Vietnam: Procedure of issuing the certificate of organization satisfying principles and norms of CGMP- ASEAN

According to Article 34 of Circular No. 06/2011/TT-BYT of the Ministry of Health of Vietnam, procedure of issuing the certificate of organization satisfying principles and norms of the ASEAN Association (CGMP- ASEAN) is specified as follows:

1. The manufacturing organization which has demanded to be issued the certificate of organization satisfying principles and norms of the “cosmetic good manufacture practice” of the ASEAN Association (CGMP- ASEAN), which serves for the export demand, sends the consideration registration file to the Medicine Management department – the Health Ministry. The file is inclusive of:

- The consideration registration applying of “cosmetic good manufacture practice” (Appendix No 13-MP);

- The copy of Business Registration Certificate of the Investment license;

- The organization chart and human of organization (the organization chart must clearly presents the  name, job title, technical, professional level of officers who are in charge of parts), the working process and experiences in the assigned fields of the officers who are in charge of parts (manufacture,  quality check, quality guarantee, storehouse);

- The training program, assessment results of training the “cosmetic good manufacture practice” at organization;

- The location chart and design of factory (includes: the general background chart, the worker’s way chart, way chart of material, package, semi-finished product, finished product, waste-treating system chart);

- The list of factory’s current equipments (involves manufacturing equipments and cosmetic quality-checking equipments) has to clearly states name, manufacture year, manufacture country and situation of equipment);

- The list of goods which are being manufactured or estimated produced (state clearly the product form);

- The self-investigation minutes of “the cosmetic good manufacturing practice” (the self-investigation minutes must clearly state investigation time, element of self-investigation delegation, self-investigation purpose, self-investigation results and time proposals and contemporary problem-solving means).

2. The authority of receiving and handling file:

The Medicine Management department – the Ministry of Health is obligated to consider files, plan and make decision to establish an investigation delegation, inform the organization at least 10 days before implementing the investigation.

The certificate of organization satisfying principles and norms of the “cosmetic good manufacture practice” is valid in 03 years since the issuing day.

The manufacture organization (the GMP registration organization for short) must pay the fee for evaluating of cosmetic manufacture standards and conditions, in accordance with the current regulations.

View details at Circular No. 06/2011/TT-BYT of the Ministry of Health of Vietnam, effective from April 01, 2011.

Thuy Tram

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