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Certificate of Eligibility for pharmacy business in Vietnam

Pharmaceuticals have an extremely important and indispensable position and role in social life. Presently, pharmaceuticals are not just a common commodity but have become an essential need of life. Pharmaceuticals play a role in treating various diseases, preventing and suppressing diseases, and enhancing the health of users. Certificate of Eligibility for pharmacy business helps the Government and Management Agencies manage product quality and evaluate the production process of different types of pharmaceuticals. In the article below, Viet An Law Firm will consolidate legal knowledge about Certificate of Eligibility for pharmacy business in Vietnam.

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    Legal basis

    • Law on Pharmacy 2016, as amended and supplemented in 2018;
    • Decree 54/2017/ND-CP detailing some articles and measures to implement the Pharmacy Law, amended and supplemented by Decree 155/2018/ND-CP and Decree 88/2023/ND-CP.

    What is the pharmaceutical business?

    Pharmaceutical business is a commercial activity related to the production, purchase, import, export, distribution, and advertising of pharmaceutical products. Pharmaceuticals are products used for health care and disease treatment, including drugs, vitamins, minerals, herbs, and other related products.

    Infrastructure, equipment, and personnel conditions

    • Every manufacturer of drugs/medicinal ingredients must have the premises, factory, laboratory, storage of drugs/medicinal ingredients, auxiliary systems, equipment, machinery for manufacture, testing, storage of drugs, quality control system, technical documents, and personnel that fulfill GMP requirements;
    • Every importer and exporter of drugs/medicinal ingredients, and provider of drug/medicinal ingredient storage services must have the premises, drug storage, storage equipment, transportation, quality control system, technical documents, and personnel that fulfill Good Storage Practice requirements;
    • Every wholesaler of drugs/medicinal ingredients has the premises, drug storage, storage equipment, transportation, quality control system, technical documents, and personnel that fulfill Good Distribution Practice requirements;
    • Every drug retailer must have the premises, a storage area, storage equipment, technical documents, and personnel that fulfill Good Retailing Practice requirements; Retailers of herbal ingredients, herbal drugs, and traditional drugs.
    • Every provider of drug/medicinal ingredient testing services must have the premises, a chemical/microbiological/biological laboratory, auxiliary systems, testing equipment, chemicals, reagents, quality control system, technical documents, and personnel that fulfill Good Laboratory Practice requirements;
    • Every provider of clinical trial services must have the premises, a clinical laboratory, a testing laboratory, biochemical testing equipment, a quality control system, technical documents, and personnel that fulfill Good Clinical Practice requirements;
    • Every provider of bioequivalence services must have the premises, a laboratory for biological fluid analysis, equipment for biological fluid analysis, an area for drug users to stay and undergo bioequivalence assessment, a quality control system, technical documents and personnel that fulfill Good Laboratory Practice requirements in the biological fluid analysis stage and fulfill Good Clinical Practice requirements in the clinical trial stage.

    Personnel qualifications

    The person in charge of pharmacy expertise and the persons holding the positions must have pharmacy practice certificates suitable for pharmacy business establishments.

    Note

    The assessment of infrastructure, equipment, and personnel shall be carried out every 03 years or on an ad hoc basis under regulations of the Minister of Health or international treaties to which Vietnam is a signatory.

    Procedures for granting Certificate of Eligibility for pharmacy business in Vietnam

    Step 1 The establishment applying for a Certificate of Eligibility for pharmaceutical business shall send documents to the Department of Health where the establishment’s business location is located.
    Step 2 After receiving the application, the Department of Health returns to the applicant for the Certificate of Eligibility for pharmaceutical business the application receipt according to Form No. 01 Appendix I of Decree No. 54/2017/ND-CP. In case there is no request to amend or supplement applications, the Department of Health:

    ·      Issue the Certificate of Eligibility for pharmaceutical business within 20 days from the date recorded on the application receipt form in cases where the facilities, techniques, and personnel have been inspected and evaluated to meet the requirements of appropriate good practice to the scope of business, not having to organize an actual assessment at the facility applying for a Certificate of Eligibility for pharmaceutical business.

    ·      Organize an on-site assessment at the facility requesting the issuance of a Certificate of Eligibility for pharmaceutical business within 20 days from the date recorded on the Application Receipt Form.

    In case there is a request to amend or supplement the dossier, within 10 working days from the date recorded on the dossier receipt, the Department of Health will send a document to the facility requesting it, which must specifically state documents and content that need to be amended and supplemented.

    Step 3 After receiving the amended and supplemented dossier, the Department of Health shall return to the application receipt form of the amended and supplemented dossier according to Form 01 in Appendix I issued with Decree 54/2017/ND-CP.

    ·      In case the amended or supplemented dossier does not meet the requirements, the Department of Health will notify the facility in writing;

    ·      In case, there is no request to amend or supplement the amended or supplemented dossier, the Department of Health shall comply with the law.

    Step 4 After assessing the actual facility, the Department of Health is responsible for:

    ·      Issue a Certificate of Eligibility for pharmaceutical business within 10 working days from the date of completion of the actual assessment in cases where there are no requests, remedies or repairs;

    ·      Issue a written notice of the contents that need to be remedied or repaired within 05 working days from the date of completion of the actual assessment in case of requests, remedies or repairs.

    Step 5 Within 20 days from the date of receipt of the written notice and documents proving the completion of remedies and repairs of the requesting facility, the Department of Health shall issue a Certificate of Eligibility for pharmaceutical business or respond to the reason for not granting.
    Step 6 Within 05 working days from the date of issuance of the Certificate of Eligibility for pharmaceutical business, the Department of Health shall publish and update the following information on the electronic portal:

    ·      Name and address of the facility issued with the Certificate of Eligibility for pharmaceutical business;

    ·      Full name of person responsible for pharmacy expertise, Pharmacy Practice Certificate number;

    ·      Number of Certificates of Eligibility for pharmaceutical business

    Cases in which the Certificate of eligibility for pharmacy business is issued

    According to Article 40 of Pharmacy Law in 2016, cases in which the Certificate of Eligibility for pharmacy business is issued as follows:

    • The pharmacy business is shut down.
    • Any of the conditions for issuance of the Certificate of Eligibility for pharmacy business is not satisfied.
    • The Certificate of eligibility for pharmacy business is issued ultra vires or against the law.
    • The pharmacy business is not operating for 12 consecutive months without notifying a pharmacy authority.

    Services of granting Certificate of Eligibility for pharmacy business in Vietnam from Viet An Law Firm

    • Advise clients on the conditions and how to meet the legal conditions for issuance of a Certificate of Eligibility for pharmaceutical business;
    • Support clients in drafting documents for issuance of Certificate of Eligibility for pharmaceutical business;
    • Represent clients to submit applications at licensing agents;
    • Monitor processing progress and intermediary exchanges between clients and licensing agents;
    • Receive the results of the Certificate of Eligibility for pharmaceutical business and hand it over to the client;
    • Consult when a pharmaceutical business goes into operation to comply with legal regulations.

    Clients who have questions related to the Certificate of Eligibility for pharmacy business in Vietnam, please contact Viet An Law Firm for the best advice!

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