BETA

Activities of Edouard FERRAND related to 2014/0257(COD)

Plenary speeches (1)

Veterinary medicinal products (A8-0046/2016 - Françoise Grossetête) FR
2016/11/22
Dossiers: 2014/0257(COD)

Amendments (58)

Amendment 34 #
Proposal for a regulation
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.
2015/05/07
Committee: AGRI
Amendment 41 #
Proposal for a regulation
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.
2015/05/07
Committee: AGRI
Amendment 43 #
Proposal for a regulation
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).
2015/05/07
Committee: AGRI
Amendment 70 #
Proposal for a regulation
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.
2015/05/07
Committee: AGRI
Amendment 74 #
Proposal for a regulation
Recital 57 a (new)
(57a) The online sale of medicinal products should be prohibited.
2015/05/07
Committee: AGRI
Amendment 76 #
Proposal for a regulation
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.
2015/05/07
Committee: AGRI
Amendment 77 #
Proposal for a regulation
Recital 59
(59) In order to ensure high standards and safety of the veterinary medicinal products offered for sale at a distance, the public should be assisted in identifying websites which are legally offering such medicinal products. A common logo should be established, which is recognisable throughout the Union, while allowing for the identification of the Member State where the person offering veterinary medicinal products for sale at a distance is established. The Commission should develop the design for such a logo. Websites offering veterinary medicinal products for sale at a distance to the public should be linked to the website of the competent authority concerned. The websites of the competent authorities of Member States, as well as that of the European Medicines Agency, should give an explanation of the use of the logo. All those websites should be linked in order to provide comprehensive information to the public.deleted
2015/05/07
Committee: AGRI
Amendment 78 #
Proposal for a regulation
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.
2015/05/07
Committee: AGRI
Amendment 81 #
Proposal for a regulation
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.
2015/05/07
Committee: AGRI
Amendment 84 #
Proposal for a regulation
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.
2015/05/07
Committee: AGRI
Amendment 85 #
Proposal for a regulation
Recital 72
(72) In order to follow the scientific developments of the sector, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of amending the rules on designation of homeopathic veterinary medicinal products for which registration procedure should be allowed.deleted
2015/05/07
Committee: AGRI
Amendment 86 #
Proposal for a regulation
Recital 73
(73) In order to protect public health, animal health and the environment, the activities and tasks attributed to the Agency in this Regulation should be adequately funded. Those activities, services and tasks should be funded through fees charged to enterprises. Those fees, however, should not affect the right of Member States to charge fees for activities and tasks at national level.deleted
2015/05/07
Committee: AGRI
Amendment 87 #
Proposal for a regulation
Recital 74
(74) In order to ensure that annexes to this Regulation are adapted to the technical and scientific developments, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission.deleted
2015/05/07
Committee: AGRI
Amendment 88 #
Proposal for a regulation
Recital 75
(75) In order to adapt this Regulation to the scientific developments of the sector, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of the use of a product outside the terms of the granted marketing authorisation, in particular regarding establishing a list of antimicrobial veterinary medicinal products for which such use should be prohibited.deleted
2015/05/07
Committee: AGRI
Amendment 90 #
Proposal for a regulation
Recital 76
(76) In order to adapt this Regulation to the scientific developments of the sector, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of amending the list of groups of veterinary medicinal products for which the centralised authorisation procedure shall be compulsory.deleted
2015/05/07
Committee: AGRI
Amendment 91 #
Proposal for a regulation
Recital 77
(77) In order to adapt this Regulation to the scientific developments of the sector, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of establishing detailed rules on the principles for the refusal or restriction of marketing authorisations of antimicrobial veterinary medicinal products, in particular with a view to preserving the efficacy of certain active substances in treating infections in humans.deleted
2015/05/07
Committee: AGRI
Amendment 93 #
Proposal for a regulation
Recital 78
(78) In order to exercise its supervisory powers effectively, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of laying down the procedure for investigating the infringements and the imposition of fines or periodic penalty payments to the holders of marketing authorisations granted under this Regulation, the maximum amounts of these penalties as well as the conditions and methods for their collection.deleted
2015/05/07
Committee: AGRI
Amendment 94 #
Proposal for a regulation
Recital 79
(79) In order to introduce harmonised standards within the Union for the methods of gathering data on the use of antimicrobials and the methods of transferring of these data to the Commission, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of establishing rules on these methods.deleted
2015/05/07
Committee: AGRI
Amendment 96 #
Proposal for a regulation
Recital 80
(80) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council19. __________________ 19 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission ' s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).deleted
2015/05/07
Committee: AGRI
Amendment 98 #
Proposal for a regulation
Article 2 – paragraph 4 – point e a (new)
(ea) substances used to raise animal productivity levels.
2015/05/07
Committee: AGRI
Amendment 118 #
Proposal for a regulation
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.
2015/05/07
Committee: AGRI
Amendment 159 #
Proposal for a regulation
Article 16 – paragraph 7
7. The Commission shall be empowered to adopt delegated acts in accordance with Article 146 concerning amendments to Annex III in order to adapt the requirements to technical and scientific progress.
2015/05/07
Committee: AGRI
Amendment 171 #
Proposal for a regulation
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:
2015/05/07
Committee: AGRI
Amendment 186 #
Proposal for a regulation
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.
2015/05/07
Committee: AGRI
Amendment 199 #
Proposal for a regulation
Article 32 – paragraph 3
3. The Commission shall be empowered to adopt delegated acts in accordance with Article 146 in order to establish rules for the designation of the antimicrobials which are to be reserved for treatment of certain infections in humans in order to preserve the efficacy of certain active substances in humans.
2015/05/07
Committee: AGRI
Amendment 204 #
Proposal for a regulation
Article 32 – paragraph 4
4. The Commission shall, by means of implementing acts, designate antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans. These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).deleted
2015/05/07
Committee: AGRI
Amendment 238 #
Proposal for a regulation
Article 38
[...]deleted
2015/05/07
Committee: AGRI
Amendment 246 #
Proposal for a regulation
Article 40
[...]deleted
2015/05/07
Committee: AGRI
Amendment 247 #
Proposal for a regulation
Article 41
Re-examination of the opinion of the 1. Where the applicant requests a re- examination of the opinion in accordance with Article 40(5), he shall forward to the Agency detailed grounds for the request within 60 days after receipt of the opinion. 2. Within 60 days after receipt of the grounds for the request, the Agency shall re-examine its opinion. The reasons for the conclusions reached shall be annexed to the opinion. 3. Within 15 days after its adoption, the Agency shall forward its opinion to the Commission and the applicant.Article 41 deleted Agency
2015/05/07
Committee: AGRI
Amendment 275 #
Proposal for a regulation
Article 54 – paragraph 3
3. The Commission shall be empowered to adopt delegated acts in accordance with Article 146 in order to establish detailed rules on the methods of gathering data on the use of antimicrobials and the method of transfer of these data to the Agency.
2015/05/07
Committee: AGRI
Amendment 278 #
Proposal for a regulation
Article 54 – paragraph 4
4. The Commission may, by means of implementing acts, set up the format and the requirements for the data to be coldelected in accordance with this Article. These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
2015/05/07
Committee: AGRI
Amendment 282 #
Proposal for a regulation
Article 58
Variations to the terms of a marketing 1. Variation to the terms of a marketing authorisation means a change to the terms of the marketing authorisation for a veterinary medicinal product as referred to in Article 31 (‘variation’). 2. The Commission shall, by means of implementing acts, establish a list of variations to the terms of a marketing authorisation for a veterinary medicinal product requiring assessment (‘variations requiring assessment’). These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). 3. When adopting those implementing acts, the Commission shall take account of the following criteria: (a) the need for a scientific assessment of changes in order to determine the risk to public health, animal health or the environment; (b) whether changes have an impact on the safety and efficacy of the veterinary medicinal product; (c) whether changes imply a significant alteration to the summary of product characteristics.Article 58 deleted authorisation
2015/05/07
Committee: AGRI
Amendment 294 #
Proposal for a regulation
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.
2015/05/07
Committee: AGRI
Amendment 298 #
Proposal for a regulation
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.
2015/05/07
Committee: AGRI
Amendment 301 #
Proposal for a regulation
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).
2015/05/07
Committee: AGRI
Amendment 340 #
Proposal for a regulation
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.
2015/05/07
Committee: AGRI
Amendment 345 #
Proposal for a regulation
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.
2015/05/07
Committee: AGRI
Amendment 347 #
Proposal for a regulation
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.
2015/05/07
Committee: AGRI
Amendment 348 #
Proposal for a regulation
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).
2015/05/07
Committee: AGRI
Amendment 349 #
Proposal for a regulation
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.
2015/05/07
Committee: AGRI
Amendment 350 #
Proposal for a regulation
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).
2015/05/07
Committee: AGRI
Amendment 364 #
Proposal for a regulation
Article 108
[...]deleted
2015/05/07
Committee: AGRI
Amendment 367 #
Proposal for a regulation
Article 108 a (new)
Article 108a Prohibition on marketing veterinary medicinal products online Veterinary medicinal products requiring authorisation may not be marketed via the Internet.
2015/05/07
Committee: AGRI
Amendment 386 #
Proposal for a regulation
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:.
2015/05/07
Committee: AGRI
Amendment 387 #
Proposal for a regulation
Article 114 – paragraph 1 – point a
(a) the authorisation to place the veterinary medicinal product on the market provided for in Article 5 has been issued by the competent authorities of the host Member State or by the Commission;deleted
2015/05/07
Committee: AGRI
Amendment 388 #
Proposal for a regulation
Article 114 – paragraph 1 – point b
(b) the veterinary medicinal products are transported by the veterinarian in the original packaging;deleted
2015/05/07
Committee: AGRI
Amendment 389 #
Proposal for a regulation
Article 114 – paragraph 1 – point c
(c) where intended for administration to food-producing animals, the veterinary medicinal products have the same qualitative and quantitative composition of active substances as the veterinary medicinal products authorised in the host Member State;deleted
2015/05/07
Committee: AGRI
Amendment 390 #
Proposal for a regulation
Article 114 – paragraph 1 – point d
(d) the veterinarian follows the good veterinary practices applied in that Member State and ensures that the withdrawal period specified on the labelling of the veterinary medicinal product is observed;deleted
2015/05/07
Committee: AGRI
Amendment 391 #
Proposal for a regulation
Article 114 – paragraph 1 – point e
(e) the veterinarian does not retail any veterinary medicinal product to an owner or keeper of animals treated in the host Member State unless this is permissible under the rules of the host Member State, the medicinal product is intended for animals under his care, and only the minimum quantities of veterinary medicinal product necessary to complete the treatment of those animals are retailed;deleted
2015/05/07
Committee: AGRI
Amendment 392 #
Proposal for a regulation
Article 114 – paragraph 1 – point f
(f) the veterinarian keeps detailed records of the animals treated, their diagnosis, the veterinary medicinal products administered, the dose administered, the duration of treatment and the withdrawal period applied, for inspection by the competent authorities of the host Member State for a period of 3 years.deleted
2015/05/07
Committee: AGRI
Amendment 393 #
Proposal for a regulation
Article 114 – paragraph 2
2. Paragraph 1 shall not apply to immunological veterinary medicinal products which are not authorised for use in the host Member State.deleted
2015/05/07
Committee: AGRI
Amendment 446 #
Proposal for a regulation
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.
2015/05/07
Committee: AGRI
Amendment 447 #
Proposal for a regulation
Article 130 – paragraph 2
2. Member States and the Commission may refer the issue to the Agency in accordance with Article 84.
2015/05/07
Committee: AGRI
Amendment 448 #
Proposal for a regulation
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.
2015/05/07
Committee: AGRI
Amendment 449 #
Proposal for a regulation
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.
2015/05/07
Committee: AGRI
Amendment 450 #
Proposal for a regulation
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:
2015/05/07
Committee: AGRI
Amendment 451 #
Proposal for a regulation
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.
2015/05/07
Committee: AGRI
Amendment 452 #
Proposal for a regulation
Article 135
Penalties imposed by the Commission 1. The Commission may impose financial penalties on the holders of marketing authorisations granted under this Regulation if they fail to observe their obligations in accordance with this Regulation. 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 146 laying down rules concerning the initiation, duration, time-limits and conduct of the imposition of fines or periodic penalty payments to the holders of marketing authorisations granted under this Regulation, the maximum amounts of these penalties as well as the conditions and methods for their collection. 3. 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. 4. The Court of Justice shall have unlimited jurisdiction to review decisions whereby the Commission has imposed financial penalties. It may cancel, reduce or increase the fine or periodic penalty payment imposed.Article 135 deleted
2015/05/07
Committee: AGRI