on-site evaluation at the distribution entity.

Article 7. Procedure for Evaluating Compliance and Classifying Compliance with Good Distribution Practices for Medicines and Active Pharmaceutical Ingredients

1. Evaluation Procedure:

a) Step 1. The Evaluation Team shall announce the Decision establishing the Evaluation Team, its objectives, contents, and the planned schedule for the on-site evaluation at the distribution entity.

b) Step 2. The distribution entity shall present a summary of its organizational structure, personnel, and activities related to implementing and applying GDP or specific contents according to the evaluation period.

c) Step 3. The Evaluation Team shall conduct an on-site evaluation of the implementation and application of GDP at the distribution entity according to each specific content.

d) Step 4. The Evaluation Team shall convene a meeting with the distribution entity to inform it of any issues identified during the evaluation (if any); assess the severity of each issue; discuss with the distribution entity if there is disagreement between the entity and the Evaluation Team over the assessment of each issue; evaluate the degree of compliance with GDP principles and standards by the distribution entity.

e) Step 5. Draft and sign the Minutes:

The Evaluation Team is responsible for drafting the GDP Evaluation Minutes in Form No. 03 as stipulated in Appendix IV attached to this Circular; the minutes must classify the degree of compliance with GDP by the distribution entity as prescribed in Clause 2 and Clause 3 of this Article and list and analyze the issues that the entity needs to address (if any); the content agreed upon and not agreed upon between the Evaluation Team and the distribution entity.

The GDP Evaluation Minutes shall be signed and confirmed by the Head of the distribution entity and the Head of the Evaluation Team. The Minutes must include the composition of the Evaluation Team, the location, time, scope of the evaluation, and shall be made in three copies: one copy retained by the distribution entity, two copies retained by the Department of Health.

2. Assessment of the Degree of Compliance with GDP:

The assessment of the degree of compliance with GDP by the distribution entity as prescribed in Appendix IV attached to this Circular includes the following levels:

a) The distribution entity complies with GDP at Level 1.

b) The distribution entity complies with GDP at Level 2.

c) The distribution entity complies with GDP at Level 3.

Article 8. Handling the Results of Good Distribution Practice (GDP) Compliance Assessment

1. In the case where the GDP assessment report concludes that the distribution facility complies with GDP at Level 1 as stipulated in Point a, Clause 2, Article 7 of this Circular:

Within ten days from the date of completion of the on-site assessment and signing of the assessment report, the Department of Health shall issue a Business Registration Certificate for Drug Trading Conditions or a GDP Certificate according to Form No. 06 prescribed in Appendix IV attached to this Circular.

In the case where the drug distribution facility requires special supervision, within twenty days from the date of completion of the on-site assessment and signing of the assessment report, the Department of Health shall issue a Business Registration Certificate for Drug Trading Conditions or a GDP Certificate according to Form No. 06 prescribed in Appendix IV attached to this Circular.

2. In the case where the GDP assessment report concludes that the distribution facility complies with GDP at Level 2 as stipulated in Point b, Clause 2, Article 7 of this Circular:

a) Within five days from the date of completion of the on-site assessment and signing of the assessment report, the Department of Health shall send a written notice requesting the distribution facility to rectify and correct the issues recorded in the assessment report.

In the case where the drug distribution facility requires special supervision, within fifteen days from the date of completion of the on-site assessment and signing of the assessment report, the Department of Health shall send a written notice requesting the distribution facility to rectify and correct the deficiencies recorded in the assessment report.

b) After completing the rectification and correction, the distribution facility must submit a written notification accompanied by evidence (document files, images, videos, certificates) proving the completion of the rectification and correction of the deficiencies recorded in the assessment report;

c) Within twenty days from the date of receipt of the rectification report, the Department of Health shall evaluate the results of the rectification by the distribution facility and conclude on the compliance status with GDP of the distribution facility:

- If the rectification by the distribution facility meets the requirements: The Department of Health shall issue a Business Registration Certificate for Drug Trading Conditions or implement the issuance of a GDP Certificate according to Form No. 06 prescribed in Appendix IV attached to this Circular;

- If the rectification by the distribution facility does not meet the requirements, the Department of Health shall issue a written response explaining the reasons for non-issuance.

d) Within six months from the date the Department of Health issues a written request for amendments and supplements, the distribution facility must submit the amended and supplemented documents as required. After this period, if the distribution facility does not amend and supplement or if twelve months have passed since the initial submission of the application and the supplementary documents still do not meet the requirements, the submitted documents will lose their validity.

3. In the case where the GDP assessment report concludes that the distribution facility complies with GDP at Level 3 as stipulated in Point c, Clause 2, Article 7 of this Circular:

Within five days from the date of completion of the on-site assessment and signing of the assessment report, the Department of Health shall issue a written notice to the distribution facility regarding non-compliance with GDP and non-issuance of the certificate.

4. Within five days from the date of issuance of the Business Registration Certificate for Drug Trading Conditions or the GDP Certificate, the Department of Health shall publish on its official website the following information:

a) Name and address of the distribution facility;

b) Name of the person responsible for pharmaceutical expertise and their Pharmaceutical Practitioner License number;

c) Number of the Business Registration Certificate for Drug Trading Conditions and the number of the GDP Certificate (if applicable);

d) Expiry date of the GDP compliance inspection;

đ) Scope of distribution activities.

Chapter IV

ASSESSMENT OF THE MAINTENANCE OF COMPLIANCE WITH GOOD DISTRIBUTION PRACTICE FOR DRUGS AND DRUG SUBSTANCES

Article 9. Periodic Assessment of Compliance with Good Distribution Practices for Medicinal Products

1. The periodic assessment period for compliance with GDP at distribution facilities (including non-commercial distribution facilities and special-purpose drug business establishments) is three years, starting from the end date of the previous assessment (excluding any unscheduled inspections, audits, or checks conducted by the Ministry of Health or the Department of Health).

2. Each year in November, the Department of Health publishes on its official website the plan for the periodic assessment of compliance with GDP for distribution facilities in the following year.

3. Based on the periodic assessment plan published by the Department of Health, distribution facilities must submit the application for periodic assessment according to Clause 7 of this Article to the Department of Health at least thirty days before the scheduled assessment date as announced by the Department of Health.

Example: If the planned assessment date at Distribution Facility A is August 18, 2018, then Distribution Facility A must submit the application for periodic assessment to the Department of Health by July 18, 2018.

4. In cases where a distribution facility fails to submit the application for periodic assessment within the time frame stipulated in Clause 3 of this Article, the Department of Health will issue a notice requesting the facility to explain the reasons for not submitting the application within ten days from the deadline for submission as specified in Clause 3 of this Article.

5. Within thirty days from the issuance of the notice by the Department of Health requesting the distribution facility to provide an explanation for not submitting the application for periodic assessment, if the facility still fails to submit the application as required, the Department of Health will revoke the Certificate of Eligibility for Drug Business Operations issued to the facility under Clause 2 of Article 40 of the Drug Law or issue a notice requiring the non-commercial distribution facility to cease operations.

6. After submitting the application for periodic assessment of compliance with GDP within the prescribed timeframe, the distribution facility may continue to operate within the scope defined in the Certificate of Eligibility for Drug Business Operations or the GDP Certificate for non-commercial distribution facilities from the date of submission until the results of the periodic assessment are available.

7. The application for periodic assessment of compliance with GDP includes:

a) An application form for periodic assessment of compliance with GDP according to Form No. 01 attached as Appendix IV to this Circular;

b) Updated technical documentation regarding the physical infrastructure, technology, and personnel of the distribution facility (if there have been changes);

c) A summary report on the distribution activities of medicinal products and medicinal product ingredients of the facility over the last three years from the date of the most recent assessment (excluding any unscheduled inspections, audits, or checks conducted by the Ministry of Health or the Department of Health) up to the date of the application for periodic assessment.

8. The procedures for assessment, the assessment process, and classification of assessment results for compliance with GDP shall be carried out in accordance with Articles 6 and 7 of this Circular.

Article 10. Handling Results of Periodic Assessments of Compliance with Good Distribution Practices for Medicinal Products and Medicinal Product Ingredients

1. In the case where the GDP assessment report concludes that the distribution facility complies with GDP at Level 1 as stipulated in Point a, Clause 2, Article 7 of this Circular:

Within ten days from the completion of the actual assessment at the distribution facility and signing of the assessment record, the Department of Health shall issue the Certificate of Compliance with GDP according to Form No. 06 attached as Appendix IV to this Circular.

2. In cases where the GDP assessment record concludes that the distribution facility complies with GDP at level 2 as stipulated in Point b, Clause 2 of Article 7 of this Circular.

a) Within five days from the completion of the actual assessment at the distribution facility and signing of the assessment record, the Department of Health shall issue a notice requesting the facility to take corrective actions and submit a report on these actions to the Department of Health;

b) Within forty-five days from the issuance of the notice by the Department of Health, the distribution facility must complete the corrective actions and submit a report accompanied by evidence (documents, files, images, videos, certificates) proving the completion of the corrective actions recorded in the assessment record;

c) Within twenty days from receiving the report on corrective actions and accompanying evidence (documents, files, images, videos, certificates) proving the completion of corrective actions, the Department of Health shall evaluate the results of the corrective actions taken by the distribution facility and conclude on the status of compliance with GDP as follows:

- If the corrective actions taken by the distribution facility meet the requirements: The Department of Health shall issue the Certificate of Compliance with GDP;

- If the corrective actions taken by the distribution facility do not meet the requirements: The Department of Health shall issue a notice specifying the further corrective actions needed and request a supplementary report. The extended period for completing the corrective actions and submitting the report is forty-five days from the date of the notice.

d) Within ninety days from the completion of the actual assessment, if the distribution facility does not submit a report on corrective actions or if the corrective actions completed according to Point c of this Clause still fail to meet the requirements, the Department of Health shall issue a notice stating non-compliance with GDP and implement one or more measures as provided in Points a and b of Clause 3 of this Article based on the nature and severity of the violation.

3. In the case where the GDP assessment report concludes that the distribution facility complies with GDP at Level 3 as stipulated in Point c, Clause 2, Article 7 of this Circular:

Within five days from the completion of the assessment at the distribution facility and signing of the assessment record, based on the evaluation of the risks associated with the quality of medicinal products and user safety, the Department of Health shall issue a notice stating non-compliance with GDP and implement one or more measures as follows:

a) Administrative penalties according to laws on administrative violations.

b) Revoke the Certificate of Eligibility for Drug Business Operations issued and the GDP Certificate (if any) in accordance with Article 40 of the Drug Law.

In cases where a distribution facility does not comply with one or several business scopes listed in the Certificate of Eligibility for Drug Business Operations issued, the Department of Health shall revoke the Certificate of Eligibility for Drug Business Operations to remove the non-compliant business scopes and revoke the GDP Certificate (if any) in accordance with Article 40 of the Drug Law, and issue a new Certificate of Eligibility for Drug Business Operations corresponding to the compliant business scopes of the distribution facility.

4. Within five days from the date the distribution facility is assessed to maintain compliance with GDP or from the date of issuance of the decision revoking the Business Registration Certificate for pharmaceutical business issued due to the distribution facility's failure to maintain compliance with GDP, the Department of Health shall update the status of maintaining compliance with GDP on the Department of Health’s electronic information website in accordance with the provisions stipulated in Clause 4, Article 8 of this Circular for the distribution facility that maintains compliance with GDP or provide information about the revocation of the Business Registration Certificate for pharmaceutical business and the GDP Certificate (if any) issued for the distribution facility that fails to maintain compliance with GDP.

Article 11. Change Control

1. During the period between periodic assessment cycles, the distribution facility must submit an application for issuance of the Business Registration Certificate for pharmaceutical business in accordance with the provisions stipulated at Point b, Clause 1, Article 36 of the Drug Law or submit a change report in Form No. 06 prescribed in Appendix IV attached to this Circular if it falls under any of the following circumstances:

a) Changing any of the circumstances stipulated at Point b, Clause 1, Article 36 of the Drug Law;

b) Changing the storage warehouse location within the same business premises;

c) Adding a new warehouse at a new location within the same business premises;

d) Expanding the storage warehouse based on the existing warehouse structure;

đ) Repairing, changing the structure, or rearranging the storage warehouse;

e) Changing auxiliary systems or altering the design principle and operation of utility systems that affect storage requirements and conditions.

2. In the case where the distribution facility changes according to the provisions stipulated at Point a, Clause 1 of this Article, the distribution facility must submit an application for issuance of the Business Registration Certificate for pharmaceutical business in accordance with the provisions stipulated in Clause 2 and Clause 4, Article 38 of the Drug Law or submit a dossier in accordance with the provisions stipulated in Clause 2, Article 5 of this Circular for non-commercial distribution facilities.

The procedures for assessing compliance with GDP, classifying results, and handling assessment results shall be carried out in accordance with the provisions stipulated in Articles 6, 7, and 8 of this Circular.

3. In the case where the distribution facility changes according to any of the circumstances stipulated at Points b and c, Clause 1 of this Article, the distribution facility must submit a change report along with corresponding technical documentation to the Department of Health.

a) The Department of Health shall conduct an on-site assessment at the distribution facility. If the distribution facility meets the requirements, the Department of Health shall issue a document agreeing with the changes made by the distribution facility;

b) The procedures for assessing, classifying results, and handling assessment results for the distribution facility that changes according to the provisions stipulated at Point b, Clause 1 of this Article shall be carried out in accordance with the provisions stipulated in Articles 6, 7, and 10 of this Circular;

c) The procedures for assessing, classifying results, and handling assessment results for the distribution facility that changes according to the provisions stipulated at Point c, Clause 1 of this Article shall be carried out in accordance with the provisions stipulated in Articles 6, 7, and 8 of this Circular.

4. In the case where the distribution facility changes according to any of the circumstances stipulated at Points d, đ, and e, Clause 1 of this Article, the distribution facility must submit a change report along with corresponding technical documentation to the Department of Health. The Department of Health shall assess the change report submitted by the distribution facility:

a) Within ten days from the date of receipt of the notification letter, the Department of Health shall issue a document agreeing with the content of the change if the change complies with the requirements;

b) Within ten days from the date of receipt of the notification letter, the Department of Health shall issue a notification letter regarding the content that needs to be rectified and repaired if the requirements are not met;

c) Within forty-five days from the date the Department of Health issues the notification letter, the distribution facility must complete the rectification and repair work and submit a notification letter accompanied by evidence (document files, images, videos, certificates) proving the completion of the rectification and repair work recorded in the notification letter;

d) Within ten days from the date of receipt of the rectification report accompanied by evidence (document files, images, videos, certificates) proving the completion of the rectification and repair work, the Department of Health shall evaluate the rectification results of the distribution facility and conclude on the compliance status with GDP of the distribution facility:

- In the case where the rectification has met the requirements: The Department of Health shall issue a notification letter agreeing with the content of the change;

- In the case where the rectification has not met the requirements: The Department of Health shall conduct an urgent assessment, handle the assessment results in accordance with the provisions stipulated in Article 12 of this Circular.

Article 12. Unscheduled assessment, inspection, and examination of compliance with Good Distribution Practices for medicinal products and active pharmaceutical ingredients

1. The work of inspecting and examining compliance with GDP of distribution establishments shall be carried out in accordance with the provisions of the law.

2. The Department of Health shall conduct unscheduled assessments of compliance with GDP of distribution establishments in any of the following cases:

a) The distribution establishment has not yet met the requirements as stipulated in point d, Clause 4, Article 11 of this Circular;

b) A distribution establishment that complies with GDP at level 2 must undergo at least one unscheduled assessment within three years from the end date of the previous assessment period;

c) There is information reflecting, recommending, or concluding through the inspection or examination results of competent authorities that there are serious violations of GDP principles and standards.

3. The members of the Assessment Team shall be determined by the Director of the Department of Health based on the scope and purpose of the assessment.

4. The procedures for conducting unscheduled assessments and handling the results thereof at distribution establishments shall be carried out in accordance with the provisions of Articles 7 and 10 of this Circular.

Chapter V

ASSESSMENT TEAM FOR COMPLIANCE WITH GOOD DISTRIBUTION PRACTICES FOR MEDICINAL PRODUCTS AND ACTIVE PHARMACEUTICAL INGREDIENTS

Article 13. Composition and criteria for team members

1. Composition of the assessment team:

The team leader, secretary, and other members shall be decided by the Director of the Department of Health. The number of team members shall not exceed five people.

2. Staff of the assessment team must meet the following criteria:

a) They are civil servants or employees under the Department of Health or civil servants, employees, or contractual staff under units directly subordinate to the Department of Health;

b) They have a bachelor's degree or higher in pharmacy or medicine;

c) They have been trained and instructed in GPP, inspection, and assessment of GPP and are well-versed in GPP principles and standards;

d) They are honest, impartial, and strictly comply with regulations and laws during the assessment process without having conflicts of interest with the assessed distribution establishment as stipulated in Clause 3 of this Article;

đ) The team leader must have a bachelor's degree in pharmacy or higher and have at least two years of experience in pharmaceutical management work.

3. Conflict of interest evaluation principle: Members of the assessment team shall be considered to have a conflict of interest with the assessed distribution establishment if they fall into any of the following situations:

a) They have worked for the assessed distribution establishment in the last five years;

b) They have participated in advisory activities for the assessed distribution establishment in the last five years;

c) They currently have financial interests with the assessed distribution establishment;

d) Their spouse, children, parents, full siblings, parents-in-law, or parents of their spouse are working for the assessed distribution establishment.

Article 14. Responsibilities and powers of the assessment team

1. Responsibilities of the assessment team

a) Assess all activities of the distribution establishment according to the corresponding GDP principles and standards specified in Article 3 of this Circular, updated GDP principles and standards, and current relevant professional regulations; record specific contents of the assessment, identified issues, and prepare an assessment report;

b) Report the assessment results or explain the GDP assessment result report when the distribution establishment disagrees with the content of the GDP assessment report;

c) Maintain confidentiality of all information related to the assessment period and all information related to the distribution establishment’s medicinal product distribution activities, except where the distribution establishment consents or upon request by authorized state agencies for inspection, examination, or investigation purposes;

2. Authorities of the Inspection Team:

a) Inspect all areas, storage facilities, equipment of the distribution establishment, and have the right to request inspections of other related areas concerning the distribution and storage of medicinal products and active pharmaceutical ingredients;

b) Request the provision of business-related documents, quality management, and storage records of medicinal products and active pharmaceutical ingredients of the distribution establishment;

c) Collect evidence (photocopies of documents, photographs, videos) proving issues discovered during the assessment;

d) Take samples of medicinal products and active pharmaceutical ingredients for quality testing in accordance with the law;

đ) Prepare a report and require the distribution establishment to temporarily suspend part or all of its distribution activities if during the assessment it is found that the establishment has committed serious violations affecting the quality of one or more medicinal products or active pharmaceutical ingredients, and report to the authority with the power to issue formal decisions.

Chapter VI

IMPLEMENTING PROVISIONS

2

Article 15. Effective Date

1. This Circular takes effect from March 26, 2018.

2. Circular No. 48/2011/TT-BYT dated December 21, 2011, issued by the Minister of Health on Good Distribution Practices for medicinal products, ceases to be effective from the date this Circular takes effect.

Article 16. Reference Provisions

In case the regulatory legal documents and provisions cited in this Circular are amended, supplemented, or replaced, they shall be implemented according to the new regulatory legal documents.

Article 17. Transitional Provisions

1. For business establishments that have been granted a Business Registration Certificate for wholesale trade in medicinal products and active pharmaceutical ingredients or a GDP Certificate with an expiration date still valid before this Circular takes effect, the distribution establishment may continue to distribute medicinal products and active pharmaceutical ingredients until the expiration date stated on the certificate.

In case the Business Registration Certificate expires, the distribution establishment must proceed with the application for issuance of a new Business Registration Certificate in accordance with Decree No. 54/2017/NĐ-CP and undergo an assessment of compliance with GDP in accordance with Chapter III of this Circular.

In case the GDP Certificate expires earlier, the distribution establishment must proceed with the application for an assessment of continued compliance with GDP in accordance with Chapter IV of this Circular to continue operations until the expiration date stated on the Business Registration Certificate.

2. For business establishments that have been granted a Business Registration Certificate for wholesale trade in medicinal products and active pharmaceutical ingredients without an expiration date, when the GDP Certificate expires, the distribution establishment must proceed with the registration for an assessment of continued compliance with GDP in accordance with Chapter IV of this Circular.

3. For applications for a Drug Business Condition Certificate or registration for periodic GDP compliance assessment submitted to the Department of Health before this Circular takes effect, the Department of Health shall evaluate the facility according to the GDP standards issued together with Circular No. 48/2011/TT-BYT dated December 21, 2011, issued by the Minister of Health on Good Distribution Practices principles for drug distribution, or this Circular.

Article 18. Responsibility for Implementation

1. The Drug Administration Department shall be responsible for:

a) Take the lead and coordinate with relevant units to disseminate this Circular;

b) Serve as the focal point and coordinate with relevant units to guide and implement this Circular for the Departments of Health, health sectors, and distribution facilities within their assigned functions and tasks;

c) Compile and publish on the website of the Drug Administration of Vietnam a list of national distribution facilities that have been granted a Drug Business Condition Certificate or a GDP Certificate; update the status of the Drug Business Condition Certificate, GDP Certificate, GDP compliance status, and other information as stipulated in Clause 4, Article 8 of this Circular, within the scope of their assigned functions and tasks;

d) Publish updated GDP documentation on the Ministry of Health's electronic information portal and the website of the Drug Administration of Vietnam;

đ) Serve as the focal point or coordinate with the Ministry's Inspectorate to conduct inspections and audits of compliance with this Circular's regulations and handle violations within their authority;

2. The Traditional Medicine Management Department shall be responsible for:

a) Serve as the focal point and coordinate with relevant units to guide and implement this Circular for the Departments of Health, health sectors, and traditional medicine and herbal distribution facilities within their assigned functions and tasks;

b) Compile and publish on the website of the Traditional Medicine and Pharmaceutical Administration a list of national distribution facilities that have been granted a Drug Business Condition Certificate; update the status of the Drug Business Condition Certificate, GDP compliance status, and other information as stipulated in Clause 4, Article 8 of this Circular, within the scope of their assigned functions and tasks;

c) Conduct inspections and handle violations within their authority;

3. Provincial Health Departments are responsible for:

a) Coordinate with relevant units to organize the dissemination of this Circular and guide its implementation for units within their jurisdiction;

b) Receive applications for a Drug Business Condition Certificate or for GDP compliance assessment, conduct GDP compliance assessments, issue Drug Business Condition Certificates and GDP Certificates to distribution facilities within their jurisdiction;

c) Publish on the Department of Health's website a list of distribution facilities that have been granted a Drug Business Condition Certificate, their GDP compliance status, and other information as stipulated in Clause 4, Article 8 of this Circular, within the scope of their assigned functions and tasks;

d) Inspect and audit the compliance of distribution facilities within their jurisdiction; handle violations within their authority;

đ)3 Report online monthly on the Drug Administration of Vietnam's website a list of distribution facilities within their jurisdiction that have been granted a Drug Business Condition Certificate and their GDP compliance status as specified in Clause 4, Article 8 of this Circular;

4. Distribution facilities are responsible for:

a) Organizing the implementation and research of legal provisions on pharmaceuticals and the standards set forth in this Circular;

b) Ensuring continuous compliance with GDP standards throughout the operation of the distribution facility;

c) Conducting drug and medicinal ingredient distribution activities strictly within the permitted scope based on compliance with legal regulations;

During implementation, if difficulties arise, individuals and organizations are advised to report them to the Ministry of Health for review and resolution;

Place of Receipt: - Office of the Government (Official Gazette, Government Electronic Information Portal); - Minister (for signature); - Ministry of Health Electronic Portal; - To be filed: VT, QLD, PC;

CERTIFIED CONSOLIDATED DOCUMENT DEPUTY MINISTER DEPUTY MINISTER Trương Quốc Cường

ANNEX I

GOOD DISTRIBUTION PRACTICES FOR DRUGS

(Issued together with Circular No. 03/2018/TT-BYT dated February 9, 2018, by the Minister of Health);

1. General Introduction

2. Scope of Guidance

3. Terminology Explanation

4. General Principles

5. Provisions on Drug Distribution

6. Organization and Management

7. Personnel

8. Quality System

9. Premises, Warehouses, and Storage

10. Transportation Equipment and Facilities

11. Packaging and Labeling

12. Shipping and Receipt

13. Transportation and Drugs in Transit

14. Records and Documentation

15. Repackaging and Relabeling

16. Complaints

17. Product Recall

18. Returned Products

19. Counterfeit Drugs

20. Contract Activities

21. Self-Inspection

1. General Introduction

Distribution is a critical activity in the management of the drug supply chain. Generally, many individuals and entities participate in various stages of product storage and distribution. The aim of this guidance is to support the assurance of drug quality and identity throughout all stages of the distribution process. These stages include, but are not limited to, purchasing, storage, distribution, transportation, repackaging, relabeling, recordkeeping, and documentation.

This guidance provides appropriate steps to assist in fulfilling responsibilities related to different stages of the distribution process within the supply chain and prevent counterfeit drugs from entering the market through the supply chain. Each individual involved in the system must consider the relevant sections according to their specific role in the drug distribution process. In cases where production activities such as repackaging and relabeling are carried out within the distribution chain, GMP principles need to be applied to these activities.

Fake drugs constitute a real threat to public health and safety. Therefore, it is essential to protect the supply chain from the intrusion of such products. Weak links in the drug distribution process serve as gateways for fake drugs, smuggled drugs, stolen drugs, and substandard drugs to enter the supply chain. This is a concern in both developed and developing countries. The methods of entering the supply chain of these products are increasingly complex and sophisticated, leading to the emergence of secondary markets and opaque markets worldwide. The involvement of unlicensed entities in the drug distribution and business process is a particular concern. The only common approach that leads to success in the fight against fake drugs is the participation of all parties in the supply chain, and thus all parties involved in the market must actively cooperate with each other during their operations.

This guidance applies to all individuals and facilities participating in any stage of the drug distribution process from the product manufacturing facility to the entity dispensing or directly supplying the drug to the patient or the patient's representative. These entities include all parties involved in the drug business and distribution processes, drug manufacturing facilities, including finished drug manufacturing facilities, wholesale drug facilities, as well as other parties such as intermediary facilities, supply facilities, distribution facilities, logistics service facilities, trading enterprises, transportation businesses, and receiving and dispatching facilities, along with the workforce of these facilities.

To maintain the initial quality of drugs, each party involved in the distribution chain must comply with current regulations and guidelines. All activities in the drug distribution process must be carried out according to current Good Manufacturing Practices (GMP), Good Storage Practices (GSP), and Good Distribution Practices (GDP).

2. Scope of the guidance document

This document sets out requirements for drug distribution, including prescription drugs, over-the-counter drugs, vaccines, and biological products.

Principles for the distribution of drug ingredients (active pharmaceutical ingredients (APIs) and excipients) are not covered in this document. These contents are included in Good Business and Distribution Practices Guidance for Drug Ingredients in Appendix II of this Circular.

3. Terminology Explanation

Lot: Is the quantity of drugs supplied in a single shipment according to a specific order. A shipment may consist of one or more cases or boxes and may contain drugs from one or more batches.

Contamination: Is the unwanted appearance of chemical or microbial impurities or foreign substances in or on a raw material, intermediate product, or drug during processing, production, sampling, packaging, re-packaging, storage, or transportation.

Cross-contamination: Is the contamination of a raw material, intermediate product, or finished product due to another raw material or product during production, storage, and transportation.

Expire First/Use First (FEFO): Is a distribution process aimed at ensuring that stored products with the earliest expiration date are distributed and/or used first, while products with later expiration dates are distributed and/or used later.

Intermediate Product: Is a product that has been partially processed and needs to undergo further production stages before becoming a semi-finished product.

Product record: Is a complete record that helps trace ownership and transactions related to a specific drug when the product is distributed through the supply chain.

Product recall: Is the process of withdrawing or removing a drug from the supply chain due to product defects, serious adverse reaction complaints about the product, and/or because the product is fake or potentially fake. Product recalls can be initiated by the manufacturing facility, the importing facility, the wholesaler, the distributor, or a responsible entity.

Quality assurance: Is a broad concept encompassing all issues that may individually or cumulatively affect the quality of a product. It is a comprehensive set of arrangements designed to ensure that a drug meets the required standards for its intended use.

Quality system: Is an appropriate foundation system, including organizational structure, procedures, processes, resources, and systematic activities necessary to ensure confidence that a product (or service) will meet specified quality requirements.

Quarantine: Is the physical isolation or effective isolation of drugs pending a decision regarding release, rejection, or reprocessing.

Sampling: Are activities designed to obtain a representative portion of a drug through an appropriate statistical procedure for a specific purpose, such as approving shipments or releasing batches.

Shelf life: Is the period during which a drug, if properly stored, will meet established quality criteria determined by stability studies on a number of batches. The shelf life is used to determine the expiry date of each batch.

Standard Operating Procedure (SOP): Is a documented approved procedure providing instructions for performing activities that are not necessarily related to a specific product but are general (such as equipment operation procedures, maintenance and cleaning, validation, plant sanitation, environmental control, sampling, and inspection).

Storage: Is the storage of drugs in a warehouse until use.

Transportation: Is the phase during which drugs are in transit, moving through or via a route to reach the final destination point.

Means of transportation: Is a truck, pick-up truck, bus, mini-bus, car, trailer, aircraft, freight train, ship, and other means of transport used to carry drugs.

4. General Principles

4.1. All parties involved in the drug distribution process have the responsibility to ensure the maintenance of drug quality and the integrity of the distribution chain throughout the distribution process from the manufacturing facility to the entity or individual responsible for dispensing or supplying the product to the patient or the patient's representative.

4.2. The GDP principles are considered to be minimum standards for pharmaceutical distribution facilities.

4.3. The GDP principles apply to both forward-moving products within the distribution chain from the manufacturer to the dispensing or supplying entity responsible for providing the product to patients, and reverse-moving products within the chain, such as recalled or returned products.

4.4. The GDP principles must also be applied and adhered to for donated medicines.

4.5. All parties involved in the distribution process must strictly and fully apply the GDP principles, for example, in processes related to tracing the origin of the product and identifying risks to safety issues.

4.6. All parties, including the government, customs authorities, law enforcement agencies, regulatory bodies, manufacturing facilities, distribution facilities, and entities responsible for supplying medicines to patients, must cooperate with each other to ensure the quality and safety of the product and prevent patients from using counterfeit drugs or drugs not permitted for circulation.

5. Provisions on Drug Distribution

5.1. A facility may only carry out pharmaceutical distribution activities within the scope of business as prescribed by law.

5.2. The distribution facility must be a licensed facility under the law to perform the functions it intends to undertake and must be responsible for all activities related to pharmaceutical distribution that it conducts.

5.3. Distribution facilities may only distribute medicines that have a marketing authorization or import permit.

5.4. Pharmaceutical distribution facilities may only purchase medicines from facilities that have a production, wholesale, or supply license.

5.5. Distribution facilities may only supply medicines to other distribution facilities or healthcare facilities, retail outlets.

5.6. When necessary, certain activities may be delegated to organizations or individuals who have been granted appropriate licenses in accordance with the law. The delegated activities and contracts must be clearly recorded in the agreement or contract. The party receiving the delegation must comply with the GDP regulations relevant to the activity performed and must be periodically evaluated and monitored by the distribution facility to ensure compliance with the GDP principles.

6. Organization and Management

6.1. The distribution facility must establish an appropriate organizational structure illustrated by an organizational chart. Responsibilities, authorities, and relationships between employees must be clearly defined.

6.2. The duties and responsibilities of individuals must be clearly defined, documented in writing as job descriptions, and understood by the relevant individuals. Employees responsible for storing, distributing, and transporting special management medicines must have the qualifications and capabilities required by relevant regulations. All employees involved in the pharmaceutical distribution chain must be adequately informed, trained, and understand their responsibilities and tasks.

6.3. A person with specific authority and responsibility must be appointed to implement, oversee, and ensure the application and maintenance of the quality system.

6.4. Management and technical staff must have the authority and resources necessary to enable them to perform their duties, build and maintain the quality system, and identify and correct deviations from the applied quality system.

6.5. No individual should be given too broad a responsibility to prevent any potential risk to product quality.

6.6. Arrangements must be made to ensure that management and personnel are not dependent on commercial, political, financial, or other pressures or conflicts of interest that could adversely affect the quality of services provided or the integrity of the medicine.

6.7. There must be provisions and procedures regarding employee safety, asset protection, environmental protection, and product integrity.

7. Personnel

7.1. All employees involved in pharmaceutical distribution activities must have the appropriate professional qualifications for the type of medicine being distributed, be trained in the requirements of "Good Distribution Practices" and relevant laws, and be capable of meeting these requirements.

Employees must undergo initial and ongoing training appropriate to their assigned tasks according to a written training program. Training content must include topics on product safety as well as aspects of product identification, counterfeit product detection, and prevention of counterfeit products entering the distribution chain. Records of all training sessions and workshops must be kept, including details of the training topics and participants.

7.2. Key employees involved in the storage and distribution of medicines must have the necessary capability and experience to ensure that medicines are stored and distributed properly.

7.3. Adequate personnel with the necessary capability must be assigned to all stages of the pharmaceutical distribution process to maintain product quality.

7.4. Relevant laws concerning the qualifications and capabilities of employees involved in pharmaceutical distribution and storage activities must be followed.

- Warehouse managers for pharmaceuticals must have a degree in pharmacy at the intermediate level or higher. For traditional medicine distribution facilities, warehouse managers must have a degree in traditional Chinese medicine at the intermediate level or higher, or be a licensed traditional doctor or pharmacist. For distribution facilities requiring special management (narcotic drugs, psychotropic drugs, precursor chemicals used in drugs, radioactive drugs), warehouse managers must meet the requirements set forth in relevant regulations. Quality control and inspection staff must have a bachelor's degree in pharmacy.

- For vaccine and medical product distribution facilities, warehouse managers must have a degree in medicine or pharmacy at the intermediate level or higher; transportation staff must have a degree in pharmacy at the intermediate level or higher; and dispensing staff must have a degree in medicine or pharmacy at the primary level or higher.

7.5. Employees participating in activities related to receiving, storing, packaging/repackaging hazardous drugs (such as high-activity raw materials, radioactive raw materials, addictive substances, dangerous drugs, sensitive drugs, and/or environmentally harmful drugs, as well as products with a special risk of abuse, causing fire or explosion) must undergo special training.

Employees must ensure their health and be subject to regular health check-ups. Employees suffering from infectious diseases must be isolated from drug storage and transportation areas. Emergency procedures and equipment must be established to handle accidents that may affect employee safety.

7.6. Employees involved in drug distribution must wear protective clothing or uniforms appropriate for the tasks they perform. Employees handling dangerous drugs (such as highly active, toxic, easily infectious, or allergenic products) must be provided with necessary protective attire.

7.7. Personal hygiene procedures for employees must be developed and implemented in accordance with the activities carried out. These procedures must address issues related to employee health, hygiene, and attire.

7.8. Recruitment processes and conditions, including those applicable to contractual or temporary staff and other personnel who may have access to drugs, must be established to control the risk of drug products falling into the hands of unauthorized individuals or organizations.

7.9. Regulations and procedures for dealing with and punishing situations where individuals involved in drug distribution are suspected or found to be involved in any actions related to embezzlement, infringement, distortion, or falsification of any product must be established.

8. Quality System

8.1. Within an organization, ensuring quality is a management tool. The distribution facility must have a documented quality policy describing the objectives and general policies of the distributor regarding quality issues, which must be officially approved and published by the facility's leadership.

8.2 The quality system must include organizational structure, processes, resources, and synchronized actions necessary to reliably ensure that products or services and system documentation meet established quality requirements. All these actions are described as the quality system.

8.3 The quality system must include provisions to ensure that the registration/licensing entity, the entity named on the label (manufacturer, importer, distributor), relevant pharmaceutical/health authorities, and competent authorities are immediately notified in case a drug is confirmed or suspected to be counterfeit. Such products must be stored in secure areas, isolated, and clearly identified to prevent further distribution or sale.

8.4 When e-commerce is applied in drug business operations, the distribution facility must establish appropriate procedures and systems to ensure traceability and verification of drug quality. Only authorized organizations or individuals may conduct electronic transactions (including those conducted through the Internet) related to drug distribution.

8.5 Approved purchasing, supply, and inventory withdrawal procedures must be in place to ensure that drugs are purchased from legally evaluated and approved suppliers and distributed to facilities and legal entities licensed to operate under pharmaceutical laws.

8.6 Encouragement should be given to external agencies to inspect, audit, and certify compliance with quality systems (such as ISO standards or national/international guidelines). However, such certification cannot replace adherence to GDP-related guidelines.

8.7 If measures to ensure the integrity of drugs during transportation are implemented, these measures must be strictly managed. For example, if sealing control programs are applied to shipments, seal numbers must be recorded sequentially and trackable, the integrity of the seals must be monitored, and seal numbers must be verified during transportation and upon receipt. Written procedures must be in place for application in situations where counterfeit drugs or suspected counterfeits are discovered.

8.8 The distribution facility must regularly conduct potential risk assessments for drug quality and integrity. The quality system must be established and implemented to address any identified potential risks. Regular reviews and adjustments of the quality system must be conducted to help resolve newly identified risks through risk assessment.

Traceability of drug origin

8.9 Regulations must be established and applied to set up and ensure a safe, transparent, and secure distribution system, including the ability to trace products throughout the entire supply chain. This is a shared responsibility of all supply chain participants. Procedures must be in place to ensure the traceability of received and distributed product records to facilitate product recalls.

8.10 All supply chain participants must be identified and recognized, depending on the type of product and legal requirements.

8.11 Measures must be taken to ensure that drugs have accompanying records allowing traceability of origin throughout the entire distribution channel from the manufacturing/importing facility to the distribution facility or the supplying/distributing facility providing the product to patients or patient representatives (see 14.2). Records of expiration dates and batch numbers are part of the distribution record, aiding in product traceability.

The minimum information required in the accompanying records of each batch of the distribution facility to ensure traceability of origin includes:

- Receiving: Name, address, delivery facility, manufacturing facility, contact person of the delivery facility, receiving time, quantity received;

- Exporting goods: List of names, addresses, contact persons for receiving entities, export time, quantity exported, remaining stock.

8.12. If possible, and in the best case scenario, the entity should establish and maintain a product record system that allows tracking the entire process from production to distribution and issuance to users.

There must be regulations and guidelines for visually identifying and/or analyzing products that may be counterfeit. The handling procedure when a suspected product is discovered must include provisions regarding reporting and informing the registration entity/license holder, the manufacturing/importing/distributing entity named on the label, the drug/health authority, and other relevant authorities (refer to Section 19).

8.13. If appropriate, the entity should develop a product identification and coding system consistent with international practices, in collaboration with supply chain participants.

9. Premises, Warehouses, and Storage

9.1. Good Storage Practices (GSP) principles are applied in all circumstances where drugs are stored and throughout the distribution process. For additional guidance related to general storage principles, refer to the World Health Organization's Good Storage Practices Guide. WHO's Good Storage Practices Guide.

Storage Area:

9.2. Measures must be taken to prevent unauthorized individuals from entering the storage area. Employees must comply with the entity's policies to maintain a safe, secure, and efficient working environment.

9.3. The drug storage area must have sufficient space to store different groups of drugs in an orderly manner, including commercial and non-commercial products, products requiring special storage, rejected, returned, or recalled products, and suspected counterfeit products. The minimum floor area of the storage area must be 30m² with a volume of 100m³. In the case of wholesale herbal medicine warehouses, the total minimum storage area must be 200m² with a minimum volume of 600m³.² with a volume of 100m³. In the case of wholesale premises for traditional herbal medicines, the storage area must have a minimum total floor area of 200m²and a minimum capacity of 600 m³.

9.4. The storage area must be designed or adjusted to ensure the required storage conditions. Particularly, this area must be clean and dry and maintained at an acceptable temperature. Medicines must be stored at a height above the floor level and in a space that allows for cleaning and inspection. Shelves and racks must be kept clean and maintained.

9.4. The storage area must be designed or adjusted to ensure the required storage conditions. Specifically, it must be clean and dry and maintained at an acceptable temperature. Drugs must be stored above the floor level and have adequate space for cleaning and inspection. Shelves and racks must be kept clean and maintained.

9.5. The storage area must be clean, free of debris and pests. The distribution entity must ensure that the warehouse and storage areas are regularly cleaned. A written program must be established to control pest species. Any measures, insecticides, or other pest control substances must be safe and not pose a risk of contamination to drugs. Suitable cleaning procedures must be implemented to remove any spills to ensure complete removal of contamination risks.

9.6. If sampling is conducted in the storage area, it must be done in a way that prevents cross-contamination. Adequate cleaning procedures for the sampling area must be in place.

9.7. Receiving and dispatch areas must be arranged to protect products from direct weather effects. Receiving areas must be designed and equipped so that incoming shipments can be cleaned before storage if necessary.

9.8. If there is a dedicated area for isolating products, this area must have clear signage and only authorized personnel may enter. Any alternative isolation measures must provide equivalent safety levels. For example, an electronic management system could be used if it has been assessed to ensure security.

9.9. Mechanical isolation or corresponding isolation measures, such as an electronic management system, must be implemented to store removed, expired, recalled, or suspected counterfeit products. Products and related areas must be properly identified.

9.10. Unless a suitable alternative system is in place to prevent the inadvertent or unauthorized use of isolated, segregated, removed, returned, recalled, or suspected counterfeit products, separate areas must be designated for temporary storage of these products until a decision is made on their disposal.

Toxic drugs, toxic raw materials for drugs, and drugs and pharmaceutical ingredients listed in the prohibited substance catalog for certain industries must be stored separately, not mixed with other drugs, neatly arranged to avoid confusion and easy observation, and packaged securely to prevent leakage during transportation.

9.12. Drugs must be handled and stored in a way that prevents contamination, mixing, and cross-contamination.

9.13. A system must be in place to ensure that expired drugs are sold and/or distributed first (First Expired, First Out (FEFO)). Exceptions may be allowed under certain conditions, provided that full control measures are in place to prevent the distribution of expired products.

9.14. Damaged or defective products must be separated and stored separately.

9.15. The storage area must be adequately lit to allow all activities to be performed accurately and safely.

Storage Conditions and Product Control:

9.16. Storage and handling conditions for products must comply with current legal and entity regulations.

9.17. Drug storage conditions must meet the manufacturer's requirements.

9.18. There must be available means to store all medicines under appropriate conditions (e.g., environmentally controlled when necessary). These storage conditions must be recorded and documented if they are important conditions for maintaining the characteristics of the stored medicines.

9.19. Registers recording temperature monitoring data must be available for review. Temperature checks must be carried out at specified times/periods. Monitoring equipment must be checked at predetermined intervals and the results recorded and retained. All monitoring records must be kept for at least until the end of the shelf life of the stored medicine plus one additional year or as prescribed by law. The temperature uniformity assessment results must show consistent temperature throughout the entire storage area. Temperature monitoring devices must be placed in areas/positions with the greatest potential variation based on the results of the temperature uniformity assessment in the warehouse; there must be at least one self-recording temperature monitoring device with an appropriate recording frequency (usually once or twice per hour depending on the season).

For medicines and raw materials for medicines that require special storage conditions (e.g., vaccines, medical biological products), continuous monitoring equipment (e.g., temperature) must be used during storage and transportation. The use of monitoring equipment and recorded data must be documented.

9.20. Equipment used for monitoring storage conditions must be calibrated at specified frequencies.

9.21. Periodic inventory counts comparing stock medicines with record books must be conducted.

9.22. All discrepancies found during inventory counts must be investigated according to a defined procedure to check for accidental errors, incorrect issuance or receipt, theft, and/or misappropriation of medicines. Records of these investigations must be retained for a certain period.

10. Means of transport and equipment

10.1. All means of transport and equipment used in the activities of storing, distributing, or handling medicines must be suitable for their intended purpose and must protect medicines from conditions that could adversely affect the integrity of packaging, stability of the medicine, and prevent contamination or pollution in any form.

10.2. The design and use of means of transport and equipment must ensure the reduction of error risks and allow effective cleaning and/or maintenance to avoid cross-contamination, accumulation of dirt and/or any harmful effects on the quality of distributed and transported medicines. Cleaning of transport means must be performed appropriately, inspected, and fully documented.

10.3. If feasible, global positioning system (GPS) devices and engine cut-off switches should be considered for installation on transport means to enhance security for medicines while in transit.

10.4. Specialized means of transport and storage equipment should be used for transporting medicines. When specialized means of transport and equipment are not available, appropriate procedures must be in place to ensure that the quality of medicines is not affected during transportation.

10.5. Transport means, transport equipment, and containers must be selected and evaluated appropriately to ensure that medicines and raw materials for medicines are stored under required conditions during transportation.

N.6. Procedures must be in place to ensure the integrity of the product is not compromised during transportation.

10.7. In cases where third-party transportation services are used, the distribution facility must have written agreements/contracts with the transportation service provider to ensure appropriate measures are taken to protect the product, including maintaining appropriate registers and records. These agreements must comply with legal regulations.

10.8. Damaged transport means and equipment must not be used. Such means and equipment must be labeled as damaged or removed.

10.9. Operating and maintenance procedures must be established for all transport means and equipment involved in the distribution process, including cleaning and safety warning procedures.

10.10. Transport means, containers, and storage equipment must always be kept clean, dry, and free from accumulated dirt. The distribution facility must ensure that transport means used are regularly cleaned.

10.11. Transport means, containers, and storage equipment must be kept away from rodents, insects, birds, and other pests. Written programs and registers for pest control must be maintained. Cleaning and fumigation substances must not adversely affect product quality.

10.12. Equipment selected and used for cleaning transport means must not become a source of contamination. Cleaning substances for transport means must be approved by the facility manager before use.

10.13. Particular attention must be paid to the design, use, cleaning, and maintenance of equipment used to handle medicines not protected by cardboard boxes or transport packaging.

10.14. During transportation, if medicines require special storage conditions (such as temperature and/or relative humidity) different or stricter than those expected in the surrounding environment, such conditions must be provided, monitored, supervised, and recorded. All monitoring records must be retained for at least until the end of the shelf life of the distributed product plus one additional year or as prescribed by law. Monitoring data registers must be available for inspection and verification by regulatory authorities or other competent bodies.

10.15. Equipment used to monitor storage conditions such as temperature and humidity on transport vehicles and containers must be regularly calibrated.

10.16. Transport vehicles and containers must be sufficiently large to allow for orderly arrangement and storage of different product groups during transportation.

10.17. During transportation, measures must be taken to isolate discarded, recalled, or returned drugs as well as suspected counterfeit products. These products must be carefully packaged, clearly labeled, and have appropriate tracking records.

10.18. Measures must be in place to prevent unauthorized persons from entering and/or searching through transport vehicles and/or storage equipment; as well as to prevent the theft or misappropriation of drugs.

11. Packaging and Labeling

11.1. Drugs must be stored and distributed in transport packaging that does not adversely affect product quality and has sufficient capability to protect the product from external influences, including contamination.

11.2. Transport packaging must bear labels with full information about transport and storage conditions and related warnings to ensure that the product is transported correctly and safely throughout the entire transport period. The packaging must allow identification of the contents and origin of the goods inside.

11.3. In cases where there are special requirements for transport and/or storage conditions, these conditions must be recorded on the transport packaging label. If a product is intended to be transported and delivered to an area outside the manufacturer's product management system control, the transport packaging label must clearly state the name and address of the manufacturer, special transport conditions, and any specific legal requirements, including safety markings.

11.4. Generally, only internationally or nationally accepted abbreviations, names, or codes should be used in transactions.

11.5. Special care must be taken when using dry ice in transport packaging. In addition to safety issues, it must be ensured that the product does not come into contact with dry ice, as dry ice can negatively impact product quality.

11.6. Written procedures must be established for handling damaged and/or broken transport packaging. Particular attention must be paid to transport packaging containing hazardous products.

12. Delivery and receipt

12.1. Drugs may only be sold and/or distributed to entities or individuals legally engaged in pharmaceutical activities and permitted to purchase those products under the law. Documentation proving the legality of such entities or individuals must be provided before shipment.

12.2. Prior to delivery/shipping, the drug distributor must ensure that the individual or organization transporting the goods, including the contracted carrier, is aware of the drugs being transported and complies with appropriate storage and transport conditions.

12.3. Delivery/shipping and transportation of drugs may only proceed after receiving an effective delivery order or supplementary supply plan, which must be fully documented.

12.4. Written procedures for delivery/shipping must be established. These procedures must take into account the nature of the product as well as any special warnings that need attention. Drugs in quarantine must be released from storage only upon authorization by the person responsible for quality (refer to Article 6.3).

12.5. A record of the drugs delivered/shipped must be prepared, which must at least include the following information:

- Date, month, year of shipment;

- Full name and address (no abbreviations), type of business entity responsible for transportation, telephone number, and name of the contact person;

- Full name and address (no abbreviations) and status of the recipient entity/person (e.g., retail pharmacy, hospital, community health center);

- Description of the products, including name, dosage form, and concentration (if applicable);

- Quantity of products, i.e., number of cartons and quantity of products in each carton (if applicable);

- Applied transport and storage conditions;

- Order number allowing identification of the delivery order; and

- Batch number and expiration date (if not available at the time of delivery/shipping, this information must at least be kept at the receiving entity to facilitate traceability).

12.6. Delivery/shipping records must contain sufficient information to ensure traceability of the drugs. These records must facilitate the recall of any batch of products if necessary, as well as the investigation of counterfeit drugs or drugs that may be counterfeit.

12.7. Additionally, the batch number and expiration date of the drugs must be recorded at the time of receipt to facilitate traceability.

12.8. Transportation methods, including the transport vehicles used, must be carefully selected, taking into account local conditions, climate, and known seasonal changes. For drugs requiring temperature control, delivery must be carried out in accordance with required storage and transport conditions.

12.9. Delivery plans and routes must be developed, taking into account local needs and conditions. Delivery plans and routes must be feasible and systematic. Safety risks must also be considered when developing delivery plans and routes.

12.10. It is necessary to ensure that the ordered quantity of products does not exceed the storage capacity of the receiving entity.

12.11. Loading into shipping containers and transport vehicles must be done carefully and systematically according to the first-in-first-out principle to save unloading time, avoid damage to goods, and reduce security risks. Additional measures must be taken during loading and unloading of cardboard boxes to ensure they are not damaged.

12.12. Drugs that have expired or are nearing their expiration date to the point where the product will expire before use must not be supplied or received.

12.13. Upon arrival, shipments must be inspected to verify the integrity of the shipping container/sealed packaging system to ensure tamper-evident seals are intact.

13. Transportation and Drugs in Transit

13.1. Medicines and transport packaging must be protected to prevent unauthorized access or provide evidence of such access. Transport vehicles and their operators must be secured to prevent theft and other embezzlement during transportation.

13.2. The transportation process of medicines must be safeguarded and must include appropriate record-keeping to facilitate identification and verification of compliance with management requirements. All personnel involved in the transportation process must adhere to transportation policies and procedures to ensure product safety.

13.3. The person responsible for transporting medicines must be informed of all conditions related to the storage and transportation of medicines. These requirements must be followed throughout the transportation process and during any intermediate storage phases.

13.4. Medicines must be stored and transported according to procedures to ensure that:

- Product identification information is not lost;

- The product does not cause contamination and is not contaminated by other products;

- Preventive measures are taken to avoid spillage, breakage, embezzlement, or theft of medicines;

- Suitable temperature and humidity conditions are maintained throughout transportation and storage, for example, using cold chain systems for temperature-sensitive medicines.

13.5. Storage conditions specified for medicines must be maintained within permissible limits throughout transportation. If the entity or individual responsible for transportation discovers any deviation during transportation, they must notify the distributor and receiving location. In case the receiving location discovers any deviation, it must notify the distributor. When necessary, contact with the manufacturer must be made to obtain relevant information on subsequent appropriate actions.

13.6. During transportation, if medicines require special storage conditions (such as temperature and/or relative humidity) different from or stricter than those expected in the surrounding environment, these conditions must be indicated on the label by the manufacturer, monitored, and recorded.

13.7. Written procedures must be established to investigate and address non-compliance with storage requirements, such as temperature deviations.

13.8. When transporting and storing medicines containing hazardous substances such as poisons, radioactive materials, and other dangerous medicines that pose a particular risk of abuse, fire, or explosion (such as flammable liquids, solids, and compressed gases), these medicines must be stored in safe, separate, and secure areas; and transported in safe, secure packaging and vehicles designed appropriately and securely. Additionally, relevant laws and international treaties must be complied with.

13.9. Medicines containing addictive substances and other dependency-inducing substances (psychotropic substances, precursors) must be transported in safe, secure packaging and vehicles; and stored in safe, secure areas. Additionally, relevant laws and international treaties must be complied with.

13.10. Spilled medicines must be cleaned up as quickly as possible to prevent cross-contamination and other risks. Written procedures must be established to handle such incidents.

13.11. Mechanical isolation measures or equivalent measures (such as electronic means) must be implemented to store and isolate recalled, expired, suspected counterfeit, and returned medicines during transportation. These medicines must be separated, packaged securely, labeled clearly, and accompanied by appropriate identifying documentation.

13.12. The interiors of transport vehicles and packaging must be kept clean and dry while transporting medicines.

13.13. Packaging materials and containers must be designed to prevent damage to medicines during transportation. Sealing control programs must be established and managed properly.

13.14. Transport vehicle operators must self-certify and present appropriate records and logs to prove that they are authorized to transport the shipment.

13.15. Any damage to shipping containers used for transportation and any issues or incidents occurring during transportation must be recorded and reported to relevant departments, organizations, or agencies and investigated.

13.16. Appropriate documentation must accompany the transportation of medicinal products throughout the process.

14. Records and Documentation

14.1. Written guidelines and records of all activities related to the distribution of medicines, including receipt and issuance (invoices), must be maintained. Records and logs must be retained for at least seven years unless otherwise provided by law.

14.2. Distribution facilities must maintain records of all received medicines. At least, the following information must be included:

- Medicine name; concentration, content, packaging specifications, circulation permit, test report, production date, batch number, expiration date.

- Manufacturer's name, importer's name (if applicable), supplier's name, quantity received, time of receipt; inspection report.

- Name and address, telephone number, email (if available) of the purchasing facility, quantity sold, time of dispatch, medicine delivery and receipt report.

14.3. Procedures for preparing, reviewing, approving, using, and controlling changes to all distribution-related records and logs must be established and maintained. Procedures must be established for internal records and documents and for external records and documents.

14.4. Documents and especially guidelines and procedures related to any activity that may affect the quality of medicines must be carefully designed, completed, reviewed, and distributed.

14.5. The title, nature, and purpose of each document must be clearly stated. The contents of the documents must be clear and explicit. These documents must be presented in an orderly manner to facilitate review.

14.6. All documents must be completed, approved, signed, and dated by the appropriate authority and may not be altered without permission.

14.7. The format of the documents, their content, and the retention of documents related to the distribution of drugs, or related to any investigation or legal action, must comply with relevant legal provisions. In cases where the law does not provide specific regulations, the records and documents must be retained for at least one year from the date of expiration of the related product.

14.8. Distribution facilities must establish and maintain procedures for identifying, collecting, indexing, retrieving, storing, maintaining, disposing of, and accessing all relevant records and documents.

14.9. All records and ledgers must always be readily available for review and inspection and must be stored and archived using secure means to prevent unauthorized alteration, destruction, damage, and/or loss of records and documents.

14.10. Documents must be regularly reviewed and updated. When a document is modified, there must be a suitable system in place to prevent the unintentional continued use of outdated versions.

14.11. There must be a computer connected to the internet and manage drug distribution activities through software. There must be a mechanism to transfer information on drug distribution, quality between the manufacturer and customers, as well as transferring information to the relevant regulatory authorities when required.

14.12. Records and ledgers related to drug storage must be retained and made available upon request, in accordance with WHO Good Storage Practices Guidelines.

14.13. There must be a written or electronic record for each product being stored, indicating recommended storage conditions, warnings to be observed, and the time for re-inspection. Current requirements of pharmacopoeias and relevant legal regulations regarding labeling and packaging must always be followed.

Records and ledgers related to narcotic drugs, psychotropic drugs, precursors, combined preparations containing narcotic substances, combined preparations containing psychotropic substances, combined preparations containing precursors; toxic drugs, toxic raw materials for drugs, drugs and pharmaceutical ingredients listed in the prohibited substance list for certain industries and fields according to the relevant legal regulations.

14.14. There must be procedures for evaluating temperature uniformity, security measures to prevent theft or counterfeiting of products at storage facilities, and procedures for removing/disposing of unsellable or unusable products and for storing records.

14.15. For facilities that build and store records in electronic form, backup systems must be established to prevent data loss due to accidents.

15. Repackaging and Relabeling

15.1. Repackaging and relabeling must be restricted because these actions can pose risks to the safety and security of the supply chain.

15.2. In cases where repackaging and relabeling are necessary, such activities must be carried out by licensed facilities and must comply with current Good Manufacturing Practice principles and standards.

15.3. In cases where repackaging is performed by a facility other than the original manufacturing facility, such activities must at least include equivalent measures to identify and authenticate the product.

15.4. There must be a procedure to ensure the safe handling of original packaging.

16. Complaints

16.1. There must be a documented procedure for handling complaints. Complaints about products or product packaging must be distinguished from complaints related to product distribution. In cases of complaints about product quality or packaging, the original manufacturing facility and/or the registration holder/license holder must be notified as soon as possible.

16.2. All complaints and other information related to potentially defective or counterfeit products must be thoroughly reviewed according to documented procedures describing the actions to be taken, including consideration of a recall if appropriate.

16.3. Any complaint related to a defect in a drug must be recorded and thoroughly investigated to determine the origin or cause of the complaint (such as repackaging procedures or initial production processes).

16.4. If a defective drug is discovered or suspected, it must be considered whether to inspect other batches of products.

16.5. Subsequent actions following the investigation and evaluation of complaints must be carried out if necessary. A system must be in place to ensure that complaint information, feedback received from the original manufacturing facility, or the results of the complaint investigation are shared with all relevant parties.

16.6. Issues related to product quality or suspected counterfeiting must be recorded and reported to competent authorities.

17. Product Recall

17.1. A system, including documented procedures, must be established to quickly and effectively recall drugs that have been identified or suspected of being defective or counterfeit, and designate the person responsible for the recall. This system must comply with legal regulations. The recall process must be regularly reviewed and updated as needed.

17.2. When a drug recall occurs, the original manufacturing facility and/or the registration holder must be notified. When the recall is conducted by a legal entity that is not the original manufacturing facility or the registration holder/license holder, the recalling entity must contact the original manufacturing facility and/or the registration holder/license holder.

Information on drug recalls must be reported to the drug regulatory authority as prescribed by law. In cases where a recall of the original product is necessary due to indistinguishable counterfeit products, the original manufacturing facility and the relevant health administration must be notified.

17.3. The effectiveness of the organization of the product recall must be regularly evaluated. All recalled drugs must be stored in a separate area and security must be ensured during the waiting period for further processing.

17.4. During transportation, recalled drugs must be isolated and clearly marked on the label as recalled products. In cases where isolation of recalled products cannot be achieved, such products must be safely packaged, clearly labeled, and accompanied by appropriate records.

17.5. Special storage conditions for recalled drugs must be maintained throughout the storage and transportation process until a final disposal decision is made.

17.6. Immediate notification about the recall of defective or suspected defective or counterfeit products must be provided to all customers and local health management authorities where the products may have been distributed.

17.7. All records and ledgers must be readily available for the person responsible for the recall. These records and ledgers must contain complete information regarding drugs supplied to customers (including those exported).

17.8. The progress of the recall must be recorded and a final report must be prepared, including a comparison between the quantity of products received and the quantity recalled.

17.9. If necessary, an emergency recall procedure must be implemented.

18. Returned Products

18.1. Distribution facilities must accept returned or exchanged drugs according to the terms and conditions stipulated in the agreement between the distribution facility and the recipient. Both the distribution facility and the receiving facility must be responsible for managing the return process and ensuring that all stages of this activity are conducted safely and prevent counterfeit drugs from entering the system.

18.2. The evaluation and decision-making regarding the handling/disposition of returned products must be carried out by an authorized person. Characteristics of the returned products, special storage conditions required, conditions, history, and time since supply/delivery must be considered in this evaluation. When there is doubt about the quality of the drug, it shall not be released for circulation or reuse.

18.3. Suitable and safe means and equipment for transporting returned products, in accordance with storage requirements and other related requirements, must be provided.

18.4. Drugs removed and returned to the distribution facility must be properly identified and handled through a process that at least includes:

- Isolated storage in a dedicated area during quarantine;

- Equivalent isolation measures (such as electronic means).

This measure aims to avoid confusion and prevent the continued distribution of the product until a decision regarding its handling is made. Special storage conditions applicable to rejected or returned drugs must be maintained during storage and transportation until a final decision on the product is made.

18.5. Appropriate means and equipment for safely transporting removed products before disposal must be provided.

18.6. Drug destruction must be carried out in accordance with legal regulations and appropriate measures must be taken to protect the environment.

18.7. Records relating to all returned, removed, and/or destroyed drugs must be retained as required.

19. Counterfeit Drugs

19.1. Counterfeit drugs discovered in the distribution chain must be immediately separated from other drugs to avoid confusion. Counterfeit drugs must be clearly labeled indicating they are not for sale. The distribution facility must immediately report to the drug regulatory authority, the competent authority, and notify the registration holder/license holder of the original product.

19.2. Sales and distribution of suspected counterfeit drugs must be immediately halted and reported to the regulatory authority.

19.3. After confirming that the drugs are counterfeit, a formal decision on their destruction must be made to ensure they do not re-enter the market, and this decision must be recorded.

20. Contractual Operations

20.1. Any activities related to the distribution of drugs delegated to another individual or entity must be carried out by parties authorized to perform such functions and must be in the form of a written contract agreed upon by both contracting parties.

20.2. The contract must clearly define the responsibilities of each party, including the GMP principles and relevant assurance clauses. The contract must include the responsibility of the performing party to implement measures to prevent counterfeit drugs from entering the supply chain.

20.3. All contracted parties must comply with the requirements of this guidance.

20.4. Subcontracts may be accepted under certain conditions and subject to the approval of the contracting parties; however, subcontractors must be authorized to perform subcontracted functions.

20.5. Contracted parties must be periodically audited.

21. Self-Inspection

21.1. The quality system must include self-inspection activities. Self-inspections must be conducted to monitor the implementation and compliance with GMP principles and to track corrective and preventive actions, if necessary.

21.2. Self-inspections must be conducted independently and in detail by qualified and authorized personnel.

21.3. The results of all self-inspections must be documented. Inspection reports must include all observations made during the inspection and recommendations for corrective measures, if appropriate. An effective follow-up program must be established. Management must review the inspection reports and records of any corrective actions taken.

ANNEX II

GOOD DISTRIBUTION PRACTICES FOR DRUG SUBSTANCES

(Issued together with Circular No. 03/2018/TT-BYT dated February 9, 2018, by the Minister of Health);

1. Introduction

2. Quality Management

3. Organization and Personnel

4. Storage Areas

5. Purchasing, Warehousing, and Storage

6. Equipment

7. Records and Documentation

8. Repackaging and Relabeling

9. Complaints

10. Recalls

11. Returns

12. Handling of Non-Conforming Materials

13. Dispatch and Transportation

14. Contractual Operations

1. Introduction

The Good Manufacturing Practice (GMP) Guidelines for Active Pharmaceutical Ingredients (APIs) issued by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in 2000, in the ICH Q7 document. Part 17 of this ICH document includes guidelines for agents, intermediaries, businesses, distributors, repackaging facilities, relabeling facilities. This part is based on the results of the World Health Organization's (WHO) investigation into deaths related to industrial ethylene glycol being intentionally relabeled as pharmaceutical raw material, which was then incorporated into a children's medication and caused numerous fatalities. Part 17 of the GMP Guidelines for APIs applies to all parties, not just the initial manufacturing facility – which could be a business and/or owner, repackager, relabeler, distributor, or custodian of an API or intermediate during the API production process. ICH Q7 does not cover excipients.

Following incidents involving diethylene glycol and the resolution WHA52.19 of the World Health Assembly (WHA), the WHO published Good Business and Distribution Practices for Pharmaceutical Raw Materials in 2004. At the time of publication of these guidelines, the WHO had not yet adopted the ICH Q7 GMP guidance for APIs. The WHO’s guidelines for excipients, published in 1999, did not include business and distribution practices for excipients.

In 2010, the WHO published Good Manufacturing Practice (GMP) Guidelines for APIs, incorporating content from ICH Q7, including Part 17 of that document, to replace the existing WHO GMP Guidelines for APIs.

The WHO Expert Committee on Pharmaceutical Products discussed revising the Good Practices for Business and Distribution of Pharmaceutical Raw Materials at several meetings. These WHO guidelines apply to all components used in the manufacture of medicines, including APIs, excipients, and any other component.

Note: Raw materials derived from non-pharmaceutical sources such as food, industrial, or technical categories are not considered pharmaceutical raw materials unless they are produced under manufacturing conditions and quality systems as specified. For finished products, details can be found in the WHO Good Distribution Practice Guidelines for Medicines.

2. Quality Management

2.1 Within an organization, quality assurance is a management tool. In contractual situations, quality assurance also aims to build trust with suppliers. There must be a documented quality policy describing the organization's overall quality objectives and direction, and this policy must be formally expressed and approved by management. The quality policy must clearly state that the organization implements and maintains good business and distribution practices as described in these guidelines within its scope and services.

2.2 Quality management must include:

a) An appropriate infrastructure or "quality system" comprising organizational structure, processes, procedures, and resources. When developing or adjusting the quality system, the scale, structure, and complexity of the distribution organization and its activities must be taken into account.

b) An independent unit (or designated individual) responsible for all quality-related issues;

c) A suitable quality risk management system to facilitate systematic assessment, control, information, and review of product quality risks. The extent of application of the quality risk management system must reflect the implementation activities;

d) An evaluation system to ensure that the product meets specific requirements for specific purposes;

f) Necessary coordinated actions to ensure reliably that a certain raw material (or service) and related records will meet quality requirements – all these actions are referred to as quality assurance;

e) A clear documented procedure for selecting, approving, rejecting/disqualifying, and reapproving raw material and service suppliers;

g) A failure management and change control program designed to ensure continuous quality assessment and maintenance: this program must include customer notification tools if appropriate;

h) A system ensuring traceability of products and related records and documents throughout the supply chain.

2.3 The system must include, but is not limited to, the quality assurance principles outlined in this guideline document.

2.4 All entities involved in the production and supply chain must fulfill their responsibilities to ensure quality and safety of raw materials and products and ensure that these raw materials and products are suitable for their intended use according to technical standards.

2.5 Responsibilities should not be placed too heavily on any single individual to the point of creating a risk to quality. If the number of personnel at the supplier is limited, some tasks may be delegated or contracted out to suitably qualified individuals. However, it must be ensured that there are no unresolved conflicts or overlaps in the application of the principles and good business and distribution practices for raw materials as described in these guidelines.

2.6 Organizations using electronic commerce systems must have adequate procedures and specific systems in place to ensure reliability of raw material quality and traceability.

2.7 Approved outbound procedures must be in place to ensure that when raw materials are dispatched for a specific purpose, they meet quality standards and are provided by authorized suppliers.

2.8. The implementation of quality risk management principles shall utilize appropriate tools such as hazard analysis and critical control points (HACCP); encourage inspection and certification of compliance with regulations within a suitable quality system such as the ISO standards, and recognize conformity with national and/or regional standards by external agencies. However, this should not be considered as a substitute for implementing these guidelines or substituting for compliance, e.g., requirements for good manufacturing and storage practices for drugs.

2.9. There must be a system to facilitate periodic internal inspections aimed at continuous improvement/enhancement of the system. Inspection results and any corrective and preventive actions taken, including verification of their effectiveness, must be recorded and documented and brought to the attention of responsible managers.

3. Organization and Personnel

3.1. A raw material drug distribution facility must have legal personality, be issued a Business Operation Compliance Certificate according to current pharmaceutical laws, related laws, and legal documents, and must have the capacity to take responsibility for its activities.

3.2. There must be adequate organizational structure and sufficient personnel to carry out all tasks under the responsibility of the supply entity. All personnel of the entity must be familiar with the principles in relevant guidance on the storage and distribution of raw materials for drugs.

3.3. Individual responsibilities must be clearly defined, understood by relevant individuals, and documented in writing (in job descriptions or contracts). Specific activities such as instructions for performing tasks according to the entity's regulations may require special attention. Entity personnel must have appropriate qualifications, training, and authorization to perform their duties and responsibilities.

3.4. Personnel must undergo initial and ongoing training appropriate to their assigned tasks. Training must be conducted by qualified instructors/trainers according to a training program. The effectiveness of training must be verified when appropriate. Training records must be kept. All personnel must be encouraged to support the establishment and maintenance of quality standards.

3.5. Staff handling hazardous raw materials (such as highly active, toxic, infectious, or sensitive materials) must receive special training and be equipped with necessary personal protective equipment. Written policies and procedures regarding the use of personal protective equipment must be followed to minimize exposure of workers directly handling products and those in the immediate environment.

3.6. Personnel who may come into contact with unpackaged raw materials must maintain cleanliness, ensure there are no open wounds, and wear appropriate protective clothing, gloves, masks/facemasks, and goggles.

4. Storage Areas

4.1. Storage areas must be arranged, designed, constructed, adjusted, and maintained appropriately for the activities carried out. Arrangement and design of storage areas must minimize error risks and allow effective cleaning and maintenance, prevent contamination, cross-contamination, mixing, accumulation of dust or debris, and any adverse impact on raw material quality.

4.2. Measures must be in place to prevent unauthorized persons from entering storage areas.

4.3. Storage areas must be designed, equipped, and maintained to maximize protection against intrusion by insects, rodents, or other animals. Pest control programs must be implemented and maintained, and their effectiveness must be monitored.

4.4. Appropriate auxiliary means and systems (such as air control, ventilation, and lighting) must be available and suitable for the activities carried out to avoid contamination, cross-contamination, and degradation of raw material quality. Auxiliary systems that can affect product quality must be identified and monitored.

4.5. If sampling of raw materials is performed, the sampling area must be separated and in a controlled environment. Sampling in storage areas should only occur if it does not pose a risk of contamination or cross-contamination, and procedures for cleaning the sampling area must be established.

5. Purchasing, Warehousing, and Storage

Note: GSP principles apply in all situations and in areas where raw materials are stored.

5.1. Raw materials must be purchased from approved suppliers according to officially harmonized technical standards.

5.2. Actions must be taken to minimize the risk of counterfeit or substandard raw materials entering the supply chain.

5.3. An approved procedure describing activities related to receiving, storing, and distributing raw materials must be in place. Necessary steps must be taken to ensure and record that incoming shipments are correct and products originate from approved suppliers. Shipments must be inspected to check for damaged, exchanged, or tampered packaging, and ensure packaging remains sealed and seals are intact.

5.4. Storage areas must have sufficient space to store different groups of raw materials orderly.

5.5. Receiving and dispatch areas must be equipped to protect raw materials from adverse environmental conditions. Receiving areas must be designed and equipped to allow incoming consignments to be cleaned before storage, if necessary. Upon receipt, raw materials must be quarantined until released by the quality unit.

5.6. There must be quarantine areas to store received, segregated, rejected, recalled, and returned raw materials, including those with damaged packaging. Any system replacing physical quarantine, such as electronic quarantine through computerization, must ensure equivalent security levels and be appropriately evaluated and validated.

5.7. Storage areas must be kept clean and dry.

5.8. Quarantine areas and quarantined materials must be properly delineated and identified.

5.9. The storage conditions prescribed for materials must be maintained within acceptable limits throughout the storage period. Transport conditions should be checked as soon as possible after receipt to ensure they meet the requirements.

Products must be immediately transferred to appropriate storage facilities after inspection at the receiving area.

5.10. Where special storage conditions (such as temperature, humidity, or light avoidance) are required, these conditions must be met, monitored, and recorded appropriately.

Temperature uniformity assessment results must show consistent temperature across the entire warehouse. Temperature monitoring equipment must be placed in areas/positions with the greatest potential variation based on temperature uniformity assessment results in the warehouse; there must be at least one self-recording temperature monitoring device with suitable recording frequency (usually once or twice per hour depending on the season).

5.11. Radioactive materials, specially controlled raw materials (narcotics, psychotropic substances, and precursors), and other hazardous, sensitive, and/or dangerous drug substances, as well as drug substances with a high risk of abuse, flammability, and explosiveness (such as flammable liquids, combustible solids, and compressed gases) must be stored separately in areas with safety and security measures in accordance with relevant legal regulations.

Raw toxic materials for drugs, drug substances listed in the Drug Catalogue that are prohibited from use in certain industries and fields must be stored separately, not mixed with other drugs, neatly arranged to avoid confusion and easy observation, and securely packaged to prevent leakage during transportation.

5.12. Special attention must be given to the design, use, cleaning, and maintenance of all semi-finished product handling and storage equipment such as tanks and silos.

5.13. Products must be packed in a way that prevents breakage, contamination, tampering, or theft. Packaging must be sufficiently secure to maintain product quality throughout transportation. If special transport conditions are required, they must be determined, provided, and controlled. Product containers for transportation must be sealed and include authentic information about the product and the supplying entity.

5.14. Spilled products must be cleaned up as soon as possible to avoid cross-contamination and hazards.

5.15. Proper and safe storage regulations for waste materials awaiting processing must be established. Toxic and flammable materials must be stored in suitable, separate, and sealed containers placed in enclosed areas as stipulated by national laws.

5.16. A default system must be in place to ensure that materials with the earliest expiration date are sold or distributed first (first-expired/first-out). For materials without a specific expiration date, the principle of first-in/first-out applies.

5.17. There must be a process to immediately withdraw from inventory materials that have expired or are due for retesting. Materials with a retest date must be retested according to appropriate quality standards. Materials with an expiration date cannot be retested or reused after this date.

5.18. Inventory must be regularly inspected, at least regarding quantity, general condition, and retest or expiration dates. Any discrepancies must be investigated.

5.19. Control mechanisms must be in place to ensure correct selection, packaging, and distribution of products. The remaining shelf life of materials must be appropriate. All batch numbers must be recorded.

5.20. Storage areas must be clean, free of debris and pest accumulation. A written sanitation program must be implemented, specifying the frequency and methods of cleaning the facility and storage areas.

6. Equipment

6.1. Equipment must be installed, arranged, designed, constructed, adjusted, validated, used, cleaned, and maintained in a manner suitable for operation. The arrangement, design, and use of this equipment must aim to minimize error risks, allow effective cleaning and maintenance to prevent cross-contamination, dust accumulation, and any adverse effects on material quality.

6.2. Defective equipment that cannot continue to be used must be removed or labeled as defective. Defective equipment must be removed to prevent misuse.

6.3. The status of equipment must be easily identifiable.

6.4. Fixed pipelines must be clearly labeled to indicate their contents and flow direction.

6.5. All services, pipelines, and tools must be fully marked, with particular attention paid to connections or converters so that different types of gases, hazardous liquids, and other materials cannot be mistakenly interchanged.

6.6. Scales and other measuring instruments with appropriate measurement ranges and accuracy must be available and must be calibrated according to an appropriate schedule.

6.7. Specialized equipment should be used when handling and/or processing materials if necessary. In places where non-specialized equipment is used, a hygiene validation must be conducted.

6.8. Closed equipment should be used whenever possible. If open equipment is used, appropriate measures must be taken to prevent contamination.

6.9. Equipment operating and maintenance procedures must be established. Lubricants and other materials applied to surfaces of equipment directly contacting materials must be suitable, such as food-grade oil, and must not alter material quality.

6.10. Cleaning and sanitizing equipment must be selected and used in a way that does not become a source of contamination.

7. Records and Documentation

7.1. Documents, particularly guidelines and procedures related to any activity that may affect the quality of raw materials, must be designed, finalized, reviewed, and distributed carefully. All documents must be completed, approved, signed, and dated by authorized persons and shall not be altered without permission. Technical standards for raw materials, including packaging materials, must be available, reviewed, and revised periodically.

7.2. Documents must contain clear content: titles, characteristics, and purposes must be clearly stated. These documents must be organized in an orderly manner and be easily accessible for review.

7.3. A Certificate of Analysis (CoA) issued by the original manufacturer must be provided. If additional testing is conducted, all supplementary CoAs must be provided.

The CoA must include information tracing back to the original manufacturer by stating the name of the original manufacturer and the place of production. The CoA must specify which results are from testing the original raw material lot and which results are from skip-lot testing or other types of testing, and identify the organization responsible for issuing the CoA.

7.4. Prior to selling or distributing any raw material, the supplier must ensure that the CoA and test results are available and that the test results meet the technical standards as prescribed.

7.5. Original manufacturing facilities and intermediate handling facilities must always maintain traceability and transparency; this information must be available for relevant authorities and users along the supply chain upon request.

7.6. Depending on risk assessment and national regulations, quality agreements must serve as the basis for relationships between supply chain participants. Such agreements must include mechanisms for transferring information such as quality data or change management and control information.

7.7. Labels on packaging must be clear, legible, securely affixed, and printed according to the company's standardized format. Information on labels must not be erasable.

7.8. Each package must be identified with a label containing at least the following information:

- Name of the raw material (including type and reference to the pharmacopoeia if applicable);

- International Nonproprietary Name (INN), if applicable;

- Quantity (weight or volume);

- Lot number marked by the original manufacturer or the repackaging facility, if the raw material has been repackaged and relabeled;

- Date of retesting or expiration date (if applicable);

- Storage conditions;

- Handling warnings when necessary;

- Identification of the original manufacturing site;

- Name and contact information of the supplier.

7.9. Information related to storage and handling and safety data sheets must be available.

7.10. GMP and GSP records must be maintained and made available upon request.

8. Repackaging and Relabeling

8.1. Activities such as combining into a single lot, repackaging, and/or relabeling are manufacturing processes and are not encouraged. In situations where these activities are carried out, GMP principles and standards must be adhered to.

Note: It is important to note that any party involved in repackaging or mixing drug substances shall be considered a manufacturer and must submit appropriate registration documentation for such manufacturing activities. These facilities must comply with the WHO's Good Manufacturing Practice (GMP) principles and standards for drug substances as outlined in Technical Report Series No. 957, Appendix 2, 2010.

8.2. The following points should be particularly noted:

- Prevention of contamination, cross-contamination, and mix-ups;

- Suitable environmental conditions for dispensing, packaging, and sampling;

- Ensuring the safety of stored labels, cleaning verification of production lines, online testing, destruction of excess printed labels for batches, and balancing label quantities;

- Good hygiene practices;

- Maintaining batch integrity/uniformity (generally, different batches of the same solid raw material should not be mixed);

- All labels removed from original packaging during operations and new sample labels must be retained as part of the batch record;

- If multiple batches of labels are used for one operation, samples of each batch must be retained;

- Maintaining product identification, integrity, and traceability;

8.3. Upon receipt, packaging materials must be segregated and not released for use until approved, with procedures for inspecting, approving, and releasing packaging materials from storage.

8.4. When a distribution facility receives different batches of the same raw material from the same original manufacturer and combines them into a single uniform batch, each batch must meet its technical standards before combination.

8.5. Only raw materials from the same manufacturer, received by the same distribution facility, and meeting the same technical standards may be mixed. If different batches of the same raw material are mixed to form a single uniform batch, this batch must be treated as a new batch, tested, and supplied with a test certificate. In such cases, consumers must be informed that the supplied material is a mixture of batches from various manufacturers.

8.6. In all cases, traceability back to the manufacturer must be recorded by identifying the original manufacturer of a specific raw material batch and the production site of this batch.

8.7. If batches are combined or mixed, the expiration date or retest period of the oldest batch will apply to the combined or mixed batch.

8.8. If the integrity and quality of the batch are maintained during repackaging and relabeling, the original manufacturer’s test certificate must be provided.

If retesting is performed, both the original and new test certificates must be provided, provided the batch integrity is maintained. The batch referred to in the new test certificate must be traceable to the original test certificate.

8.9. Repackaging must be done using packaging materials of equivalent or better quality and suitability compared to the original packaging material.

8.10. Reusing packaging materials is not encouraged unless they have been cleaned through an approved process. Recycled packaging materials may not be used unless there is evidence that the quality of the packaged material will not be adversely affected.

8.11. Repackaging should only be conducted if effective environmental controls are in place to ensure no risk of contamination, cross-contamination, quality degradation, physical/chemical changes, or mix-ups. The air quality supplied to the area must be suitable for the activities being carried out, e.g., having adequate efficient air filtration systems.

8.12. Appropriate procedures must be followed to ensure effective label control.

8.13. Packaging of repackaged raw materials and relabeled packaging must include the name of the original manufacturer and the name of the repackaging/distribution facility.

8.14. Procedures must be in place to ensure the maintenance of material identity and quality through appropriate means, both before and after repackaging.

8.15. Each repackaged batch must be tested to ensure the material meets the technical standards set forth in the documentation.

8.16. Procedures must be in place to ensure that, in addition to test results, the repackaging documentation is reviewed before repackaged material is released from storage.

8.17. Sampling, testing, and release procedures for batches must comply with GMP principles and standards.

8.18. Only official pharmacopoeia methods or validated testing methods may be used for analysis. Alternative methods used instead of those specified in a monograph in the pharmacopoeia for testing purposes must be proven to be suitable and equivalent.

8.19. Non-conforming test results must be investigated and documented.

8.20. Representative samples of raw materials in sufficient quantity must be retained for at least one year after the expiration date or retest period has passed, or three years after distribution completion.

8.21. Repackaging and relabeling facilities must ensure that the stability of the material is not adversely affected by repackaging or relabeling. Stability studies must be conducted to adjust the expiration date or retest period if the material is repackaged into a different container than the original manufacturer used. It is recognized that certain excipients may not require additional stability studies.

9. Complaints

9.1. All complaints and other relevant information concerning potentially defective materials must be thoroughly reviewed according to documented procedures describing actions to be taken and specific criteria for determining whether to recall a product. Complaint records must be kept and trended at regular intervals.

9.2. Any complaint related to defective materials must be recorded and thoroughly investigated to determine the source or cause of the complaint (such as repackaging processes or initial production processes). Corrective and preventive actions must be taken as appropriate and documented.

9.3. If any defect is detected or suspected in any raw material, it must be determined whether further inspection of other batches is necessary.

9.4. When necessary, follow-up actions following investigations and complaints assessments shall be conducted, which may include recall actions.

9.5. In case of defects discovered during production or packaging, quality degradation issues, or any serious quality problems occurring with any raw material, the manufacturer and consumers must be notified.

10. Recalls

10.1. A system for timely and effective removal from the market of raw materials that have been identified or suspected to be defective must be established.

10.2. The original manufacturing facility must be informed in the event of a product recall.

10.3. Written procedures for organizing any recall activities must be in place. Such procedures must be periodically reviewed and updated.

10.4. All recalled raw materials must be stored in secure areas pending their final disposition.

10.5. In cases of severe situations or potential threats to life, all consumers and competent authorities in all countries where a raw material may have been distributed must be immediately informed of any intended recall.

10.6. All records and ledgers must be readily available for those responsible for the recall. These records must contain full information about the raw materials supplied to customers (including exported raw materials).

10.7. The effectiveness of recall organization must be evaluated periodically.

11. Returned Raw Materials

11.1. Raw materials returned to the supplier must be identified and segregated appropriately. Storage and transportation conditions of returned raw materials must be assessed to determine the quality of the returned goods.

11.2. The quality unit or designated person must decide on the disposal of returned raw materials according to an official and documented investigation process. Corrective and preventive actions must be taken as appropriate.

12. Handling of Non-Conforming Materials

12.1. Non-conforming raw materials must be handled through a process that prevents their reintroduction to the market. Records and documentation of all activities, including destruction, disposal, return, and reclassification, must be kept.

12.2. An investigation must be carried out to determine if other batches are also affected. Corrective and preventive measures must be implemented when necessary.

12.3. Disposal of raw materials, including downgrading for alternative purposes, must be documented.

13. Dispatch and Transportation

13.1. Raw materials must be stacked, handled, and transported in such a way as to maintain controlled conditions (such as temperature, protection from environmental impact) if applicable. Transportation must not adversely affect the raw materials. Any transport means used must be approved through a written procedure unless the transport means has been selected by the customer.

13.2. Special transportation and/or storage requirements must be indicated on the label and/or in the transport record. If the raw material is expected to be transported outside the manufacturer's raw material management system, the manufacturer's name and address, the quality of the raw material contained, special transportation conditions, and any other special legal requirements must be indicated on the label and/or in the transport record.

13.3. Cơ sở cung ứng nguyên liệu phải bảo đảm rằng bên nhận hợp đồng vận chuyển nguyên liệu nắm được và cung cấp được các điều kiện bảo quản và vận chuyển phù hợp, v.d. thông qua kiểm tra.

13.4. Phải có quy trình bảo đảm vệ sinh sạch sẽ và ngăn ngừa nhiễm chéo khi vận chuyển chất lỏng (bồn chứa) và bán thành phẩm hay nguyên liệu đã đóng gói.

13.5. Việc vận chuyển bán thành phẩm nguyên liệu đòi hỏi phải lưu ý rất nhiều cảnh báo để tránh ô nhiễm và nhiễm chéo. Tốt nhất là dùng thiết bị, bồn chứa hoặc bao bì chuyên dụng.

Khi không có phương tiện vận chuyển và trang thiết bị chuyên dụng thì phải có quy trình phù hợp để bảo đảm chất lượng của nguyên liệu làm thuốc không bị ảnh hưởng trong quá trình vận chuyển. Việc dọn vệ sinh phương tiện vận chuyển phải được thực hiện phù hợp, được kiểm tra và ghi chép đầy đủ.

10.5. Các phương tiện vận chuyển, trang thiết bị vận chuyển, các thùng chứa hàng cần phải được lựa chọn, đánh giá phù hợp nhằm đảm bảo thuốc, nguyên liệu làm thuốc được bảo quản ở điều kiện yêu cầu trong quá trình vận chuyển.

13.6. Vật liệu bao gói và bao bì vận chuyển phải phù hợp cho mục đích ngăn ngừa hư hỏng đối với nguyên liệu trong quá trình vận chuyển.

13.7. Đối với vận chuyển bán thành phẩm thì phải áp dụng các quy trình làm vệ sinh đã được thẩm định giữa các lần xếp hàng và danh mục các hàng hóa bị hạn chế trước đó phải được cung cấp cho phía công ty vận chuyển.

13.8. Cần tiến hành các bước nhằm ngăn chặn tình trạng tiếp cận trái phép nguyên liệu được vận chuyển.

13.9. Các yêu cầu quốc tế chung về an toàn (như phòng tránh cháy nổ và ô nhiễm môi trường) phải được tuân thủ.

14. Hoạt động hợp đồng

14.1. Bất kỳ hoạt động nào được thực hiện, theo hướng dẫn GMP và GTDP, được ủy thác cho một bên khác đều phải được thỏa thuận thông qua hợp đồng bằng văn bản.

14.2. Trước khi đi đến thỏa thuận, bên hợp đồng phải đánh giá mức độ tuân thủ GTDP của bên nhận hợp đồng.

14.3. Tất cả các bên nhận hợp đồng phải đáp ứng các yêu cầu trong hướng dẫn này. Đặc biệt lưu ý ngăn chặn tình trạng ô nhiễm chéo và phải duy trì khả năng truy nguyên.

14.4. Phải có hợp đồng hoặc thỏa thuận chính thức bằng văn bản và được duyệt ký giữa bên hợp đồng và bên nhận hợp đồng trong đó xác định chi tiết trách nhiệm của các bên theo GTDP và bên nào chịu trách nhiệm đối với biện pháp bảo đảm chất lượng nào.

14.5. Có thể được phép ký hợp đồng phụ trong những điều kiện nhất định và tùy thuộc vào phê duyệt của bên giao kết hợp đồng, đặc biệt là đối với các hoạt động như lấy mẫu, phân tích, đóng gói lại và dán nhãn lại./.

PHỤ LỤC III

PHÂN LOẠI MỨC ĐỘ TỒN TẠI VÀ MỨC ĐỘ ĐÁP ỨNG CỦA CƠ SỞ PHÂN PHỐI THUỐC, NGUYÊN LIỆU LÀM THUỐC

(Ban hành kèm theo Thông tư số 03/2018/TT-BYT ngày 09 tháng 02 năm 2018 của Bộ trưởng Bộ Y tế)

I. Phân loại mức độ tồn tại

1. Tồn tại nghiêm trọng: là những sai lệch so với tiêu chuẩn GDP dẫn đến thuốc, nguyên liệu làm thuốc không đảm bảo chất lượng, an toàn, hiệu quả và gây nguy cơ ảnh hưởng nghiêm trọng đến sức khỏe, tính mạng của người sử dụng hoặc của cộng đồng; hoặc là sự kết hợp của một số tồn tại nặng cho thấy một thiếu sót nghiêm trọng của hệ thống. Tồn tại này bao gồm cả những hoạt động làm tăng nguy cơ đưa thuốc giả đến người sử dụng.

2. Tồn tại nặng: là tồn tại không nghiêm trọng nhưng có thể dẫn đến việc bảo quản sản phẩm, nguyên liệu không tuân thủ theo hướng dẫn bảo quản của nhà sản xuất, hoặc liên quan tới một sai lệch lớn so với các quy định của GDP hoặc điều kiện bảo quản; hoặc liên quan tới việc không tuân thủ các quy trình bảo quản hoặc việc người có thẩm quyền không đáp ứng đủ yêu cầu về trách nhiệm trong công việc; hoặc tổ hợp của các tồn tại khác, không tồn tại nào trong tổ hợp đó được xem là tồn tại nặng, nhưng khi xuất hiện cùng nhau các tồn tại này sẽ tạo thành một tồn tại nặng và cần được phân tích và báo cáo như một tồn tại nặng.

3. Tồn tại nhẹ: Là những tồn tại mà không xếp loại thành tồn tại nghiêm trọng hoặc tồn tại nặng, nhưng là một sai lệch so với các tiêu chuẩn GDP.

II. Đánh giá mức độ đáp ứng GDP

1) Mức độ 1: Cơ sở không có tồn tại nghiêm trọng và tồn tại nặng.

2) Mức độ 2: Cơ sở không có tồn tại nghiêm trọng và có tồn tại nặng.

3) Mức độ 3: Cơ sở có tồn tại nghiêm trọng.

PHỤ LỤC IV:

BIỂU MẪU
(Ban hành kèm theo Thông tư số 03/2018/TT-BYT ngày 09 tháng 02 năm 2018 của Bộ trưởng Bộ Y tế)

Mẫu số 01/GDP: Đơn đăng ký đánh giá duy trì đáp ứng GDP

TÊN ĐƠN VỊ CHỦ QUẢN TÊN CƠ SỞ -------	CỘNG HÒA XÃ HỘI CHỦ NGHĨA VIỆT NAM Độc lập - Tự do - Hạnh phúc ---------------
Số: ......../..........	........., ngày…… tháng ..... năm 20…….

ĐƠN ĐĂNG KÝ ĐÁNH GIÁ VIỆC DUY TRÌ ĐÁP ỨNG “THỰC HÀNH TỐT PHÂN PHỐI THUỐC, NGUYÊN LIỆU LÀM THUỐC”

Kính gửi: Sở Y tế..........

Tên cơ sở: ............................................................................................................................
Địa chỉ kho: ..........................................................................................................................
Điện thoại: ..................	Fax: ...........................	Email: .....................................................
Người liên hệ: .....................................................		Chức danh: .............................................
Điện thoại: ..........................................................		Email: .....................................................

Đã được cấp Giấy chứng nhận đủ điều kiện kinh doanh dược số:........................, ngày cấp:......... với loại hình và phạm vi kinh doanh (hoặc Đã được cấp Giấy chứng nhận GDP số:..........., ngày cấp........: với phạm vi chứng nhận):

.............................................................................................................................................

.............................................................................................................................................

Thực hiện Thông tư số 03/2018/TT-BYT ngày 09 tháng 02 năm 2018 của Bộ Y tế quy định về Thực hành tốt phân phối thuốc, nguyên liệu làm thuốc, sau khi tiến hành tự thanh tra và đánh giá đạt yêu cầu; cơ sở chúng tôi xin đề nghị với Sở Y tế được tái đánh giá việc duy trì đáp ứng tiêu chuẩn GDP (và cấp Giấy chứng nhận GDP - trường hợp cơ sở có yêu cầu) đối với phạm vi quy định trong Giấy chứng nhận đủ điều kiện kinh doanh dược (hoặc đối với phạm vi trong quy định về chức năng nhiệm vụ - trường hợp cơ sở không vì mục đích thương mại) của chúng tôi.

Chúng tôi xin gửi kèm bản đăng ký này các tài liệu sau đây:

1. Bản cập nhật Hồ sơ tổng thể của cơ sở;

2. Báo cáo tóm tắt hoạt động phân phối thuốc, nguyên liệu làm thuốc của cơ sở trong 03 năm gần đây.

Giám đốc cơ sở (Ký, ghi rõ họ tên, đóng dấu)

Mẫu số 02/GDP: Đơn đăng ký đánh giá đáp ứng GDP đối với cơ sở kinh doanh không vì mục đích thương mại.

TÊN ĐƠN VỊ CHỦ QUẢN TÊN CƠ SỞ -------	CỘNG HÒA XÃ HỘI CHỦ NGHĨA VIỆT NAM Độc lập - Tự do - Hạnh phúc ---------------
Số: ......../..........	........., ngày…… tháng ..... năm 20…….

ĐƠN ĐĂNG KÝ ĐÁNH GIÁ VIỆC ĐÁP ỨNG TIÊU CHUẨN “THỰC HÀNH TỐT PHÂN PHỐI THUỐC, NGUYÊN LIỆU LÀM THUỐC” CỦA CƠ SỞ PHÂN PHỐI KHÔNG VÌ MỤC ĐÍCH THƯƠNG MẠI

Kính gửi: Sở Y tế............................

Tên cơ sở: ............................................................................................................................
Địa chỉ kho bảo quản: ...........................................................................................................
Điện thoại: ..................	Fax: ...........................	Email: .....................................................
Người liên hệ: .....................................................		Chức danh: .............................................
Điện thoại: ..................	Fax: ...........................	Email: .....................................................

Thực hiện Thông tư số 03/2018/TT-BYT ngày 09 tháng 02 năm 2018 của Bộ Y tế quy định về Thực hành tốt phân phối thuốc, nguyên liệu làm thuốc, sau khi tiến hành tự thanh tra và đánh giá đạt yêu cầu; cơ sở chúng tôi xin đề nghị với Sở Y tế được đánh giá việc đáp ứng tiêu chuẩn GDP và cấp Giấy chứng nhận GDP đối với phạm vi trong quy định về chức năng nhiệm vụ của chúng tôi như sau:

.............................................................................................................................................

.............................................................................................................................................

Chúng tôi xin gửi kèm bản đăng ký này các tài liệu sau đây:

1. Tài liệu pháp lý về việc thành lập và chức năng nhiệm vụ của đơn vị;

2. Hồ sơ tổng thể của cơ sở.

Thủ trưởng đơn vị (Ký, ghi rõ họ tên, đóng dấu)

Mẫu số 03/GDP: Biên bản đánh giá GDP

ỦY BAN NHÂN DÂN TỈNH... SỞ Y TẾ.... -------	CỘNG HÒA XÃ HỘI CHỦ NGHĨA VIỆT NAM Độc lập - Tự do - Hạnh phúc ---------------
Số: ............./..............	........., ngày…… tháng ..... năm 20 …….

BIÊN BẢN ĐÁNH GIÁ

"Thực hành tốt Phân phối thuốc, nguyên liệu làm thuốc"

Căn cứ Quyết định số ........ ngày ......... của.......................... về việc thành lập đoàn kiểm tra triển khai áp dụng các tiêu chuẩn "Thực hành tốt phân phối thuốc, nguyên liệu làm thuốc" của, thành phần đoàn đánh giá gồm:

1 ........................................ - Trưởng đoàn.

2......................................... - Thư ký.

3 ........................................ -

Tên cơ sở:

- Địa chỉ:

-Tên người đại diện pháp luật và tên người chịu trách nhiệm chuyên môn

- Bản đăng ký đánh giá đề ngày ................ của .................................................................

- Ngày tiến hành đánh giá ..................................................................................................

- Nội dung đánh giá: việc triển khai áp dụng các tiêu chuẩn "Thực hành tốt phân phối thuốc, nguyên liệu làm thuốc" của Bộ Y tế

- Tiếp đoàn có:

1 ..........................

2 ..........................

3 ..........................

I/ Một số ý kiến của đoàn kiểm tra:

Sau khi thẩm định hồ sơ, nghe báo cáo của Công ty và tiến hành kiểm tra thực tế, Đoàn đánh giá có một số ý kiến sau:

A. Ưu điểm:

1. Tổ chức và quản lý: .........................................................................................................

2. Nhân sự: ..........................................................................................................................

3. Quản lý chất lượng:.........................................................................................................

4. Cơ sở kho tàng và bảo quản:...........................................................................................

5. Phương tiện vận chuyển và trang thiết bị: .......................................................................

6. Bao bì và nhãn trên bao bì: .............................................................................................

7. Giao hàng và gửi hàng: ...................................................................................................

8. Vận chuyển thuốc trong quá trình vận chuyển:.................................................................

9. Hồ sơ tài liệu: ...................................................................................................................

10. Đóng gói lại và dán nhãn lại: ..........................................................................................

11. Khiếu nại: .......................................................................................................................

12. Thu hồi:...........................................................................................................................

13. Sản phẩm bị loại và bị trả về:.........................................................................................

14. Thuốc giả:......................................................................................................................

15. Nhập khẩu:.....................................................................................................................

16. Hoạt động theo hợp đồng:.............................................................................................

17. Tự kiểm tra:

B. Tồn tại:

STT	Tồn tại	Tham chiếu	xếp loại
1.
1.1.
1.2.
2.
2.1.
2.2.
3.

II/ Kết luận:

1. Mức độ đáp ứng GDP:....................................................................................................

2. Yêu cầu...........................................................................................................................

III/ Ý kiến của Cơ sở

.............................................................................................................................................

Biên bản được thống nhất giữa Đoàn kiểm tra và Công ty ................................................

Biên bản này được làm thành hai bản, kèm theo bản Danh mục đánh giá. Công ty giữ một bản, Sở Y tế giữ một bản./.

Trưởng Đoàn đánh giá

Thư ký

Lãnh đạo cơ sở

Mẫu số 04/GDP: Phiếu tiếp nhận hồ sơ

UBND TỈNH... SỞ Y TẾ.... -------	CỘNG HÒA XÃ HỘI CHỦ NGHĨA VIỆT NAM Độc lập - Tự do - Hạnh phúc ---------------
Số: ............/...............	........., ngày…… tháng ..... năm 20 …….

PHIẾU TIẾP NHẬN

HỒ SƠ .....................................⁽²⁾...............................

1. Đơn vị nộp: ....................................................................................................................

2. Địa chỉ đơn vị nộp hồ sơ (trường hợp nộp hồ sơ qua đường bưu điện):

2. Hình thức nộp: Trực tiếp □ Bưu điện □

Nộp lần đầu □ Nộp bổ sung lần..⁽³⁾... □

3. Số, ngày tháng năm văn bản của đơn vị (nếu có): .........................................................

4. Danh mục tài liệu⁽⁴⁾: ........................................................................................................

Ghi chú: Phiếu tiếp nhận này chỉ có giá trị xác nhận cơ sở đã nộp hồ sơ tại cơ quan tiếp nhận hồ sơ

NGƯỜI NHẬN HỒ SƠ (Ký và ghi rõ họ tên)

Ghi chú:

(1) Số tiếp nhận hồ sơ

(2) Tên thủ tục hành chính.

(3) Ghi lần bổ sung hồ sơ.

(4) Các tài liệu tương ứng theo thủ tục hành chính được quy định tại Luật dược và Nghị định này (liệt kê chi tiết hoặc danh mục kèm theo).

Mẫu số 05/GDP: Hồ sơ tổng thể về cơ sở phân phối thuốc, nguyên liệu làm thuốc

HỒ SƠ TỔNG THỂ VỀ CƠ SỞ PHÂN PHỐI THUỐC, NGUYÊN LIỆU LÀM THUỐC

1. Thông tin chung vè cơ sở phân phối

1.1 Thông tin liên hệ của cơ sở phân phối

- Tên cơ sở: .........................................................................................................................

- Địa chỉ Văn phòng:, ................số điện thoại...................... Fax .........................................

- Địa chỉ kho bảo quản:......................................................., số điện thoại ..........................

- Giám đốc:........................................................................., số điện thoại ..........................

- Người chịu trách nhiệm chuyên môn: ............................., số điện thoại............................

- Phạm vi kinh doanh: ..........................................................................................................

- Giấy chứng nhận đăng ký kinh doanh số ..........................................................................

- Giấy chứng nhận đủ điều kinh doanh dược số .................................................................

1.2 Các hoạt động phân phối thuốc, nguyên liệu làm thuốc được cấp phép của cơ sở tại địa chỉ trên

- Danh mục các loại sản phẩm phân phối ...........................................................................

- Danh mục các đạt kiểm tra GDP được tiến hành tại cơ sở, bao gồm thông tin về ngày tháng, tên của cơ quan có thẩm quyền thực hiện việc kiểm tra.

- Bản sao của Giấy chứng nhận đăng ký kinh doanh, giấy chứng nhận đủ điều kiện kinh doanh thuốc nếu có.

- Bản sao giấy chứng nhận đủ điều kiện kinh doanh thuốc hoặc Giấy chứng nhận GPP của từng nhà thuốc trong chuỗi, Giấy chứng nhận đạt GDP (trường hợp đã được đánh giá) của cơ sở bán buôn nếu tổ chức chuỗi nhà thuốc.

2. Nhân sự

- Sơ đồ nhân sự của cơ sở, bao gồm vị trí quản lý chất lượng, quản lý kho bảo quản, kiểm tra chất lượng, giao nhận, kinh doanh ..................................................................

- Danh sách nhân sự của cơ sở: tên, chức danh, trình độ chuyên môn,............................

3. Kho bảo quản

- Sơ đồ vị trí địa lý của kho bảo quản thuốc/nguyên liệu làm thuốc/vắc xin sinh phẩm trong mặt bằng tổng thể của cơ sở,

- Bản vẽ thiết kế kho và các khu vực bảo quản cho các sản phẩm khác nhau, các khu vực biệt trữ và xử lý các chất có độc tính cao, hoạt chất nguy hiểm và các nguyên liệu nhạy cảm, (nếu có);

- Mô tả ngắn gọn về các điều kiện bảo quản cụ thể (nếu áp dụng) nhưng không được thể hiện trên các bản vẽ.

4. Danh mục thiết bị bảo quản, phương tiện vận chuyển

- Liệt kê danh mục các thiết bị chính sử dụng để bảo quản, vận chuyển, thời hạn kiểm định thiết bị.

5. Hồ sơ tài liệu

- Mô tả chung về hệ thống hồ sơ tài liệu của cơ sở (ví dụ hệ thống tài liệu điện tử, tài liệu bản cứng).

- Danh mục các quy định, hồ sơ, tài liệu liên quan đến hoạt động phân phối thuốc/ nguyên liệu làm thuốc.

- Danh mục các quy trình, thao tác chuẩn thực hiện việc phân phối thuốc/nguyên liệu làm thuốc

- Báo cáo về hệ thống chất lượng của cơ sở phân phối tổ chức chuỗi nhà thuốc GPP

6. Tự thanh tra

- Mô tả ngắn gọn về hệ thống tự thanh tra của cơ sở, kết quả tự thanh tra và tự đánh giá mức độ đáp ứng đạt yêu cầu GDP của cơ sở.

Mẫu số 06/GDP: Báo cáo thay đổi của cơ sở phân phối

TÊN ĐƠN VỊ CHỦ QUẢN TÊN CƠ SỞ -------	CỘNG HÒA XÃ HỘI CHỦ NGHĨA VIỆT NAM Độc lập - Tự do - Hạnh phúc ---------------
Số: ......../..........	........., ngày…… tháng ..... năm 20…….

BÁO CÁO THAY ĐỔI VỀ THỰC HÀNH TỐT PHÂN PHỐI THUỐC, NGUYÊN LIỆU LÀM THUỐC

Kính gửi: Sở Y tế ........................

Tên cơ sở: .........................................................................................................................

Địa chỉ kho:.........................................................................................................................

Điện thoại: ...................................... Fax: ............................. Email: ...............................

Người liên hệ:........................................................................ Chức danh: .........................

Điện thoại: ...................................... Fax: ............................. Email:.................................

Người chịu trách nhiệm chuyên môn:, ..................................... năm sinh: ........................

Số Chứng chỉ hành nghề dược: ........................................................................................

Nơi cấp;...................................... ...... năm cấp, ............... có giá trị đến .............. (nếu có)

Đã được cấp Giấy chứng nhận đủ điều kiện kinh doanh dược số:................................... ,

ngày cấp: .............. với loại hình và phạm vi kinh doanh (hoặc Đã được cấp Giấy chứng nhận GDP số:......................., ngày cấp:......................... với phạm vi chứng nhận):

.............................................................................................................................................

.............................................................................................................................................

Cơ sở chúng tôi xin báo cáo các nội dung thay đổi như sau:

.............................................................................................................................................

.............................................................................................................................................

Danh mục tài liệu liên quan đến thay đổi (tùy theo loại hình thay đổi, kèm theo các tài liệu tương ứng).

Sau khi nghiên cứu Luật Dược và các quy định khác về hành nghề dược, chúng tôi xin cam đoan thực hiện đầy đủ các văn bản pháp luật, các quy chế chuyên môn dược có liên quan. Đề nghị Sở Y tế.... đánh giá việc đáp ứng GDP đối với thay đổi nêu trên của cơ sở chúng tôi.

Chúng tôi xin gửi kèm bản báo cáo này các tài liệu sau đây:

1. Bản sao Giấy chứng nhận đủ điều kiện kinh doanh dược đã cấp (hoặc Giấy chứng nhận GSP đã cấp cho cơ sở không vì mục đích thương mại);

2. Bản sao Giấy chứng nhận đăng ký kinh doanh (hoặc Tài liệu pháp lý về việc thành lập và chức năng nhiệm vụ của cơ sở không vì mục đích thương mại) (phù hợp với nội dung bổ sung/ thay đổi);

3. Hồ sơ tổng thể của cơ sở đã cập nhật các nội dung thay đổi.

Thủ trưởng đơn vị (Ký, ghi rõ họ tên, đóng dấu)