An NSF International Company API GMP QP Declaration and Guidance - Final versions published by EMA
Monday the 9th June 2014
The long awaited QP declaration template and accompanying guidance have now been published on the EMA website.
- see http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2014/06/WC500167853.doc
- and http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2014/06/WC500167852.pdf
The template has been somewhat simplified when compared to the draft that was originally published in December 2010; e.g. the information related to API supply chain has been removed but it does still require that all sites involved in the manufacture of the active substance should be stated, including intermediate sites.
The QP Declaration has to be submitted with new Marketing Authorisation (MA) applications and with Variations to existing MAs that relate to the API for all human and veterinary products, including biological/biotechnological products.
Whilst the guidance says that the template is not mandatory it does state that “Applicants are therefore strongly recommended to use the template to facilitate the validation of regulatory submissions and their review.” It is very likely that the Regulatory Authorities in some EU Member States will treat it as mandatory (e.g. the UK has been ‘requesting’ the use of the 2010 draft version for several years).
