03 practical notes on GDP Certificate procedures under Vietnamese law

In the previous article, BLawyers Vietnam summarized Vietnam’s legal regulations on GDP certificates as well as practical notes on GDP certificate dossiers for Vietnamese enterprises.

In this article, BLawyers Vietnam provides further information on the procedure for granting GDP certificate pursuant to Vietnamese law for distributors of medicinal products and medicinal materials.

1. Conditions on management and personnel of medicinal products and medicinal materials distributors

In addition to the business management operating system, the enterprise must also ensure the quality of the distribution management system. To guarantee the quality of the distribution management system, the enterprise should:

1. Detail the positions, the relationships between them, and the individuals holding those positions. If it is a complex organization, it is necessary to represent it with a diagram to ensure the visual clarity of the structure. Note that positions such as the chief pharmacist, warehouse manager, quality manager, and other equivalent positions must have professional pharmaceutical qualifications.
2. Create Standard Operating Procedures (the “SOPs”) which serve to articulate and guide the general processes not necessarily related to specific medicinal products or medicinal materials. This ensures transparency in the company’s internal operations, guarantees the quality of the medicinal products and medicinal materials, and facilitates easy management.

2. Infrastructure conditions for meeting GDP Certificate procedures

Appendix I – Good Distribution Practices for medicinal products, and Appendix II – Good Distribution Practices for medicinal materials, issued within Circular No. 03/2018/TT-BYT, have provided specific, detailed guidelines for enterprises. These appendices delineate operational procedures as well as the standards for actions and processes of distribution facilities; and regulate the preservation condition of medicinal products and medicinal materials as well as the design and construction of infrastructure to ensure GDP compliance. Accordingly, these documents offer guidance as follows:

1. Good storage practices (“GSP”) principles are applicable in all circumstances where medicinal products are stored and throughout the distribution process;
2. Records relating to the storage of medicinal products should be kept and be readily available upon request;
3. GSP principles are applicable in all circumstances in all areas where medicinal materials are stored;
4. Records should be kept and must be readily available upon request.

Based on these regulations, although the business operates in the field of distribution of medicinal products and medicinal materials, the enterprise must also be able to construct infrastructure in such a way that it meets the conditions for preserving medicinal products and medicinal materials according to GSP principles.

3. Conditions for foreign-invested enterprises to distribute medicinal products and medicinal materials

Based on Circular No. 34/2013/TT-BCT publicizing roadmaps for goods trading and goods trading-related activities of foreign-invested enterprises in Vietnam, foreign-invested enterprises in Vietnam are not allowed to exercise distribution rights for certain products and goods, including pharmaceuticals.

To meet the drug distribution needs and issue a GDP Certificate to foreign-invested enterprises in Vietnam, the facility should construct and process medicinal products and materials following Good Manufacturing Practice principles (“GMP”). Additionally, the facility must initiate the GMP Certificate issuing procedure in accordance with the Pharmaceutical Law 2016 and other guiding documents.

At the same time, the enterprise must ensure that the facility is constructed according to GDP principles, aiming to meet the requirements for documentation and records to simultaneously obtain a GMP certificate and a GDP certificate. The foreign-invested enterprises will then be granted the right to distribute to the market their own manufactured medicinal products and medicinal materials.

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