V okviru te priloge GMP obsegajo sistem, v katerem proizvajalec sprejema specifikacije proizvoda in/ali procesa od odobritve za dajanje na trg (MA) / identifikacijske številke zdravila (DIN) ali imetnika licence ali vlagatelja, in zagotavlja, da je izdelek izdelan v skladu s temi specifikacijami (ekvivalentno certificiranju odgovornih oseb v ES).
For the purpose of this Annex, GMP includes the system whereby the manufacturer receives the specifications of the product and/or process from the marketing authorisation (MA)/drug identification number (DIN) or licence holder or applicant and ensures the product is made in compliance with the specifications (equivalent to qualified person certification in the EC).