Vsako izvoženo serijo mora spremljati potrdilo, ki ga zagotovi proizvajalec (samopotrdilo) po celoviti kvalitativni analizi, kvantitativni analizi vseh aktivnih sestavin in drugih preskušanjih ali preverjanjih, ki so potrebna za zagotavljanje kakovosti izdelka v skladu z zahtevami dovoljenja za promet.
Each batch exported shall be accompanied by a batch certificate established by the manufacturer (self- certification) after a full qualitative analysis, a quantitative analysis of all the active ingredients and all the other tests or checks necessary to ensure the quality of the product in accordance with the requirements of the marketing authorisation.