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

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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
Issuing body: Ministry of HealthEffective date:
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Official number:07/2018/TT-BYTSigner:Truong Quoc Cuong
Type:CircularExpiry date:Updating
Issuing date:12/04/2018Effect status:
Known

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Fields:Commerce - Advertising , Food and drug , Medical - Health

SUMMARY

To announce list of drugs restricted from retail

On April 12, 2018, the Ministry of Health issues the Circular No. 07/2018/TT-BYT 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. One of the contents of this Circular is announcing list of drugs restricted from retail.

Drugs restricted from retail mean drugs subject to the requirements on strict control 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.

List of drugs restricted from retail conclude some drugs used in tuberculosis treatment such as: Streptomycin; Kanamycin; Amikacin; drugs used in HIV treatment such as Nevirapine…

Based on the local disease structure, provincial-level Departments of Health shall issue a written permission for sale of a number of drugs on the list of drugs restricted from retail; the local disease structure shall be determined based on annual health statistics, surveys and scientific researches already announced…

This Circular takes effect on June 01, 2018.

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Effect status: Known

THE MINISTRY OF HEALTH

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No. 07/2018/TT-BYT

THE SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

Hanoi, April 12, 2018

CIRCULAR

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

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 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 regulations

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. Reporting and updating the list of persons who have 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. Operations 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 prescribed at Point k, Clause 2, Article 42 of the Law on Pharmacy;

5. Sale of other drugs at dispensaries located in ethnic minority areas, mountainous areas, on islands and in areas with extremely difficult socio-economic conditions 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 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 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 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 responsible for professional pharmacy activities at drug retailing establishments and persons in charge of clinical pharmacy at medical examination and treatment establishments who are foreigners or overseas Vietnamese must be recognized as being fluent in Vietnamese. Those who are not fluent in Vietnamese must 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 shall be inscribed with 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 of 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 serving pharmacy practice

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

2. In case a practitioner registers a language other than his/her mother tongue or Vietnamese for use in pharmacy practice, he/she must be tested and recognized by an education establishment 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: English, French, Russian, Chinese, Japanese and Korean.

3. A pharmacy practitioner shall be recognized as being fluent in Vietnamese or another language serving 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 establishment after attending 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 establishment after attending a training course using Vietnamese or the language he/she registers for use in pharmacy practice as prescribed in Clause 2 of this Article.

Degrees and certificates prescribed at Points a and b of this Clause must be issued within 5 years counted up to the date of dossier submission.

Article 5. Criteria for recognition of being qualified for acting 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 establishment 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 degree in medicine or pharmacy issued by a lawful Vietnamese or foreign training establishment after attending a training course using the language he/she registers for practicing as an interpreter;

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 the language he/she registers for practicing as an interpreter;

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

Degrees and certificates prescribed at Points a and b, Clause 2 of this Article must be issued within 5 years counted up to the date of dossier submission.

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

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

Education establishments may conduct testing and recognition of fluency in Vietnamese or other languages or qualification for acting as interpreters in pharmacy practitioners (below referred to as education establishment 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 section of the 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 serving pharmacy practice.

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