Variations to a veterinary manufacturer’s authorisation
Changes to manufacturer’s authorisations are made by submission of a variation application. Variations to manufacturer’s authorisations are classed as either a technical variation or an administrative variation and this determines the fee due.
In order to facilitate the approval of variation applications, applicants are encouraged to provide relevant documentation to support the proposed variation. List of supporting documentation can be found in the Guide to Applying for a New or Variation to a Manufacturer's Authorisation.
Guide to Applying for a New or Variation Manufacturer's Authorisation.
Application form for variation to a Manufacturer's Authorisation
Details of applicable fees are available in our fee application from. Please note there is a separate fee application form for veterinary products.
Guide to Fees for Veterinary Products
Submission of applications:
Applicants are encouraged to submit applications electronically to email@example.com.
Alternatively, applications can be posted to the following address:
Health Product Regulatory Authority (HPRA)
Kevin O’Malley House