THE GOVERNMENT | | THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness |
No. 54/2017/ND-CP | | Hanoi, May 8, 2017 |
DECREE
Detailing a number of articles of and providing measures for implementing the Pharmacy Law[1]
Pursuant to the June 19, 2015 Law on Organization of the Government;
Pursuant to the April 6, 2016 Pharmacy Law;
At the proposal of the Minister of Health;
The Government promulgates the Decree detailing a number of articles of and providing measures for implementing the Pharmacy Law.
Chapter I
GENERAL PROVISIONS
Article 1. Scope of regulation and subjects of application
1. This Decree prescribes pharmacy practice certificates; pharmaceutical business; drug import and export; registration for circulation of drug materials, adjuvants and capsule shells; assessment of overseas drug manufacture establishments; competence, form and procedures for recall of drug materials and measures for disposing of recalled drug materials; dossiers, order, procedures and competence for grant of written certifications of drug information and advertising contents; and measures for management of drug prices.
2. This Decree applies to domestic and foreign organizations and individuals involved in pharmacy activities in Vietnam.
Article 2. Interpretation of terms
In this Decree, the terms and phrases below are construed as follows:
1. Drug information means the collection and provision of information relating to drugs, including indications, contraindications; dosage, use instructions, adverse drug reactions and other information relating to the quality, safety and efficacy of drugs, by a responsible establishment in order to meet information requirements of state management agencies in charge of pharmacy, medicine or pharmacy practicing organizations and individuals or drug users.
2. Drug introduction workshop means a drug introduction meeting or drug-related scientific discussion for medicine practitioners.
3. Semi-finished drug product means a drug product which has undergone one, several or all steps of the processing or manufacturing process, except the final step of packaging.
4. Import price means the customs value of an imported drug which is written on the customs value declaration at a Vietnamese port after customs clearance.
5. Whole cost of a domestically manufactured drug includes the direct material, fuel, tool, equipment and energy cost plus (+) direct labor cost plus (+) direct machine and equipment depreciation plus (+) general production cost plus (+) financing cost (if any) plus (+) selling cost plus (+) management cost minus (-) costs distributed to by-products (if any).
6. Wholesale price means the selling price applied between pharmaceutical business establishments or applied by a pharmaceutical business establishment to medical examination and treatment establishments.
7. Tentative wholesale price means the price declared by drug importers, drug manufacturers or establishments ordering drug processing (for drugs processing under orders) to competent state agencies.
8. Retail price is the selling price applied directly to drug buyers at drug retailing establishments.
9. Retail margin means the difference in money between the selling price and buying price of a drug retailing establishment.
10. Retail margin rate means the percentage between the retail margin and the buying price of a drug at a drug retailing establishment.
Chapter II
PHARMACY PRACTICE CERTIFICATES
Section 1
DOSSIERS AND PROCEDURES FOR GRANT, RE-GRANT, MODIFICATION AND REVOCATION OF PHARMACY PRACTICE CERTIFICATES
Article 3. Specific provisions on dossiers of application for pharmacy practice certificates
1. A dossier of application for a pharmacy practice certificate must comply with Article 24 of the Pharmacy Law and the following specific provisions:
a/ An application for a pharmacy practice certificate, made according to Form No. 2 in the Appendix to this Circular, enclosed with 2 white-background portrait photos of the applicant, of a size of 4 cm x 6 cm, taken within 6 months by the date of application;
b/ Certified copies of professional degrees. Degrees granted by foreign training institutions must be enclosed with certified copies of equivalence certificates issued by competent equivalence recognition agencies under Clause 2, Article 18 of this Decree;
c/ A health certificate or a certified copy of a health certificate issued by a medical examination and treatment establishment in accordance with the Law on Medical Examination and Treatment;
d/ A written certification of the period of practice, made according to Form No. 3 in the Appendix to this Decree. If the applicant has practiced at more than one establishment, the period of practice is the aggregate of periods of practice at these establishments, in this case, certificates issued by all these establishments are required;
dd/ In case of applying for a pharmacy practice certificate covering multiple operations which are subject to different requirements on period of practice and establishment of professional practice, the dossier must comprise one or some written certifications of the period and contents of practice issued by one or some establishments meeting the requirements applicable to each professional operation or working position. In case of applying for a pharmacy practice certificate covering multiple operations which are subject to the same requirements on period of practice or establishment of professional practice, it is not required to obtain a written certification for each operation;
e/ The original or a certified copy of the written certification of the examination result issued by an examination-organizing institution defined in Clause 2, Article 28 of this Decree, in case the practice certificate is granted on the basis of examination;
g/ For foreigners and overseas Vietnamese applying for pharmacy practice certificates on the basis of dossier consideration, a dossier of application must also comprise documents proving satisfaction of the language requirements prescribed in Clause 2, Article 14 of the Pharmacy Law.
2. Papers granted by foreign authorities must be consularly legalized under regulations and translated into Vietnamese; their Vietnamese translations must be notarized under regulations.
3. The dossier prescribed in this Article shall be made in 1 set.
Article 4. Specific provisions on dossiers of request for re-grant of pharmacy practice certificates
1. A dossier of request for re-grant of a pharmacy practice certificate must comply with Article 25 of the Pharmacy Law and the following specific provisions:
a/ A written request for re-grant of a pharmacy practice certificate, made according to Form No. 4 in the Appendix to this Circular, enclosed with 2 white-background portrait photos of the applicant, of a size of 4 cm x 6 cm, taken within 6 months by the date of request;
b/ A copy of the granted pharmacy practice certificate, unless the certificate is lost.
2. The dossier prescribed in this Article shall be made in 1 set.
Article 5. Specific provisions on dossiers of request for modification of pharmacy practice certificates
1. A dossier of request for modification of a pharmacy practice certificate must comply with Article 26 of the Pharmacy Law and the following specific provisions:
a/ A written request for modification of a pharmacy practice certificate, made according to Form No. 5 in the Appendix to this Decree, enclosed with 2 white-background portrait photos of the applicant, of a size of 4 cm x 6 cm, and taken within 6 months by the date of request;
b/ In case of change of personal information of a practitioner, there must be one of the following papers relating to the change: people’s identity card, passport, household registration book, citizen identity card or a written certification relating to the change granted by a competent agency in accordance with law;
c/ In case of change of scope of operation, there must be the following papers proving the change: relevant professional degrees and written certification of the period of practice at an appropriate establishment.
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