In the Annex to Implementing Regulation (EU) 2021/17, point B is amended as follows: (1) in point 12, the following point is added:
EN
‘h) — to production equipment (when described in the dos­ The change shall not result in any changes or Amendment of the relevant section(s) of the dossier.’ sier) including processes related to the equipment modifications of the production process or quality of the product.
24.5.2023
ANNEX
(2) point 24 is replaced by the following: ‘24
a) — batch release including batch control or testing of a The change shall not be applicable to a biological or sterile or non-sterile finished product immunological medicinal product.
Method transfer from the former to the new site shall have been successfully completed.
b) — batch release not including batch control or testing of a At least one batch control/testing site remains within the sterile or non-sterile finished product EEA or in a country where an operational and suitably scoped GMP mutual recognition agreement (MRA) exists between the country concerned and the EU, that is able to carry out product testing for the purpose of batch release within the EEA.
Official Journal of the European Union
Replacement or addition of a manufacturer responsible The manufacturer or the site shall already be introduced Amendment of the relevant section(s) of the dossier, for: in the Union IT systems storing and providing including revised product information, as appropriate.
organisational data.
Qualified person (QP) declaration.’
The site shall be appropriately authorised and satisfactorily inspected.
L 136/3