Manufacture of Medicinal Products (Human and Veterinary)

Authorisation/Licence

The Irish Medicines Board (IMB) is responsible for the regulation of manufacturers of medicinal products in Ireland.

For medicinal products for human use and for investigational medicinal products, the applicable legislation is the Medicinal Products (Control of Manufacture) Regulations, 2007 (S.I. No. 539 of 2007).

For veterinary medicinal products the applicable legislation is the European Communities (Animal Remedies) (No. 2) Regulations 2007 (S.I. No 786 of 2007)

Manufacturers of medicinal product for human and veterinary use are required to be authorised by the Irish Medicines Board (IMB) for the activities which are carried out.

In order to obtain an authorisation, a manufactures must make application to the IMB and must comply with the requirements of Good Manufacturing Practice (GMP) as defined in European legislation and guidelines. To ensure that compliance with these requirements is maintained, GMP inspectors monitor this through regular on-site inspections.

If you wish to contact the IMB to discuss the manufacture of medicinal products (human or veterinary), contact us at

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

Telephone: +353-1-6764971
e:mail: compliance@imb.ie

The Irish Medicines Board - www.imb.ie

Manufacture of Medicinal Products (Human and Veterinary)