[ParlTrack]

Proposal for a regulation
Article 1 – paragraph 1 – point 4 – point c

Regulation (EC) No 726/2004
Article 3 – paragraph 4

‘The Commission shall be empowered to adopt delegated acts in accordance with Article 87b in order to amend the Annex to technical and scientific progress without extending the scope of the centralised procedureAnnex may not be amended without the approval of the competent health authorities of the Member States.’;

2015/04/30
Committee: AGRI

Edouard FERRAND, Philippe LOISEAU

Proposal for a regulation
Article 1 – paragraph 1 – point 9

Regulation (EC) No 726/2004
Article 16 – paragraph 4

(9) Article 16(4) is replaced by the following: ‘4. The Commission shall be empowered to adopt delegated acts in accordance with Article 87b establishing procedures for the examination of applications for variations to the terms of marketing authorisations and for the examination of applications for the transfer of marketing authorisations.’;deleted

2015/04/30
Committee: AGRI

Edouard FERRAND, Philippe LOISEAU

Proposal for a regulation
Article 1 – paragraph 1 – point 15

Regulation (EC) No 726/2004
Article 67 – paragraph 3 – subparagraph 1

(15) the first subparagraph of Article 67(3) is replaced by the following: ‘The Agency’s revenue shall consist of a contribution from the Union, fees paid by undertakings for obtaining and maintaining Union marketing authorisations and for other services provided by the Agency, or by the coordination group as regards the fulfilment of its tasks in accordance with Articles 107c, 107e, 107g, 107k and 107q of Directive 2001/83/EC and charges for other services provided by the Agency.’;deleted

2015/04/30
Committee: AGRI

Edouard FERRAND, Philippe LOISEAU

Proposal for a regulation
Article 1 – paragraph 1 – point 16

Regulation (EC) No 726/2004
Article 70 – paragraph 1 – introductory part

1. The Commission shall, on the basis of the principles set out in paragraph 2, ~~adopt implementing acts in accordance with the procedure laid down in Article 87(2) specifying~~submit proposals to the Member States on:

2015/04/30
Committee: AGRI

Edouard FERRAND, Philippe LOISEAU

Proposal for a regulation
Article 1 – paragraph 1 – point 16

Regulation (EC) No 726/2004
Article 70 – paragraph 2 – introductory part

2. ~~When adopting the implementing acts referred to in paragraph 1~~In its proposals, the Commission shall take the following into account:

2015/04/30
Committee: AGRI

Edouard FERRAND, Philippe LOISEAU

Proposal for a regulation
Article 1 – paragraph 1 – point 17

Regulation (EC) No 726/2004
Article 84 – paragraph 3 – subparagraph 1

~~The Commission may~~3. Member States alone shall be empowered to impose financial penalties on the holders of marketing authorisations granted under this Regulation if they fail to observe obligations laid down in connection with the marketing authorisations granted in accordance with this Regulation.

2015/04/30
Committee: AGRI

Edouard FERRAND, Philippe LOISEAU

Proposal for a regulation
Article 1 – paragraph 1 – point 17

Regulation (EC) No 726/2004
Article 84 – paragraph 3 – subparagraph 3

For the conduct of the investigation the Commission ~~may~~shall cooperate with national competent authorities and rely on resources provided by the Agency.

2015/04/30
Committee: AGRI

Edouard FERRAND, Philippe LOISEAU

Proposal for a regulation
Article 1 – paragraph 1 – point 17

Regulation (EC) No 726/2004
Article 84 – paragraph 3 – subparagraph 4

Where the Commission adopts a decision imposing a financial penalty, it shall publish a concise summary of the case, including the names of the marketing authorisation holders involved and the amounts of and reasons for the financial penalties imposed, having regard to the legitimate interest of the marketing authorisation holders in the protection of their business secrets.deleted

2015/04/30
Committee: AGRI

Edouard FERRAND, Philippe LOISEAU

Proposal for a regulation
Article 1 – paragraph 1 – point 20

Regulation (EC) No 726/2004
Article 87b

(20) Article 87b is replaced by the following: ‘Article 87b 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The delegation of power referred to in Articles 3(4), 10b (1), 14(7), 16(4) and 84(3) shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this Regulation. 3. The delegation of power referred to in Articles 3(4), 10b (1), 14(7), 16(4) and 84(3) 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. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Articles 3(4), 10b (1), 14(7), 16(4) and 84(3) 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.’;deleted

2015/04/30
Committee: AGRI

9 Amendments of Philippe LOISEAU related to 2014/0256(COD)

ParlTrack - 2011-2024