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Regulation (EU) 2021/2282 CHAPTER V — FINAL PROVISIONS

Article 32–Article 36 · 5 articles

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Exercise of the delegation

Article 32

1.   The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2.   The power to adopt delegated acts referred to in Article 9(5) shall be conferred on the Commission for an indeterminate period of time from 11 January 2022. 3.   The delegation of power referred to in Article 9(5) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4.   Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5.   As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6.   A delegated act adopted pursuant to Article 9(5) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

Committee procedure

Article 33

1.   The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2.   Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. 3.   Where the Committee delivers no opinion, the Commission shall not adopt the draft implementing act and Article 5(4), third subparagraph, of Regulation (EU) No 182/2011 shall apply.

Preparation of implementing acts

Article 34

1.   The Commission shall adopt the implementing acts referred to in Articles 15, 20, 25 and 26 at the latest by the date of application of this Regulation. 2.   When preparing those implementing acts, the Commission shall take into account the distinctive characteristics of the medicinal product, medical device and in vitro diagnostic medical device sectors.

Amendment to Directive 2011/24/EU

Article 35

1.   Article 15 of Directive 2011/24/EU is deleted. 2.   References to the deleted Article shall be construed as references to this Regulation.

Entry into force and date of application

Article 36

1.   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union . 2.   It shall apply from 12 January 2025.

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Articles on this page are reproduced verbatim from official open data. See the attribution line.

Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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