Under European and Irish legislation, all veterinary medicines must be authorised (licensed) before being marketed in a Member State. Veterinary medicines which are marketed in Ireland must therefore be authorised.

Marketing authorisations may be obtained using one of the following procedures.

National procedure, with an application directly to the IMB. This procedure should be used only to obtain an authorisation for the product in Ireland and not in any other Member State or as the basis for a future mutual-recognition application to other Member States.

Mutual-recognition procedure (MRP), with an application in one or more Member State, based on an authorisation already granted for the medicinal product by another Member State. 

Decentralised procedure (DCP) for products that have not already been granted a marketing authorisation in the EU. A DCP application is  submitted simultaneously in more than one Member states.

Further information is available from the Guide to the Decentralised and Mutual Recognition Procedures for Veterinary Medicinal Products using Ireland as RMS which is available in the publications section of the IMB website.

Centralised procedure for products of biotechnology and products of significant innovation, therapeutic interest or technical advance. The European Commission grants marketing authorisations under this procedure, which are valid for the entire European Union.

General information on marketing authorisations is given in Chapter 1 of Volume 6A of the Notice to Applicants.

More detailed advice on the following licensing activities is available in this section of our website:

• New product application 
• IMB as RMS in the MRP and DCP
• Joint labelling procedure with the UK
• Partnership initiative between Ireland,  the UK and Belgium for national applications
• Variation application
• Renewal  application
• Transfer application
• Withdrawal
• Marketing status notification
• Batch specific request
• Parallel importation
• Homeopathic registration
• Herbal veterinary medicines
• Premixes
• On-Line Applications