[MEDICAL LAW CONSULTING]

QUESTION:
I want advice
Procedures for certification as a traditional pharmacy for many generations and for traditional medicine
Before 2013, the Ministry of Culture had to get a mat, which was commended by the king of the Nguyen Dynasty and given the name of the pharmacy: KHAI MINH DUONG. And some of the specimens my father gave to the Ministry of Culture for display purposes.
So now, I want to go to the Ministry of Culture to ask for documents about my pharmacy.

ANSWER:
Hello, thank you for sending a question to MEDLAW, based on the information you provided, MEDLAW advises as follows:

Currently, there is no specific legal regulation on the recognition or granting of a certificate of "heirloom pharmacy for many generations", but only regulations on the granting of a certificate of traditional medicine. Therefore, in order to operate a business that sells traditional medicines, you first need to be granted a Certificate of Traditional Chinese Medicine (hereinafter referred to as GCN). Decision 39/2007/QD-BYT detailing the Regulation on approval and issuance of “Certificate of traditional medicine”. The person granted the Certificate must be a person with full civil act capacity; have the right to inherit as prescribed by law; must know the specific herbs and medicinal ingredients, preparation, usage, dosage, route of administration, indications, contraindications and diagnosis of diseases and be approved by local authorities (communes/wards/towns) ) is certified as a person whose clan or family has a long-standing and effective family remedy for a certain disease, is trusted by the people in the area and has no civil dispute over that remedy (Article 12). 4 Decision 39/2007/QD-BYT). In addition, the procedures and dossiers for consideration and approval for issuance of Certificates are specified in Articles 6 and 7 of Decision 39/2007/QD-BYT. Regarding the process of receiving and reviewing applications, please refer to Article 8, Article 9 Quyết định 39/2007/QĐ-BYT.

After being granted a certificate by a competent authority, if you have registered to establish a traditional medicine business establishment, you can continue doing business. If you have not yet registered your business, you can register as a household business or establish a business. Business registration code according to Decision 27/2018/QD-TTg, the business of traditional remedies on the List of drugs, pharmaceutical chemicals and herbal ingredients. In addition, traditional drug trading establishments must meet the statutory requirements on production, preservation, professional responsible persons, etc., as prescribed in Clause 2, Article 69 of the Law on Pharmacy 2016 and Article 31. 

About re-applying documents about Khai Minh Duong Pharmacy, you can directly contact the Ministry of Culture, Sports and Tourism for detailed explanations of the process and procedures in the most specific and accurate way. Head office is at No. 20, Lane 2, Hoa Lu, Hai Ba Trung District, Hanoi. In addition, you can ask questions directly on the official website of the Ministry of Culture, Sports and Tourismhttps://bvhttdl.gov.vnOr call 0243.9745845 for detailed instructions.

Specifically, the legal basis for your case is as follows:

According to Clause 2, Article 69 of the Law on Pharmacy 2016 on the satisfaction of traditional drug manufacturers:

2. A manufacturer of traditional drugs for nationwide circulation or a retailer of traditional drugs must satisfy the following conditions:
3. a) A traditional drug manufacturing establishment must have a location, production workshop, testing laboratory, a warehouse for storing drugs and medicinal ingredients, ancillary systems, equipment and machinery for production and testing. drug preservation, quality management system, professional and technical documents and personnel compliance with Good Manufacturing Practice for traditional drugs;
4. b) Establishments specializing in the retailing of herbal ingredients, herbal medicines and traditional drugs must comply with regulations on storage locations, areas, preservation equipment, professional and technical documents and personnel;
5. c) The person in charge of pharmacy expertise and the person in charge of drug quality of a traditional drug manufacturer must have the professional diplomas specified at Point a or c, Clause 1, Article 13 of this Law and have 02 years of professional practice at a pharmacy establishment suitable to the practitioner's expertise, except for the case specified at Point d of this Clause. The person in charge of pharmacy expertise of a manufacturer of traditional drugs for nationwide circulation may concurrently be the person in charge of drug quality assurance of the manufacturer;
6. c) The person in charge of pharmacy expertise and the person in charge of drug quality of a traditional drug manufacturer must have the professional diplomas specified at Point a or c, Clause 1, Article 13 of this Law and have 02 years of professional practice at a pharmacy establishment suitable to the practitioner's expertise, except for the case specified at Point d of this Clause. The person in charge of pharmacy expertise of a manufacturer of traditional drugs for circulation may concurrently be the person in charge of drug quality assurance of the manufacturer;

dd) The person in charge of pharmacy expertise of the traditional drug retailer shall comply with the provisions of Clause 4, Article 18 of this Law.

dd) The person in charge of pharmacy expertise of the traditional drug retailer shall comply with the provisions of Clause 4, Article 18 of this Law. 

1. Establishments producing traditional drugs for nationwide circulation must satisfy the requirements at Points a, c and d, Clause 2, Article 69 of the Law on Pharmacy.
2. An establishment importing traditional drugs must have a location, drug storage warehouse, preservation equipment, means of transport, a quality management system, professional and technical documents, and personnel that meet the requirements of Good Manufacturing Practices. management of 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.
3. Establishments providing traditional medicine preservation services must have locations, drug storage warehouses, preservation equipment, means of transport, quality management systems, professional and technical documents and qualified personnel. Good practice of drug preservation for traditional medicines. Persons responsible for pharmacy expertise of establishments exporting or importing traditional drugs as prescribed in Clause 1, Article 22 of the Law on Pharmacy.
4. Traditional medicine wholesalers must have locations, drug storage warehouses, preservation equipment, means of transportation, quality management systems, professional and technical documents and personnel that meet Good Distribution Practices. drug distribution 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.
5. Conditions for establishments specializing in retailing of herbal ingredients, herbal drugs and traditional drugs:
6. a) 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;
7. b) Having a fixed and separate location; sturdy construction; the area is suitable to the business scale; arranged in a dry, cool, safe place, far from pollution sources, ensuring fire and explosion prevention;
8. c) There must be a storage area and storage equipment in accordance with the storage requirements stated on the label.

Medicinal herbs and traditional drugs must be preserved separately from traditional herbal ingredients and flavors.

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.

Prescribed herbal medicines and traditional drugs must be displayed for sale (if any) and stored in a separate area; In case of being sold and stored in the same area as non-prescription drugs, they must be kept separate and clearly marked "Prescription drugs" to avoid confusion.

An establishment specializing in retailing of herbal drugs or traditional drugs or specializing in retailing of herbal ingredients only needs to have a corresponding storage area to preserve herbal drugs or traditional drugs or to preserve herbal ingredients and traditional medicines;

1. d) Instruments 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;

dd) Having appropriate records or measures to store information about import and export activities and traceability;

1. e) Retailers of herbal ingredients, herbal medicines 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.

e) Retailers of herbal ingredients, herbal medicines 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.

1. g) 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 herbal ingredients or herbal medicines. , traditional medicine.

The content of our consultation is based on the information provided by the Client, is for reference only and based on the legal provisions in force at the time of consultation. In case you ever need detailed consultation, please contact us directly for specific advice. 

In case you ever need detailed consultation, please contact us directly for specific advice.

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