BETA

Activities of Françoise GROSSETÊTE related to 2008/0045(COD)

Plenary speeches (2)

Variations to the terms of marketing authorisations for medicinal products - Counterfeiting of medicinal products (debate)
2016/11/22
Dossiers: 2008/0045(COD)
Variations to the terms of marketing authorisations for medicinal products - Counterfeiting of medicinal products (debate)
2016/11/22
Dossiers: 2008/0045(COD)

Reports (1)

REPORT Report on the proposal for a directive of the European Parliament and of the Council amending Directive 2001/82/EC and Directive 2001/83/EC as regards variations to the terms of marketing authorisations for medicinal products PDF (221 KB) DOC (301 KB)
2016/11/22
Committee: ENVI
Dossiers: 2008/0045(COD)
Documents: PDF(221 KB) DOC(301 KB)

Amendments (11)

Amendment 6 #
Proposal for a directive – amending act
Article 1 – point 1
Directive 2001/82/EC
Article 10 – paragraph 3
(1) Article 10(3) is replaced by the following: “3. By way of derogation from Article 11, the Commission shall establish a list of substances essential for the treatment of equidae and for which the withdrawal period shall be not less than six months according to the control mechanisms laid down in Decisions 93/623/EEC and 2000/68/EC. This 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).”deleted
2008/07/18
Committee: ENVI
Amendment 7 #
Proposal for a directive – amending act
Article 1 – point 2
Directive 2001/82/EC
Article 11 – paragraph 2
(2) In Article 11(2), the third subparagraph is replaced by the following: “However, the Commission may modify these specific withdrawal periods. Those measures, designed to amend non- essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).”deleted
2008/07/18
Committee: ENVI
Amendment 8 #
Proposal for a directive – amending act
Article 1 – point 3
Directive 2001/82/EC
Article 13 – paragraph 1
(3) In Article 13(1), the fourth subparagraph is replaced by the following: “However, the ten-year period provided for in the second subparagraph shall be extended to 13 years in the case of veterinary medicinal products for fish or bees or other species designated by the Commission. 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).”deleted
2008/07/18
Committee: ENVI
Amendment 9 #
Proposal for a directive – amending act
Article 1 – point 4
Directive 2001/82/EC
Article 17 – paragraph 1
(4) In Article 17(1), the second subparagraph is replaced by the following: “If it appears justified in the light of new scientific evidence, the Commission may adapt points (b) and (c) of the first subparagraph. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).”deleted
2008/07/18
Committee: ENVI
Amendment 10 #
Proposal for a directive – amending act
Article 1 – point 7
Directive 2001/82/EC
Article 50a – paragraph 2
(7) Article 50a (2) is replaced by the following: “2. The Commission shall adopt any amendments which may be necessary to adapt the provisions of Paragraph 1 to take account of scientific and technical progress. Those measures, designed to amend non- essential elements of this directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).”deleted
2008/07/18
Committee: ENVI
Amendment 11 #
Proposal for a directive – amending act
Article 1 – point 8
Directive 2001/82/EC
Article 51
(8) In Article 51, the first subparagraph is replaced by the following: “The principles and guidelines of good manufacturing practice for veterinary medicinal products referred to in Article 50(f) shall be adopted by the Commission in the form of a Directive addressed to the Member States. Those measures, 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).”deleted
2008/07/18
Committee: ENVI
Amendment 12 #
Proposal for a directive – amending act
Article 1 – point 9
Directive 2001/82/EC
Article 67 – point a a
(9) In Article 67, point (aa) is replaced by the following: “(aa) veterinary medicinal products for food-producing animals. However, Member States may grant exemptions from this requirement according to criteria established by the Commission. The establishment of those criteria, a 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). Member States may continue to apply national provisions until either: – the date of application of the decision adopted in accordance with the first subparagraph; or – 1 January 2007, if no such decision has been adopted by 31 December 2006;”deleted
2008/07/18
Committee: ENVI
Amendment 13 #
Proposal for a directive – amending act
Article 1 – point 10
Directive 2001/82/EC
Article 68 – paragraph 3
(10) Article 68(3) is replaced by the following: “3. The Commission shall adopt any amendments to the list of substances referred to in paragraph 1. Those measures, designed to amend non- essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).”deleted
2008/07/18
Committee: ENVI
Amendment 14 #
Proposal for a directive – amending act
Article 1 – point 11
Directive 2001/82/EC
Article 75 – paragraph 6
(11) Article 75(6) is replaced by the following: “6. The Commission may amend paragraph 5 in the light of the experience gained from its operation. Those measures, designed to amend non- essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).”deleted
2008/07/18
Committee: ENVI
Amendment 15 #
Proposal for a directive – amending act
Article 1 – point 12
Directive 2001/82/EC
Article 79
(12) Article 79 is replaced by the following: “Article 79 The Commission shall adopt any amendments which may be necessary to update Articles 72 to 78 to take account of scientific and technical progress. Those measures, designed to amend non- essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).”deleted
2008/07/18
Committee: ENVI
Amendment 16 #
Proposal for a directive – amending act
Article 1 – point 13
Directive 2001/82/EC
Article 88
(13) Article 88 is replaced by the following: “Article 88 The Commission shall adopt any changes which are necessary in order to adapt Annex I to take account of technical progress Those measures, designed to amend non- essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).”deleted
2008/07/18
Committee: ENVI