Medicines Authorisation

Our role is to evaluate applications for veterinary medicines and grant marketing authorisations to products that meet EU quality, safety and efficacy standards, This ensures that the benefits of using the medicines outweighs any risk to the animal, the user, the environment and, when applicable, consumers of treated animals. Our main activities include:

• Authorising new products, including new medicines and parallel imports,
• Registering homeopathic medicines and medicines for exotic pets, aquarium fish and cage birds,
• Maintaining existing authorisations and registrations, including any variations to the underlying information, as well as transfers and withdrawals.

Monitoring the quality, safety and efficacy of medicines on the market in Ireland, including medicines with a central EU marketing authorisation. This monitoring system is known as pharmacovigilance and involves monitoring adverse reaction signals following use of medicines in the field.

The HPRA has compiled a list of other regulatory functions and services we perform or have limited involvement in, as set out below:

• Advertising

• Allocating the method of supply
   

• Batch Specific Request
        

• Labelling procedure
             

• Recent updates to the list of authorised veterinary medicines

• Transfers, Withdrawals and Renewals of marketing authorisations
   

• Service Item Animals Remedies