Conditions for opening a pharmacy of traditional medicine by Vietnamese law
When you want to open a pharmacy, you must meet certain legal conditions, such as a pharmacy practice certificate. So what are the conditions for opening a traditional medicine pharmacy? So, please follow the article below of Lawyer X for more information on the conditions for opening a traditional medicine pharmacy!
Legal grounds
– Pharmacy Law 2016
– Decree 54/2017/ND-CP
– Decree 155/2018/ND-CP
What are the conditions for trading in traditional medicines?
Under Article 31 of Decree 54/2017/ND-CP (amended at Points a and b, Clause 10, Article 5 of Decree 155/2018/ND-CP), conditions for trading in traditional drugs are as follows:
– 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.
– Besides, 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 Good Practices. drug preservation for traditional drugs. Persons are responsible for pharmacy expertise of establishments exporting or importing traditional drugs as prescribed in Clause 3, Article 17 of the Law on Pharmacy.
– After that, establishments providing traditional drug preservation services must have a location, drug storage warehouse, preservation equipment, means of transport, a quality management system, professional and technical documents, and qualified personnel. Good drug preservation practice for traditional medicines. Persons are responsible for pharmacy expertise of establishments exporting or importing traditional drugs as prescribed in Clause 1, Article 22 of the Law on Pharmacy.
– Traditional medicine wholesalers must-have locations, drug storage warehouses, preservation equipment, means of transport, quality management systems, professional and technical documents, and personnel that meet Good 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.
– So, conditions for establishments specializing in retailing of herbal ingredients, herbal drugs, 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;
+ Having a fixed, separate location; sturdy construction; the area is suitable for the business scale; arranged in a dry, cool, safe place, far away from pollution sources.
+ There must be a storage area and storage equipment by the storage requirements stated on the label.
Toxic medicinal materials must display for sale (if any) and stored in a separate area; In case they displayed for sale and stored in the same area as other medicinal herbs, they must keep separate and marked “poisonous medicinal herbs” to avoid confusion.
An establishment specializing in retailing herbal drugs or traditional drugs or specializing in retailing herbal ingredients only needs to have a corresponding storage area for the preservation of herbal drugs or traditional drugs or preservation of herbal ingredients and traditional medicines.
Medicinal herbs and traditional drugs must be preserved separately from traditional herbal ingredients and flavors.
Besides, toxic medicinal materials must display for sale (if any) and store 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 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 selling and storing in the same area as non-prescription drugs, they must keep separate and mark “Prescription drugs” to avoid confusion.
An establishment specializing in retailing herbal drugs or traditional drugs or specializing in retailing herbal ingredients only needs to have a corresponding storage area to preserve herbal drugs or traditional drugs or preserve herbal ingredients and traditional medicines;
– Tools and packages that come into direct contact with herbal drugs, traditional drugs, and herbal ingredients must not affect the quality of herbal drugs, traditional drugs, or herbal ingredients;
– Secondly, having appropriate records or measures to keep information on import and export activities and traceability;
– Then, detailers 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.
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, and traditional medicine.
Thus, according to the above regulations, you must ensure that you comply with the above conditions to be able to open a traditional pharmacy.
What are the conditions for granting a pharmacy practice certificate?
Under Article 13 of the 2016 Pharmacy Law, the conditions for granting a pharmacy practice certificate are as follows:
Having a diploma, certificate, or professional certificate (hereinafter referred to as a professional diploma) granted or recognized in Vietnam suitable to the job position and pharmaceutical business establishment, including:
– University diploma in pharmacy (hereinafter referred to as Pharmacist Degree);
– Secondly, a university diploma in general medicine;
– University degree in traditional medicine or university in traditional pharmacy;
– Then, a university diploma in biology;
– University diploma in chemistry;
– College diploma in pharmacy;
– Post-secondary diploma in pharmacy;
– College or intermediate medical diploma;
– Diploma in traditional medicine or traditional pharmacy;
– Diplomas and certificates of primary pharmacy;
– Certificate of herbal medicine, certificate of traditional medicine or other diplomas, certificates or certificates in traditional medicine and pharmacy issued before the effective date of this Law.
The application of the conditions on diplomas, certificates, and certificates specified at Point l of this Clause shall be prescribed by the Minister of Health by the socio-economic development conditions and the demand for medical examination and treatment of the people in each locality in each period.
Issuance, re-issuance, and modification of pharmacy practice certificates by the law
Article 12 of the 2016 Law on Pharmacy stipulates the grant, re-issuance, and modification of the pharmacy practice certificate as follows:
Issuance of pharmacy practice certificates shall be carried out in the form of consideration for applicants or examination for persons wishing to apply and apply to the following cases:
– An applicant for a pharmacy practice certificate for the first time;
– Persons who have been granted pharmacy practice certificates but their pharmacy practice certificates are revoked according to the provisions of Article 28 of this Law.
In case the pharmacy practice certificate is revoked as prescribed in Clauses 4, 6, 10, or 11 Article 28 of this Law, the pharmacy practice certificate will only be granted after 12 months from the date of revocation.
Re-issuance of pharmacy practice certificates applies to cases of loss or damage.
Adjustment of contents of a pharmacy practice certificate applies to cases where a person who has been granted a pharmacy practice certificate has changed the scope of practice, a form of issuance of the pharmacy practice certificate, or information of the certificate holder’s pharmacy practice.
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Frequently asked questions
According to the provisions of Article 11 of the Law on Pharmacy 2016 stipulating that the positions requiring a pharmacy practice certificate are as follows:
– The person in charge of pharmacy expertise of the pharmacy business establishment.
– Person in charge of quality assurance of establishments manufacturing drugs and medicinal ingredients.
– Persons in charge of clinical pharmacy work of medical examination and treatment establishments.
Thus, according to the above regulations, opening a pharmacy must have a pharmacy practice certificate.
– Being examined for penal liability, serving a court judgment or decision; during the period of being banned from practicing medicine or doing work related to pharmacy activities according to court judgments or decisions;
– Limited capacity for civil acts.
Traditional medicine (including traditional herbs) is a drug with herbal ingredients that are processed, prepared, or mixed according to the theory and method of traditional medicine or according to folk experience into a preparation in the form of traditional or modern preparation.
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