[ParlTrack]

Proposal for a directive
Recital 34

(34) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use42 provides a legal framework to assess the quality, safety and efficacy of medicinal products including nicotine containing products. A significant number of nicotine-containing products were already authorised under this regulatory regime. The authorisation takes into account the nicotine content of the product in question. Subjecting all nicotine-containing products, whose nicotine content equals or exceeds the content of a nicotine containing product previously authorised under Directive 2001/83/EC, to the same legal framework clarifies the legal situation, levels out differences between national legislations, ensures equal treatment of all nicotine containing products usable for smoking cessation purposes and creates incentives for research and innovation in smoking cessation. This should be without prejudice to the application of Directive 2001/83/EC to other products covered by this Directive if the conditions set by Directive 2001/83/EC are fulfilled. __________________ 42 OJ L 311, 28.11.2001, p. 67, as last amended by Directive 2011/62/EU, OJ L 174, 1.7.2011, p. 74.deleted

2013/05/28
Committee: ITRE

Robert GOEBBELS

Proposal for a directive
Article 18

~~[...]~~deleted

2013/05/28
Committee: ITRE

Robert GOEBBELS

Proposal for a directive
Article 22 – paragraph 2

2. The power to adopt delegated acts referred to in Articles 3(2), 3(3), 4(3), 4(4), 6(3), 6(9), 6(10), 8(4), 9(3), 10(5), 11(3), 13(3), 13(4)~~, 14(9), 18(2)~~ and 1~~8(5~~4(9) shall be conferred on the Commission for an indeterminate period of time from [Office of Publications: please insert the date of the entry into force of this Directive].

2013/05/28
Committee: ITRE

Robert GOEBBELS

Proposal for a directive
Article 22 – paragraph 3

3. The delegation of powers referred to in Articles 3(2), 3(3), 4(3), 4(4), 6(3), 6(9), 6(10), 8(4), 9(3), 10(5), 11(3), 13(3), 13(4)~~, 14(9), 18(2)~~ and 1~~8(5~~4(9) 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.

2013/05/28
Committee: ITRE

Robert GOEBBELS

Proposal for a directive
Article 22 – paragraph 5

5. A delegated act pursuant to Articles 3(2), 3(3), 4(3), 4(4), 6(3), 6(9), 6(10), 8(4), 9(3), 10(5), 11(3), 13(3), 13(4)~~, 14(9), 18(2)~~ and 1~~8(5~~4(9) 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.

2013/05/28
Committee: ITRE

Robert GOEBBELS

Proposal for a directive
Article 26 – paragraph 1 – point b

~~(b) nicotine containing products below the threshold set out in Article 18(1);~~deleted

2013/05/28
Committee: ITRE

Activities of Robert GOEBBELS related to 2012/0366(COD)

Plenary speeches (2)

Amendments (6)

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