Latest Information

Publications

• The European Commission published revision 10 of the application form for a marketing authorisation of a medicinal product for human use in April 2013.
• Application for a variation to a manufacturing/importation authorisation or wholesaler's authorisation
• Application for GMP certificate for API
• Transfers
• Application for a manufacturer's authorisation / licence

Legislation

• Eudralex - Volume 4 Good Manufacturing Practice (GMP) Guidelines
• Consolidated Directive
• Consolidated Directive 2001/82/EC
• Medicinal Products (Control of Advertising) Regulations 2007 (SI 541 of 2007)
• Medicinal Products (Control of Wholesale Distribution) Regulations 2007 (SI 538 of 2007)

Links

• European Medicines Agency Q&As on GMP
• European Medicines Agency

Consultation

• Consultation - Electronic Submissions

News

• Rapid Revision of heparin monographs June 2008
• IMB will be modifying the format of the current Manufacturer’s Authorisation so that the information

Events

• Compliance Information Days September 2012
• GMP and Market Compliance Information Day 2008