Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products (Text with EEA relevance)

The Commission shall adopt appropriate arrangements for the examination of variations to the terms of marketing authorisations granted in accordance with this Directive. The Commission shall adopt these arrangements in the form of an implementing regulation. That measure, designed to amend non-essential elements of this Directive, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).’

1 The Commission shall adopt appropriate arrangements for the examination of variations to the terms of marketing authorisations granted in accordance with this Directive.

2 The Commission shall adopt the arrangements referred to in paragraph 1 in the form of an implementing regulation. That measure, designed to amend non-essential elements of this Directive, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 121(2a).

3 When adopting the arrangements referred to in paragraph 1, the Commission shall make efforts to make it possible to submit a single application for one or more identical changes made to the terms of a number of marketing authorisations.

4 A Member State may continue to apply national provisions on variations applicable at the time of entry into force of the implementing regulation 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, the implementing regulation shall apply to that medicinal product from that date.

5 Where a Member State decides to continue to apply national provisions pursuant to paragraph 4, it shall notify the Commission thereof. If a notification has not been made by 20 January 2011, the implementing regulation shall apply.’

1 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 20 January 2011 at the latest. They shall forthwith communicate to the Commission the text thereof. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2 Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

This Directive is addressed to the Member States.