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 Distribution 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.

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. For guidance applicants should refer to the HPRA Guide to New Applications and Variations to Wholesale Distribution Authorisations.

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).

Other helpful documents

Guidance documents on the wholesaling of medicinal products in Ireland

• Guide to Good Distribution Practice of Medicinal Products for Human Use

• European Commission Guidance on Good Distribution Practice of Medicinal Products for Human Use 

• Guide to Wholesaling and Brokering of Medicinal Products for Human Use in Ireland

• Guide to Quality System for General Sale Wholesale Distributors

• Guide to Control and Monitoring of Storage and Transportation Conditions

Legislation

• Legislation relevant to wholesale distribution can be found on our legislation page.

Topics relevant to the wholesaling of medicinal products in Ireland

• Notification System for exempt medicinal products

• Carrying out Recall and Related Actions on the Irish Market 

• Controlled Drugs 

• Falsified Medicines Legislation

• Parallel Importation

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: