Because the pharmaceutical industry is a conditioned company, it is critical to ensure that there exist conditions for facilities and raw materials, … A Business Eligibility Certificate will be issued to the business establishment or organization once it has been determined to be eligible. So, how is the process of obtaining a Certificate of Eligibility for Pharmaceutical Business governed? To clarify more this issue, Hong Bang Law Firm would like to send to Clients the following advice:
Legal basis
- Law on Pharmacy No. 105/2016/QH13 dated April 6, 2016 of the National Assembly;
- Decree No. 54/2017/ND-CP dated May 8, 2006 of the Government detailing a number of articles and measures to implement the Law on Pharmacy;
- Circular No. 277/2016/TT-BTC dated November 14, 2016 of the Minister of Finance on guidelines for implementation of the law on pharmacy;
- Decree No. 155/2018/ND-CP dated November 12, 2018 of the Government amending and supplementing one – number of regulations related to business investment conditions under the state management of the Ministry of Health.
Conditions for issuance of certificates of eligibility for pharmaceutical business
Infrastructure, equipment, and personnel conditions:
- Every manufacturer of drugs/medicinal ingredients must have the premises, factory, laboratory, storage of drugs/medicinal ingredients, auxiliary systems, equipment, machinery for manufacture, testing, storage of drugs, quality control system, technical documents and personnel that fulfill GMP requirements;
- Every importer and exporter of drugs/medicinal ingredients, provider of drug/medicinal ingredient storage services must have the premises, drug storage, storage equipment, transportation, quality control system, technical documents and personnel that fulfill Good Storage Practice requirements;
- Every wholesaler of drugs/medicinal ingredients have the premises, drug storage, storage equipment, transportation, quality control system, technical documents and personnel that fulfill Good Distribution Practice requirements;
- Every drug retailer must have the premises, a storage area, storage equipment, technical documents and personnel that fulfill Good Retailing Practice requirements; Retailers of herbal ingredients, herbal drugs, traditional drugs shall comply with Point b Clause 2 Article 69 hereof;
- Every provider of drug/medicinal ingredient testing services must have the premises, a chemical/microbiological/biological laboratory, auxiliary systems, testing equipment, chemicals, reagents, quality control system, technical documents and personnel that fulfill Good Laboratory Practice requirements;
- Every provider of clinical trial services must have the premises, a clinical laboratory, testing laboratory, bio-chemical testing equipment, quality control system, technical documents and personnel that fulfill Good Clinical Practice requirements;
- Every provider of bioequivalence services must have the premises, a laboratory for biological fluid analysis, equipment for biological fluid analysis, an area for drug users to stay and undergo bioequivalence assessment, quality control system, technical documents and personnel that fulfill Good Laboratory Practice requirements in the biological fluid analysis stage and fulfill Good Clinical Practice requirements in the clinical trial stage.
Where a provider of bioequivalence study service only fulfills Good Laboratory Practice requirements in biological fluid analysis, it must sign a contract or cooperate with a provider of clinical trial services that fulfills Good Clinical Practice requirements to carry out clinical trial in the process of bioequivalence study.
Procedure
Dossier
Applications for the certificate of eligibility for pharmaceutical business include:
- An application form for the Certificate of eligibility for pharmacy business;
- Technical documents corresponding to the changed Business Conditions;
- A certified copy of the Certificate of Business Registration or a legal document proving the establishment of the establishment;
- Certified copy of pharmacy practice certificate.
Competent agencies
The Ministry of Health for the case of requesting the issuance of certificates of eligibility for pharmaceutical business for the following establishments:
- Production establishments of drugs and raw materials for making drugs;
- Establishments for exporting and importing drugs and raw materials for making drugs;
- Establishments trading in drug preservation services and drug-making raw materials;
- Establishments trading in drug testing services and drug-making materials;
- Clinical drug testing service establishments;
- Drug bio-equivalent testing service establishments
The Department of Health where the establishment is located is located in case of request for issuance of a Certificate of eligibility for pharmaceutical business in one of the following cases:
- Wholesale establishments of drugs and raw materials for making drugs;
- Drug retail establishments including pharmacies, drug counters, drug cabinets of commune health stations, establishments specializing in retailing pharmaceuticals, medicinal drugs, traditional medicines;
Implementation time
- 20 days from the date of receipt of the full dossier in case the facility is not required to go for assessment;
- 30 days from the date of receipt of sufficient dossiers in case of having to go to the facility assessment.
Services of Hong Bang Law Firm
- Advise clients to prepare dossiers;
- Support clients to notarized and certify documents of foreign countries (if any);
- Draft, prepare and check the validity of the dossier;
- Represent clients to carry out procedures with competent authority;
- Hand over the results to the clients.
If you need more detailed advice and answers as well as how to access this service, please contact directly our Lawyer Nhat Nam via hotline: 0912.35.65.75, 0912.35.53.53 or call the toll free legal consultation hotline 1900.6575 or send a service request via email: lienheluathongbang@gmail.com
Wishing you and your family good health, peace and success!
Best regards!
