A Manufacturer’s/Importation Authorisation (MIA) is required if a company is involved in manufacturing and/or importation activities relating to human, veterinary or investigational medicinal product, within the EUThe term manufacturing and/or importation includes any of the following manufacturing activities as detailed by the HPRA:  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. Where the company is involved in the movement of goods within the EEA only a Wholesale Distribution Authorisation is required.

Identify business activity

If you are considering establishing a site in Ireland, the HPRA recommend that you engage with them at an early stage to facilitate the process.

There are three types of manufacturer’s authorisation as detailed below and a separate authorisation is for each product type.

  • Manufacturer’s authorisation for human medicinal products authorises manufacturing activities concerned with medicinal products for human use and allows the importation of medicinal products for human use from countries outside the EEA.
  • Manufacturer’s authorisation for veterinary medicinal products authorises manufacturing activities concerned with medicinal products for veterinary use and allows the importation of medicinal products for veterinary use from countries outside the EEA.
  • Manufacturer’s authorisation for investigational medicinal products authorises manufacturing activities concerned with investigational medicinal products for use in clinical trials in humans and allows the importation of investigational medicinal products for human use from countries outside the EEA.

HPRA guide to applications for a new and variation to a manufacturer’s authorisation details the different types of activities and requirements.

Develop Site Master File and QMS

In order to obtain an MIA, the company must demonstrate compliance with the principles of Good Manufacturing Practice (GMP) and will need to have in place a Quality Management System (QMS), premises and equipment that are EU GMP compliant and sufficient trained personnel to carry out the required tasks.

The Site Master File should be prepared in line with EU GMP guidance regarding the structure and content of this document that details the business activities, premises, processes and personnel. This document is required as part of the application.

QMS should be developed to include all necessary policies, procedures and work instructions.

Hire and train relevant Personnel

As part of the application process, key personnel need to me named on the licence. For a manufacturing organization this requires the head of manufacturing and head of quality to be named and for batch certification, a suitable qualified and trained Qualified Person (QP) will need to be named.

Ensure Inspection Readiness

In order to receive an authorisation to manufacture, import or release medicinal products, a potential authorisation holder must demonstrate compliance with the principles of Good Manufacturing Practice (GMP). The HPRA will carry out a GMP inspection as part of the authorisation process to ensure that the QMS, premises and personnel are in line with requirements. Therefore, it is important that your business is inspection ready at the time of application.

MIA maintenance

Once the MIA is granted, the authorisation holder will need maintain their MIA in line with any changes within the business. A variation to the MIA will need to be submitted for approval for the key changes, including but not limited to i) addition or deletion of activities ii) addition or deletion of contract manufactures iii) addition or deletion of contract laboratories iv) changes in key personnel, including QPs and iv) addition or deletion of products being imported from outside the EEA. Approval of variations can take up to 60 days and therefore it is important to manage these changes diligently. For an IMP MIA, there are immediate notification and expedited assessment routes to handle variations in specific instances that will allow variations to be approved immediately on notification or within 2 weeks, respectively.

webinar presentation on mia

For additional information please find references below:

https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/adv-g0019-guide-to-scientific-and-regulatory-advice-for-gxp-activities-v1.pdf?sfvrsn=4

https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/guide-to-new-applications-and-variations-to-manufacturer’s-authorisations.pdf?sfvrsn=40

https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/fin-g0002-guide-to-fees-for-human-products-v26.pdf?sfvrsn=66

If you would like to get in touch with MIAS Pharma, please contact us here or call us on +353 (1) 846 3605.

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