Applications for a Manufacturing Authorisation

Manufacturers of human and veterinary medicines in Ireland are required to hold a Manufacturing Importation Authorisation.

A manufacturing authorisation is needed if a company is involved in all or any of the following activities:  processing of a dosage form, primary packaging, secondary packaging, batch certification and/or quality control.

In order to receive an authorisation to manufacture medicinal products, a potential authorisation/licence holder must show compliance with the principles of Good Manufacturing Practice (GMP). Compliance with these principles is decided by the HPRA through regular site inspections.

To apply for a Manufacturing Authorisation/Licence, an application should be submitted to the Licensing Section of the HPRA. Application for a manufacturer's or importer's authorisation. See the Guide to applying for a manufacturer's or importer's authorisation.

Other helpful documents:

Explanatory notes for Pharmaceutical Manufacturers on the preparation of a Site Master File:


Legislation:

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
Fees for veterinary 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