GDP Certificates and 03 practical notes on GDP Certificate dossiers

GDP and 03 practical notes

To operate in the pharmaceutical industry, enterprises not only must meet the usual business requirements, but also must comply with various licenses for pharmaceutical business regulated by Vietnamese law. Among them, the Certificate of Good Distribution Practice for medicinal products and medicinal materials (“GDP Certificate“) is one of the important and necessary licenses for pharmaceutical businesses in Vietnam.

In this article, BLawyers Vietnam summarizes current regulations of Vietnamese law on the GDP Certificate and 03 practical notes on documents needed for the issuance of the GDP Certificate.

1. What is GDP?

GDP” stands for Good Distribution Practices.

The Law on Pharmacy 2016, along with Circular No. 03/2018/TT-BYT, outlines Good Distribution Practices for Medicinal products and Medicinal materials as a set of principles and standards for the distribution of medicinal products and medicinal materials. These practices are vital for maintaining the integrity of medicinal products and materials throughout the distribution chain by means of adequate control of the numerous activities which occur during the distribution process, as well as providing a tool to secure the distribution system from unapproved medicinal products and medicinal materials.

2. GDP Certificates and Certificates of eligibility for pharmacy businesses

In reality, documents used for inspection of compliance with GDP principles by a pharmacy business establishment are those included in its application for a Certificate of eligibility for a pharmacy business. Therefore, enterprises that are distributors only need to submit 01 application for a Certificate of eligibility for the pharmaceutical business, along with specific required documents to assess the degree of compliance with GDP principles.

After being evaluated, the enterprise will achieve one of the following degrees of compliance with GDP principles:

  1. GDP degree 1 distributor;
  2. GDP degree 2 distributor; or
  3. GDP degree 3 distributor.
3. Some practical notes on GDP Certificate dossiers

The registration documents for a GDP Certificate are a complex dossier, requiring extremely strict conditions in both the pharmaceutical field and other related techniques to be met. According to our experience supporting clients, BLawyers Vietnam provides below 03 practical notes on Technical Documents about distribution facilities (“Technical Documents”), as follows:

  1. Regarding the list of distributed products in Item 1.2 of Technical Documents, it is necessary to systemize the products into a table with columns including these headings: Product name, Active ingredients, and Warranty conditions management. At the same time, enterprises need to divide the table into 3 sections, corresponding to these products: medicinal products and medicinal materials preserved under normal conditions; medicinal products and medicinal materials requiring special storage conditions (if any); and medicinal products and medicinal materials under special control (if any).
    • Storage conditions can be referred to as Circular No. 36/2018/TT-BYT on Good Storage Practices for medicinal products and medicinal materials. Although the above records and documents are intended to assess the enterprise’s ability to distribute medicinal products and medicinal materials, the enterprise still needs to ensure the preservation of medicinal products and medicinal materials at a facility in good condition according to the standards of the Ministry of Health.
  2. Regarding storage warehouses in the Technical Documents, it is necessary to visually show warehouse design with warehouse infrastructure conditions suitable for distribution facilities and good storage practices for medicinal products and medicinal materials principles. In cases where it cannot be shown on the Technical Documents, warehouse design documents must be attached to the Technical Documents.
    • Regarding storage conditions in the warehouse that are not shown in the design, they should be clearly stated in the Technical Documents or shown in the warehouse design attached to the file. Enterprises need to present the infrastructure, equipment, and preservation principles for each type of product with different storage conditions: normal conditions, special storage conditions (for medicinal products and medicinal materials require special storage conditions) and special control (for medicinal products and medicinal materials under special control).
  3. Regarding Item 4 of Technical Documents, the list of storage equipment needs to be filled with storage equipment, compiled in the list. The list should detail information such as device name, quantity, country of manufacture, year of manufacture, and condition. If the equipment list is a large quantity, it can be attached with Technical Documents.
    • Regarding transportation vehicles, it is necessary to ensure that storage environment in vehicles meets preservation standards according to regulations on transportation vehicles for distribution facilities. If the distribution facility does not have vehicles that meet transportation regulations and must rent vehicles from a transportation service provider that meets GDP transportation conditions, the enterprise must include the Technical Documents with the documents proving the vehicle rental; for example, the Service Supply Contract, and clearly state the document information in the Technical Documents.

The above is not official advice from BLawyers Vietnam. If you have any questions or suggestions about the above, please contact us at consult@blawyersvn.com. We would love to hear from you.

Date: 22 March 2024

Writer: Thai Bui

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