Manufacturer's/ importer's authorisation
A manufacturer's/ importer's authorisation covering manufacturing and/or importation activities may be referred to as an MIA. Due to different legislative basis, separate MIAs are required depending on the scope of products it covers.
| Types of authorisation | Scope |
| MIA for medicines for human use produced in Ireland (MIA). | Manufacturing activities for medicinal products for human use. Importation of medicinal products for human use from countries outside the EEA. |
| MIA for medicines for veterinary use in Ireland (V MIA). | Manufacturing and testing activities for medicinal products for veterinary use. Importation of medicinal products for veterinary use from countries outside the EEA. |
| MIA for investigational medicinal products (IMPs) for use in clinical trials (IMP MIA). | Manufacturing activities for IMPs for use in clinical trials in humans. Importation of IMPs for human use from countries outside the EEA. |
New applications for a Manufacturer's/ Importer's Authorisation (MIA)
The pre-submission process
Companies who intend to apply within the next 6 months for a MIA should request a pre-submission meeting by completing the Request for pre-submission meeting for MIA form. A copy of this form is available below on this page. The completed form and request for a meeting can be sent to the HPRA's Compliance department.
By providing pre-submission advice relating to MIA applications the HPRA’s objectives are to:
- Assist a company so that their application can have a successfully outcome within the required legislative timeline.
- Discuss key project milestones related to the development of the pharmaceutical quality system and high-level qualification activities related to the premises and equipment.
- Obtain advanced notice of future applications to help ensure availability of inspection resources.
An on-line meeting will be scheduled with the company's personnel and members of the HPRA's inspection team. During this meeting, the company can present information about their manufacturing activities. They can also ask questions in relation to the application process and clarify any essential aspects that need to be in place at the time of inspection.
A MIA application form will be provided to the company when it has been confirmed that they are ready for an inspection within 4 to 6 weeks.
An earlier regulatory review meeting to discuss GMP facility design can also be facilitated. An in-person meeting with GMP inspectors can be arranged that includes review of qualification and validation activities during the building of a new facility or significant upgrading of an existing site. Companies considering establishing a manufacturing site in Ireland are encouraged to contact the HPRA's Inspection Group at an early stage. Further details are available in our Guide to scientific and regulatory advice for GXP activities. A copy of this Guide is available below on this page.
Will a hard copy of the authorisation be issued?
The HPRA do not routinely issue hard copies of Manufacturing Authorisations (MIAs), Wholesale Distribution Authorisation (WDAs) and Active Substances Registrations (ASRs). These can be found on the EudraGMDP website. The authenticity or integrity of electronic authorisations may be verified on the EudraGMDP database.
You can find a list of authorised manufacturers of medicines on the EudraGMDP website.