Authorisation - Wholesale Distribution of Medical Products for Human Use

The Irish Medicines Board (IMB) is responsible for the regulation of pharmaceutical wholesalers and distributors in Ireland. The applicable legislation is the Medicinal Products (Control of Wholesale Distribution) Regulations, 2007 (S.I. No. 538 of 2007) as amended.

With certain exceptions, distributors of human medicines are required to hold a wholesaler’s authorisation.

NOTE: The Department of Agriculture, Food and the Marine is responsible for the licensing of Wholesalers of Medicinal Products for Veterinary use.

To obtain an authorisation to distribute medicinal product compliance with the principles of Good Distribution Practice (GDP) must be demonstrated. “Good Distribution Practice (GDP) is that part of quality assurance which ensures that products are consistently stored, transported and handled under suitable conditions as required by the marketing authorisation (MA) or product specification and that traceability is ensured.”

To verify that the appropriate systems are in place inspectors monitor compliance with the GDP principles through regular on-site inspections.

A Guidance document on the wholesaling of Medicinal Products for Human Use in Ireland is available in the Publications section of this website.

If you wish to contact the IMB to discuss wholesaling and distribution of pharmaceuticals, contact us at

Licensing Section,
Compliance Department,
Irish Medicines Board,
Kevin O'Malley House,
Earlsfort Centre,
Earlsfort Terrace,
Dublin 2,
Ireland.

Phone: +353-1-6764971
Or please E-Mail: compliance@imb.ie

The Irish Medicines Board - www.imb.ie

Authorisation - Wholesale Distribution of Medical Products for Human Use