Inspections
Inspections: Procedures for granting permits, certificates, etc. and reporting changes
Required supporting documents
A. Pharmaceutical products for human use
- 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 an initial license for the production - packaging of an investigational pharmaceutical product. Granting of a license for the production - packaging of an investigational pharmaceutical product (EOF Circular 3159/14-1-2011)
- Granting a permit to import from a Third Country. Granting a permit to import from a Third Country (EOF Circular 3160/14-1-2011)
- 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)
- Conducting an inspection in Third Countries
- Change of name of pharmaceutical factory
- Possibility of attaching an authenticity tape
- Granting a permit to produce, package, repackage, store or conduct inspections in production units of active pharmaceutical ingredients (APIs) (EOF Circular 3154/14-1-2011)
- 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)
- Content of MRA product batch certificates (EOF Circular 58446/20-10-2004)
- Granting a pharmaceutical product certificate
- Granting a pharmaceutical product certificate
- Granting a certificate of legal operation
- Raw Materials and Finished Products: Keeping Control Books
B. Precursors
- Granting a permit to import and/or trade precursor substances
- Precursor substances: Instructions for storage and handling specifications
C. Supporting documents for the appointment of a Responsible Scientist
- Appointment or replacement of responsible scientists
- Appointment or replacement of a qualified person
D. Preparation of preparations in factories following orders
hospitals, private clinics, diagnostic centers
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”
- Procedure for granting a Certificate - Declaration for the use of Ethyl or Isopropyl Alcohol in pharmaceutical products for human and veterinary use "exclusively for export" (EOF Circular 3169/14-01-2011)
G. Granting of a Certificate of Compliance with the Principles of Good Laboratory Practice
