Commission Implementing Regulation (EU) 2023/997 of 23 May 2023 amending Implementing Regulation (EU) 2021/17 establishing a list of variations not requiring assessment in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2023/997
• Articles: 3

Article 1

The Annex to Implementing Regulation (EU) 2021/17 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX

ANNEX

In the Annex to Implementing Regulation (EU) 2021/17, point B is amended as follows:

(1)

in point 12, the following point is added:

‘h)

—

to production equipment (when described in the dossier) including processes related to the equipment

The change shall not result in any changes or modifications of the production process or quality of the product.

Amendment of the relevant section(s) of the dossier.’

(2)

point 24 is replaced by the following:

‘24

Replacement or addition of a manufacturer responsible for:

The manufacturer or the site shall already be introduced in the Union IT systems storing and providing organisational data.

The site shall be appropriately authorised and satisfactorily inspected.

Amendment of the relevant section(s) of the dossier, including revised product information, as appropriate.

Qualified person (QP) declaration.’

a)

—

batch release including batch control or testing of a sterile or non-sterile finished product

The change shall not be applicable to a biological or 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 sterile or non-sterile finished product

At least one batch control/testing site remains within the 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.