The pharmacy business is one of the conditional business sectors in Vietnam. Accordingly, when the subject conducts business activities of drugs and medicinal ingredients; Trading in medicine and medicinal raw material preservation services; Trading in drug testing services and medicinal ingredients; and providing clinical drug testing services; Businesses providing drug bioequivalence testing services must meet legal business conditions to receive a business license. In the following article, Viet An Law will focus on analyzing the current condition registration of pharmacy business in Vietnam such as wholesale and retail of drugs and medicinal ingredients.
Legal basis
WTO, CPTPP
Law on Pharmacy 2016, as amended and supplemented in 2018 ;
Decree 54/2017/ND-CP detailing several 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 pharmacy business?
Article 2 of the current Pharmacy Law defines pharmacy business means one, some, or all stages of the investment process, including inter alia manufacture, sale, and provision of services related to drugs and medicinal ingredients on the market to make a profit.
Accordingly, pharmacy businesses must have a Certificate of eligibility for pharmacy business to meet professional conditions when conducting conditional business activities according to the provisions of the Investment Law 2020 (Appendix IV – List of Industries conditional business investment)
Market access conditions for foreign investors in the pharmacy business
The pharmacy business is regulated in the distribution services group, including pharmacy wholesale and retail services. Note that, “pharmacy” committed to opening the market to foreign investors within the WTO framework does not include non-pharmacy nutritional products in the form of tablets, capsules, or powders.
With a similar commitment, within the framework of CPTPP, Vietnam also issued a statement reserving the right to apply and maintain any measures related to cross-border services and investment in pharmacy products within the scope of the CPTPP definition of pharmacy as above.
Conditions for granting Certificate of eligibility for pharmacy business to drug wholesalers and retailers
Condition
Medicine wholesale establishment
Medicine retail establishment
Infrastructure
Have a location, drug storage warehouse, storage equipment, vehicles, quality management system, technical documents, and personnel that meet Good Distribution Practices of drugs and medicinal ingredients;
Have a location, storage area, storage equipment, technical documents, and personnel that meet Good Pharmacy Practices; For establishments specializing in retailing medicinal herbs, medicinal drugs, and traditional drugs, comply with the provisions of Point b, Clause 2, Article 69 of the Pharmacy Law;
Personnel
The person in charge of the profession must have a university diploma in pharmacy (pharmacist degree)
Have a professional degree in the field of vaccines, biological products, pharmacy materials, herbal medicines, and traditional medicines if doing business in the above categories.
Have 02 years of professional practice in one of the following professional practice contents: Wholesale of drugs and medicinal ingredients; Pharmacy management at pharmacy management agencies and specific expertise for medicinal materials, vaccines, biological products and medicinal materials, herbal drugs, traditional drugs at appropriate pharmacy establishments and Pharmacy Practicing Certificate.
The person in charge of the profession must have a Pharmacy Practice Certificate
The person responsible for professional pharmacy must have a university diploma in pharmacy and 02 years of professional practice at an appropriate pharmacy facility. The person responsible for pharmacy expertise at the pharmacy can also be the person doing clinical pharmacy work at the pharmacy.
The person in charge of pharmacy expertise at the pharmacy must have one of the following professional qualifications: A university diploma in pharmacy or College diploma in pharmacy or an Intermediate diploma in pharmacy and 18 months of professional practice at a suitable pharmacy facility.
Conditions of establishments specializing in retailing medicinal herbs, herbal medicines, and traditional medicines
According to the guidance in Clause 5, Article 31 of Decree 54/2017/ND-CP, retail establishments of medicinal materials, herbal drugs, and traditional drugs, in addition to the conditions for regular drug retailers, must additionally meet the following specific conditions:
Infrastructure conditions
Have a fixed, separate location; solidly built; area suitable for business scale; arrange in a high, cool, safe place, away from sources of pollution;
There must be a storage area and storage equipment suitable to the storage requirements stated on the label, especially to separate and clearly label “poisonous medicinal herbs” to avoid confusion with other medicinal herbs;
Tools and packaging in direct contact with herbal drugs, traditional drugs, and medicinal materials must ensure that they do not affect the quality of herbal drugs, traditional drugs, and medicinal materials;
Have appropriate records or measures to store information about import and export activities and traceability of origin.
In case a retail establishment sells other items according to the provisions of law, these items must be displayed for sale and stored in a separate area and must not affect medicinal materials, medicinal drugs, or drugs traditional.
Personnel conditions
Have one of the following degrees: Pharmacist degree, University diploma in traditional medicine or traditional pharmacy, College diploma in pharmacy, Intermediate diploma in pharmacy, Intermediate diploma in Traditional medicine or traditional pharmacy, or primary pharmacy certificate/diploma.
For toxic medicinal herbs, prescription medicinal herbs, and traditional prescription medicines, the person directly retailing and advising the buyer must be the person in charge of the retail establishment’s expertise;
Application dossier for issuance of Certificate of eligibility for pharmacy business
According to the provisions of Article 32 of Decree 54/2017/ND-CP guiding Article 38 of the Law on Pharmacy, the application file for a Certificate of eligibility for pharmacy business includes:
Application for issuance of Certificate of eligibility for pharmacy business according to Form No. 19, 20, and 21 in Appendix I issued with Decree 54/2017/ND-CP;
A certified copy of the Enterprise Registration Certificate or legal documents proving the establishment of the establishment;
Certified copy of Pharmacy Practice Certificate.
Technical documents corresponding to establishments that wholesale drugs and medicinal ingredients; Drug retail establishments, including:
Certificate of good practice at the business location (if any); In case the facility has been assessed to meet Good Practices, at the request of the facility, issue a Good Practices Certificate; The agency issuing the Certificate of eligibility for pharmacy business will simultaneously issue the Good Practice Certificate along with this dossier.
For establishments that wholesale drugs and medicinal ingredients: Documents on location and warehouse for storing drugs and medicinal ingredients, storage equipment, vehicles, quality management system, and human resources according to the principles of Good Distribution Practices of drugs and medicinal ingredients;
For drug retail establishments: Documents on location, storage area, storage equipment, technical documents, and personnel according to the principles of Good Drug Retail Practice.
For establishments specializing in retailing pharmacy materials, medicinal drugs, and traditional drugs: Documents proving that they meet the above conditions for establishments specializing in retailing pharmacy materials, herbal drugs, and traditional drugs.
For establishments that wholesale drugs and medicinal ingredients
Documents on locations and warehouses for storing drugs, medicinal ingredients, storage equipment, vehicles, quality management systems, technical documents, and personnel according to the principles of Good Practice in the distribution of drugs and medicinal ingredients;
For drug retail establishments
Documents on location, storage area, storage equipment, technical documents, and personnel according to the principles of Good Pharmacy Practice.
Authority to issue Certificates
The Department of Health where the medical business is located issues a Certificate of eligibility for pharmacy business to establishments that wholesale and retail drugs and medicinal ingredients. The issued certificate is updated on the electronic information portal of the Department of Health licensing.
Procedures for issuance of Certificate of eligibility for pharmacy business
Step 1. The facility applying for a Certificate of eligibility for pharmacy business applies directly or by mail.
Step 2. After receiving the application, the receiving agency returns the application receipt to the requesting facility.
Step 3. Competent authority reviews documents:
In case it is necessary to amend or supplement documents, the dossier-receiving agency shall send a document to the requesting facility clearly stating the required documents within 07 working days from the date recorded on the dossier receipt form and set out 10 days to respond. In case the amended or supplemented dossier does not meet the requirements, the agency receiving the dossier will notify the facility in writing. In case of a response, the receiving agency continues to carry out the next activities.
Issue a Certificate of eligibility for pharmacy business within 20 days in cases where the facilities, techniques, and personnel have been inspected and assessed to meet Good Practices, without having to organize an actual assessment at the proposed facility.
Organize a site inspection at the facility within 20 days from the date recorded on the application receipt form. After completing the actual assessment, the following two cases occur:
Issue the Certificate of eligibility for pharmacy business within 10 working days from the date of completion of the actual assessment for 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 request, remediation, or repair.
Note: In case of amendment or supplementation, the applicant should note:
Within 20 days from the date of receipt of the written notice and documents proving the completion of remediation and repair from the requesting establishment, the agency issuing the Certificate of eligibility for pharmacy business shall issue the Certificate of eligibility for pharmacy business. receive eligibility for pharmacy business or answer the reason for not granting it.
Within 06 months from the date the dossier-receiving agency issues a written notification of amendments and supplements, the requesting facility must submit the amended and supplemented dossier as requested. After the above deadline, if the establishment does not amend or supplement or after 12 months from the date of the first submission of the application, if the additional application does not meet the requirements, the submitted application is no longer valid.
Services for applying for a Certificate of eligibility for pharmacy business registration from Viet An Law
Advise clients on the conditions and how to meet the legal conditions for issuance of a Certificate of eligibility for pharmacy business;
Support clients in drafting documents for issuance of Certificate of eligibility for pharmacy business;
Representing clients to submit applications at licensing agencies;
Monitor processing progress and intermediary exchanges between clients and licensing agencies;
Receive the results of the Certificate of eligibility for pharmacy business and hand it over to the clients;
Consulting when a pharmacy business goes into operation to comply with legal regulations.
Clients who have questions related to legal regulations on the condition of registration of pharmacy business in Vietnam or establishing wholesale and retail drug establishments, please contact Viet An Law Firm for the most effective advice.
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