Variations to a Manufacturing Authorisation

Application form for variation to an MIA or wholesalers authorisation
Changes to manufacturing/importation authorisations / licence or wholesaler’s authorisations are made by submission of a variation application. 

In order to facilitate the expedited 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 guidance document via the following link:

Guide to Applications to vary an MIA or Wholesaler's Authorisation

Fees:

Variations to manufacturing/importation authorisations or wholesaler’s authorisations are classed as either a technical variation or an administrative variation. Details of applicable fees are available in our fee application from. Please note there is a separate fee application form for human products and veterinary products.

Guide to Fees for Human Products
Guide to Fees for Veterinary Products

Submission of applications:

Applicants are encouraged to submit applications electronically to compliance@hpra.ie.
Alternatively, applications can be posted to the following address:
Health Product Regulatory Authority (HPRA)
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2