Variations to a Manufacturer’s Authorisation

Changes to manufacturer’s authorisations are made by submission of a variation application. Variations to manufacturer’s authorisations are classed as either a technical variation or an administrative variation and this determines the fee due.

In order to facilitate the approval of variation applications, applicants are encouraged to provide relevant documentation to support the proposed variation.  List of supporting documentation can be found in the Guide to Applying for a New or Variation to a Manufacturer's Authorisation.

There is a provision for the expedited assessment of variations related to contract manufacturers (listed in Annex 3 of the MIA) and contract laboratories (listed in Annex 4 of the MIA) for manufacturer’s authorisation for investigational medicinal products (IMP). An expedited assessment will be completed within seven working days if the submission includes the information required in the expedited assessment form and all of the appropriate supporting documentation, as detailed in the guide below.

Documentation:

Guide to Applying for a New or Variation Manufacturer's Authorisation.

Application form for variation to a Manufacturer's Authorisation  
Expedited assessment application form for variation to Annex 3 or 4 of an IMP Authorisation

Fees:

Details of applicable fees are available in our fee application from. Please note there is a separate fee application form for human products.

Guide to Fees for Human 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