Applications for a Manufacturer’s Authorisation
Manufacturers of human and 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, physical importation of medicinal products or batch certification of medicinal products coming from a third country. 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.
There are three types of manufacturer’s authorisations depending on the intended purpose:
Type of authorisation
Manufacturer’s authorisation for human medicinal products
Authorisation of manufacturing activities concerned with medicinal products for human use.
Authorisation for importation of medicinal products for human use from countries outside the EEA.
Manufacturer’s authorisation for veterinary medicinal products
Authorisation of manufacturing activities concerned with veterinary medicinal products.
Authorisation for importation of medicinal products for veterinary use from countries outside the EEA
Manufacturer’s authorisation for investigational medicinal products
Authorisation of manufacturing activities concerned with investigational medicinal products for use in clinical trials in humans.
Authorisation for importation of investigational medicinal products for human use from countries outside the EEA.
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.
Companies which intend to import active substances, in order to manufacture medicinal products for human use, are required to obtain an active substance registration (ASR). Information regarding the process to obtain an ASR can be found in the Guide to registration requirements for Active Substance Manufacturers, Importers and Distributors in Ireland.
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.
From September 2020, the HPRA issued electronic authorisations with e-Signatures and do not routinely issue hard copies of Manufacturing Authorisations, Wholesale Distribution Authorisations and Active Substances Registrations. Authenticity or integrity of electronic authorisations issued by HPRA, may be verified on the EudraGMDP database or alternatively enquiries can be submitted to the compliance mailbox (firstname.lastname@example.org).
Other helpful documents
The following documents will be of interest to individuals preparing an application:
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 human products
Submission of applications
Applicants are encouraged to submit applications electronically to email@example.com
Alternatively, applications can be posted to the following address:
Health Product Regulatory Authority (HPRA)
Kevin O’Malley House