The applications for issuance, reissuance and adjustment of the Certificate of eligibility for pharmacy business in Vietnam
I have the following question related to the issuance, reissuance and adjustment of the Certificate of eligibility for pharmacy business that needs to be answered. According to current legal regulations, what do applications for issuance, reissuance and adjustment of the Certificate of eligibility for pharmacy business in Vietnam include?
The applications for issuance, reissuance and adjustment of the Certificate of eligibility for pharmacy business in Vietnam (Image from the Internet)
According to the provisions of Clause 13 and Clause 14, Article 4 of Decree 155/2018/ND-CP and Article 32 of Decree 54/2017/ND-CP, an application for issuance, reissuance or adjustment of Certificate of eligibility for pharmacy business according to Article 38 of the Law on Pharmacy consists of:
1. Form No. 19, 20 or 21 in Appendix I enclosed herewith for issuance, reissuance or adjustment of the Certificate of eligibility for pharmacy business respectively;
2. Technical documents specified in Clause 1b and Clause 2b Article 38 of the Law on Pharmacy, including the Certificate of eligibility for pharmacy business or Certificate of Good Practice at the business location (if any) and the following documents:
a) If the applicant is a manufacturer of drugs or medicinal materials, documents about the location, factory, testing laboratory, storage area, auxiliary systems, machinery for manufacturing and storing drugs, quality control system, documents about technologies and personnel according to Good Manufacturing Practice (GMP) for drugs and medicinal materials.
If the applicant applies for a Certificate of eligibility for pharmacy business that allows sale of drugs or medicinal materials it manufactures to retailers and health facilities, documents about technologies and personnel according to GDP for drugs and medicinal materials are required;
b) If the applicant is an importer or exporter of drugs or medicinal materials or a provider of drug or medicinal material storage services, documents about the location, storage area, storage equipment, vehicles, quality control system, documents about technologies and personnel according to GSP for drugs and medicinal materials.
If the applicant applies for a Certificate of eligibility for pharmacy business that allows sale of drugs or medicinal materials imported to retailers and health facilities, documents about technologies and personnel according to GDP requirements applied to drugs and medicinal materials are required;
c) If the applicant is a wholesaler of drugs or medicinal materials, documents about the location, storage area, storage equipment, vehicles, quality control system, documents about technologies and personnel according to GDP for drugs and medicinal materials;
d) If the applicant is a drug retailer, documents about the location, storage area, storage equipment, vehicles, quality control system, documents about technologies and personnel according to Good Pharmacy Practice (GPP) requirements.
If the applicant is a retailer of herbal materials, herbal drugs or traditional drugs, documents proving fulfillment of the requirements in Clause 5 Article 31 hereof according to regulations of the Minister of Health;
dd) If the applicant is a provider of drug or medicinal material testing services, documents about the location, testing laboratory, auxiliary system, testing equipment, chemicals, reagents, quality control system, documents about technology and personnel according to Good Laboratory Practice (GLP) requirements;
e) If the applicant is a provider of clinical trial services, documents about the location, clinical trial room, testing laboratory, testing equipment, quality control system, documents about technology and personnel according to Good Clinical Practice (GCP) requirements;
g) If the applicant is a provider of bioequivalence study services, documents about the location, the laboratory for biological fluid analysis, equipment for biological fluid analysis, the area for monitoring drug users serving bioequivalence study, the quality control system, documents about technology and personnel according to GLP requirements for the biological fluid analysis and GCP requirements for the clinical study.
In the cases where the provider of bioequivalence study services signs a contract or cooperates with a clinical trial service provider that meets GCP requirements in carrying out the clinical trial, the documents according to GCP are not required.
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