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 New Applications and Variations to Manufacturer's Authorisations .
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.
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).
Guide to New Applications and Variations to Manufacturer's Authorisations.
Application for variation to a manufacturer's authorisation
IMP expedited assessment of variations to Annex 3 and or 4 application form
IMP immediate notification of variations to Annex 3 and or 4 application form
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 email@example.com
Alternatively, applications can be posted to the following address:
Health Product Regulatory Authority (HPRA)
Kevin O’Malley House