56 Amendments of Philippe LOISEAU related to 2014/0257(COD)
Amendment 34 #
Proposal for a regulation
Recital 2
Recital 2
(2) In the light of the experience acquired and following the assessment by the Commission of the functioning of the market for veterinary medicinal products, the need for the legal framework for veterinary medicinal products shouldto be adapted to scientific progress, the current market conditions and economic reality cannot be said to have been proven.
Amendment 41 #
Proposal for a regulation
Recital 14
Recital 14
(14) Where a Member State or the Commission considers that there are reasons to believe that a veterinary medicinal product may present a potential serious risk to human or animal health or to the environment, athe scientific evaluation carried out by the applicant’s Member State should be compared with a scientific evaluation of the product should be undertaken at Union level, leading to a single decision on the area of disagreement, binding on the Member States concerned, being taken on the basis of an overall benefit-risk assessment.
Amendment 43 #
Proposal for a regulation
Recital 14 a (new)
Recital 14 a (new)
(14a) In the event of disagreement, the Member State should be free to ban a substance it regards as dangerous (including in food derived from imported animals).
Amendment 70 #
Proposal for a regulation
Recital 56
Recital 56
(56) The conditions governing the supply of veterinary medicinal products to the public should be harmonised in the Union. Veterinary medicinal products should only be supplied by persons authorised to do so by the Member State where they are established. At the same time, in order to improve access to veterinary medicinal products in the Union, retailers that are authorised to supply veterinary medicinal products by the competent authority in the Member State where they are established should not be allowed to sell prescription and non-prescription veterinary medicinal products via the Internet to buyers in other Member States.
Amendment 74 #
Proposal for a regulation
Recital 57 a (new)
Recital 57 a (new)
(57a) The online sale of medicinal products should be prohibited.
Amendment 76 #
Proposal for a regulation
Recital 58
Recital 58
(58) When examining the compatibility with Union law of the conditions for the supply of medicinal products, the Court of Justice of the European Union has recognised, in the context on medicinal products for human use, the very particular nature of medicinal products whose therapeutic effects distinguish them substantially from other goods. The Court of Justice has also held that health and life of humans rank foremost among the assets and interests protected by the Treaty and that it is for Member States to determine the level of protection which they wish to afford to public health and the way in which that level has to be achieved. Since that level may vary from one Member State to another, Member States must be allowed some discretion as regards the conditions for the supply on their territory of medicinal products to the public. Therefore Member States should be able to subject the supply of medicinal products offered for sale at a distance by means of information society services to conditions justified by the protection of public health. Such conditions should not unduly restrict the functioning of the internal market, the online sale of medicinal products should be prohibited.
Amendment 77 #
Proposal for a regulation
Recital 59
Recital 59
Amendment 78 #
Proposal for a regulation
Recital 61
Recital 61
(61) Advertising, even on non-prescription medicinal products, could affect public and animal health and distort competition. Therefore, advertising of veterinary medicinal products should satisfy certain criteria. Persons qualified to prescribe or supply can properly evaluate the information available in advertising because of their knowledge, training and experience in animal health. The advertising of veterinary medicinal products to persons who cannot properly appreciate the risk associated with their use may leads to medicine misuse or overconsumption which is liable to harm public or animal health, or the environment, and should be prohibited.
Amendment 81 #
Proposal for a regulation
Recital 62
Recital 62
(62) Where medicinal products are authorised within a Member State and have been prescribed in that Member State by a member of a regulated animal health profession for an individual animal or group of animals, it should in principle be possible for that veterinary prescription to be recognised and for the medicinal product to be dispensed in another Member State. The removal of regulatory and administrative barriers to such recognition shouldmust not affect any professional or ethical duty for dispensing professionals to refuse to dispense the medicine stated in the prescription.
Amendment 84 #
Proposal for a regulation
Recital 70
Recital 70
(70) Companies and authorities are frequently confronted with the need to distinguish between veterinary medicinal products, feed additives, biocidal products and other products. In order to avoid inconsistencies in the treatment of such products, to increase legal certainty, and to facilitate the decision process by Member States, a coordination group of Member States should be established, and among other tasks it should provide on a case-by- case basis a recommendation whether a product falls within the definition of a veterinary medicinal product. In order to ensure legal certainty the Commission may decide whether a specific product is a veterinary medicinal product.
Amendment 85 #
Proposal for a regulation
Recital 72
Recital 72
Amendment 86 #
Proposal for a regulation
Recital 73
Recital 73
Amendment 87 #
Proposal for a regulation
Recital 74
Recital 74
Amendment 88 #
Proposal for a regulation
Recital 75
Recital 75
Amendment 90 #
Proposal for a regulation
Recital 76
Recital 76
Amendment 91 #
Proposal for a regulation
Recital 77
Recital 77
Amendment 93 #
Proposal for a regulation
Recital 78
Recital 78
Amendment 94 #
Proposal for a regulation
Recital 79
Recital 79
Amendment 96 #
Proposal for a regulation
Recital 80
Recital 80
Amendment 98 #
Proposal for a regulation
Article 2 – paragraph 4 – point e a (new)
Article 2 – paragraph 4 – point e a (new)
(ea) substances used to raise animal productivity levels.
Amendment 118 #
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
1. A veterinary medicinal product shall be placed on the market only when a marketing authorisation has been granted in respect of the product by a competent authority in accordance with Articles 44, 46 or 48 or by the Commission in accordance with Article 40.
Amendment 159 #
Proposal for a regulation
Article 16 – paragraph 7
Article 16 – paragraph 7
Amendment 171 #
Proposal for a regulation
Article 29 – paragraph 1 – introductory part
Article 29 – paragraph 1 – introductory part
1. A competent authority or the Commission shall classify the following veterinary medicinal products as subject to veterinary prescription:
Amendment 186 #
Proposal for a regulation
Article 31 – paragraph 2
Article 31 – paragraph 2
2. The competent authority or the Commission shall make the decision granting the marketing authorisation publicly available and record it in the database referred to in Article 51.
Amendment 199 #
Proposal for a regulation
Article 32 – paragraph 3
Article 32 – paragraph 3
Amendment 204 #
Proposal for a regulation
Article 32 – paragraph 4
Article 32 – paragraph 4
Amendment 238 #
Proposal for a regulation
Article 38
Article 38
Amendment 246 #
Proposal for a regulation
Article 40
Article 40
Amendment 247 #
Proposal for a regulation
Article 41
Article 41
Amendment 275 #
Proposal for a regulation
Article 54 – paragraph 3
Article 54 – paragraph 3
Amendment 278 #
Proposal for a regulation
Article 54 – paragraph 4
Article 54 – paragraph 4
Amendment 282 #
Proposal for a regulation
Article 58
Article 58
Amendment 294 #
Proposal for a regulation
Article 60 – paragraph 2
Article 60 – paragraph 2
2. If necessary, competent authorities or, where the veterinary medicinal product is authorised under the centralised marketing authorisation procedure, the Commission shall amend the decision granting a marketing authorisation in accordance with the change.
Amendment 298 #
Proposal for a regulation
Article 63 – paragraph 1
Article 63 – paragraph 1
1. When applying for variations to the terms of several marketing authorisations held by the same marketing authorisation holder and granted by different competent authorities and/or the Commission, the marketing authorisation holder shall submit an application to all competent authorities concerned and the Agency.
Amendment 301 #
Proposal for a regulation
Article 65 – paragraph 1
Article 65 – paragraph 1
1. Within 30 days of the completion of the procedure laid down in Article 64(6) and (7) a competent authority or the Commission shall amend the marketing authorisation or reject the variation and inform the applicant of the grounds for the rejection. In case of centralised marketing authorisation, the Commission shall, by means of implementing acts, take a final decision amending the marketing authorisation or rejecting the variation. These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Amendment 340 #
Proposal for a regulation
Article 79 – paragraph 6
Article 79 – paragraph 6
6. The Agency shall evaluate the adverse events to the centrally authorised veterinary medicinal products, manage risks and recommend measures to the Ccommissionpetent authorities. The Ccommissionpetent authorities shall take the measures referred to in Articles 130 to 135 concerning marketing authorisations where necessary.
Amendment 345 #
Proposal for a regulation
Article 81 – paragraph 5
Article 81 – paragraph 5
5. Where necessary, based on the results of the signal management process referred to in paragraph 4 the competent authorities or the Commission shall take appropriate measures as referred to in Articles 130 to 135.
Amendment 347 #
Proposal for a regulation
Article 82 – paragraph 3
Article 82 – paragraph 3
3. When an application for re-examination has been submitted, the limited market marketing authorisation shall remain valid until a decision on the application has been adopted by the competent authority or the Commission.
Amendment 348 #
Proposal for a regulation
Article 82 – paragraph 5
Article 82 – paragraph 5
5. The competent authority or the Commission may at any time grant a marketing authorisation valid for an unlimited period of time in respect of a veterinary medicinal product authorised for a limited market, provided that the holder of the marketing authorisation for a limited market submits the missing comprehensive quality and efficacy data referred to in Article 21(1).
Amendment 349 #
Proposal for a regulation
Article 83 – paragraph 3
Article 83 – paragraph 3
3. When an application for re-examination has been submitted, the marketing authorisation shall remain valid until a decision on the application has been adopted by the competent authority or the Commission.
Amendment 350 #
Proposal for a regulation
Article 83 – paragraph 4
Article 83 – paragraph 4
4. The competent authority or the Commission may at any time grant a marketing authorisation valid for an unlimited period of time, provided that the marketing authorisation holder submits the missing comprehensive safety and efficacy data referred to in Article 22(1).
Amendment 386 #
Proposal for a regulation
Article 114 – paragraph 1 – introductory part
Article 114 – paragraph 1 – introductory part
1. A veterinarian providing services in a Member State other than the one where he is established (the ‘host Member State’) may administer veterinary medicinal products authorised in the host Member State to animals in another Member State which are under his care in the amount required for the treatment of those animals where the following conditions are fulfillmay neither provide services nor prescribe in a Member State other than the one where he is established:.
Amendment 387 #
Proposal for a regulation
Article 114 – paragraph 1 – point a
Article 114 – paragraph 1 – point a
Amendment 388 #
Proposal for a regulation
Article 114 – paragraph 1 – point b
Article 114 – paragraph 1 – point b
Amendment 389 #
Proposal for a regulation
Article 114 – paragraph 1 – point c
Article 114 – paragraph 1 – point c
Amendment 390 #
Proposal for a regulation
Article 114 – paragraph 1 – point d
Article 114 – paragraph 1 – point d
Amendment 391 #
Proposal for a regulation
Article 114 – paragraph 1 – point e
Article 114 – paragraph 1 – point e
Amendment 392 #
Proposal for a regulation
Article 114 – paragraph 1 – point f
Article 114 – paragraph 1 – point f
Amendment 393 #
Proposal for a regulation
Article 114 – paragraph 2
Article 114 – paragraph 2
Amendment 446 #
Proposal for a regulation
Article 130 – paragraph 1
Article 130 – paragraph 1
1. In the event of a risk to public or animal health or to the environment that requires urgent action, the competent authorities or, in the case of centralised marketing authorisations, the Commission may impose temporary safety restrictions on the marketing authorisation holder, including suspending the marketing authorisation and/or prohibiting the supply of a veterinary medicinal product. Other Member States and, where the temporary safety restriction is imposed by a competent authority, the Commission shall be informed of the temporary safety restriction imposed on the following working day at the latest.
Amendment 447 #
Proposal for a regulation
Article 130 – paragraph 2
Article 130 – paragraph 2
2. Member States and the Commission may refer the issue to the Agency in accordance with Article 84.
Amendment 448 #
Proposal for a regulation
Article 131 – paragraph 1
Article 131 – paragraph 1
1. The competent authority or the Commission shall suspend or withdraw the marketing authorisation if the benefit-risk balance of the veterinary medicinal product is unfavourable.
Amendment 449 #
Proposal for a regulation
Article 131 – paragraph 2
Article 131 – paragraph 2
2. The competent authority or the Commission shall suspend or withdraw the marketing authorisation or request the marketing authorisation holder to submit an application for a variation to the terms of the marketing authorisation where the withdrawal period is inadequate to ensure that foodstuffs obtained from the treated animal do not contain residues which might constitute a public health hazard.
Amendment 450 #
Proposal for a regulation
Article 131 – paragraph 3 – introductory part
Article 131 – paragraph 3 – introductory part
3. The competent authority or the Commission may suspend or withdraw the marketing authorisation or request the marketing authorisation holder to submit an application for a variation to the terms of the marketing authorisation in case of any of the following:
Amendment 451 #
Proposal for a regulation
Article 131 – paragraph 4
Article 131 – paragraph 4
4. For the purpose of paragraphs 1 to 3, before taking action, the Commission shall request, where appropriate, the opinion of the Agency within time-limit which it shall determine in the light of the urgency of the matter, in order to examine the reasons. Whenever practicable, the holder of the marketing authorisation for the veterinary medicinal product shall be invited to provide oral or written explanations.
Amendment 452 #
Proposal for a regulation
Article 135
Article 135