Latest Information

Publications

• Application for variation of a manufacturer's or wholesaler's authorisation / licence
• Application for a renewal of a manufacturer's or wholesaler's authorisation
• Application for a new laboratory approval
• Application for a manufacturer's authorisation / licence
• Guidance Note on the Notification System for Exempt Medicinal Products

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)

FAQs

• How does a company apply for a licence to manufacture, possess or supply controlled drugs and is there a list of controlled drugs
• Is there a fee charged for a licence renewal?
• How long does it take to process an export certificate application?
• Can a licence / export certificate application be submitted by email?
• What is the routine inspection frequency for wholesalers in Ireland?

Links

• 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
• Notification System for Exempt (Unauthorised) Products

Events

• GMP and Market Compliance Information Day 2008