Variations to a Wholesale Distribution Authorisation

Application for a variation to a wholesaler’s authorisation 

Changes to a wholesaler’s authorisations are made by submission of an Application to vary a wholesale distribution authorisation
Applicants should refer to the HPRA Guide to New Applications and Variations to Wholesale Distribution Authorisations for further guidance.

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 a 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