I. LEGAL BASIS
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Law on Pharmacy No. 105/2016/QH13, effective from January 1, 2017.
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Law No. 44/2024/QH15 amending and supplementing a number of articles of the Law on Pharmacy.
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Decree No. 54/2017/ND-CP detailing a number of articles and measures for implementing the Law on Pharmacy.
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Decree No. 155/2018/ND-CP amending and supplementing some regulations related to business investment conditions under the state management scope of the Ministry of Health.
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Decree No. 88/2023/ND-CP amending and supplementing a number of articles of Decree No. 54/2017/ND-CP dated May 8, 2017, and Decree No. 155/2018/ND-CP dated November 12, 2018.
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Circular No. 20/2017/TT-BYT detailing a number of articles of the Law on Pharmacy and Decree No. 54/2017/ND-CP regarding specially controlled drugs and medicinal ingredients.
II. WHAT ARE PHARMACY BUSINESS ESTABLISHMENTS AND SPECIALLY CONTROLLED DRUGS?
1. Pharmacy business establishments
Pursuant to Clause 13, Article 17a of the 2024 Law on Pharmacy (amending and supplementing the 2016 Law on Pharmacy), pharmacy business establishments include:
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Establishments manufacturing drugs and medicinal ingredients;
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Establishments exporting and importing drugs and medicinal ingredients;
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Establishments providing drug and medicinal ingredient preservation services;
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Establishments wholesaling drugs and medicinal ingredients;
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Establishments retailing drugs, including pharmacies, dispensaries, commune health station medicine cabinets, and specialized retail establishments for herbal materials, herbal drugs, and traditional drugs;
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Establishments providing drug and medicinal ingredient testing services;
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Establishments providing clinical trial services;
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Establishments providing bioequivalence testing services.
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Establishments organizing pharmacy chains that must meet the conditions specified in point (c) of this clause, have 02 or more affiliated pharmacies that have been granted the Certificate of Eligibility for Pharmacy Business, and have a unified quality management system to apply to all pharmacies in the chain.
2. Specially controlled drugs
Pursuant to Clause 26, Article 2 of the 2016 Law on Pharmacy, specially controlled drugs include:
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Drugs and medicinal ingredients: Narcotic drugs, psychotropic drugs, precursor drugs, combined drugs containing narcotic active ingredients, combined drugs containing psychotropic active ingredients, combined drugs containing precursors, radiopharmaceuticals, and radioisotopes (Appendices I, II, III of Circular 20/2017/TT-BYT).
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Toxic drugs and toxic ingredients for drug manufacturing in the list issued by the Ministry of Health.
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Drugs and active ingredients in the list of substances prohibited from use in some specific sectors and fields as prescribed by the Government (Appendix VII of Circular 20/2017/TT-BYT).
III.CONDITIONS, DOSSIER, AND PROCEDURE FOR ISSUING THE CERTIFICATE
1. Conditions for trading in specially controlled drugs
Pursuant to Article 34 of the 2016 Law on Pharmacy, establishments trading in specially controlled drugs must have written approval from the competent state authority when meeting the following conditions:
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Regarding physical facilities, equipment, and personnel: Must comply with Article 33 of the Law on Pharmacy, suitable to the conditions of each business establishment.
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Regarding security measures: Must meet the regulations in Articles 43, 44, 45, 46, 47, and 48 of Decree No. 54/2017/ND-CP, which cover physical facilities, personnel, drug delivery and receipt procedures, drug trading regulations, reporting regimes, and regulations on the destruction of specially controlled drugs.
2. Application dossier
Pursuant to Article 49 of Decree 54/2017/ND-CP and Clause 31, Article 8 of Decree 155/2018/ND-CP:
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Application form for the Certificate of Eligibility for Pharmacy Business (Form No. 19, Appendix I in Appendix II of Decree No. 155/2018/ND-CP).
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Certificate of Eligibility for Pharmacy Business and/or Certificate of Good Practice at the business location (if any).
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Other technical documents depending on the establishment:
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For wholesale establishments: Documents on location, storage warehouses, preservation equipment, transportation means, quality management systems, technical professional documents, and personnel according to Good Distribution Practice (GDP) principles.
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For retail establishments: Documents on location, preservation areas, preservation equipment, technical professional documents, and personnel according to Good Pharmacy Practice (GPP) principles.
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Certified copy of the Enterprise Registration Certificate or legal documents proving the establishment of the facility.
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Certified copy of the Pharmacy Practice Certificate.
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Explanatory document demonstrating the establishment meets security measures to prevent the loss of specially controlled drugs (Form No. 18, Appendix II of Decree 54/2017/ND-CP).
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List of drugs and preparation procedures for retail establishments (pharmacies) if they compound specially controlled drugs according to prescriptions.
3. Implementation Procedure
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Step 1: Prepare and submit the dossier
– Method: Submit directly, via postal service, or online through the public service portal.
– Competent authority: The Department of Health where the business is located.
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Step 2: Dossier processing
– Upon receipt, the Department of Health issues a Dossier Receipt Slip (Form No. 01, Appendix I, Decree No. 54/2017/ND-CP).
– If no amendments are required: Issue the Certificate within 20 days from the date on the Receipt Slip (if no physical assessment is needed).
– If amendments are required: The Department of Health sends a written notice detailing the necessary modifications within 10 working days.
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Step 3: Post-amendment processing
– After receiving the supplemented dossier, the Department of Health issues a new Receipt Slip.
– If it still fails to meet requirements, a written notice is sent (as in Step 2). If it is satisfactory, the procedure continues as normal.
- Step 4: Physical assessment (if applicable)
– Issue the Certificate within 10 working days from the completion of the assessment if no remediation is required.
– Issue a written notice requesting remediation within 05 working days from the completion of the assessment if issues need fixing.
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Step 5: Final review and issuance
– Within 20 days from receiving the establishment’s report and evidence of completed remediation, the Department of Health shall issue the Certificate or provide a reason for refusal.
– Note: Establishments have 06 months to submit supplemented documents after a request. If they fail to do so, or if after 12 months from the initial submission the dossier still does not meet requirements, the application becomes invalid.
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Step 6: Public announcement
– Within 05 working days of issuance, the Department of Health will publish the following on its web portal:
+ Name and address of the certified establishment;
+ Full name of the person professionally responsible for pharmacy, and their Practice Certificate number;
+ The Certificate of Eligibility for Pharmacy Business number.
Above is our comprehensive article on the Procedure for issuing the Certificate of Eligibility for Pharmacy Business to establishments trading in specially controlled drugs. Should Clients require more detailed consultation, answers, or wish to utilize this service, please contact Lawyer Nguyen Duc Trong directly via hotline: 0912.35.65.75, or send a service request via email: lawyer@hongbanglawfirm.com.
Wishing you and your family health, peace, and success!
Best regards!
