Medicines Authorisation

This part of our website includes information for marketing authorisation holders and other industry stakeholders. Explanatory and background information is provided and relevant HPRA guides and forms are available to download.

• Advertising

• Allocating the method of supply
   

• Batch Specific Request
   

• Herbal and Homeopathic Medicines
   

• Labelling procedure
   

• New Product
   

• Recent updates to the list of authorised Veterinary Medicines

• Parallel Trade

• Signal Management 
   

• Pharmacovigilance
   

• Renewals, Transfers & Withdrawls
   

• Service Item Animals Remedies
   

• Variations