Bulk distributing company license gives you the right to purchase goods in large quantities from producers and sell them to retailers.
It is also known as a seller’s permit, wholesale permit or resale license.
Bulk distributing company license Applications
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.
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:
Health Product Regulatory Authority (HPRA)
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2