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.
From September 2020, the HPRA issued electronic authorisations with e-Signatures and do not routinely issue hard copies of Manufacturing Authorisations, Wholesale Distribution Authorisations and Active Substances Registrations. Authenticity or integrity of electronic authorisations issued by HPRA, may be verified on the EudraGMDP database or alternatively enquiries can be submitted to the compliance mailbox (compliance@hpra.ie).
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