Article 1
Open ↗The Annex to Implementing Regulation (EU) 2021/17 is amended in accordance with the Annex to this Regulation.
Source
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)
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)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Article 2
Open ↗This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
Supplementary provisions
ANNEXSupplementary provisions
Open ↗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.
Other acts of the same type
Commission Implementing Regulation (EU) 2023/494 of 28 February 2023 approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications (‘Emmental français est-central’ (PGI))Regulation (EU) 2023/435 of the European Parliament and of the Council of 27 February 2023 amending Regulation (EU) 2021/241 as regards REPowerEU chapters in recovery and resilience plans and amending Regulations (EU) No 1303/2013, (EU) 2021/1060 and (EU) 2021/1755, and Directive 2003/87/ECCommission Implementing Regulation (EU) 2023/446 of 27 February 2023 amending Implementing Regulation (EU) 2018/2019 as regards certain plants for planting of Ligustrum delavayanum and Ligustrum japonicum originating in the United Kingdom and Implementing Regulation (EU) 2020/1213 as regards the phytosanitary measures for the introduction of those plants for planting into the Union territoryCommission Implementing Regulation (EU) 2023/461 of 27 February 2023 approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications (‘Prosciutto di Parma’ (PDO))Commission Delegated Regulation (EU) 2023/905 of 27 February 2023 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council as regards the application of the prohibition of use of certain antimicrobial medicinal products in animals or products of animal origin exported from third countries into the Union (Text with EEA relevance)Council Regulation (EU) 2023/426 of 25 February 2023 amending Regulation (EU) No 269/2014 concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of UkraineCouncil Regulation (EU) 2023/427 of 25 February 2023 amending Regulation (EU) No 833/2014 concerning restrictive measures in view of Russia’s actions destabilising the situation in UkraineCouncil Implementing Regulation (EU) 2023/428 of 25 February 2023 implementing Article 12(2) of Regulation (EU) 2017/1770 concerning restrictive measures in view of the situation in MaliCouncil Implementing Regulation (EU) 2023/429 of 25 February 2023 implementing Regulation (EU) No 269/2014 concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of UkraineCouncil Implementing Regulation (EU) 2023/430 of 25 February 2023 implementing Regulation (EU) 2020/1998 concerning restrictive measures against serious human rights violations and abusesCouncil Implementing Regulation (EU) 2023/419 of 24 February 2023 implementing Article 8a of Regulation (EC) No 765/2006 concerning restrictive measures in view of the situation in Belarus and the involvement of Belarus in the Russian aggression against UkraineCommission Implementing Regulation (EU) 2023/452 of 24 February 2023 registering a geographical indication of a spirit drink under Article 30(2) of Regulation (EU) 2019/787 of the European Parliament and of the Council (‘Grappa della Valle d’Aosta / Grappa de la Vallée d’Aoste’)
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
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