EMA updated the pre- and post-authorisation procedural advice by adding a technical information to remind the applicants that the registration of new sites and organisations for centrally-authorised medicinal products in Organisation Management Service (OMS) will become mandatory as of 1st November 2021 prior to the associated regulatory submissions to the Agency (e.g. transfer of the marketing authorisation, addition of a manufacturing site) (cf. our News of 01/10/2021).
The EMA would like to emphasise the importance of these site/organisation registrations in OMS prior to pre- and post-authorisation submissions, in order to avoid …
