Qualified Persons Declaration Template and Guidance Published by EMA
The long-awaited Qualified Persons template for declarations concerning Good Manufacturing Practice compliance of active substances and the accompanying guidance have been published on the European Medicines Agency (EMA) website.
The QP template has been somewhat simplified since it was published as a draft in December 2010. The information related to the active pharmaceutical ingredient (API) supply chain has been removed, but it does still require stating all sites involved in the manufacture of the active substance, including intermediate sites.
A QP declaration has to be submitted with new marketing authorization (MA) applications and with variations to existing MAs that relate to the API for all human and veterinary products, including biological/biotechnological products.
While 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 the template as mandatory. For example, the UK has been requesting the use of the template since the 2010 draft version.