8 Amendments of Esther DE LANGE related to 2008/0211(COD)
Amendment 185 #
Proposal for a directive
Article 5 – paragraph 3
Article 5 – paragraph 3
(3) the development, manufacture or testing of the quality, effectiveness and safety of drugs, food- and feed-stuffs and other substances or productmedicinal or veterinary products and devices having either of the aims referred to in point (2);
Amendment 186 #
Proposal for a directive
Article 5 – paragraph 3 a (new)
Article 5 – paragraph 3 a (new)
(3a) the development, manufacture or testing of the quality, effectiveness and safety of substances or products, other than those referred to in point (3), having either of the aims referred to in point (2);
Amendment 212 #
Proposal for a directive
Article 8 – paragraph 2 a (new)
Article 8 – paragraph 2 a (new)
2a. The Commission shall, within 12 months after the entry into force of this Directive, set up a high-level Committee, which shall include representatives of all stakeholders, to review the use of non- human primates and define replacement strategies. The Committee shall issue recommendations and report annually to the European Parliament and the Council on its activities.
Amendment 293 #
Proposal for a directive
Article 34 – paragraph 1
Article 34 – paragraph 1
1. The Commission mayshall undertake controls of the infrastructure and operation of national inspections in Member States. To that end, the Commission shall set up a system to monitor each Member State’s inspections and enforcement of this Directive on average every three years, to ensure harmonised practices for the use and care of animals used or intended to be used in scientific procedures.
Amendment 355 #
Proposal for a directive
Article 43 – paragraph 1
Article 43 – paragraph 1
1. Member States shall ensure that the decision to grant an authorisation is taken and communicated to the user establishment at the latest within 360 days from the submission of the application. Should the Member State fail to take a decision within that period, the authorisation shall be deemed to have been granted, where the project concerned involves only procedures classified as "up to mild" and non-human primates are not used. In all other cases, no such presumption shall apply.
Amendment 362 #
Proposal for a directive
Article 43 – paragraph 2
Article 43 – paragraph 2
2. Notwithstanding paragraph 1, in exceptional circumstances and where the project is non-routine, multi-disciplinary and innovative, the decision to grant an authorisation shall be taken and communicated to the user establishment within 690 days from the submission of the application.
Amendment 366 #
Proposal for a directive
Article 45
Article 45
The Commission and Member States shall contribute to the development and, financially and otherwise, to the development and, where appropriate, scientific validation of alternative approaches that couldintended to provide the same or higher level of information as that obtained in procedures using animals but that do not involve the use of animals or use fewer animals or that entail less painful procedures and shall take such other steps as they consider appropriate to encourage research in this field.
Amendment 369 #
Proposal for a directive
Article 45 a (new)
Article 45 a (new)
Article 45a European Centre for Validation of Alternative Methods 1) The Commission shall, 12 months after the entry into force of this Directive, review and strengthen the role of the European Centre for the Validation of Alternative Methods to facilitate the development and use of alternatives to animal procedures. The Centre referred to in paragraph 1 shall cooperate with the National Reference Centres for Alternative Methods described in Article 46 in order to: 1) develop a strategy for the implementation of the replacement, reduction and refinement approach; 2) identify what is required in order to carry out research into alternative procedures; 3) provide advice, guidance and information on replacement, reduction and refinement to competent authorities, the scientific community, the public and relevant stakeholders; 4) coordinate pre-validation and validation studies; 5) in consultation with relevant regulatory bodies, both national and international, identify new alternative methods suitable for validation as well as specific requirements for their validation; 6) facilitate the scientific endorsement and regulatory acceptance of alternatives to animal tests used for regulatory purposes.