Export Certification

The Irish Medicines Board is responsible for issuing export certificates for medicinal products and active ingredients or to certify the Good Manufacturing Process compliance of a manufacturing site.

The Irish Medicines Board issues the following certificates:

Certificate of a Pharmaceutical Product
One original certificate is issued per product

GMP Certificate of Manufacturer of Finished Products / Active Ingredients
The manufacturer must be based in the Republic of Ireland. Four original certificates are issued per application.

Certificate of Free Sale
The product must have a valid Product Authorisation and must be on the market in the Republic of Ireland.
Four original certificates are issued per application

Certificate of Manufacture and Free Sale
The product must have a valid Product Authorisation and must be on the market in the Republic of Ireland. The manufacturing facility must also hold a valid Manufacturer’s license issued by the IMB. Four original certificates are issued per application.

Price Certificate
The product must have a valid Product Authorisation and must be on the market in the Republic of Ireland. The cost stated on the certificate will be verified by the Compliance Department. Four original certificates are issued per application.

Certification
Applicants for documents to be certified by the Irish Medicines Board must hold a valid Manufacturer's licence issued by the IMB. The applicants must also supply a declaration stating that the information in the document being certified by the Irish Medicines Board is true and correct.
One original document is certified per application

A request for a certificate may be refused, in which case there is an appeals procedures which may be followed by the applicant.

Applications may be submitted by post to:-

The Compliance Department
Irish Medicines Board
Kevin O'Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Ireland

Or

The Compliance Department, Irish Medicines Board by fax on 01-6764061 or via e-mail to exportcerts@imb.ie

Details relating to payment for applications sent by fax or emails should be noted on the application form.

All applications must contain the following information:

-Completed Export Certificates Application Form
-Completed draft of the certificate applied for, where applicable
–Relevant fee
-(standard EU147, Fast-track €277)
-Attachments, if applicable

The Irish Medicines Board - www.imb.ie

Export Certification