Applications for a Wholesale Distribution Authorisation

The Health Products Regulatory Authority is responsible for the regulation of Pharmaceutical wholesalers and distributors in Ireland.

With certain exceptions, those involved in the procurement, holding, supply or export of medicinal products in Ireland are required to hold a Wholesale Dealers Authorisation.

In order to receive an authorisation to wholesale medicinal products, a potential authorisation/licence holder must show compliance with the principle of Good Distribution Practice (GDP). Compliance with these principles is decided by the HPRA through regular site inspections.

Please note: The Department of Agriculture, Food and the Marine is responsible for the issuance of Veterinary Wholesale Authorisations. For further details click here. 

To apply for a Wholesale Authorisation, an application should be submitted to the Licensing Section of the HPRA. Application for a new wholesale distribution authorisation

 

Other helpful documents:

Guidance documents on the wholesaling of medicinal products in Ireland:

 

Legislation:

 

Fees:

Applications for Manufacturing Importation Authorisation are charged separately if they are for human or veterinary products. Details of applicable fees are available below.

Fees for Human 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