Công văn 20215/QLD-CL hướng dẫn công bố cơ sở sản xuất thuốc đạt tiêu chuẩn PIC/S-GMP và EU-GMP do Cục Quản lý dược ban hành

According to the Joint Circular No. 01/2012/TTLT-BYT-BTC dated January 19th 2012 of the Ministry of Health and the Ministry of Finance, guiding the bid for procurement of drugs in medical facilities, and the Circular No. 11/2012/TT-BYT dated June 8th 2012 of the Ministry of Health, guiding the invitation to bid for procurement of drugs in medical facilities, the contractors having drugs registered in Vietnam and produced by the manufacturers conformable with Good Manufacturing Practice (GMP) according to EU’s or PIC/S’s principles (EU-GMP or PIC/S-GMP), and issued with Certificates by competent agencies of EMA, PIC/S, or ICH, may bid for the groups of drugs produced in member states of EMA, or ICH, or PIC/S.

After the issue of the Official Dispatch No. 14448/QLD-GT dated September 21st 2012 of the Drug Administration of Vietnam, providing the List of drug manufacturers conformable with PIC/S-GMP and EU-GMP standards, the Drug Administration of Vietnam guides the making of the application for announcement and reannouncement, contents of the GMP Certificates, and criteria for announcement as follows:

1. The application for announcement of the conformity to PIC/S –GMP standards or EU-GMP standards:

a) The applicant for announcement is a Vietnamese enterprise that has been issued with the Certificate of eligibility for trading drugs, or a foreign enterprise or a foreign drug manufacturer having drugs registered in Vietnam that have been issued with an operation license.

b) The application for announcement is provided in the Annex enclosed with the Official Dispatch No. 14448/QLD-GT dated September 21st 2012 of the Drug Administration of Vietnam; the information must be sufficient, and the application must be signed by a competent person of the applying enterprise, and bear the seal of the applying enterprise.

2. The certificate of conformity to PIC/S –GMP or EU-GMP standards and the equivalent:

a) The Certificate of conformity to PIC/S-GMP or EU-GMP; Japan-GMP or CGMP-USA or GMP-Canada is issued by drug management agencies being members of PIC/S, or drug management agencies of countries or states (of federations) of member states of EU, or competent agencies of member states of ICH (such as the Ministry of Labor, Health, and Welfare of Japan (MLHW – Japan).

b) The Certificate of GMP must be a consularly legalized original, or an authenticated copy which has been consularly legalized. When the language of the Certificate of GMP is not English nor Vietnamese, its notarized Vietnamese translation is compulsory.

3. Certification contents:

The Certificate of conformity to PIC/S –GMP or EU-GMP must provide the following information:

- Name of the Certificate of GMP issuer

- Number of the Certificate of GMP.

- Date of issue of the Certificate of GMP.

- Name, signature, and position of the signer of the Certificate; the seal (if any).

- Name of the certified manufacturer: full name in English;

- Address of the certified manufacturer: detailed address.

- The Certificate of GMP must specify that the GMP standards follow:

+ PIC/S –GMP; or

+ EU-GMP (may be replaced with: “Directives 2003/94/EC”, “Directives 2001/83/EC” or “Directives European Commission”).

+ For the Certificates issued by U.S. Food and Drug Administration (FDA), MLHW – Japan, Canadian Drug Administration: the GMP standards applicable to these countries must be specified: cGMP (US), Japan – GMP (Japan), Division 2 of the Food and Drugs Regulations (GMP) (Canada)…

- The certified forms of drugs:

+ Ingredient: pharmaceuticals;

+ Finished products: the production line performs all stages of the production process (from ingredients to finished products), e.g. solid oral medications, injectables, sterile injectables, biological products, herbal medicines, tablets, capsules, ointment, slave, liquid drugs, etc.

If the Certificate only specifies that only one or some stages of the production process meet GMP standards, the applicant must provide the proof that the remaining stages in the whole drug production process are conformable with GMP standards as stated in “Applicable GMP standards” above.

- The Certificate of GMP must be unexpired when the Drug administration of Vietnam receives the application for announcement. If the Certificate of GMP does not show its expiration date, the period from the latest inspection to the date on which the Drug Administration of Vietnam receives the application must not exceed 36 months.

When the applicant only presents the unauthenticated copy of the Certificate of GMP, the applicant must provide the website of an agency competent to provide information about the inspection and issue of the Certificate.

b) When the applicant only presents the Certificate of Pharmaceutical Products (CPP), the applicant must provide proof that the manufacturer is in the list manufacturers inspected and certified by competent agencies, together with the information similar to that of the Certificate of GMP; the period from the latest inspection to the date on which the Drug Administration of Vietnam receives the application must not exceed 24 months, and the website of the agency competent to provide information about the inspection and assessment of the manufacturer.

The CPP must be an consularly legalized original, or an authenticated copy which has been consularly legalized. When the language of the CPP is not English nor Vietnamese, its notarized Vietnamese translation is compulsory.

4. Verifying the application and announcement of drug manufacturers conformable with PIC/S-GMP and EU-GMP standards:

a) The Drug Administration of Vietnam shall verify the applications for the announcement of conformity to PIC/S-GMP or EU-GMP standards of the drug manufacturers having drugs registered and circulated in Vietnam, certified by the competent agencies participating in PIC/S, EU or ICH.

- If the application is satisfactory, the Drug administration of Vietnam shall post the name of the manufacturer and relevant information on the website of the Drug Administration of Vietnam (www.dav.gov.vn) – List of Drug manufacturers conformable with PIC/S-GMP and EU-GMP.

When the application requests the announcement of CPPs or Certificates of GMP by product name, the Drug Administration of Vietnam shall announce the specific names of the certified drugs.

- If the application is not satisfactory, the Drug administration of Vietnam shall send notification of unsatisfactory application to the applicant.

b) When a manufacturer in the List of Drug manufacturers conformable with PIC/S-GMP and EU-GMP does not apply for another announcement after 03 months from the expiry date of the Certificate of GMP, the Drug administration of Vietnam shall remove its name from the List of Drug manufacturers conformable with PIC/S-GMP and EU-GMP.

The Drug administration of Vietnam shall inform Services of Health of central-affiliated cities and provinces, drug manufacturers and traders. Enterprises are recommended to send written reports on the difficulties arising during the course of implementation to the Drug administration of Vietnam for consideration./.

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This document is handled by Dữ Liệu Pháp Luật . Document reference purposes only. Any comments, please send to email: [email protected]