Each application for marketing authorisation is accompanied by the particulars and documents referred to in the Directive 2001/83/EC European regulation and in addition they comply with the national registration rules.
The relevant provisions of the current Pharmacopoeia, the existing CHMP guidelines and the Pharmacovigilance legislation are also observed.
The diagnostic kits are supplied with CoA and CoC stating and proving the conformity to the registration file. Registration dossiers are compiled in a common technical dossier (CTD) format and updated during the whole life-cycle of the products. The Registration dossiers are also available in electronic Common Technical Dossier (eCTD) format.
The diagnostic kits are registered in several countries and as the market is broadening, they are continuously under registration processes. For present status of registrations in your country or region please contact us at firstname.lastname@example.org.