Medicines Authorisation

This part of our website includes information for marketing authorisation holders and other industry stakeholders.

Products for which medicinal claims are made or which contain substances likely to have effects on the body are considered as medicines, and will therefore need a marketing authorisation from the HPRA. The marketing authorisation is issued with a Product Authorisation (PA) number which is included on the medicine box / container.

Individuals or companies requiring further information on the procedures for licensing human medicines in Ireland should review the relevant documents, including guides and forms, and explanatory information provided. You can also contact us at info@hpra.ie

Details of European guidelines which are applied during the review of new marketing authorisation applications, variations and renewals and the relevant application forms are available on the European Commission website


Licensing Procedures 
 
New Products 
 
Variations
 
Renewals, Transfers and Withdrawals
 
Parallel Importation
 
Batch Specific Requests
 
Herbal Medicines 
 
Homeopathic Medicines 
 
Legal Supply Status and Reclassification of Medicines
 

Drug-Device Consultations
 
Electronic Submissions
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Access to Medicines Prior to Authorisation


Notification System for Exempt (unauthorised) Products