Certificate of good distribution practice
The certification of good distribution practice is issued by the pharmaceutical inspector to the inspected business entity:
- in 90 days from the inspection if the business entity performs wholesale of medicinal products in accordance with the principles and guidelines of good distribution practice for medicinal products or for substances,
- or in 15 days from the issue or modification of the licence for medicinal products wholesale or entry or modification in the registry of substances wholesalers.
The pharmaceutical inspector can issue a decision annulling the certificate of good distribution practice, if the inspection shows that the holder of the licence for wholesale medicinal products or business entity entered in the register of substances wholesalers does not implement the principles and guidelines of good distribution practice for medicinal products or substances.
The validity of the certificate of good distribution practice is formally 5 years from the last inspection. It can be shortened according to the inspection findings.
Conditions and evidence
- Organisation operates in accordance with the principles of good distribution practice Person responsible for the acceptance, storage and transport of medicinal products and review of documentation
- Judicial remedy: Appeal
- Competent authority: Ministry of Health