Inspections
Inspections: Procedures for granting permits, certificates, etc. and reporting changes
Required supporting documents
A. Pharmaceutical products for veterinary use
- Change of name of pharmaceutical factory
- Raw Materials and Finished Products: Keeping Control Books
- Conducting an inspection in Third Countries
- Content of MRA product batch certificates (EOF Circular 58446/20-10-2004)
- Granting of initial production-packaging license. Extension of initial production-packaging license. Granting of license to control pharmaceutical products (EOF Circular 3156/14-1-2011)
- Granting of a permit for the possibility of importing from a third country. Granting of a permit for importing from a third country (EOF Circular 18013/4-3-2013)
- Granting a production - packaging license for pharmaceutical products (EOF Circular 3157/14-1-2011)
- Granting a production - packaging license exclusively for export (EOF Circular 3158/14-1-2011)
- Granting a permit to transfer a production process (EOF Circular 34357/21-05-2009)
- Granting a pharmaceutical product certificate
- Granting a certificate of legal operation
- Granting a pharmaceutical product certificate
- Granting a permit for the Production, Packaging, Repackaging, Storage or Conducting Inspections in production units of active pharmaceutical ingredients (APIs) (EOF Circular 3154/14-1-2011)
B. Medicated feed
- Granting a license to produce medicated animal feed (EOF Circular 3171/14-01-2011)
- Granting a permit to transfer a production process (EOF Circular 34357/21-05-2009)
C. Precursors
- Granting a permit to import and/or trade precursor substances
- Precursor substances: Instructions for storage and handling specifications
D. Supporting documents for the appointment of a Responsible Scientist
- Appointment or replacement of responsible scientists
- Appointment or replacement of a qualified person
E. Issuance of GMP certificates
- Issuance of GMP certificates
- Issuance of permits for the production of pharmaceutical products, certificates of compliance with GMP rules and copies thereof
- Good manufacturing rules
Good manufacturing practices for cytotoxic pharmaceutical products
Measures for the issuance of “non-compliance” certificates with the Good Friday Rules
Q&A document
F. Granting a certificate for the use of Alcohol in pharmaceutical products “exclusively for export”
G. Granting of a Certificate of Compliance with the Principles of Good Laboratory Practice





