PROCEDURE FOR ISSUANCE OF CERTIFICATE OF ELIGIBILITY FOR PHARMAMCY BUSINESS
Business activities include
– Trading in drugs/medicinal ingredients
– Provision of drug/medicinal ingredient storage services
– Provision of drug/medicinal ingredient testing services
– Provision of clinical trial services
– Provision of bioequivalence study services
Pharmacy business establishments include
– Manufacturers of drugs/medicinal ingredients
– Exporters, importers of drugs/medicinal ingredients
– Providers of drug/medicinal ingredient storage services
– Wholesalers of drugs/medicinal ingredients
– Drug retailers, including drugstores, dispensaries of hospitals and medical stations of communes, retailers of herbal ingredients, herbal drugs, traditional drugs
– Providers of drug/medicinal ingredient testing services
– Providers of clinical trial services
– Providers of bioequivalence study services
Conditions for issuance of Certificate of eligibility for pharmacy business
– Infrastructure, equipment, and personnel conditions
|
No. |
Scope of business |
Requirements |
Certificate |
|
1 |
Manufacturer of drugs/medicinal ingredients |
Premises, laboratoty, warehouse, raw materials, utilities systems, equipment, quality management system, technical documents and personnel. |
GMP |
|
2 |
Importer and exporter of drugs/medicinal ingredients, provider of drug/medicinal ingredient storage services |
Premises, warehouse, transportation, quality system management, technical documents and personnel. |
GSP
|
|
3 |
Wholesaler of drugs/medicinal ingredients |
Warehouse, transportation, quality system management, technical documents and personnel. |
GDP |
|
4 |
Retailer |
Storage area, technical documents and personnel. |
GDP |
|
5 |
Drug/medicinal ingredient testing services
|
Chemical/ microbiology laboratory, utilities, testing equipment, chemicals, reagents, quality management system, technical documents and personnel. |
GLP |
|
6 |
Clinical trial services |
Clinical laboratory, testing laboratory, bio-chemical testing equipment, quality management system, technical documents and personnel |
GCP |
|
7 |
Bioequivalence services |
Laboratory for biological fluid analysis, equipment for biological fluid analysis, an area for drug users to stay and undergo bioequivalence assessment, quality management system, technical documents and personnel |
GLP, GCP |
– There is pharmacy practice certificate suitable for the pharmacy business establishments.
– The assessment of infrastructure, equipment and personnel shall be carried out every 03 years or the unscheduled inspection.
Conditions for trading in controlled drugs and drugs restricted from retailing
– Fulfillment of every condition specified in Conditions for issuance of Certificate of eligibility for pharmacy busine;
– Availability of measures for protecting controlled drugs/medicinal ingredients from loss;
The cases of issuance, reissuance, adjustment of Certificate of eligibility for pharmacy business
- New issuance
– Applying for the first time
– Changes its scope of business and thus changes the applicable conditions; or changes the business location
– The certificate of eligibility for pharmacy business is revoked.
- Reissuance
– Be lost or damaged
– Incorrectly stated on the Certificate of eligibility for pharmacy business.
- Adjustment
Changes to the name of the establishment, business location, person in charge, or scope of pharmacy business without changing the conditions for pharmacy business.
The power to issue, reissue, adjust, revoke Certificates of eligibility for pharmacy business
– The Ministry of Health: Manufacturers/ Exporters, importers/ storage services/ testing services/ clinical trial services/ bioequivalence study services of drugs/medicinal ingredients.
– The Department of health: Drug retailers.
Dossier for issuance, reissuance, adjustment of Certificate of eligibility for pharmacy business
- New issuance
- In the cases applying for the first time, be revoked:
– An application form
– Corresponding technical documents of the pharmacy business establishment;
– Legal documents proving the existence of the establishment;
– A certified true copy of the pharmacy practice certificate.
- In the cases changes its scope of business and thus changes the applicable conditions; or changes the business location
– An application form
– Technical documents corresponding to the changes;
– A certified true copy of the certificate of enterprise registration or legal documents proving the existence of the establishment;
– A certified true copy of the pharmacy practice certificate.
- Reissuance
– An application form
– The Certificate of eligibility for pharmacy business that is incorrect.
- Adjustments
– An application form
– A certified true copy of the pharmacy practice certificate if the position that requires the pharmacy practice certificate is changed;
– A certified true copy of the certificate of enterprise registration or legal documents proving the change in the name or address of the establishment.
Procedures for issuance, reissuance, adjustment of Certificate of eligibility for pharmacy business
- Submit dossier, directly or by post to a competent authority.
After receiving the dossier, the receiving authority shall give the applicant form No. 01 in Appendix I Decree 54
- Issuance
– Issue the Certificate of eligibility for pharmacy business within 20 days, if complied with relevant Good Practice requirements.
– The competent authority performs a site inspection within 20 days.
– After the site inspection is done:
- a) Issue the Certificate of eligibility for pharmacy business within 10 working days in case there are no observations that must give corrective actions.
- b) Issue a notification of necessary corrective actions and preventive actions (if any) within 05 working days.
- c) Issue the Certificate of eligibility for pharmacy business within 20 days from the day on which the notification and documents proving that all necessary corrective actions are taken and received.
- Reissuing and adjusting
– Re-issue or adjust the Certificate of Eligibility for Pharmacy Business within 15 days
– Reissue or adjust the Certificate of eligibility for pharmacy business within 07 days because of the fault of the issuing authority
– If the application is not satisfactory, within 05 working days the receiving authority shall request the applicant in writing to complete the application
- Note
– Within 06 months from the day on which additional documents are requested in writing by the receiving authority, the applicant shall submit additional documents as requested. If the applicant fails to satisfy such request by the aforementioned deadline or the application is not satisfactory within 12 months from the first time it is submitted, the application will be rejected.
– After Issue the Certificate of eligibility for pharmacy business, within 05 working days, the receiving authority shall update the following information on website:
- a) The name and address of the holder of the Certificate of eligibility for pharmacy business;
- b) Full name of the chief pharmacist and his/her pharmacy practice certificate number;
- c) Number of the Certificate of eligibility for pharmacy business.
– The Certificate of eligibility for pharmacy business shall be made into 02 copies according to Form No. 22 in Appendix I enclosed herewith. 01 copy will be given to the applicant while the other retained by the issuing authority.
– If the applicant has met Good Practice requirements, the authority that issues the Certificate of eligibility for pharmacy business shall issue the Certificate of Good Practice.
Cases in which the Certificate of eligibility for pharmacy business is revoked
- The pharmacy business is shut down.
- Any of the conditions for issuance of the Certificate of eligibility for pharmacy business is not satisfied.
- The Certificate of eligibility for pharmacy business is issued ultra vires or against the law.
- The pharmacy business is not operating for 12 consecutive months without notifying a pharmacy authority.
Management of Certificates of eligibility for pharmacy business
A Certificate of eligibility for pharmacy business does not have an expiry date.