Without prejudice to the standards for potency, safety and production procedures provided for in Community legislation, vaccines reconstituted from antigen stored within the Community antigen and vaccine bank shall meet at least the minimum standards for potency, safety and production procedures laid down in the European Pharmacopoeia and the relevant provisions of the OIE Manual.
Brez poseganja v standarde o učinkovitosti, varnosti in proizvodnih postopkih, predvidenih v zakonodaji Skupnosti, morajo cepiva, pridobljena iz antigena, shranjenega v banki antigenov in cepiv Skupnosti, izpolnjevati vsaj minimalne standarde o učinkovitosti, varnosti in proizvodnih postopkih, predpisanih v Evropski farmakopeji ter ustreznih določbah Priročnika OIE.