Công văn 1902/BYT-QLD

On March 07, 2017, the Prime Minister signed the Resolution No. 30/NQ-CP according to which the Government permits implementation of applicable regulations of law that do not contravene the 2016 Law on Pharmacy until the effective date of the Government's Decree No. 54/2017/NĐ-CP elaborating the implementation of the 2016 Law on Pharmacy (hereinafter referred to as “Decree No. 54/2017/NĐ-CP”).

Below are instructions of the Ministry of Health on implementation of the Government’s Resolution No. 30/NQ-CP:

I. Procedures under the 2005 Law on Pharmacy and its instructional documents that may be applied until the effective date of Decree No. 54/2017/NĐ-CP:

1. Procedures for export, licensing export of drugs/medicinal ingredients.

2. Procedures for import of commercial drugs, vaccines, biologicals without registration numbers in Vietnam, including:

a) Commercial drugs containing active ingredients without registration numbers or active ingredients with registration numbers but are not available in sufficient quantity; biologicals for prevention and treatment of diseases;

b) Rare drugs, drugs serving treatment in special cases at health facilities;

c) Vaccines, biologicals serving special treatment at treatment facilities, vaccination centers and testing laboratories;

d) Drugs serving epidemic control or disaster relief.

dd) Drugs serving national health programs;

e) Drugs provided as emergency aid or humanitarian aid;

g) Drugs used for clinical trial, as samples for registration, serving research, testing, bioavailability study or bioequivalence study;

h) Drugs for display and other cases of temporary import of drugs;

i) Drugs imported for disease treatment without commercial purposes.

3. Procedures for licensing import of active ingredients for production of drugs for export, drugs serving national defense and security, epidemic prevention, research into drug production, testing, research.

4. Procedures for licensing import of excipients, softgel shells, reference materials and primary packages of drugs.

5. Procedures for licensing parallel import of proprietary drugs.

6. Procedures for inspection of imported vaccines and biologicals.

7. Procedures for granting clearance to export and import of drugs/medicinal ingredients.

8. Procedures for licensing import and export of narcotic drugs, psychotropic drugs, drug precursors, narcotic ingredients, psychotropic ingredients, precursors, commercial combined drugs containing narcotic ingredients, psychotropic ingredients or drug precursors.

9. Procedures for licensing domestic purchase of narcotic drugs, psychotropic drugs, precursors, narcotic ingredients, psychotropic ingredients or precursors.

10. Procedures for non-commercial import and export of narcotic drugs, psychotropic drugs and drug precursors.

11. Procedures for receiving applications for registration of drug information, pharmaceutical conferences; issuance of pharmaceutical sales representative’s cards to holders of bachelor’s degrees in pharmacy and associate degrees in pharmacy.

12. Procedures for confirmation of drug advertisement contents.

13. Procedures for declaration and re-declaration of drug prices.

14. Procedures for recall of drugs, degrees of recall, handling of recalled drugs and scope of recall.

15. Procedures for issuance, reissuance, renewal, adjustment of the Certificate of eligibility for pharmacy business of drug manufacturers, drug wholesalers, drug retailers and clinical trial laboratories.

16. Procedures for reissuance of the pharmacy practice certificate.

II. Instructions on receipt of applications, formality, and transition clauses

1. Regarding the pharmacy practice certificate:

a) In the cases where a person whose pharmacy practice certificate expires after December 31, 2016 submits an application for reissuance of the certificate before the effective date of Decree No. 54/2017/NĐ-CP he/she may keep using the expired certificate pending issuance of a new certificate until a notice is given by the authority that received the application.

b) In the cases where the holder of a pharmacy practice certificate which expires after December 31, 2016 fails to submit an application for reissuance of the certificate before the effective date of Decree No. 54/2017/NĐ-CP he/she may not uses the expired certificate;

c) Documents and procedures for issuance of the pharmacy practice certificate are specified in the 2016 Law on Pharmacy.

2. Regarding the certificate of eligibility for drug business:

a) In the cases where a pharmacy business establishment whose certificate of eligibility for drug business expires after December 31, 2016 submits an application for renewal of the certificate before the effective date of Decree No. 54/2017/NĐ-CP it may keep using the expired certificate pending the renewal until a notice is given by the authority that received the application.

b) In the cases where a pharmacy business establishment whose certificate of eligibility for drug business expires after December 31, 2016 fails to submit an application for renewal of the certificate before the effective date of Decree No. 54/2017/NĐ-CP it may not use the expired certificate.

3. Regarding drug registration:

a) In the cases where the registration number of drug expires after December 31, 2016 and a declaration that the drug is produced and sold in accordance with the application for registration that has been granted and retained by the Ministry of Health (Drug Administration of Vietnam) has been submitted, the registration number is still effective until new instructions are given;

b) If the registration number of drug expires after December 31, 2016 but a declaration specified in (a) is not submitted, the registration number will be invalidated.

4. A foreign enterprise whose license to trade in drugs and medicinal ingredients in Vietnam or license to trade in vaccines, biologicals and ingredients thereof in Vietnam expires after December 31, 2016 may keep using such license to follow procedures for export and import of drugs/medicinal ingredients until the effective date of Decree No. 54/2017/NĐ-CP.

5. Manufacturers, exporters, importers, wholesalers, retailers, suppliers, users of narcotic drugs, psychotropic drugs, drug precursors, narcotic ingredients, psychotropic ingredients, precursors, commercial combined drugs containing narcotic ingredients, psychotropic ingredients or drug precursors shall keep implementing the Government's Decree No. 102/2016/NĐ-CP dated July 01, 2016 and relevant legislative documents until the effective date of Decree No. 54/2017/NĐ-CP.

III. The procedures that are not mentioned in this document shall be suspended until the effective date of Decree No. 54/2017/NĐ-CP.

Difficulties that arise during the implementation of this document should be reported to the Ministry of Health (Drug Administration of Vietnam) for timely consideration./.