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.
Please note: when contacting the HPRA in relation to an application, please provide the Case Reference Number (CRN) and/or PA number, Procedure Number & CESP if available.
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