Circular No. 03/2018/TT-BYT on Good Distribution Practice (GDP) for Medicines and Active Pharmaceutical Ingredients

CIRCULAR

when violating management and operation of on Good Distribution Practices for Medicines and Active Pharmaceutical Ingredients of traditional

                                                             

Pursuant to the Law pursuant to Resolution No. 105/2016/QH13 dated April 6, 2016 on Medicines;

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;

Decree No. 75/2017/NĐ-CP dated 20 the 6 Article 2. The receipt, handling of reflections and petitions from individuals and organizations concerning administrative regulations shall be carried out in accordance with Decree No. 20/2008/NĐ-CP dated February 14, 2008 of the Government on the receipt, handling of reflections and petitions from individuals and organizations concerning administrative regulations (amended and supplemented by Decree No. 48/2013/NĐ-CP dated May 14, 2013 on amending and supplementing certain articles of decrees related to administrative procedure control and Decree No. 92/2017/NĐ-CP dated August 7, 2017 on amending and supplementing certain articles of decrees related to administrative procedure control).7 of the Government 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 stipulate Good Distribution Practices for Medicines and Active Pharmaceutical Ingredients.

 PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates the announcement of application and assessment 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 activities of dividing and moving, storing medicines during the process of transferring from the warehouse of medicine manufacturing facilities, imported medicine warehouses, or distribution facilities to users or other distribution points, or between distribution points using different transportation means.

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

3. Good Distribution Practices for Medicines and Active Pharmaceutical Ingredients is 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 over activities during the distribution process and preventing unauthorized medicines and active pharmaceutical ingredients from entering the distribution system.

5. Non-compliance is deviation from the principles and standards of GDP or current regulations on drug management.

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

7. GDP is the abbreviation for the English term "Good Distribution Practices," which is translated into Vietnamese as "Good Distribution Practices."

Chapter II

ANNOUNCEMENT OF APPLICATION OF GOOD DISTRIBUTION PRACTICES FOR MEDICINES AND ACTIVE PHARMACEUTICAL INGREDIENTS

MEDICINES AND MEDICINE INGREDIENTS

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

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

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

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

Article 4. Subjects Applying the Principles and Standards of Good Distribution Practices for Medicines and Active Pharmaceutical Ingredients

1. Medicine distribution facilities shall implement and comply with GDP as stipulated in Appendix I attached to this Circular and updated documents announced on the Ministry of Health's Electronic Information Portal and the Drug Administration's Electronic Information Website.

2. Active pharmaceutical ingredient distribution facilities shall implement GDP as stipulated in Appendix II attached to this Circular and updated documents announced on the Ministry of Health's Electronic Information Portal and the Drug Administration's Electronic Information Website.

4. Distribution facilities applying updated GDP documents must do so within 12 months if there is a change in storage warehouses or equipment for distributing medicines and active pharmaceutical ingredients, or within six months for other updates, calculated from the date the updated documents are published on the Ministry of Health's Electronic Information Portal or the Drug Administration's Electronic Information Website.

Chapter III

ASSESSMENT OF COMPLIANCE WITH GOOD DISTRIBUTION PRACTICES

MEDICINES AND MEDICINE INGREDIENTS

Article 5. Documents serving as the basis for evaluating compliance with Good Distribution Practices (GDP) for drug distribution

For technical documents on the distribution entity presented according to the overall dossier template as prescribed in Model No. 05 of Appendix IV attached hereto or the updated overall dossier in case of expansion of scope of operations.

2. The documents serving as the basis for evaluating GDP compliance for non-commercial distribution entities include:

b) Technical documents on the distribution entity presented according to the overall dossier template prescribed in Model No. 05 of Appendix IV attached hereto.

3. In cases where the distribution entity applies for both a GDP Compliance Certificate and a Business Registration Certificate for pharmaceutical activities, the distribution entity must clearly state this in the Application Form for a Business Registration Certificate for pharmaceutical activities.

Article 6. Procedure for Evaluating Compliance with Good Distribution Practices for Drugs and Drug Ingredients

The distribution entity submits one set of documents as prescribed in Article 5 of this Circular along with the review fee as stipulated by the Minister of Finance regarding the review fee for standards and conditions for drug and drug ingredient distribution to the Department of Health.

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

b) Clauses 2, 3, 4, and 5 of Article 51 of Decree No. 54/2017/ND-CP for distribution entities that engage in the sale of toxic drugs, toxic drug ingredients; drugs and drug substances listed in the prohibited substance list for certain industries and fields;

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

1. Evaluation process:

a) Step 1. The Evaluation Team announces the Decision establishing the Evaluation Team, its purpose, content, and planned schedule for the evaluation at the distribution entity;

b) Step 2. The distribution entity presents a summary of its organizational structure, personnel, and implementation and application of GDP or specific contents according to the evaluation round;

c) Step 3. The Evaluation Team conducts an on-site evaluation of the implementation and application of GDP at the distribution entity according to specific contents;

d) Step 4. The Evaluation Team meets with the distribution entity to inform of any issues identified during the evaluation (if any); assess the severity of each issue; discuss with the distribution entity in cases where the distribution entity disagrees with the Evaluation Team's assessment of each issue; evaluate the degree of compliance with GDP principles and standards by the distribution entity;

The Evaluation Team is responsible for drafting the GDP Evaluation Minutes according to Model No. 03 prescribed in Appendix IV attached hereto; the minutes must classify the degree of GDP compliance of the distribution entity as stipulated in Clause 2 and Clause 3 of this Article and list and analyze the issues that the distribution entity needs to address (if any); the agreed and disagreed contents between the Evaluation Team and the distribution entity.

The GDP Evaluation Minutes must be signed and confirmed by the Head of the distribution entity and the Leader of the Evaluation Team. The Evaluation Minutes must reflect the composition of the Evaluation Team, location, time, scope of evaluation, and 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 of the distribution entity as stipulated in Appendix IV attached hereto 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.

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 as 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 as prescribed in Appendix IV attached to this Circular.

2. In the case where the 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:

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 document requesting the distribution facility to rectify and correct the issues noted in the assessment report.

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

- 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 as 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 response explaining the reasons for non-issuance.

d) Within six months from the date the Department of Health sends a request for amendment and supplementation, 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 and the supplementary documents still do not meet the requirements, the submitted documents will lose their validity.

3. In the case where the 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 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

"5. The pre-tax weighted average cost of capital i (%) is determined according to the formula below:FOR DRUGS AND DRUG SUBSTANCES

1. The periodic assessment period for compliance with GDP at distribution facilities (including non-commercial distribution facilities and special-purpose pharmaceutical business establishments) is three years 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).

For example, if Facility A is scheduled to be assessed on August 18, 2018, then Facility A must submit its application for assessment to the Department of Health no later than July 18, 2018.

b) Updated technical documentation regarding the physical infrastructure, technical equipment, 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 previous 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 current application for periodic assessment.

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

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

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 a 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.

- If the corrective actions taken by the distribution facility meet the requirements: The Department of Health shall issue a 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 further corrective actions needed and request a supplementary report. The extended period for completing these actions and submitting the report is forty-five days from the date of the notice.

Within five days from the completion of the assessment at the distribution facility and signing of the assessment record, based on the evaluation of 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 of the following measures based on the nature and severity of the violation:

a) Administrative penalties according to laws on administrative violations.

b) Revoke the issued Pharmaceutical Business License and the GDP Certificate (if applicable) in accordance with Article 40 of the Drug Law.

If the distribution facility does not comply with one or more business scopes specified in the issued Pharmaceutical Business License, the Department of Health shall revoke the license to remove the non-compliant business scopes and revoke the GDP Certificate (if applicable) in accordance with Article 40 of the Drug Law and issue a new Pharmaceutical Business License consistent with the compliant business scopes of the distribution facility.

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.

1. The inspection and supervision of compliance with GDP by distribution entities 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 by distribution entities in any of the following cases:

a) The distribution entity has not adequately addressed the requirements as stipulated in point d, Clause 4, Article 11 of this Circular;

b) A distribution entity that complies with GDP at level 2 must undergo an unscheduled assessment at least once within a three-year period from the end date of the previous assessment cycle;

3. The composition 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 entities shall be implemented in accordance with the provisions of Articles 7 and 10 of this Circular.

Chapter V

ASSESSMENT TEAM FOR COMPLIANCE WITH

GOOD DISTRIBUTION PRACTICES FOR MEDICINES AND ACTIVE PHARMACEUTICAL INGREDIENTS

Article 13. Composition and Qualifications of Members 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 members in the Assessment Team shall not exceed five persons.

2. Staff of the Assessment Team must meet the following criteria:

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

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 entity as stipulated in Clause 3 of this Article;

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

3. Conflict of Interest Assessment Principle: An Assessment Team member shall be considered to have a conflict of interest with the assessed distribution entity if they fall into any of the following situations:

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

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

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

d) Their spouse, children, parents, siblings, or parents of their spouse or parents of their partner are working for the assessed distribution entity.

Article 14. Responsibilities and Authorities of the Assessment Team

1. Responsibilities of the Assessment Team

a) Assess all activities of the distribution entity 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, issues identified, and prepare an assessment report;

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

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

2. Authorities of the Inspection Team:

a) Inspect all areas, storage facilities, equipment belonging to the distribution entity, and may request inspections of other related areas concerning drug distribution and storage activities;

b) Request provision of documents and materials related to business operations, quality management, and drug storage activities of the distribution entity;

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

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

đ) Prepare a report and require the distribution entity to temporarily suspend part or all of its distribution activities if serious violations affecting the quality of one or more drug products are found during the assessment, and report to the authority with the power to issue formal decisions for handling.

Chapter VI

IMPLEMENTATION PROVISIONS

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 regarding Good Distribution Practice Principles for Medicines 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

In case the Business Registration Certificate expires, the distribution entity must follow the procedures to apply for a new Business Registration Certificate in accordance with Decree No. 54/2017/NĐ-CP and undergo an assessment of compliance with GDP as stipulated in Chapter III of this Circular.

If the GDP Certificate expires earlier, the distribution entity must follow the procedures to apply for an assessment of continued compliance with GDP as stipulated in Chapter IV of this Circular to continue operations until the expiration date indicated on the Business Registration Certificate.

Article 18. Responsibility for Implementation

1. The Drug Administration Department shall be responsible for:

a) Take the lead and coordinate with relevant units to organize the dissemination of this Circular;

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

c) Compile and publish on the Electronic Information Website of the Drug Administration Department a list of national distribution facilities that have been granted a Certificate of Eligibility to Operate in the Pharmaceutical Business, a GDP Certificate; update the status of the Certificate of Eligibility to Operate in the Pharmaceutical Business, the GDP Certificate, the status of GDP compliance, 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 Drug Administration Department's Electronic Information Website;

đ) Serve as the focal point or coordinate with the Ministry Inspectorate to conduct inspections and audits of compliance with the provisions of this Circular 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 Department of Health, the Health Sector, and traditional medicine and herbal distribution facilities within their assigned functions and tasks;

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

c) Carry out inspection and handling of violations within their authority;

3. Provincial Health Departments are responsible for:

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

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

đ) Regularly report monthly updates on the list of distribution facilities within their jurisdiction that have been granted a Certificate of Eligibility to Operate in the Pharmaceutical Business and the status of GDP compliance as specified in Clause 4, Article 8 of this Circular to the Drug Administration Department;

4. Distribution facilities are responsible for:

a) Organizing the research and implementation of pharmaceutical laws and regulations and the standards set forth in this Circular;

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

During the implementation process, if there are difficulties or obstacles, organizations, entities, and individuals are requested to reflect them to the Ministry of Health for consideration and resolution.