29.08.2021.

Objavljenja finalna verzija Reflection paper on good manufacturing practice and marketing authorisation holders

Nakon drafta s početka 2020. godine, Europska agencija za lijekove (EMA) sada je objavila finalnu verziju dokumenta Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders. U situacijama kada MAH nije i proizvođač lijeka često se pojavljuju pitanja odgovornosti ili razgraničenja odgovornosti između MAH-a i proizvođača s obzirom na različite GMP aspekte, stoga će ovaj dokument bez sumnje biti od velike koristi svakom MAH-u koji nije proizvođač, a sigurno će u brojnim situacijama koristiti i proizvođačima koji nisu MAH.

Kako bi se što bolje sagledali važnosti i opseg novog dokumenta, u nastavku donosimo skraćeni izvadak iz uvodnog dijela:

This Reflection Paper is focussed on the GMP-related responsibilities that apply to Marketing Authorisation Holder (MAH) companies. While it is recognised that many MAH companies are not directly engaged in the manufacture of medicinal products themselves, the current Guide to GMP refers, in several places, to MAHs and their responsibilities in relation to GMP. In general, these responsibilities range from responsibilities that relate to outsourcing and technical agreements, to ones that require the MAH to perform certain specific tasks (e.g. evaluating the results of product quality reviews, agreeing irradiation cycles with manufacturers, etc.). This Reflection Paper seeks to provide clarity as to what the various responsibilities are and what they mean for MAHs at a practical level. It should be noted that, as indicated in Annex 16 of the GMP Guide, the ultimate responsibility for the performance of a medicinal product over its lifetime, its safety, quality and efficacy, lies with the MAH. It is also important to note that, while certain activities of an MAH may be delegated to a manufacturer or other party, the MAH retains the responsibilities which are outlined in this paper. It is acknowledged that many MAHs are part of large and complex global organisations which operate shared Pharmaceutical Quality Systems. While tasks pertaining to the MAH responsibilities outlined in this paper may be delegated to other groups or entities within the global organisation, the actual responsibilities of the MAH may not be delegated. MAH companies should have a system in place to ensure that they remain up-to-date with current GMP requirements and updates thereafter.

Pogledajte Reflection Paper