Activities of Angélique DELAHAYE related to 2014/0257(COD)
Plenary speeches (1)
Veterinary medicinal products (A8-0046/2016 - Françoise Grossetête) FR
Amendments (48)
Amendment 71 #
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 - where appropriate, veterinarians - who are 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 be allowed to sell prescription and non- prescription veterinary medicinal products via the Internet to buyers in other Member States.
Amendment 72 #
Proposal for a regulation
Recital 56 a (new)
Recital 56 a (new)
(56a) Any ban on veterinarians supplying medicines could make it impossible for some Member States to maintain a network of veterinarians covering all of their territory. Such territorial coverage is of key importance in ensuring high- quality epidemiological monitoring of existing and emerging diseases.
Amendment 73 #
Proposal for a regulation
Recital 56 b (new)
Recital 56 b (new)
(56b) Decoupling prescription from supply does not lower the consumption of antibiotics. This is borne out by the fact that the Member States in which antibiotics consumption is highest have already decoupled prescription from supply, while the Member States that have reduced consumption the most are those in which the two are still coupled.
Amendment 109 #
Proposal for a regulation
Article 4 – paragraph 1 – point 20 – point b
Article 4 – paragraph 1 – point 20 – point b
(b) veterinary medicinal products for animal species other than cattle, sheep, pigs, chickens, dogs and cats;
Amendment 112 #
Proposal for a regulation
Article 4 – paragraph 1 – point 20 – point b a (new)
Article 4 – paragraph 1 – point 20 – point b a (new)
(ba) veterinary medicinal products for animal species the national population of which is not large enough for research and development costs to be amortised during the data protection period specified in Article 34.
Amendment 166 #
Proposal for a regulation
Article 21 – paragraph 2
Article 21 – paragraph 2
2. By way of derogation from Article 5(2), a marketing authorisation for a limited market shall be granted for a period of 3 years. At the end of that period, the holder may request, in the light of scientific data and on grounds of pharmacovigilance and efficiency, that this authorisation be converted into an open-ended authorisation.
Amendment 188 #
Proposal for a regulation
Article 32
Article 32
Amendment 209 #
Proposal for a regulation
Article 34 – paragraph 1 – point a
Article 34 – paragraph 1 – point a
(a) 10 years for the veterinary medicinal products for cattle, sheep, pigs, chickens, dogs and cats;
Amendment 214 #
Proposal for a regulation
Article 34 – paragraph 1 – point b
Article 34 – paragraph 1 – point b
(b) 14 years for antimicrobial veterinary medicinal products for cattle, sheep, pigs, chickens, dogs and cats containing an antimicrobial active substance which has not been an active substance in a veterinary medicinal product authorised within the Union on the date of the submission of the application;
Amendment 226 #
Proposal for a regulation
Article 35 – paragraph 1
Article 35 – paragraph 1
1. Where a variation is approved in accordance with Article 65 extending the marketing authorisation to another species listed in Article 34(1)(a), the period of the protection provided for in that Article shall be prolonged by 1two years for each additional target species, provided that the variation has been submitted at least 3 years before the expiration of the protection period laid down in Article 34(1)(a).
Amendment 248 #
Proposal for a regulation
Article 4 – paragraph 1 – point 20 – point b a (new)
Article 4 – paragraph 1 – point 20 – point b a (new)
(ba) veterinary medicinal products for animal species the national population of which is not large enough for research and development costs to be amortised during the data protection period specified in Article 34.
Amendment 357 #
Proposal for a regulation
Article 107 – paragraph 1
Article 107 – paragraph 1
1. The retail of veterinary medicinal products shall be conducted only by persons who are permitted to carry out such operations under national law, veterinarians where appropriate.
Amendment 358 #
Proposal for a regulation
Article 21 – paragraph 2
Article 21 – paragraph 2
2. By way of derogation from Article 5(2), a marketing authorisation for a limited market shall be granted for a period of 3 years. At the end of that period, the holder may request, in the light of scientific data and on grounds of pharmacovigilance and efficiency, that this authorisation be converted into an open-ended authorisation.
Amendment 361 #
Proposal for a regulation
Article 107 – paragraph 2
Article 107 – paragraph 2
2. Persons qualified to prescribe veterinary medicinal products in accordance with applicable national law, veterinarians where appropriate, shall retail antimicrobial products only for animals which are under their caresupervision and after diagnosis by a veterinarian, and only in the amount required for the treatment concerned.
Amendment 369 #
Proposal for a regulation
Article 22 – paragraph 1 – point c
Article 22 – paragraph 1 – point c
(c) a requirement to conduct post- authorisation studiessupply post- authorisation data based on post- authorisation studies identified as necessary on the basis of changes in the benefit-risk balance and on data gathered from the product’s use in the field.
Amendment 378 #
Proposal for a regulation
Article 110 – paragraph 2
Article 110 – paragraph 2
2. A veterinary prescription shall only be issued by a person qualified to do so in accordance with applicable national law, a veterinarian where appropriate and only after a veterinary diagnosis. These persons shall, by reason of their initial and continuing training, have the skills necessary to prescribe and issue veterinary medicinal products for all the species they treat.
Amendment 438 #
Proposal for a regulation
Article 34 – paragraph 1 – point a
Article 34 – paragraph 1 – point a
(a) 10 years for the veterinary medicinal products for cattle, sheep, pigs, chickens, dogs and cats;
Amendment 439 #
Proposal for a regulation
Article 125 – paragraph 1 a (new)
Article 125 – paragraph 1 a (new)
1a. To combat fraud, the competent authorities shall establish a plan for spot checks on veterinary practices and herds to verify that medicinal products held comply with quality standards.
Amendment 440 #
Proposal for a regulation
Article 34 – paragraph 1 – point b
Article 34 – paragraph 1 – point b
(b) 14 years for antimicrobial veterinary medicinal products for cattle, sheep, pigs, chickens, dogs and cats containing an antimicrobial active substance which has not been an active substance in a veterinary medicinal product authorised within the Union on the date of the submission of the application;
Amendment 448 #
Proposal for a regulation
Article 35 – paragraph 1
Article 35 – paragraph 1
1. Where a variation is approved in accordance with Article 65 extending the marketing authorisation to another species listed in Article 34(1)(a), the period of the protection provided for in that Article shall be prolonged by 1two years for each additional target species, provided that the variation has been submitted at least 34 years before the expiration of the protection period laid down in Article 341(1)(a).
Amendment 519 #
Proposal for a regulation
Article 68 – paragraph 1
Article 68 – paragraph 1
1. A harmonised summary of product characteristics shall be prepared in accordance with the procedure laid down in Article 69 for groups of similar veterinary medicinal products, other than homeopathic veterinary medicinal products, which have the same qualitative and quantitative composition of their active substances and the same pharmaceutical form and have been shown to be bio-equivalents, for which national marketing authorisations have been granted in different Member States before 1 January 2004the entry into force of this new Regulation and for which summaries of product characteristics approved at national level demonstrate a proven difference (‘similar products’).
Amendment 521 #
Proposal for a regulation
Article 68 – paragraph 2 a (new)
Article 68 – paragraph 2 a (new)
2a. Marketing authorisation holders may, pursuant to Article 69, request a harmonisation of the various national marketing authorisations granted for the same veterinary medicinal product.
Amendment 522 #
Proposal for a regulation
Article 68 – paragraph 2 b (new)
Article 68 – paragraph 2 b (new)
2b. A single set of quality data and a harmonised summary of product characteristics shall be prepared for veterinary medicinal products, other than homeopathic veterinary medicinal products, which have the same qualitative and quantitative composition of their active substances and the same pharmaceutical form and marketing authorisation holder, and for which national marketing authorisations have been granted in different Member States (‘same products’). The coordination group shall establish procedural rules for the harmonisation of ‘same products’.
Amendment 523 #
Proposal for a regulation
Article 68 – paragraph 2 c (new)
Article 68 – paragraph 2 c (new)
2c. National marketing authorisations may be harmonised with decentralised marketing authorisations and/or mutual recognition marketing authorisations if they are for the same product.
Amendment 535 #
Proposal for a regulation
Article 69 – paragraph 3
Article 69 – paragraph 3
3. Within 120 days of his appointment, the rapporteur shall present to the coordination group a report regarding possible harmonisation of summaries of product characteristics for the similar veterinary medicinal products in the group and propose a harmonised summary of products characteristicwith a proposal for harmonisation of the conditions for use of the group of essentially similar veterinary medicinal products or for marketing authorisation for same veterinary medicinal products.
Amendment 538 #
Proposal for a regulation
Article 69 – paragraph 4 – introductory part
Article 69 – paragraph 4 – introductory part
4. Harmonised summaries of product characteristics for veterinary medicinal productsconditions of use shall contain all oft least the following information:
Amendment 540 #
Proposal for a regulation
Article 69 – paragraph 4 – point a
Article 69 – paragraph 4 – point a
(a) all species mentioned in the marketing authorisations granted by Member States in respect of the essentially similar products in the group;
Amendment 543 #
Proposal for a regulation
Article 69 – paragraph 4 – point b
Article 69 – paragraph 4 – point b
(b) all therapeutic indications and dosages mentioned in the marketing authorisations granted by Member States in respect of the essentially similar products in the group, except for indications regarding the prophylactic use of antimicrobials;
Amendment 545 #
Proposal for a regulation
Article 69 – paragraph 4 – point c
Article 69 – paragraph 4 – point c
(c) the shortesta withdrawal period of those stated in the summaries of the product characteristicswhich ensures that consumers are adequately protected.
Amendment 552 #
Proposal for a regulation
Article 69 – paragraph 6
Article 69 – paragraph 6
6. In the event of an opinion in favour of adopting a harmonised summary of the product characteation of conditions of use or of a harmonisation of a marketing authorisaticson, each Member State shall vary athe marketing authorisation in conformity with the agreement within 30 days of receipt of the information regarding the agreement from the rapporteurs of the products in their territory so that the elements listed in paragraph 4, where they are already included in the summaries of characteristics for a product belonging to that group, are in conformity with the agreement within 30 days of receipt of the information regarding the agreement from the rapporteur. Those marketing authorisations shall now be considered as mutually recognised marketing authorisations granted by virtue of this Regulation.
Amendment 560 #
Proposal for a regulation
Article 71 – paragraph 1
Article 71 – paragraph 1
Upon request from the coordination group or the Agency, holders of the marketing authorisations for products included in a group of essentially similar products identified for a harmonisation of the summaries of the product characteristics shall submit information concerning their products, or individual holders of marketing authorisations for the same product identified for harmonisation of marketing authorisations shall submit information concerning their products, including a proposal for the harmonisation of the summaries of the product characteristics for their medicines belonging to that group.
Amendment 659 #
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 refissing key studies have been submitted by the marketing authorisation holder and that no safety issues or absence of effectiveness have been obserrved to in Article 22(1)during field usage.
Amendment 732 #
Proposal for a regulation
Article 109 – title
Article 109 – title
Retail ofnly of medicinal products which are subject to prescription, or active substances, with anabolic, anti-infectious, anti- parasitic, anti-inflammatory, hormonal or psychotropic veterinary medicinal productproperties
Amendment 738 #
Proposal for a regulation
Article 109 – paragraph 1
Article 109 – paragraph 1
1. Only manufacturers, wholesale distributors and retailers authorised specifically to do so in accordance with applicable national law shall be allowed to supply and purchase prescription veterinary medicinal products which have anabolic, anti- infectious, anti-parasitic, anti- inflammatory, hormonal or psychotropic properties or substances which may be used as veterinary medicinal products having those properties.
Amendment 743 #
Proposal for a regulation
Article 109 – paragraph 3 – subparagraph 1 – introductory part
Article 109 – paragraph 3 – subparagraph 1 – introductory part
Those manufacturers and suppliers shall keep detailed records of the following information in respect of each purchase and sale transaction pertaining to prescription veterinary medicinal products:
Amendment 772 #
Proposal for a regulation
Article 110 – paragraph 4
Article 110 – paragraph 4
4. Veterinary prescriptions shall be recognised throughout the Union. The removal of regulatory and administrative barriers to such recognition should not affect any professional or ethical duty for dispensing professionals to refuse to dispense the medicine stated in the prescription. A veterinary medicinal product prescribed shall be supplied in accordance with applicable national law.
Amendment 900 #
Proposal for a regulation
Article 125 – paragraph 1 a (new)
Article 125 – paragraph 1 a (new)
1a. To combat fraud, the competent authorities shall establish a plan for spot checks on veterinary practices and herds to verify that medicinal products held comply with quality standards, in order to combat fraud.
Amendment 906 #
Proposal for a regulation
Article 129 – paragraph 4
Article 129 – paragraph 4
Amendment 907 #
Proposal for a regulation
Article 129 – paragraph 5 – subparagraph 1
Article 129 – paragraph 5 – subparagraph 1
Amendment 908 #
Proposal for a regulation
Article 129 – paragraph 5 – subparagraph 2
Article 129 – paragraph 5 – subparagraph 2
Amendment 909 #
Proposal for a regulation
Article 129 – paragraph 6
Article 129 – paragraph 6
Amendment 910 #
Proposal for a regulation
Article 129 – paragraph 7
Article 129 – paragraph 7
Amendment 911 #
Proposal for a regulation
Article 129 – paragraph 7 – subparagraph 1
Article 129 – paragraph 7 – subparagraph 1
Amendment 912 #
Proposal for a regulation
Article 129 – paragraph 7 – subparagraph 2
Article 129 – paragraph 7 – subparagraph 2
Amendment 913 #
Proposal for a regulation
Article 129 – paragraph 8
Article 129 – paragraph 8
Amendment 914 #
Proposal for a regulation
Article 129 – paragraph 9
Article 129 – paragraph 9
Amendment 915 #
Proposal for a regulation
Article 129 – paragraph 10
Article 129 – paragraph 10
Amendment 916 #
Proposal for a regulation
Article 129 – paragraph 11
Article 129 – paragraph 11