Regulation (EU) 2019/5 of the European Parliament and of the CouncilShow full title

Article 2 Amendments to Directive 2001/83/EC

Directive 2001/83/EC is amended as follows:

(1)

in Article 1, the following point is inserted:

‘26a.

Variation or variation to the terms of a marketing authorisation:

An amendment to the contents of the particulars and documents referred to in:

(a)

Article 8(3) and Articles 9 to 11 of this Directive and Annex I thereto, Article 6(2) of Regulation (EC) No 726/2004 and in Article 7 of Regulation (EC) No 1394/2007; and

(b)

the terms of the decision granting the marketing authorisation for a medicinal product for human use, including the summary of the product characteristics and any conditions, obligations, or restrictions affecting the marketing authorisation, or changes to the labelling or the package leaflet related to changes to the summary of the product characteristics.’;

(2)

Article 23b is amended as follows:

(a)

paragraphs 1 to 4 are replaced by the following:

‘1. Variations shall be classified in different categories depending on the level of risk to public health and the potential impact on the quality, safety and efficacy of the medicinal product concerned. Those categories shall range from changes to terms of the marketing authorisation that have the highest potential impact on the quality, safety or efficacy of the medicinal product, to changes that have no or minimal impact thereon.

2. The procedures for examination of applications for variations shall be proportionate to the risk and impact involved. Those procedures shall range from procedures that allow implementation only after approval based on a complete scientific assessment to procedures that allow immediate implementation and subsequent notification by the marketing authorisation holder to the competent authority.

2a. The Commission is empowered to adopt delegated acts in accordance with Article 121a in order to supplement this Directive by:

(a) specifying the categories in which variations shall be classified; and

(b) establishing procedures for the examination of applications for variations to the terms of marketing authorisations.

3. When adopting the delegated acts referred to in this Article, the Commission shall endeavour to make possible the submission of a single application for one or more identical changes made to the terms of different marketing authorisations.

4. A Member State may continue to apply national provisions on variations applicable at the time of entry into force of Commission Regulation (EC) No 1234/2008(1) to marketing authorisations granted before 1 January 1998 to medicinal products authorised only in that Member State. Where a medicinal product subject to national provisions in accordance with this Article is subsequently granted a marketing authorisation in another Member State, Regulation (EC) No 1234/2008 shall apply to that medicinal product from that date.’;

(b)

in paragraph 5, the words ‘the implementing regulation’ are replaced by the words ‘Regulation (EC) No 1234/2008’;

(3)

Articles 121a, 121b and 121c are replaced by the following:

‘Article 121a

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 Articles 22b, 23b(2a), 47, 52b and 54a shall be conferred on the Commission for a period of five years from 28 January 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

3. The delegation of power referred to in Articles 22b, 23b(2a), 47, 52b and 54a 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(2).

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 Articles 22b, 23b(2a), 47, 52b and 54a shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and to 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.’.

(1)

Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (OJ L 334, 12.12.2008, p. 7).’;

(2)

OJ L 123, 12.5.2016, p. 1.’.