Variations to a Wholesale Distribution Authorisation

Application for a variation to a manufacturing/importation authorisation/licence or wholesaler’s authorisation 

Changes to manufacturing/importation authorisations / licence or wholesaler’s authorisations are made by submission of an Application to vary a wholesale distribution authorisation

In order to facilitate the expedited approval of variation applications, applicants are encouraged to provide relevant documentation to support the proposed variation.  

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