48 Amendments of Mireille D'ORNANO related to 2014/0257(COD)
Amendment 112 #
Proposal for a regulation
Recital 8
Recital 8
(8) With a view to harmonising the internal market for veterinary medicinal products in the Union and improving their free movement, rules should be established concerning the procedures for authorisation of such products that ensure the same conditions for all applications and a transparent framework for all interested parties.
Amendment 115 #
Proposal for a regulation
Recital 10
Recital 10
(10) The national procedure for authorising veterinary medicinal products should be maintained because of varying needs in different geographical areas of the Union as well as the business models of small and medium sized enterprises (SMEs). It should be ensured that marketing authorisations granted in one Member State arcan easily be recognised in other Member States, while safeguarding the decision- making independence of each Member State.
Amendment 125 #
Proposal for a regulation
Recital 19
Recital 19
(19) Taking into account the need for simple rules on changes to the marketing authorisations of veterinary medicinal products, only changes that may affect animal health, public health or the environment should require a scientific assessment. In any case, such changes may only apply to use within the same species.
Amendment 129 #
Proposal for a regulation
Recital 23
Recital 23
(23) Companies have less interest in developing veterinary medicinal products for markets of a limited size, which are subject to the same regulatory constraints as those of larger markets. In order to promote the availability of veterinary medicinal products within the Union for those marketspecies affected by therapeutic gaps, in some cases it should be possible to grant marketing authorisations without a complete application dossier having been submitted, on the basis of a benefit-risk assessment of the situation and, where necessary, subject to specific obligations. In particular, this should be possible in the case of veterinary medicinal products for use in minor species or for the treatment or prevention of non-contagious diseases that occur infrequently or in limited geographical areas. These provisions shall not apply to antimicrobials. Member States must remain able to ban the use of medicinal products authorised in accordance with such procedures.
Amendment 158 #
Proposal for a regulation
Recital 38
Recital 38
(38) If an antimicrobial is administered and used incorrectly, this presents a risk to public or animal health. Therefore antimicrobial veterinary medicinal products should only be available on veterinary prescription. Persons having the right to prescribeVeterinarians have a key role in ensuring prudent use of antimicrobials and consequently they should not be influenced, directly or indirectly, by economic incentives when prescribing those products. Therefore the supply of veterinary antimicrobials by those health professionals should be restricted to the amount required for treatment of the animals under their care, after examination of sick animals and those likely to have been contaminated.
Amendment 166 #
Proposal for a regulation
Recital 38 a (new)
Recital 38 a (new)
(38a) One of the main reasons for human and animal resistance to antibiotics is the use of broad-spectrum antibiotics owing to uncertainty about which bacterial strain to treat. Veterinarians should be encouraged to use rapid, on-the-spot diagnostic tests to determine precisely which microbial agent is responsible for the infection and its sensitivity to different antibiotics.
Amendment 167 #
Proposal for a regulation
Recital 39
Recital 39
(39) It is important to consider the international dimension of the development of antimicrobial resistance when assessing the benefit-risk balance of certain veterinary antimicrobials in the Union. Any measure restricting the use of those products may affect the trade of products of animal origin or the competitiveness of certain animal production sectors in the Union. Moreover, antimicrobial resistant organisms can spread to humans and animals in the Union through consumption of products of animal origin imported from third countries, from direct contact with animals or humans in third countries or by other means. Therefore, measures restricting the use of veterinary antimicrobials in the Union should be based on scientific advice and should be considered in the context of cooperation with third countries and international organisations addressingas public health should take precedence over any economic consideration, the restrictions applied in the European Union must also be applied in the same way to imported products. For the same reasons, and in order to support its antimicrobial resistance in order the ensure consistency with their activities and policiesal production sectors, the Union must take the necessary measures to promote local consumption and self-sufficiency in the internal market.
Amendment 181 #
Proposal for a regulation
Recital 53
Recital 53
(53) The quality of veterinary medicinal products manufactured within the Union should be guaranteed by requiring compliance with the principles of good manufacturing practice for medicinal products irrespective of the final destination of the medicinal products. The same requirements must apply to veterinary medicinal products manufactured in third countries and imported into the Union.
Amendment 187 #
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 be allowed to sell prescription and non-prescription veterinary medicinal products via the Internet to buyers in other Member States, after the destination Member State has obtained a licence.
Amendment 294 #
Proposal for a regulation
Article 8 – paragraph 2 – introductory part
Article 8 – paragraph 2 – introductory part
2. Approvals of clinical trials shall be granted on condition that food-producing animals used in the clinical trials or their produce do not enter the human food chain unless:.
Amendment 295 #
Proposal for a regulation
Article 8 – paragraph 2 – point a
Article 8 – paragraph 2 – point a
Amendment 296 #
Proposal for a regulation
Article 8 – paragraph 2 – point b
Article 8 – paragraph 2 – point b
Amendment 303 #
Proposal for a regulation
Article 9 – paragraph 1 – point e
Article 9 – paragraph 1 – point e
(e) the target species and the time required for elimination from the food chain for food-producing animals, for each species;
Amendment 305 #
Proposal for a regulation
Article 9 – paragraph 1 – point g a (new)
Article 9 – paragraph 1 – point g a (new)
(ga) whether it can be used in organic farming, and the necessary precautions, where applicable;
Amendment 323 #
Proposal for a regulation
Article 12 – paragraph 1 – point d
Article 12 – paragraph 1 – point d
(d) the target species, the dosage for each species, the method and route of administration and advice on correct administration, if necessary; whether it can be used for organically- farmed animals;
Amendment 325 #
Proposal for a regulation
Article 12 – paragraph 1 – point m
Article 12 – paragraph 1 – point m
Amendment 354 #
Proposal for a regulation
Article 21 – paragraph 1 – point a
Article 21 – paragraph 1 – point a
(a) the benefit of the immediate availability on the market of the veterinary medicinal product to the animal or public health outweighs the risk inherent in the fact that certain documentinformation has not been provided;
Amendment 355 #
Proposal for a regulation
Article 21 – paragraph 1 – point b
Article 21 – paragraph 1 – point b
(b) the applicant provides the evidence that the veterinary medicinal product is intended for a limited market, detailing his sales prospects, in units, over the first five years of sale and the development costs.
Amendment 359 #
Proposal for a regulation
Article 21 – paragraph 2 a (new)
Article 21 – paragraph 2 a (new)
2a. Member States may ban the use of veterinary medicinal products for limited markets.
Amendment 365 #
Proposal for a regulation
Article 22 – paragraph 1 – point a
Article 22 – paragraph 1 – point a
(a) a requirement to introduce conditions or restrictions, in particular concerning to ensure the safety of the veterinary medicinal product and that it is only prescribed and supplied by veterinarians;
Amendment 472 #
Proposal for a regulation
Article 49 – paragraph 1
Article 49 – paragraph 1
1. If a Member State raises, within the time period referred to in Article 46(4) or Article 48(5) its objections to the assessment report, proposed summary of product characteristics or proposed labelling and package leaflet, a detailed statement of the reasons shall be provided to the reference Member State, the other Member States and the applicant. The points of disagreement shall be referrnotified without delay to the coordination group for mutual recognition and decentralised procedures set up by Article 142(‘the coordination group’) by the reference Member State.
Amendment 474 #
Proposal for a regulation
Article 49 – paragraph 4
Article 49 – paragraph 4
4. In the event of an opinion in favour of granting a marketing authorisation, the reference Member State shall record the agreement of Member States, close the procedure and inform Member States and the applicant accordingly. The Member State which raised the objection may maintain a prohibition and ask the applicant to submit a national application.
Amendment 500 #
Proposal for a regulation
Article 58 – paragraph 2
Article 58 – paragraph 2
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). Such acts shall remain subject to the opinion of the Member States, in line with Regulation 182/2011.
Amendment 581 #
Proposal for a regulation
Article 73 – paragraph 2 – point c
Article 73 – paragraph 2 – point c
(c) any environmental incidents observed following administration of a veterinary medicinal product to an animal, in particular, any contamination from effluent or contamination of water by veterinary medicinal products shall be considered an adverse effect and be measured by the relevant local authorities;
Amendment 601 #
Proposal for a regulation
Article 75 – paragraph 2 a (new)
Article 75 – paragraph 2 a (new)
2a. Veterinarians shall have dedicated access to the database, enabling them to investigate the observed effects in a detailed manner. The database shall include a warning system for veterinarians, whose representatives shall be regularly consulted in order to improve the system.
Amendment 633 #
Proposal for a regulation
Article 78 – paragraph 1 – point b
Article 78 – paragraph 1 – point b
(b) allocating a reference numbers to the pharmacovigilance system master file and communicating the reference number of the pharmacovigilance master file of each product to the product database;
Amendment 656 #
Proposal for a regulation
Article 82 – paragraph 1
Article 82 – paragraph 1
1. Before the expiry of the period of validity of 3Each years, marketing authorisations for a limited market granted in accordance with Article 21 shall be re- examined on application from the marketing authorisation holder. To this end, the holder of marketing authorisation for a limited market shall provide their sales figures for the authorised medicinal product, broken down by Member State and by species, and the outlook for the five years to come. After the initialthird re-examination, it shall be re- examined every 5three years.
Amendment 658 #
Proposal for a regulation
Article 82 – paragraph 2
Article 82 – paragraph 2
2. The application for a re-examination shall be submitted to the competent authority that granted the authorisation or to the Agency at least 6 months before the expiry of the limited market marketing authorisation and; it shall demonstrate that the veterinary medicinal product remains for use in a limited market and that the marketing authorisation holder complies, if applicable, with the conditions referred to in Article 21(1). If the sales achieved exceed the predicted sales by over 10 %, the authorisation holder shall have 24 months in which to submit an application for authorisation in accordance with the non-exceptional procedure. After the assessment of the application for authorisation has been carried out, the exceptional authorisation shall be null and void. During the assessment of the exceptional procedure, the annual controls shall be implemented.
Amendment 662 #
Proposal for a regulation
Article 84 – paragraph 1
Article 84 – paragraph 1
1. Where the interests of the Union or national interests are involved, and in particular the interests of public or animal health or of the environment related to the quality, safety or efficacy of veterinary medicinal products or the free movement of products within the Union, any Member State or the Commission may refer its concern to the Agency for the application of the procedure laid down in Article 85. The matter of concern shall be clearly identified.
Amendment 698 #
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 lawVeterinarians shall retail antimicrobial products only for animals which are under their care, and only in the amount required for the treatment concerned.
Amendment 719 #
Proposal for a regulation
Article 108 – paragraph 1
Article 108 – paragraph 1
1. Persons permitted to supply veterinary medicinal products in accordance with Article 107(1) may offer veterinary medicinal products without a prescription, exclusively for animals kept as pets, by means of information society services in the meaning of Directive 98/34/EC of the European Parliament and of the Council28 to natural or legal persons established in the Union under the condition that those medicinal products comply with the legislation of the destination Member State. __________________ 28 Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (OJ L 204, 21.7.1998, p. 37).
Amendment 720 #
Proposal for a regulation
Article 108 – paragraph 2 – point b
Article 108 – paragraph 2 – point b
(b) a hyperlink to the website of the Member State of establishment set up in accordance with paragraph 5; in all EU languages
Amendment 721 #
Proposal for a regulation
Article 108 – paragraph 5 – subparagraph 1 – introductory part
Article 108 – paragraph 5 – subparagraph 1 – introductory part
Each Member State shall set up a website regarding sale of veterinary medicinal products at a distance, providing at least the following information, in all EU languages:
Amendment 766 #
Proposal for a regulation
Article 110 – paragraph 3
Article 110 – paragraph 3
3. Where a veterinary medicinal product is supplied on prescription, the quantity prescribed and supplied shall be restricted to the amount required for the treatment or therapy concerned. This quantity shall in particular take account of the strictly necessary duration of treatment.
Amendment 806 #
Proposal for a regulation
Article 115 – paragraph 1 – introductory part
Article 115 – paragraph 1 – introductory part
1. By way of derogation from Article 111, where there is no authorised veterinary medicinal product in a Member State for a condition affecting the life expectancy of a non-food producing animal, the veterinarian responsible may, under his/her direct personal responsibility and in particular to avoid causing unacceptable sufferingin the interest of animal health and welfare, exceptionally treat the animal concerned with the following:
Amendment 815 #
Proposal for a regulation
Article 115 – paragraph 1 – point a – point ii
Article 115 – paragraph 1 – point a – point ii
(ii) in the absence thereof, a veterinary medicinal product authorised under this Regulation in another Member State for use in the same species for another condition or, non-cumulatively, in another species, for the same condition or for another condition, after securing in writing the agreement of the owner of the animal and providing full information on the fact that the medicinal product used is not authorised;
Amendment 820 #
Proposal for a regulation
Article 115 – paragraph 1 – point a – point iii
Article 115 – paragraph 1 – point a – point iii
(iii) a medicinal product for human use authorised in the Member State concerned in accordance with Directive 2001/83/EC of the European Parliament and of the Council30 or Regulation (EC) No 726/2004, with the exception of antimicrobials; __________________ 30 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
Amendment 825 #
Proposal for a regulation
Article 115 – paragraph 1 – point b
Article 115 – paragraph 1 – point b
(b) if there is no product as referred to in point (a), a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription by a person authorised to do so under national legislatioissued by a veterinarian.
Amendment 830 #
Proposal for a regulation
Article 115 – paragraph 2
Article 115 – paragraph 2
2. The veterinarian may administer the medicinal product personally or allow another person to do so under the veterinarian's responsibilityhis responsibility as a prescriber.
Amendment 832 #
Proposal for a regulation
Article 116 – paragraph 1 – introductory part
Article 116 – paragraph 1 – introductory part
1. By way of derogation from Article 111, where there is no authorised veterinary medicinal product in a Member State for a condition affecting a food-producing animal of a non-aquatic species, the veterinarian responsible may, under his direct personal responsibility and in particular to avoid causing unacceptable suffering and on condition that any subsequent use of products from the animal in the food chain is definitively precluded, exceptionally treat the animal concerned with any of the following, which are indicated in order of desirability:
Amendment 839 #
Proposal for a regulation
Article 116 – paragraph 1 – point a
Article 116 – paragraph 1 – point a
(a) a veterinary medicinal product authorised under this Regulation in the Member State concerned for use with another food-producing animal species, or for another condition in the same species;
Amendment 842 #
Proposal for a regulation
Article 116 – paragraph 1 – point b
Article 116 – paragraph 1 – point b
(b) a veterinary medicinal product authorised under this Regulation in another Member State for use in the same species or in another food-producing species for the same condition or for anotherfor the same condition;
Amendment 848 #
Proposal for a regulation
Article 116 – paragraph 1 – point c
Article 116 – paragraph 1 – point c
(c) a medicinal product for human use authorised in the Member State concerned in accford ance with Directive 2001/83/EC or under Regulation (EC) No 726/2004, orother food- producing species for the same condition;
Amendment 853 #
Proposal for a regulation
Article 116 – paragraph 1 – point d
Article 116 – paragraph 1 – point d
d) if there is no product as referred to in point (a), a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription by a person authorised to do so under national legislation., all of whose active ingredients are authorised in a Member State for a food-producing species;
Amendment 855 #
Proposal for a regulation
Article 116 – paragraph 1 – point d a (new)
Article 116 – paragraph 1 – point d a (new)
(da) in the case of milk-producing animals, the medicinal product referred to in paragraphs (a) to (d) must without fail be authorised for another milk-producing species;
Amendment 872 #
Proposal for a regulation
Article 117 – paragraph 1 – point b – point ii
Article 117 – paragraph 1 – point b – point ii
(ii) if the product is not authorised for any milk producing species, 7 daythe length of time necessary for the total elimination of the risk of contamination of the milk by the product and its metabolites;
Amendment 873 #
Proposal for a regulation
Article 117 – paragraph 2
Article 117 – paragraph 2
2. The Commission shall be empowered to adopt delegated acts in accordance with Article 146 in order to amendpropose to Parliament and the Council amendments to the rules laid down in paragraph 1 in the light of new scientific evidence.
Amendment 896 #
Proposal for a regulation
Article 124 – paragraph 2
Article 124 – paragraph 2
2. The prohibition laid down in paragraph 1 shall not apply to advertising to persons permitted to prescribe or supply veterinary medicinal products if such supply is performed under the authority of a veterinarian.