1. Legal grounds
– Law on Pharmacy 2016;
– Decree 54/2017/ND-CP detailing a number of articles and measures to implement the Law on Pharmacy;
– Decree 155/2018/ND-CP amending and supplementing a number of regulations related to business investment conditions under the scope of state management of the Ministry of Health.

2. Conditions for trading in traditional drugs
2.1. For establishments producing traditional drugs for nationwide circulation
Must meet the provisions at Points a, c and d, Clause 2, Article 69 of the Law on Pharmacy 2016 as follows
Traditional medicine production establishments must have locations, production workshops, testing laboratories, warehouses for storing drugs and medicinal ingredients, auxiliary systems, equipment and machinery for production, testing and maintenance. drug management, quality management system, professional and technical documents and personnel compliance with Good Manufacturing Practice for traditional drugs;
– The person in charge of pharmacy expertise and the person in charge of drug quality of a traditional drug manufacturer must have a professional diploma as prescribed and have 2 years of professional practice at a pharmaceutical establishment suitable to his/her specialty. subject of the practitioner, except for the case specified at Point d of this Clause;…
– The person in charge of pharmacy expertise, the person in charge of drug quality assurance of the cooperative or household business producing traditional drugs must have one of the professional qualifications specified at Points a, c, and e. , g, i or l Clause 1 Article 13 of this Law and have 2 years of professional practice at a pharmacy establishment suitable to the practitioner’s expertise, except for the case specified at Point c, Clause 2, Article 13 of this Law. ;…

2.2. For establishments importing traditional medicines
There must be a place, drug storage warehouse, storage equipment, means of transport, quality management system, professional and technical documents and personnel meeting Good Storage Practices for traditional drugs. . Persons responsible for pharmacy expertise of establishments exporting or importing traditional drugs as prescribed in Clause 3, Article 17 of the Law on Pharmacy 2016.

2.3. For establishments providing traditional medicine preservation services
There must be a place, drug storage warehouse, storage equipment, means of transport, quality management system, professional and technical documents and personnel meeting Good Storage Practices for traditional drugs. . The person in charge of pharmacy expertise of the establishment exporting or importing traditional drugs as prescribed in Clause 1, Article 22 of the Law on Pharmacy 2016.

2.4. For Traditional Medicine Wholesalers
Must have a location, drug storage warehouse, storage equipment, means of transport, quality management system, professional and technical documents and personnel that meet Good Distribution Practice for traditional drugs . Person in charge of pharmacy expertise of a traditional drug wholesaler as prescribed in Clause 3, Article 16 of the Law on Pharmacy 2016.

2.5. For establishments specializing in retailing of herbal ingredients, herbal medicines, and traditional drugs
– The person in charge of pharmacy expertise of a retailer of herbal ingredients, herbal drugs or traditional drugs as prescribed in Clause 4, Article 18 of the Law on Pharmacy 2016;
– Having a fixed and separate location; sturdy construction; the area is suitable to the business scale; arranged in a high, cool, safe place, far away from pollution sources;
– There must be a storage area and storage equipment in accordance with the storage requirements stated on the label.
Toxic medicinal materials must be displayed for sale (if any) and stored in a separate area; In case they are displayed for sale and stored in the same area as other medicinal herbs, they must be kept separate and clearly marked “poisonous medicinal herbs” to avoid confusion.
An establishment specializing in retailing of herbal drugs, traditional drugs or retailing of herbal ingredients only needs to have a corresponding storage area for the preservation of herbal drugs or traditional drugs or for the preservation of herbal ingredients and traditional medicines.
– Tools and packages in direct contact with herbal drugs, traditional drugs and herbal ingredients must not affect the quality of herbal drugs, traditional drugs or herbal ingredients;
– Having appropriate records or measures to keep information on import and export activities and traceability;
– Retailers of herbal ingredients, herbal drugs or traditional drugs must have one of the diplomas specified at Points a, c, e, g, i or l, Clause 1, Article 13 of the Law on Pharmacy 2016.
For toxic herbal ingredients, prescription herbal drugs, and prescription traditional drugs, the person who directly retails and advises the buyer must be the person responsible for the specialty of the retailer;
– In case the retail establishment trades in other items as prescribed by law, these items must be displayed for sale and preserved in a separate area without affecting the medicinal herbs, herbal medicines, traditional medicine.

3. Order and procedures for granting a certificate of eligibility for pharmacy business
Pursuant to Article 33 of Decree 54/2017/ND-CP, specifically as follows:
Step 1: The applicant for the Certificate of eligibility for pharmacy business shall submit the application in person or by post to the competent authority.
Step 2: After receiving the dossier, the dossier-receiving agency returns the application receipt to the requesting establishment.
Step 3: When there is a request to amend and supplement the dossier for the case specified at Point a, Clause 3 of this Article, within 07 working days from the date on which the application is received, the receiving agency shall: receive a dossier with a written request to the requesting establishment, which must specify documents and contents that need to be amended and supplemented. After receiving the amended and supplemented dossier, the dossier-receiving agency shall return to the requesting establishment the receipt of the amended and supplemented dossier.
– In case the revised or supplemented dossier does not meet the requirements, the application-receiving agency shall notify the establishment in writing;
– In case there is no request for amendment or supplementation to the amended or supplemented dossier, the application-receiving agency shall follow Step 4.
Step 4: In case there is no request to amend or supplement the dossier, the agency issuing the Certificate of eligibility for pharmacy business:
– Issuance of the Certificate of eligibility for pharmacy business within 20 days from the date on which the application is received, if the physical, technical and personnel facilities have been inspected and assessed to be satisfactory. Good practice in line with the business scope, not the actual assessment organization at the establishment applying for the Certificate of eligibility for pharmacy business.
– Organize the actual assessment at the establishment applying for the Certificate of eligibility for pharmacy business within 20 days from the date indicated on the application receipt.
Step 5: After the actual assessment of the establishment, the agency issuing the Certificate of eligibility for pharmacy business is responsible for:
– Issue the Certificate of eligibility for pharmacy business within 10 working days from the date of completion of the actual assessment in case there is no request, remedy or repair;
– Issue a written notice of the contents to be remedied or repaired within 05 working days from the date of completion of the actual assessment, in case of request, remedy or repair.
– Within 20 days from the date of receipt of the written notice and documents proving the completion of the remedy or repair by the applicant, the agency issuing the Certificate of eligibility for pharmacy business shall issue a Certificate of eligibility for pharmacy business. certificate of eligibility for pharmacy business or answer the reason it has not been granted.
Step 6: Within 05 working days from the date of issuance of the Certificate of eligibility for pharmacy business, the application-receiving agency shall publish and update on its website the following information:
– Name and address of the establishment granted the Certificate of eligibility for pharmacy business;
– Full name of person in charge of pharmacy expertise, number of pharmacy practice certificate;
– Number of Certificate of eligibility for pharmacy business.

4. The agency issuing the Certificate of eligibility for pharmacy business
4.1. Ministry of Health
In case of application for a Certificate of eligibility for pharmacy business in one of the following cases:
– Manufacturers of drugs and medicinal ingredients;
– Establishments that export and import drugs and medicinal ingredients;
– Establishments providing storage services for drugs and medicinal ingredients;
– Establishments providing testing services for drugs and medicinal ingredients;
– Establishments providing clinical trial services;
– Establishments providing bioequivalence testing services of drugs.

4.2. The Department of Health where the facility is located is located
In case of application for a Certificate of eligibility for pharmacy business in one of the following cases:
– Wholesalers of drugs and medicinal ingredients;
– Drug-retailing establishments include drugstores, drugstores, medicine cabinets at commune health stations, establishments specializing in retailing of herbal ingredients, herbal medicines, and traditional drugs;

5. Some notes
– Within 06 months from the day on which the application-receiving agency issues a written notice of amendment and supplementation, the requesting establishment must submit the requested amendment or supplement. After the above time limit, if the establishment does not amend or supplement, or after 12 months from the date of first submission of the dossier, the additional dossier does not meet the requirements, the submitted dossier is no longer valid.
– The Certificate of eligibility for pharmacy business is made in 02 copies: 01 copy is issued to the applicant for the Certificate of eligibility for pharmacy business; 01 copy is kept at the agency issuing the Certificate of eligibility for pharmacy business.
In case the establishment has been assessed to meet Good Practice, the agency issuing the Certificate of eligibility for pharmacy business shall issue the Certificate of Good Practice if the establishment requests for the Certificate of Good Practice.

The above is the advice of Khoa Tin Law on: “Submission of advice and procedures for applying for a certificate of pharmacy business for traditional medicine trading establishments”
In case customers have unclear problems or need to discuss further, please call us immediately at 0983.533.005 for a free consultation.

Best regards./.