Si porta all’attenzione di tutte le aziende farmaceutiche che sul sito del CMDh è stata pubblicata la versione aggiornata a Marzo 2015 delle “Questions & Answers” relativamente alle variazioni dei termini delle autorizzazioni all'immissione in commercio di medicinali, presentate ai sensi del regolamento (CE) n. 1234/2008 della Commissione e successive modificazioni.

Si evidenzia che in tale versione è stata inserita una nuova Q&A (numero 3.24), relativa alla modifica della titolarità dell’officina di produzione del prodotto finito (A.5) e pertanto tale modifica dovrà essere presentata secondo i criteri indicati in tale Q&A.

Si riporta integralmente il testo della Q&A 3.24:

Question 3.24

Which type of variation should be submitted for the change in the name and/or address of a manufacturer/importer of the finished product (including batch release or quality control testing sites), e.g. in case the change in name and/or address is due to change of the holder of the manufacturing authorization?

Answer:

According to EU legislation, a Manufacturing Authorisation is only issued to cover manufacturing sites located in the EEA region. A change of holder concerns a change in the legal entity and requires the issue of a new Manufacturing Authorisation. In these situations, such a change can only be submitted under category A.5, provided the specified condition is fully met and a copy of a new Manufacturing Authorisation is presented. This means that there is no physical change to the actual manufacturing site and that additionally all manufacturing operations remain the same. Manufacturing operations cover the manufacturing activities for which the site is responsible, including if relevant manufacturing processes and controls, as well as the relevant GMP related responsibilities and relationships with other companies. Therefore, at the point of transfer of the Manufacturing Authorisation, to be acceptable under A.5 any changes should be purely administrative in nature.
In the event that the specified condition is not met, rather than automatically defaulting to a Type IB under category A.5, depending upon the nature of what is changing, exceptionally the change should be presented under the relevant B Category, normally B.II.b.1 or B.II.b.2 and be suitably supported.