Circular No. 07/2018/TT-BYT dated April 12, 2018 of the Ministry of Health on detailing a number of articles of the Law on Pharmacy and the Government’s Decree No. 54/2017/ND-CP of May 8, 2017, detailing a number of articles of, and providing measures for implementing, the Law on Pharmacy

CIRCULAR

Detailing a number of articles on pharmaceutical business of the Law on Pharmacy and the Government’s Decree No. 54/2017/ND-CP of May 8, 2017, detailing a number of articles of, and providing measures for implementing, the Law on Pharmacy^[1]

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

Pursuant to the Government’s Decree No. 54/2017/ND-CP of May 8, 2017, detailing a number of articles of, and providing measures for implementing, the Law on Pharmacy;

Pursuant to the Government’s Decree No. 75/2017/ND-CP of June 20, 2017, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of the Director of the Drug Administration of Vietnam;

The Minister of Health promulgates the Circular detailing a number of articles on pharmaceutical business of the Law on Pharmacy and the Government’s Decree No. 54/2017/ND-CP of May 8, 2017, detailing a number of articles of, and providing measures for implementing, the Law on Pharmacy.

Chapter I

GENERAL PROVISIONS

Article 1.Scope of regulation

This Circular provides in detail pharmaceutical business, covering:

1. Language requirements in pharmacy practice in Vietnam for foreigners and overseas Vietnamese as prescribed in Clause 2, Article 14 of the Law on Pharmacy.

2. Public notification of the list of persons who possess a pharmacy practice certificate and are practicing at pharmaceutical business establishments as prescribed at Point g, Clause 2, Article 42 of the Law on Pharmacy.

3. Operation of establishments engaged in pharmacy activities not requiring a certificate of eligibility for pharmaceutical business prescribed in Article 35 of the Law on Pharmacy.

4. Sale of drugs on the list of drugs restricted from retail as prescribed at Point k, Clause 2, Article 42 of the Law on Pharmacy.

5. Sale of other drugs at dispensaries in ethnic minority areas, mountainous areas, on islands and in areas with extremely difficult socio-economic conditions as prescribed at Point b, Clause 1, Article 48 of the Law on Pharmacy.

6. Pharmaceutical business establishments’ employees who provide drug information to medical practitioners as prescribed at Point b, Clause 6, Article 76 of the Law on Pharmacy.

7. Organization and operation of advisory councils for grant of pharmacy practice certificates as prescribed in Clause 11, Article 6 of the Government’s Decree No. 54/2017/ND-CP of May 8, 2017, detailing a number of articles of, and providing measures for implementing, the Law on Pharmacy (below referred to as Decree No. 54/2017/ND-CP.)

Article 2.Subjects of application

This Circular applies to Vietnamese agencies, organizations and individuals; overseas Vietnamese; and foreign organizations and individuals engaged in pharmacy practice, pharmaceutical business, or pharmacy activities not requiring a certificate of eligibility for pharmaceutical business in Vietnam.

Chapter II

LANGUAGE REQUIREMENTS IN PHARMACY PRACTICE FOR FOREIGNERS AND OVERSEAS VIETNAMESE

Article 3.Language requirements in pharmacy practice

1. Persons in charge of professional pharmacy activities at drug retailing establishments and persons in charge of clinical pharmacy at health establishments who are foreigners or overseas Vietnamese must be those recognized as being fluent in Vietnamese. Those who are not fluent in Vietnamese shall register another language for use in pharmacy practice and have interpreters meeting the requirements prescribed in Article 5 of this Circular.

2. For foreigners or overseas Vietnamese who have not yet been recognized as being fluent in Vietnamese for pharmacy practice, their pharmacy practice certificates must have the phrase “requiring interpreters for conducting professional practice”. When conducting pharmaceutical practice, their dossiers of application for grant of a certificate of eligibility for pharmaceutical business must comprise contracts signed with interpreters meeting the requirements prescribed in Clauses 1 and 2, Article 5 of this Circular.

Article 4.Criteria for recognizing foreigners and overseas Vietnamese as being fluent in Vietnamese or other languages in pharmacy practice

1. A pharmacy practitioner shall be recognized as being fluent in Vietnamese in pharmacy practice when he/she is tested and recognized by an education institution prescribed in Article 6 of this Circular, except the cases prescribed in Clause 3 of this Article.

2. In case a pharmacy practitioner registers a language other than his/her mother tongue or Vietnamese for use in pharmacy practice, he/she shall be tested and recognized by an education institution prescribed in Article 6 of this Circular as being fluent in such language, except the cases prescribed in Clause 3 of this Article. Pharmacy practitioners may register one of the following languages for use in pharmacy practice: English, French, Russian, Chinese, Japanese and Korean.

3. A pharmacy practitioner shall be recognized as being fluent in Vietnamese or another language in pharmacy practice without having to sit an exam if falling into one of the following cases:

a/ Possessing an intermediate degree in medicine, pharmacy or traditional medicine issued by a lawful Vietnamese or foreign training institution after completing a training course using Vietnamese or the language he/she registers for use in pharmacy practice as prescribed in Clause 2 of this Article;

b/ Possessing a certificate of completion of a training course on medicine, pharmacy or traditional medicine of a term of 12 (twelve) months or longer using Vietnamese or the language he/she registers for use in pharmacy practice as prescribed in Clause 2 of this Article;

c/ Possessing a university degree in medicine, pharmacy or traditional medicine issued by a lawful Vietnamese or foreign training institution after completing a training course using Vietnamese or the language he/she registers for use in pharmacy practice as prescribed in Clause 2 of this Article.

The degrees and certificates prescribed at Points a and b of this Clause must be those issued no more than 5 (five) years before the date of dossier submission.

Article 5.Criteria for recognition of persons being qualified for acting as interpreters in pharmacy practice

1. A person will be recognized as being qualified for acting as an interpreter in pharmacy practice after being tested and recognized by an education institution prescribed in Article 6 of this Circular, except the cases prescribed in Clause 2 of this Article.

2. An interpreter shall be recognized as being qualified for acting as an interpreter in pharmacy practice without having to sit an exam if falling into one of the following cases:

a/ Possessing an intermediate or higher degree in medicine or pharmacy issued by a lawful Vietnamese or foreign training institution after completing a training course using the language he/she registers for use in practicing as an interpreter;

b/ Possessing a certificate of completion of a training course on medicine or pharmacy of a term of at least 12 (twelve) months using the language he/she registers for use in practicing as an interpreter;

c/ Possessing an intermediate or higher degree in medicine, pharmacy or traditional medicine and a university degree in foreign language suitable to the language he/she registers for use in practicing as an interpreter.

The degrees and certificates prescribed at Points a and b, Clause 2 of this Article must be those issued no more than 5 (five) years before the date of dossier submission.

3. A person may work as an interpreter for only one pharmacy practitioner during the period when such practitioner practices his/her profession.

Article 6.Education institutions conducting testing and recognition of fluency in Vietnamese or other languages or qualification for acting as interpreters in pharmacy practice

Education institutions may conduct testing and recognition of fluency in Vietnamese or other languages or qualification for acting as interpreters in pharmacy practice (below referred to as education institution conducting language competency testing serving pharmacy practice) if meeting the following requirements:

1. Being a Vietnam’s medicine or pharmacy university.

2. Having a faculty or division of one of the languages specified in Clause 2, Article 4 of this Circular and meeting the requirements for evaluation of competency of Vietnamese language use in professional practice under the Minister of Education and Training’s Circular No. 17/2015/TT-BGDDT of September 1, 2015, promulgating the Framework of Vietnamese language competency for foreigners.

3. Having a question bank for testing and recognition of fluency in Vietnamese or other languages or qualification for acting as interpreters in pharmacy practice.

Article 7.Dossiers and procedures for announcement of education institutions eligible for conducting language competency testing serving pharmacy practice

1. A dossier must comprise:

a/ An announcement of education institution’s eligibility for conducting language competency testing serving pharmacy practice, made according to Form No. 01 in Appendix I to this Circular;

b/ Certified copies of papers proving the establishment and operation of the education institution;

c/ Papers proving the existence of the foreign-language faculty or division prescribed in Clause 2, Article 6 of this Circular and a list of full-time lecturers of the faculty or division;

d/ The question bank used for testing and recognition of fluency in Vietnamese or other languages or qualification for acting as interpreters in pharmacy practice for at least one of the languages prescribed in Clause 2, Article 4 of this Circular.

2. In case an education institution which has been announced as being eligible for conducting testing and recognition of fluency in Vietnamese or other languages or qualification for acting as interpreters in pharmacy practice now requests for addition of another language prescribed in Clause 2, Article 4 of this Circular, the dossier must comprise the papers specified at Points a, c and d, Clause 1 of this Article.

3. Procedures:

a/ The education institution shall send 1 set of dossier of request for announcement prescribed in Clause 1 or 2 of this Article to the Ministry of Health (the Administration of Science, Technology and Training);

b/ The Ministry of Health (the Administration of Science, Technology and Training) shall issue a dossier receipt made according to Form No. 2 in Appendix I to this Circular;

c/ Within 5 (five) working days from the date stated in the dossier receipt, the Ministry of Health (the Administration of Science, Technology and Training) shall announce on its portal the education institution’s eligibility for conducting language competency testing serving pharmacy practice. In case of refusal, it shall issue a written reply clearly stating the reason.

Article 8.Cases of cancellation of announcement of an education institution’s eligibility for conducting language competency testing serving pharmacy practice

1. The institution terminates activities of language competency testing and recognition serving pharmacy practice.

2. The institution no longer meets one of the requirements prescribed in Article 6 of this Circular.

3. The papers in dossiers of request for announcement of eligibility for conducting language competency testing serving pharmacy practice have been forged.

Article 9.Procedures for cancellation of announcement of eligibility for conducting language competency testing serving pharmacy practice

1. Within 5 (five) working days after receiving a competent agency’s conclusions proposing cancellation of announcement of an education institution’s eligibility for conducting language competency testing serving pharmacy practice or after receiving a request for cancellation of announcement concerning a case prescribed in Article 8 of this Circular, the Ministry of Health (the Administration of Science, Technology and Training) shall cancel the announcement of eligibility according to its competence; if deciding not to cancel the announcement, it shall issue a written reply clearly stating the reason to the cancellation requester.

2. Within 5 (five) working days after issuing a decision on cancellation of an education institution’s eligibility for conducting language competency testing serving pharmacy practice, the Ministry of Health (the Administration of Science, Technology and Training) shall:

a/ Publish the decision on its portal and send it to provincial-level Health Departments nationwide;

b/ Update on its portal information on cancellation of the education institution’s eligibility for conducting examination of languages serving pharmacy practice.

Article 10.Dossiers and procedures for request for testing and recognition of fluency in Vietnamese or other languages or qualification for acting as interpreters in pharmacy practice

1. A dossier for request for testing and recognition as being fluent in a language in pharmacy practice must comprise:

a/ A request for testing and recognition as being fluent in a language serving pharmacy practice, made according to Form No. 3 in Appendix I to this Circular;

b/ A certified copy of the requester’s people’s identity card or citizen identity card or passport or personal identity number sheet or an equivalent paper which remains valid;

c/ Two 4 cm x 6 cm white-background color photos, taken no more than 6 months before the date of dossier submission.

2. Procedures for testing and recognition:

a/ The requester shall send 1 set of dossier prescribed in Clause 1 of this Article to an education institution announced as eligible for conducting language competency testing serving pharmacy practice as prescribed at Point c, Clause 3, Article 7 of this Circular;

b/ Within 30 days after receiving a complete and valid dossier, the education institution shall conduct examination and issue a certificate, made according to Form No. 4 in Appendix I to this Circular, for the cases prescribed in Clauses 1 and 2, Article 4; and Clause 1, Article 5, of this Circular. In case of refusal to issue a certificate, it shall issue a written reply clearly stating the reason.

The education institution shall publicly notify testing results within 3 (three) working days after obtaining such results.

3. A dossier of request for recognition as being fluent in Vietnamese or other languages or being qualified for acting as interpreters in pharmacy practice must comprise:

a/ A request for recognition as being fluent in Vietnamese or other languages or being qualified for acting as interpreters in pharmacy practice, made according to Form No. 5 provided in Appendix I to this Circular;

b/ The papers and photos as prescribed at Points b and c, Clause 1 of this Article;

c/ Certified copies of the degrees and certificates prescribed in Clause 3, Article 4 of this Circular, for the cases of requesting recognition of being fluent in Vietnamese or other languages serving pharmacy practice, or of the degrees and certificates prescribed in Clause 2, Article 5, of this Circular, for the cases of requesting recognition as being qualified for acting as interpreters in pharmacy practice.

4. Procedures for recognition:

a/ The requester shall send 1 set of dossier prescribed in Clause 3 of this Article to an education institution announced as eligible for conducting language competency testing serving pharmacy practice prescribed at Point c, Clause 3, Article 7 of this Circular;

b/ Within 10 working days after receiving a complete and valid dossier, the education institution shall issue a certificate, made according to Form No. 4 in Appendix I to this Circular, for the cases prescribed in Clause 3, Article 4; and Clause 2, Article 5, of this Circular. In case of refusal to issue a certificate, it shall issue a written reply clearly stating the reason.

The education institution shall publicly notify recognition results within 3 (three) working days after obtaining such results.

Chapter III

REPORTING AND PUBLISHING LISTS OF PHARMACY PRACTITIONERS

Article 11.Reporting to competent agencies lists of persons possessing a pharmacy practice certificate and currently practicing at establishments

Within 30 (thirty) days after commencing operation or having a change with regard to persons possessing a pharmacy practice certificates and currently practicing at their establishments, pharmacy business establishments shall notify provincial-level Departments of Health of the localities where they are operating of the list of persons possessing a pharmacy practice certificate and currently practicing at establishments, made according to Form No. 06 in Appendix I to this Circular, enclosed with its electronic file, or update the list online under the guidance of the provincial-level Departments of Health.

Article 12.Publishing the list of persons possessing a pharmacy practice certificate

Within 5 (five) working days after receiving a list of persons possessing a pharmacy practice certificate and practicing at an establishment in its locality, a provincial-level Department of Health shall publish such list on its website as prescribed in Article 11 of this Circular.

Chapter IV

OPERATION OF ESTABLISHMENTS ENGAGED IN PHARCEUTICAL ACTIVITIES NOT REQUIRING A CERTIFICATE OF ELIGIBILITY FOR PHARMACEUTICAL BUSINESS

Article 13.General provisions on establishments engaged in non-commercial pharmaceutical activities

1. Establishments engaged in non-commercial pharmaceutical activities are establishments which do not register operation under the Law on Enterprises and are engaged in the pharmaceutical activities prescribed in Clause 2 of this Article, including:

a/ Non-business units;

b/ Armed forces units providing services under the financial autonomy or pricing mechanism prescribed by the Government and not falling into the case prescribed at Point d, Clause 1, Article 35 of the Law on Pharmacy;

c/ Pharmacy departments of health establishments; and vaccine and drug stores of expanded immunization establishments.

2. Non-commercial pharmaceutical activities include activities of manufacturing, preparing, processing, preserving, transporting and distributing drugs and drug materials; testing drugs and drug materials; testing bioequivalence of drugs, and conducting clinical trial of drugs.

3. The assessment of satisfaction of good practice criteria for establishments engaged in non-commercial pharmaceutical activities must comply with good practice regulations promulgated by the Minister of Health. Establishments engaged in non-commercial pharmaceutical activities shall comply with the good practice roadmap prescribed in Article 142 of Decree No. 54/2017/ND-CP.

Article 14.Dossiers and procedures for announcing business establishments with drug dispensaries

1. A dossier of request for announcement of a business establishment with drug dispensaries must comprise:

a/ An announcement of a business establishment with drug dispensaries, made according to Form No. 7 in Appendix I to this Circular;

b/ A copy of the establishment decision or investment certificate or enterprise registration certificate bearing the signature and seal of such establishment;

c/ A certified copy of the diploma or certificate of elementary or higher degree in pharmacy of the person in charge of professional pharmacy activities;

d/ A list of drugs expected to be sold at drug dispensaries, which must be those permitted for sale at drug dispensaries as provided in Appendix II to this Circular;

dd/ Photos of drug cabinets, counters and dispensaries;

e/ A process of inspecting and controlling drug quality and drug export and import by the establishment.

2. Procedures for announcing business establishments with drug dispensaries

a/ Before commencing operation, a business establishment with drug dispensaries shall submit directly or send by post 1 set of dossier of request for declaration of a business establishment with drug dispensaries as prescribed in Clause 1 of this Article to the provincial-level Department of Health of the locality where the establishment is located;

b/ Upon receiving the dossier, the provincial-level Department of Health shall issue a dossier receipt, made according to Form No. 02 in Appendix I to this Circular;

c/ Within 5 (five) working days from the date stated in the dossier receipt, the provincial-level Department of Health shall announce on its website the list of eligible business establishments with drug dispensaries. If refusing to make an announcement, the provincial-level Department of Health shall issue a written reply stating the reason.

Article 15.Cases of cancellation of announcement of a business establishment with drug dispensaries

1. The establishment terminates the operation of drug dispensaries or terminates its operation.

2. The establishment fails to satisfy one of the conditions on a business establishment with drug dispensaries specified at Point b, Clause 2, Article 35 of the Law on Pharmacy.

3. The contents of announcement of a business establishment with drug dispensaries are made ultra vires or illegal.

4. The papers in the dossier of request for announcement of a business establishment with drug dispensaries have been forged.

5. The establishment has not operated for 12 (twelve) consecutive months without notifying such to the provincial-level Department of Health of the locality where the establishment is located.

Article 16.Procedures for canceling announcement of a business establishment with drug dispensaries

1. Within 5 (five) working days after obtaining a competent agency’s conclusion which proposes cancellation of the announcement of a business establishment with drug dispensaries, or after receiving the request for cancellation of announcement concerning one of the cases specified in Article 15 of this Circular, the provincial-level Department of Health shall cancel the announcement of the business establishment with drug dispensaries under its management; if deciding not to cancel the announcement, it shall issue a written reply to the cancellation requester, stating the reason.

2. Within 5 (five) working days after issuing a decision canceling the announcement of a business establishment with drug dispensaries, the provincial-level Department of Health shall:

a/ Publish this decision on its website and send it to the Ministry of Health and other provincial-level Departments of Health nationwide;

b/ Update on its website the information on cancellation of the announcement of business establishments with drug dispensaries.

Article 17.Responsibilities of establishments engaged in pharmacy activities not requiring a certificate of eligibility for pharmaceutical business

1. To have a signboard showing the name and address, and person in charge of professional pharmacy activities, of the establishment; and form, scope and areas of operation of the establishment.

2. To take responsibility for the satisfaction and maintenance of the conditions on operation of the establishment; and origin and quality of drugs supplied by the establishment.

Chapter V

SALE OF DRUGS ON THE LIST OF DRUGS RESTRICTED FROM RETAIL AND SALE OF OTHER DRUGS AT DRUG DISPENSARIES

Article 18.List of drugs restricted from retail

1. Drugs restricted from retail are drugs subject to the requirements on strict supervision of prescription, prescription-based sale and use to ensure safety and effect of drugs, and prevent drug abuse in treatment which is likely to cause drug dependence or nonresponse to drugs when patients use such drugs or other drugs.

2. The list of drugs restricted from retail is provided in Appendix III to this Circular.

Article 19.Sale of drugs on the list of drugs restricted from retail

Based on the local disease structure, provincial-level Departments of Health shall issue a written permission for retail of a number of drugs on the list of drugs restricted from retail prescribed in Article 55 of Decree No. 54/2017/ND-CP. The local disease structure shall be determined based on annual health statistics, surveys and scientific researches already announced.

Article 20.Sale of other drugs at drug dispensaries in ethnic minority areas, mountainous areas, on islands and in areas with extremely difficult socio-economic conditions

Based on the local disease structure determined under Article 19 of this Circular, provincial-level Departments of Health shall issue a written permission for drug dispensaries in ethnic minority areas, mountainous areas, on islands and in areas with extremely difficult socio-economic conditions to sell a number of other types of prescription drugs outside the list of essential drugs.

Chapter VI

DRUG INFORMATION PROVIDERS OF PHARMACEUTICAL BUSINESS ESTABLISHMENTS

Article 21.Requirements on drug information providers

1. Drug information provider is a person recruited by a pharmaceutical business establishment and granted a drug information provider’s card by the head of such establishment to provide drug information to medical practitioners.

2. A drug information provider must satisfy the following requirements:

a/ Possessing a collegial or higher degree in medicine or pharmacy;

b/ Being recruited and trained by a pharmaceutical business establishment in professional operations and skills related to drug information provision and legal documents on pharmacy.

3. The following persons may not be recruited to work as drug information providers:

a/ Being examined for penal liability or serving a court’s judgment or decision; or being banned from practicing or performing a job related to pharmacy activities under a court’s judgment or decision;

b/ Having limited civil act capacity.

Article 22.Responsibilities of drug information providers

1. To wear drug information provider’s cards granted by pharmaceutical business establishments and comply with internal rules issued by health establishments under Clause 2, Article 24 of this Circular when providing drug information. To provide drug information only after obtaining the consent of medical practitioners.

2. To provide information about drugs permitted for sale in Vietnam which are on the list of drugs designated by pharmaceutical business establishments and provide only drug information written in the registered drug labels and use instruction inserts or drug information certified by a competent agency of the Ministry of Health.

3. To produce legal materials proving that drug information is valid at the request of the heads of health establishments or of medical practitioners.

4. To collect reports on adverse drug reactions and reports on quality of drugs introduced for pharmaceutical business establishments to summarize and submit them to a competent agency of the Ministry of Health under national guidelines for pharmacovigilance issued by the Ministry of Health.

5. To refrain from:

a/ Providing drug information inconsistent with the information registered and certified at competent state agencies, or issuing materials on drug information not yet certified by competent state agencies;

b/ Providing drug information about drugs not designated by pharmaceutical business establishments;

c/ Using material benefits in any form to influence physicians or drug users in order to promote the prescription, trading and use of drugs;

d/ Providing drug information inconsistent with the documents specified in Clause 3, Article 76 of the Law on Pharmacy;

dd/ Giving comparisons and introductions stating that their establishments’ drugs are better than others’ without supporting scientific documents approved by competent agencies;

e/ Providing information about products other than drugs;

g/ Carrying out activities related to the purchase, sale and deposit of drugs with medical practitioners;

h/ Accessing patients, medical records or drug prescriptions, or making discussions with, or requesting provision of information about, patients;

i/ Issuing drug information documents to the entities other than those certified by competent agencies of the Ministry of Health.

Article 23.Responsibilities of heads of pharmaceutical business establishments where drug information providers practice

1. To take responsibility for the operation of, and drug information provided by, drug information providers of their establishments.

2. To provide training for drug information providers recruited by their establishments to satisfy the requirements specified in Clause 2, Article 21 of this Circular.

3. To provide drug information providers with adequate legal papers and professional and technical materials to ensure that drug information provided by drug information providers is valid under this Circular.

4. To grant drug information provider’s cards, made according to Form No. 08 in Appendix I to this Circular, to drug information providers of their establishments who satisfy the conditions specified in Clause 2, Article 21 of this Circular.

5. Within 7 (seven) working days from the date of grant of drug information provider’s cards, a pharmaceutical business establishment shall send the list of card holders, made according to Form No. 09 in Appendix I to this Circular, enclosed with an electronic file, or send online this list to the provincial-level Department of Health of the locality where the drug information providers practice under the latter’s guidance.

In case of addition or replacement of a drug information provider, the pharmaceutical business establishment shall grant a modified drug information provider’s card and update the modified list of drug information providers according to the procedures for initial grant of a drug information provider’s card.

6. A drug information provider’s card shall be revoked in the following cases:

a/ The drug information provider terminates his/her labor contract with the pharmaceutical business establishment;

b/ The drug information provider no longer practices;

c/ The drug information provider falls into one of the cases specified in Clause 3, Article 21 of this Circular;

d/ The drug information provider commits one of the acts specified in Clause 5, Article 22 of this Circular.

7. Within 7 (seven) working days from the date of revocation of drug information provider’s cards, the pharmaceutical business establishment shall send the list of persons who have their drug information provider’s cards revoked, made according to Form No. 10 in Appendix I to this Circular, enclosed with an electronic file, or send online this list to the provincial-level Department of Health of the locality where the drug information providers practice under the latter’s guidance.

8. A drug information provider’s card shall not be re-granted within 12 (twelve) months from the date of its revocation for the persons falling into the case specified at Point d, Clause 6 of this Article.

Article 24.Responsibilities of heads of health establishments where drug information providers practice

1. To permit only persons who possess drug information provider’s cards to provide drug information and distribute drug information documents permitted for circulation or certified by competent state agencies of the Ministry of Health.

2. To issue, and organize the implementation of, internal rules on the participants in, and place and time of holding, meetings to provide drug information for medical practitioners, and other relevant regulations for drug information providers to practice at the health establishments in accordance with this Circular.

3. To take measures to prevent acts of providing drug prescriptions and use instructions committed by medical practitioners of the health establishments for profit-making purpose as a result of being influenced by material or financial benefits or in any other form by drug information providers.

4. To immediately stop drug information providers from practicing within the health establishments when detecting their failure to perform their responsibilities prescribed in Article 22 of this Circular.

Article 25.Responsibilities of a provincial-level Department of Health of the locality where drug information providers practice

1. To announce, or cancel the announcement of, the list of persons who are granted drug information provider’s cards on its website within 7 (seven) working days after receiving this list or the list of persons who have their drug information provider’s cards revoked under Clause 5 or 7, Article 23 of this Circular.

2. To direct health establishments in the locality to ensure that their heads fully perform the responsibilities prescribed in Article 24 of this Circular when drug information providers practice in their establishments.

3. To examine and inspect drug information provision activities; to handle violations committed by drug information providers and pharmaceutical business establishments where drug information providers practice in the locality in order to ensure compliance with this Circular.

Chapter VII

ORGANIZATION AND OPERATION OF ADVISORY COUNCILS FOR GRANT OF PHARMACY PRACTICE CERTIFICATES

Article 26.Formation of councils

1. The Minister of Health shall issue a decision forming the Advisory Council for Grant of Pharmacy Practice Certificates after Test (below referred to as the Ministry of Health’s Advisory Council).

2. Directors of provincial-level Departments of Health shall issue decisions forming advisory councils for grant of pharmacy practice certificates after consideration of application dossiers (below referred to as advisory councils of provincial-level Departments of Health).

Article 27.Composition of a council

1. An advisory council of a provincial-level Department of Health must have at least 5 (five) members, including the chairperson, vice chairperson, secretary and other members, who are a leader of the provincial-level Department of Health, and representatives of leaders of related specialized divisions, representatives of the pharmacy association, the state management agency in charge of education, and a public university or college as prescribed in Clause 3 of this Article, and officers of related units of the provincial-level Department of Health.

2. The Ministry of Health’s Advisory Council must have at least 5 (five) members, including the chairperson, vice chairperson, secretary and other members, who are a leader of the Ministry of Health, a leader of the Drug Administration of Vietnam, a leader of the Agency of Administration of Traditional Medicine in case pharmacy practice covers only trading in medicinal materials and traditional drugs, a leader of the Agency of Science, Technology and Training, a leader of the Department of Legal Affairs, representatives of the pharmacy association, the state management agency in charge of education, and a public university or college as prescribed in Clause 3 of this Article, and officers of related units of the Ministry of Health.

3. In case a professional title has not been identified in the applicant’s diploma as prescribed in Article 17 of Decree No. 54/2017/ND-CP, the advisory council must have representatives of the state management agency in charge of education and a public university or college.

4. In case a member of the advisory council is a representative of a unit or an organization, he/she must be the head of or a person assigned by such unit or organization.

Article 28.Operation of advisory councils

1. An advisory council shall formulate its operation regulation and submit it to the Minister of Health or director of the provincial-level Department of Health for approval, and organize the implementation of this regulation after it is approved.

2. An advisory council shall advise agencies granting pharmacy practice certificates on the grant, re-grant and revocation of pharmacy practice certificates.

Chapter VIII

IMPLEMENTATION PROVISIONS

Article 29.Effect

1. This Circular takes effect on June 1, 2018.

2. The Minister of Health’s Circular No. 13/2009TT-BYT of September 1, 2009, guiding drug information and advertising activities, ceases to be effective on the date this Circular takes effect.

Article 30.Reference provision

In case the legal documents and regulations referred to in this Circular are amended, supplemented or replaced, the new ones shall apply.

Article 31.Transitional provisions

1. From January 1, 2019, pharmacy practitioners defined in Clause 1, Article 3 of this Circular who are granted pharmacy practice certificates before the effective date of this Circular must have interpreters or must satisfy the language requirements for pharmacy practice specified in this Circular.

2. Persons who are granted drug information provider’s cards under the Minister of Health’s Circular No. 13/2009TT-BYT of September 1, 2009, guiding drug information and advertising activities, may continue providing drug information until the expiry dates of their cards.

3. For dossiers of application for certificates of eligibility for drug trading prescribed in Article 28 of the Government’s Decree No. 89/2012/ND-CP of October 24, 2012, amending and supplementing a number of articles of the Government’s Decree No. 79/2006/ND-CP of August 9, 2006, detailing a number of articles of the Law on Pharmacy, for which the originals of pharmacy practice certificates of persons in charge of professional pharmacy activities have been submitted, the dossier-receiving agency shall return such originals in the following cases:

a/ The pharmaceutical business establishment replaces the person in charge of professional pharmacy activities;

b/ The pharmaceutical business establishment terminates operation;

c/ The dossier of application for a certificate of eligibility for pharmaceutical business is rejected in writing by the dossier-receiving agency;

d/ The person named in the pharmacy practice certificate requests the return of the original certificate.

When returning the original of a pharmacy practice certificate, the dossier-receiving agency shall keep its copy bearing a seal certifying that this copy has been compared with the original, and make a record of handover of the original of a pharmacy practice certificate according to Form No. 11 in Appendix I to this Circular. The dossier-receiving agency and the person who is returned the original certificate shall each keep 1 copy of this record.

Article 32.Implementation responsibility

The Drug Administration of Vietnam, the Agency of Administration of Traditional Medicine, the Administration of Science, Technology and Training, and units under the Ministry of Health, provincial-level Departments of Health, and related agencies, organizations and individuals shall implement this Circular.

Provincial-level Departments of Health shall intensify monitoring and inspecting drug retail establishments in localities that sell drugs on the list of drugs restricted from retail prescribed in this Circular.

Any problems arising in the course of implementation of this Circular should be promptly reported to the Ministry of Health (the Drug Administration of Vietnam, the Agency of Administration of Traditional Medicine, and the Administration of Science, Technology and Training) for consideration and settlement.-

For the Minister of Health
Deputy Minister
TRUONG QUOC CUONG

* The appendices to this Circular are not translated.