Circular No. 07/2018/TT-BYT detailing certain provisions of the Drug Law and Decree No. 54/2017/NĐ-CP of the Government dated May 8, 2017, providing detailed regulations and implementation measures for the Drug Law.

CIRCULAR

 

Detailed regulations certain provisions on pharmaceutical business under the Drug Law and Decree No. 54/2017/ND-CP dated May 8, 2017 of the Government detailing certain provisions and measures to implement the Drug Law

 

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The Minister of Health issues this Circular qetails certain provisions on pharmaceutical business under the Drug Law and Decree No. 54/2017/ND-CP dated May 8, 2017 of the Government detailing certain provisions and measures to implement the Drug Law. Article 1. Scope

 

PART I

GENERAL PROVISIONS

 

This Circular stipulates detailed regulations on pharmaceutical business, including: đAdjustment

1. Requirements for using language in pharmaceutical practice in Vietnam for foreigners and overseas Vietnamese citizens as provided for in Clause 2, Article 14 of the Drug Law.

2. Notification and public disclosure of the list of persons holding Pharmaceutical Practice Certificates practicing at pharmaceutical business establishments as provided for in Point g, Clause 2, Article 42 of the Drug Law.

3. Activities of establishments engaging in pharmaceutical activities not subject to issuance of a Certificate of Compliance with Conditions for Pharmaceutical Business as provided for in Article 35 of the Drug Law.

4. Sale of medicines listed in the Restricted Retail Medicines List as provided for in Point k, Clause 2, Article 42 of the Drug Law.

5. Additional sale of medicines at pharmacy counters in areas inhabited by ethnic minorities, mountainous regions, islands, and areas with particularly difficult socio-economic conditions as provided for in Point b, Clause 1, Article 48 of the Drug Law.

6. Persons introducing medicines from pharmaceutical business establishments to medical practitioners as provided for in Point b, Clause 6, Article 76 of the Drug Law.

7. Organization and operation of the Advisory Council for Issuing Pharmaceutical Practice Certificates as provided for in Clause 11, Article 6 of Decree No. 54/2017/ND-CP dated May 8, 2017 of the Government detailing certain provisions and measures to implement the Drug Law (hereinafter referred to as Decree No. 54/2017/ND-CP).

This Circular applies to agencies, organizations, and individuals in Vietnam, overseas Vietnamese citizens; foreign organizations and individuals engaged in pharmaceutical practice, pharmaceutical business, or engaging in pharmaceutical activities not subject to issuance of a Certificate of Compliance with Conditions for Pharmaceutical Business in Vietnam.

Article 2. Applicability

REQUIREMENTS FOR LANGUAGE USE

 

Chapter II

IN PHARMACEUTICAL PRACTICE FOR FOREIGNERS AND OVERSEAS VIETNAMESE CITIZENS

Article 3. Requirements for language use in pharmaceutical practice

 

1. The person responsible for pharmaceutical matters at retail drug stores and the clinical pharmacist at medical examination and treatment facilities who are foreigners and overseas Vietnamese citizens must be recognized as proficient in Vietnamese, and if they are not proficient in Vietnamese, they must register their language of use and have an interpreter available as provided for in Article 5 of this Circular.

2. Foreigners and overseas Vietnamese citizens who have not been recognized as proficient in Vietnamese in pharmaceutical practice must indicate "interpreter required during practice" on their Pharmaceutical Practice Certificate. When practicing pharmaceuticals, the application for a Certificate of Compliance with Conditions for Pharmaceutical Business must include a contract with an interpreter meeting the requirements set out in Clauses 1 and 2 of Article 5 of this Circular.

Criteria for recognizing foreigners and overseas Vietnamese citizens as proficient in Vietnamese or proficient in another language in pharmaceutical practice

Article 41. A person practicing pharmaceuticals is recognized as proficient in Vietnamese when they are tested and certified as such by an educational institution specified in Article 6 of this Circular, except in cases provided for in Clause 3 of this Article.2. If a practitioner registers a language other than their native language or Vietnamese for pharmaceutical practice, they must be tested and certified as proficient in that language by an educational institution specified in Article 6 of this Circular, except in cases provided for in Clause 3 of this Article. The language registered for pharmaceutical practice may be one of the following: English, French, Russian, Chinese, Japanese, and Korean.3. A person practicing pharmaceuticals is recognized as proficient in Vietnamese or proficient in another language in pharmaceutical practice without testing if they fall into one of the following categories: a) Hold a diploma in a pharmaceutical or traditional medicine program at the associate degree level or higher issued by a legitimate educational institution in Vietnam or abroad where the language of instruction was Vietnamese or the language registered for pharmaceutical practice as provided for in Clause 2 of this Article; b) Hold a certificate of completion of a pharmaceutical or traditional medicine training course lasting twelve months or more where the language of instruction was Vietnamese or the language registered for pharmaceutical practice as provided for in Clause 2 of this Article; c) Hold a bachelor's degree in a pharmaceutical or traditional medicine program issued by a legitimate educational institution in Vietnam or abroad where the language of instruction was Vietnamese or the language registered for pharmaceutical practice as provided for in Clause 2 of this Article. Diplomas and certificates specified in Points a and b of this Clause must be issued within five years prior to the date of submission of the application.

Criteria for recognizing interpreters as qualified for pharmaceutical practice

1. An interpreter is recognized as qualified for pharmaceutical practice when they are tested and certified by an educational institution specified in Article 6 of this Circular, except in cases provided for in Clause 2 of this Article.

2. An interpreter is recognized as qualified for pharmaceutical practice without testing if they fall into one of the following categories:

a) Hold a diploma in a pharmaceutical or traditional medicine program at the associate degree level or higher issued by a legitimate educational institution in Vietnam or abroad where the language of instruction was the language they intend to interpret for pharmaceutical practice.

b) Hold a certificate from completing a specialized training course in medicine, pharmacy, or traditional medicine with a duration of 12 (twelve) months or more, where the language used during the training is Vietnamese or the language that the practitioner registers to use in their pharmacy practice as stipulated in Clause 2 of this Article;

c) Possess a bachelor's degree in medicine, pharmacy, or traditional medicine issued by a legitimate educational institution in Vietnam or abroad, where the language used during the training is Vietnamese or the language that the practitioner registers to use in their pharmacy practice as stipulated in Clause 2 of this Article;

The certificates and certificates specified in points a and b of this clause must be issued within a period not exceeding 05 (five) years, calculated from the date of submitting the application;

Article 5Criteria for recognizing individuals as having sufficient proficiency in interpreting for pharmacy practice;

1. An individual is recognized as having sufficient proficiency in interpreting for pharmacy practice when they are tested and certified by the educational institution specified in Article 6 of this Circular, except in cases stipulated in Clause 2 of this Article;

2. An interpreter is recognized as having sufficient proficiency in interpreting for pharmacy practice without undergoing testing if they fall under any of the following circumstances:

a) Hold a diploma in a specialized associate degree in medicine, pharmacy, or higher, issued by a legitimate educational institution in Vietnam or abroad, where the language used during the training is the language that the interpreter registers to interpret;

b) Hold a certificate from completing a specialized medical or pharmaceutical training course lasting twelve (12) months or more, with the language used during the training being the language for which the interpreter registers to interpret;

c) Possess a diploma in a specialized medical or pharmaceutical field at the intermediate level or higher and a bachelor's degree in a foreign language that corresponds to the language for which the interpreter registers to interpret.

The certificates and licenses specified in points a and b of Clause 2, Article 4 of this Decree must be issued within no more than five (5) years, calculated from the date of submission of the application.

3. An interpreter may only provide interpreting services for one pharmacist at the same time while the pharmacist is practicing pharmacy.

Article 6. Educational institutions are authorized to conduct examinations and recognize proficiency in Vietnamese or fluency in another language or sufficient interpreting skills in pharmacy practice

Educational institutions are authorized to conduct examinations and recognize proficiency in Vietnamese or fluency in another language or sufficient interpreting skills in pharmacy practice (hereinafter referred to as educational institutions conducting language examinations in pharmacy practice) when meeting the following requirements:

1. Being a specialized university in medicine or pharmacy in Vietnam.

2. Having a department or subject in a foreign language specified in Clause 2, Article 4 of this Circular and meeting the criteria for evaluating Vietnamese language proficiency in specialized fields as stipulated in Circular No. 17/2015/TT-BGDĐT dated September 1, 2015, issued by the Minister of Education and Training on the Vietnamese language proficiency framework for foreigners.

3. Having a bank of examination questions to conduct examinations and recognize proficiency in Vietnamese or fluency in another language or sufficient interpreting skills in pharmacy practice.

Article 7. Documents, This Decree regulates the implementation of electronic linkage for a group of administrative procedures: Registration of establishment of business households - issuance of Certificate of Eligibility for Security and Public Order Conditions - issuance of Certificate of Permission for Eligibility to Operate Karaoke Services (hereinafter referred to as the Electronic Linkage Administrative Procedure for Issuance of Certificate of Permission for Eligibility to Operate Karaoke Services); responsibilities of agencies, organizations, business households, and individuals in implementing administrative procedures. announcing language 教育 including computer-based multiple choice tests education institutions Industry and pharmacy practice

1. Documents:

a) A notice of the educational institution conducting language examinations in pharmacy practice according to Model No. 01 prescribed in Appendix I attached to this Circular;

b) A certified copy of documents proving the establishment and operation of the educational institution;

c) Documents proving the existence of a department or subject in a foreign language as specified in Clause 2, Article 6 of this Circular and a list of full-time faculty members of the department or subject in a foreign language;

d) A bank of examination questions used to examine and recognize proficiency in Vietnamese or fluency in another language or sufficient interpreting skills in pharmacy practice for at least one of the languages specified in Clause 2, Article 4 of this Circular.

2. In cases where an educational institution has been announced as meeting the conditions for conducting examinations and recognizing proficiency in Vietnamese or fluency in another language or sufficient interpreting skills in pharmacy practice and requests to add additional languages specified in Clause 2, Article 4 of this Circular for examination and recognition, the application shall be made in accordance with points a, c, and d of Clause 1 of this Article.

3. Procedures:

a) The educational institution submits one set of application documents for announcement in accordance with Clauses 1 and 2 of this Article to the Ministry of Health (Science and Technology Department);

b) The Ministry of Health (Science and Technology Department) issues to the educational institution a Receipt of Application Documents according to Model No. 02 prescribed in Appendix I attached to this Circular;

c) Within five (5) working days from the date recorded on the Receipt of Application Documents, the Ministry of Health (Science and Technology Department) is responsible for announcing the language examination institution in pharmacy practice on the Ministry of Health’s Electronic Information Portal. If not announced, a written response explaining the reasons must be provided.

Article 8. Cases of revoking the announcement of educational institutions conducting language examinations in pharmacy practice

1. Ceasing operations of language examinations and recognitions in pharmacy practice.

2. Not meeting one of the requirements stipulated in Article 6 of this Circular.

3. Falsifying documents in the application for announcing an educational institution conducting language examinations in pharmacy practice.

Article 9. Procedure for Revoking the Announcement of Language Testing Educational Institutions in the Practice of Pharmacy

1. Within 05 (five) working days from the date of the conclusion of the competent authority containing a recommendation to revoke the announcement or receiving a request to revoke the announcement related to the case stipulated in Article 8 of this Circular, the Ministry of Health (Department of Science, Technology and Training) shall revoke the announcement of language testing educational institutions in the practice of pharmacy under its management; if not revoking the announcement, it must provide a response in writing to the organization or individual making the request to revoke and clearly state the reasons.

2. Within 05 (five) working days from the date of issuing the decision to revoke the announcement of language testing educational institutions in the practice of pharmacy, the Ministry of Health (Department of Science, Technology and Training) shall be responsible for:

a) Publishing the decision to revoke the announcement of language testing educational institutions in the practice of pharmacy on the Ministry of Health's Electronic Information Portal and sending this decision to all Provincial Health Departments nationwide;

b) Updating information on the revocation of the announcement of language testing educational institutions in the practice of pharmacy on the Ministry of Health's Electronic Information Portal.

Article 10. Documents, This Decree regulates the implementation of electronic linkage for a group of administrative procedures: Registration of establishment of business households - issuance of Certificate of Eligibility for Security and Public Order Conditions - issuance of Certificate of Permission for Eligibility to Operate Karaoke Services (hereinafter referred to as the Electronic Linkage Administrative Procedure for Issuance of Certificate of Permission for Eligibility to Operate Karaoke Services); responsibilities of agencies, organizations, business households, and individuals in implementing administrative procedures. requesting examination and recognition of proficiency in Vietnamese or another language or sufficient translation level in pharmacy practice

1. The application dossier for examination and recognition of language proficiency in the practice of pharmacy includes:

a) An application form for examination and recognition of language proficiency in the practice of pharmacy according to Form No. 03 prescribed in Appendix I attached to this Circular;

b) A certified copy of the identity card or citizen identification card or passport or personal identification number or other equivalent document still valid;

c) Two color photographs measuring 04 cm x 06 cm taken against a white background within a period not exceeding six months, calculated from the date of submission of the dossier.

2. Examination and Recognition Procedures:

a) The applicant sends one set of the dossier prescribed in Clause 1 of this Article to the announced language testing educational institution specified in Point c, Clause 3, Article 7 of this Circular;

b) Within 30 days from the date of receipt of complete and valid dossiers, the language testing educational institution issues a certificate according to Form No. 04 prescribed in Appendix I attached to this Circular for cases stipulated in Clauses 1 and 2, Article 4, and Clause 1, Article 5 of this Circular. If a certificate is not issued, a written response must be provided with clear reasons stated.

Within 03 (three) working days from the date of examination results, the educational institution must publicly post the examination results.

3. The application dossier for recognition of proficiency in Vietnamese or another language or sufficient translation level in the practice of pharmacy includes:

a) An application form for recognition of proficiency in Vietnamese or another language or sufficient translation level in the practice of pharmacy according to Form No. 05 prescribed in Appendix I attached to this Circular;

b) The documents and photographs specified in Points b and c of Clause 1 of this Article;

c) A certified copy of the diploma or certificate prescribed in Clause 3, Article 4 of this Circular for cases requesting recognition of proficiency in Vietnamese or another language for the practice of pharmacy; and the diploma or certificate prescribed in Clause 2, Article 5 of this Circular for applicants requesting recognition of sufficient translation level in the practice of pharmacy.

4. Recognition Procedures:

a) The applicant sends one set of the dossier prescribed in Clause 3 of this Article to the announced language testing educational institution specified in Point c, Clause 3, Article 7 of this Circular;

b) Within 10 working days from the date of receipt of complete and valid dossiers, the educational institution issues a certificate according to Form No. 04 prescribed in Appendix I attached to this Circular for cases stipulated in Clause 3, Article 4, and Clause 2, Article 5 of this Circular. If a certificate is not issued, a written response must be provided with clear reasons stated.

Within 03 (three) working days from the date of recognition results, the educational institution must publicly post the recognition results.

 

Chapter III

ANNOUNCEMENT AND PUBLIC DISCLOSURE LIST

INSPECTOR PRACTICE OF PHARMACY

 

Article 11. Notificationof the list of persons holding a Pharmaceutical Practice Certificate currently practicing at the facility to the competent authority Within thirty (30) days from the date of commencement of operations or any change in the personnel holding a Pharmaceutical Practice Certificate currently practicing, the pharmaceutical business establishment must notify the Department of Health of the province or centrally governed city (hereinafter referred to as the Department of Health) where the pharmaceutical business establishment operates of the list of persons holding a Pharmaceutical Practice Certificate currently practicing at the establishment, providing information according to Form No. 06 prescribed in Appendix I attached hereto, along with an electronic file or updating online in accordance with the guidance of the Department of Health.

Article 12. Public Disclosure

of the list of persons holding a Pharmaceutical Practice Certificate Within five (5) working days from the date of receipt of the list of persons holding a Pharmaceutical Practice Certificate currently practicing at the establishment operating within its jurisdiction, the Department of Health shall be responsible for publicly disclosing on the Department of Health's Electronic Information Portal the list of persons holding a Pharmaceutical Practice Certificate in accordance with Article 11 of this Circular.

ACTIVITIES OF ESTABLISHMENTS ENGAGED IN PHARMACEUTICAL ACTIVITIES

 

Chapter IV

NOT SUBJECT TO ISSUANCE OF A LICENSE FOR LEGAL BUSINESS OPERATIONS

General provisions on establishments engaged in pharmaceutical activities not for commercial purposes

 

Article 13. 1. An establishment engaged in pharmaceutical activities not for commercial purposes is an entity that does not register its operations under the Enterprise Law, engaging in pharmaceutical activities as stipulated in Clause 2 of this Article, including the following entities: a) Public service units;

b) Establishments belonging to armed forces participating in service provision under self-financing mechanisms or pricing regulations set by the Government, excluding cases specified in Point d, Clause 1, Article 35 of the Medicine Law;

c) Pharmacy departments of medical examination and treatment facilities; vaccine and medicine storage warehouses of expanded immunization facilities.

2. Pharmaceutical activities not for commercial purposes include production, compounding, processing, storage, transportation, distribution, testing, and clinical trials of medicines and raw materials for medicines.

3. The assessment of compliance with Good Practices for establishments engaged in pharmaceutical activities not for commercial purposes shall be carried out in accordance with the regulations on Good Practices issued by the Minister of Health. Establishments engaged in pharmaceutical activities not for commercial purposes shall implement Good Practices in accordance with the timeline set forth in Article 142 of Decree No. 54/2017/NĐ-CP.

Article 14. Documents and Procedures for Announcing Establishments Engaged in Retail Pharmacy Operations

1. Documents for announcing establishments engaged in retail pharmacy operations

a) Declaration of an establishment engaged in retail pharmacy operations according to Form No. 07 prescribed in Appendix I attached hereto;

b) Copy of the Decision on Establishment or Investment Certificate or Business Registration Certificate of the establishment, certified and stamped by the establishment;

c) Certified copy of the primary pharmaceutical qualification or higher of the person responsible for professional matters;

d) List of medicines intended to be sold at the pharmacy counter. This list must be within the list of medicines allowed to be sold at the pharmacy counter as prescribed in Appendix II attached hereto;

đ) Photographs of the medicine storage cabinets, counters, and shelves;

e) Quality control and monitoring procedures: quality of medicines; import and export of medicines by the establishment.

2. Procedures for announcing establishments engaged in retail pharmacy operations

a) Prior to commencing operations, an establishment engaged in retail pharmacy operations shall submit directly or send via postal mail one set of documents for announcing an establishment engaged in retail pharmacy operations as stipulated in Clause 1 of this Article to the Department of Health where the establishment is located;

b) Upon receiving the documents, the Department of Health shall issue a Receipt for Submission of Documents for Announcement to the establishment engaged in retail pharmacy operations according to Form No. 02 prescribed in Appendix I attached hereto;

c) Within five (5) working days from the date recorded on the Receipt for Submission of Documents for Announcement, the Department of Health shall be responsible for publicly disclosing on the Department of Health's Electronic Information Portal the list of establishments engaged in retail pharmacy operations meeting the conditions. In case of non-disclosure, a written response stating the reasons must be provided.

b) When receiving the application, the Department of Health issues to the business entity operating a pharmaceutical display shelf a Receipt for Application Submission according to Form No. 02 as prescribed in Appendix I attached to this Circular;

c) Within 05 (five) working days from the date recorded on the Receipt for Application Submission, the Department of Health is responsible for publishing on its Electronic Information Website the list of business entities operating a pharmaceutical display shelf that meet the conditions. In case of non-publication, a written response must be provided stating the reasons;

Article 15. Cases for Revoking the Announcement of Business Establishments with Pharmacy Shelves

1. Termination of the operation of pharmacy shelves or termination of the operation of business establishments with pharmacy shelves.

2. Failure to meet one of the requirements for business establishments with pharmacy shelves stipulated in point b, Clause 2, Article 35 of the Medicine Law.

3. The content of the announcement of business establishments with pharmacy shelves is beyond the authority or contains content contrary to the law.

4. Forgery of documents in the announcement file of business establishments with pharmacy shelves.

5. Not operating continuously for 12 (twelve) months without notifying the Department of Health where the establishment is located.

Article 16. Procedures for Revoking the Announcement of Business Establishments with Pharmacy Shelves

1. Within 05 (five) working days from the date of the conclusion of the competent authority in which it recommends revocation of the announcement or receives a request for revocation related to the cases specified in Article 15 of this Circular, the Department of Health shall revoke the announcement of business establishments with pharmacy shelves under its management jurisdiction; if not revoked, it must provide a written response to the organization or individual requesting revocation and clearly state the reasons.