Applications for a Veterinary Manufacturer’s Authorisation
Manufacturers of veterinary medicines in Ireland are required to hold a manufacturer’s authorisation.
A manufacturer’s authorisation is needed if a company is involved in any of the following manufacturing activities: processing of a dosage form, primary packaging, secondary packaging, batch certification, importation of medicinal products from a third country and/or quality control testing. A manufacturer’s authorisation covering manufacturing and/or importation activities may be referred to as an MIA.
The Compilation of Community Procedures on Inspections and Exchange of Information includes under section 1.3.1 guidance on the classification of biological medicinal products. Where manufacture of the biological active substance is part of a continuum of steps in the manufacture of a medicinal product then the HPRA considers this to be finished product manufacture and requires an MIA. Please contact the HPRA Compliance Department if there is any doubt with regard to classification of the manufacture of a biological active substance / biological medicinal product.
Companies considering establishing a manufacturing site in Ireland are encouraged to engage with the HPRA at an early stage in order to facilitate the authorisation process. Further details can be found in the Guide to Scientific and Regulatory Advice for GxP activities.
In order to receive an authorisation to manufacture medicinal products, a potential authorisation holder must demonstrate compliance with the principles of Good Manufacturing Practice (GMP). GMP inspections are usually carried out as part of the authorisation process.
Prior to submitting an application, applicants should refer to the HPRA Guide to applications for a new and variation to a manufacturer’s authorisation. A completed Application for a manufacturer's or importer's authorisation form should be submitted to the Licensing Section of the HPRA.
Other helpful documents:
The following documents will be of interest to individuals preparing an application:
Legislation:
Fees
Applications for a manufacturer’s authorisation are charged separately if they are for human or veterinary products. Details of applicable fees are available below.
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