Applications for a variation to a Manufacturer's/ Importer's Authorisation (MIA)
You must apply for a variation to a Manufacturer's/ Importer's Authorisation (MIA) if there are any proposed changes to the manufacturing site that holds an authorisation. There are two types of variations:
- An administrative variation is considered a minor change to the MIA.
- A technical variation is considered a major change to the MIA. A GMP inspection may be required as part of the assessment for this type of variation.
Variations to authorisation of investigational medicinal products
An expedited assessment of a variation to an investigational medicinal products (IMP) authorisation applies to:
- Third country-based contract manufacturing sites and
- Contract laboratories (Annex 3 and 4) of IMP authorisations.
An immediate notification of a variation to an IMP authorisation is applicable to:
- EU/EEA based contract manufacturing sites and
- Contract laboratories (Annex 3 and 4) of IMP authorisations only.
What are the timelines for a variation?
For technical and administrative variations of standard applications, the timeline can vary from 30 to 90 days. This depends on whether additional information is requested by the HPRA and if an inspection is required.
For an expedited and immediate notification of variation, the timeline is 7 working days.
Where can I find the application form?
You can find the relevant application forms at the following links:
Where can I find more information?
You can find more information on applying for a variation in our Guide to applications for a variation to a manufacturer's authorisation.
Please note that the organisation and location ID numbers must be provided on the application form. The legal site address and the manufacturing site address should match the details on the EMA's SPOR database and the Irish CORE database. You can find more information about the Organisation Management Service on the EMA's website.
What are the fees?
The fee charged for an application depends on whether the variation is classed as a technical or administrative variation.
You must make sure that the application is accompanied with proof of payment. You can find more information on fees, fee applications, and payment of fees on our dedicated pages (human product fees page and veterinary products fees page).