46 Amendments of Iratxe GARCÍA PÉREZ related to 2014/0257(COD)
Amendment 157 #
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 are the only professional authorised to prescribe medicinal products to animals, 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 professionalveterinarians should be restricted to the amount required to continue the treatment until the medicinal product prescribed by the veterinarian is obtained by the farmer or by the owner and only for treatment of the animals under their care.
Amendment 253 #
Proposal for a regulation
Article 4 – paragraph 1 – point 24
Article 4 – paragraph 1 – point 24
(24) 'veterinary prescription‘ means any prescription for a veterinary or human medicinal product issued by a professional person qualified to do so veterinarian once a veterinary diagnosis has been established following accordance wi clinical examination of the applicable national lawnimal or in the light of continuous health checks on the animal;
Amendment 258 #
Proposal for a regulation
Article 4 – paragraph 1 – point 27 a (new)
Article 4 – paragraph 1 – point 27 a (new)
(27a) “industrial process" referring to veterinary medicinal products containing autologous or allogeneic cells or tissues include list all process that should be considered as industrial for these specific product.
Amendment 262 #
Proposal for a regulation
Article 4 – paragraph 1 – point 27 b (new)
Article 4 – paragraph 1 – point 27 b (new)
(27b) "Summary product characteristics" is the resume of the product technical characteristics on quality, safety and efficacy for the healthcare professionals.
Amendment 264 #
Proposal for a regulation
Article 4 – paragraph 1 – point 27 c (new)
Article 4 – paragraph 1 – point 27 c (new)
(27c) "Adverse events" is any of the undesirable events described in art. 73 (2).
Amendment 265 #
Proposal for a regulation
Article 4 – paragraph 1 – point 27 d (new)
Article 4 – paragraph 1 – point 27 d (new)
(27d) "Serious adverse events" is an adverse events which results in death, is life-threatening, results in significant disability or incapacity, is a congenital anomaly/birth defect, or which results in permanent or prolonged signs in the animals treated.
Amendment 326 #
Proposal for a regulation
Article 12 – paragraph 1 – point m a (new)
Article 12 – paragraph 1 – point m a (new)
(ma) Qualitative and quantitative composition.
Amendment 343 #
Proposal for a regulation
Article 16 – paragraph 6
Article 16 – paragraph 6
Amendment 362 #
Proposal for a regulation
Article 21 – paragraph 3 a (new)
Article 21 – paragraph 3 a (new)
3a. A requirement to notify the competent authorities of any adverse event relating to the use of the veterinary medicinal product.
Amendment 366 #
Proposal for a regulation
Article 22 – paragraph 1 – point b
Article 22 – paragraph 1 – point b
(b) a requirement to notify the competent authorities of any incidadverse event relating to the use of the veterinary medicinal product;.
Amendment 377 #
Proposal for a regulation
Article 25 – paragraph 1
Article 25 – paragraph 1
The competent authority shall ascertain that the manufacturers of veterinary medicinal products from third countries comply with EU legislation applicable, are able to manufacture the veterinary medicinal product concerned and/or carry out control tests in accordance with the methods described in the documentation submitted in support of the application in accordance with Article 7(1).
Amendment 394 #
Proposal for a regulation
Article 29 – paragraph 3 – point c
Article 29 – paragraph 3 – point c
(c) the summary of the product characteristics of the veterinary medicinal product does not contain any warnings of potential serious side effecadverse events deriving from its correct use;
Amendment 437 #
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 (reared for meat), pigs, chickens, salmons, dogs and cats;.
Amendment 465 #
Proposal for a regulation
Article 46 – paragraph 1
Article 46 – paragraph 1
1. Applications and the dossier for decentralised marketing authorisation shall be submitted to all the Member States. The Member State chosen by the applicant (‘is the ('reference Member State').
Amendment 467 #
Proposal for a regulation
Article 48 – paragraph 1
Article 48 – paragraph 1
1. Applications and the dossier for mutual recognition of marketing authorisations shall be submitted to all the Member States. The Member State that granted the first national marketing authorisation is the (‘"reference Member State'").
Amendment 563 #
Proposal for a regulation
Article 72 – paragraph 1
Article 72 – paragraph 1
1. Marketing authorisation holders shall elaborate and maintain a system for collecting information on the riskadverse events of veterinary medicinal products as regards animal health, public health and the environment enabling them to fulfil their pharmacovigilance responsibilities listed in Articles 73, 76 and 77 (‘pharmacovigilance system').
Amendment 587 #
Proposal for a regulation
Article 73 – paragraph 2 – point f a (new)
Article 73 – paragraph 2 – point f a (new)
(fa) Any suspected transmission via a veterinary medicinal product of any infectious agent.
Amendment 606 #
Proposal for a regulation
Article 76 – paragraph 1
Article 76 – paragraph 1
1. Competent authorities shall record in the pharmacovigilance database and copied to the Marketing authorisation holders all adverse events which were reported to them by healthcare professionals and animal holders and that occurred in the territory of their Member State, within 30 days following the receipt of the adverse event report.
Amendment 608 #
Proposal for a regulation
Article 76 – paragraph 2
Article 76 – paragraph 2
2. Marketing authorisation holders shall record in the pharmacovigilance database all adverse events which were reported to them by healthcnotified electronically all serious adverse events and human events relating to the use of veterinary medicinal products that are pbrofessionals and animal holders and that occurred within the Union or in a third country with regard to their authorised veterinary medicinal products, wiught to his attention or which he can reasonably be expected to have knowledge to the competent authority of the Member State on whose territory the incident occurred and no later than 15 days following receipt of the information. The rest of adverse events relating the use of veterinary medicinal products that are brought to the attention of the Marketing authorization holder or which he can reasonably be expected to have knowledge, should be notified electronically to the pharmacovigilance database no later thian 30 days following the receipt of the adverse event report. information.
Amendment 616 #
Proposal for a regulation
Article 76 – paragraph 4
Article 76 – paragraph 4
Amendment 617 #
Proposal for a regulation
Article 76 – paragraph 5
Article 76 – paragraph 5
Amendment 636 #
Proposal for a regulation
Article 78 – paragraph 1 – point j
Article 78 – paragraph 1 – point j
(j) monitoring theCarrying out a Signal detection of adverse events included in pharmacovigilance system anddatabase to ensuringe that if needed, an appropriate corrective action plan is prepared and implemented; . The Signal detection should be made every six months during the first two years of effective commercialization of the product and afterwards yearly and the analysis and results should be sent to competent authorities.
Amendment 641 #
Proposal for a regulation
Article 79 – paragraph 1
Article 79 – paragraph 1
1. Competent authorities shall evaluate all adverse events reported to them by marketing authorisation holders, healthcare professionals and animal holders, manage risks and take the measures referred to in Articles 130 to 135 concerning marketing authorisations where necessary.
Amendment 646 #
Proposal for a regulation
Article 81 – paragraph 1
Article 81 – paragraph 1
1. Marketing authorisation holders, Competent authorities and the Agency shall cooperate in monitoring the data in the pharmacovigilance database to determine whether there is any change to the benefit-risk balance of veterinary medicinal products with a view to detecting risks to animal health, public health and protection of the environment (‘'signal management process').
Amendment 653 #
Proposal for a regulation
Article 81 – paragraph 5 a (new)
Article 81 – paragraph 5 a (new)
5a. Unless other requirements have been laid down as a condition for the granting of the marketing authorisation or subsequently established by competent authority, reports of all adverse reactions shall be submitted to the competent authorities in the form of a periodic safety report, immediately upon request or at least every six months after authorisation until the placing on the market. Periodic safety updated reports shall also be submitted immediately upon request or at least every six months during the first two years following the initial placing on the market, yearly for the following two years and thereafter at three-yearly intervals. The periodic safety updated reports shall include a scientific evaluation of the risk- benefit balance of the veterinary medicinal product.
Amendment 695 #
Proposal for a regulation
Article 107 – paragraph 2
Article 107 – paragraph 2
2. Persons qualified to prescribeVeterinarians shall supply veterinary medicinal products in acconly ford ance with applicable national law shall retail antimicrobial products only for animals which are under their careimals which are under their care subject to a veterinary diagnosis based on clinical examination of the animal concerned or, exceptionally, permanent monitoring of its health, and only in the amount required forto continue the treatment concerneduntil the medicinal product prescribed by the veterinarian is obtained by the farmer or by the owner.
Amendment 765 #
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. The maximum quantity of veterinary medicinal products supplied at one time may not, however, exceed one month's treatment. For chronic diseases and for periodic treatments the maximum quantity should not exceed three month's treatment.
Amendment 805 #
Proposal for a regulation
Article 115 – paragraph 1 – introductory part
Article 115 – paragraph 1 – introductory part
1. By way of derogation from Article 111, whereMember States shall take the necessary measures to ensure that, if there is no authorised veterinary medicinal product in a Member State for a condition affecting a non-food producing animalspecies, by way of exception, the veterinarian responsible may, under his/her direct personal responsibility and in particular to avoid causing unacceptable suffering, exceptionally treat the animal concerned with the following:
Amendment 810 #
Proposal for a regulation
Article 115 – paragraph 1 – point a – introductory part
Article 115 – paragraph 1 – point a – introductory part
(a) a veterinary medicinal product: authorised in the Member State concerned under this Regulation for use with another animal species, or for another condition in the same species; or
Amendment 812 #
Proposal for a regulation
Article 115 – paragraph 1 – point a – point i
Article 115 – paragraph 1 – point a – point i
Amendment 814 #
Proposal for a regulation
Article 115 – paragraph 1 – point a – point ii
Article 115 – paragraph 1 – point a – point ii
Amendment 817 #
Proposal for a regulation
Article 115 – paragraph 1 – point a – point iii
Article 115 – paragraph 1 – point a – point iii
Amendment 824 #
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 legislation.either:
Amendment 826 #
Proposal for a regulation
Article 115 – paragraph 1 – point b – point i (new)
Article 115 – paragraph 1 – point b – point i (new)
(i) a medicinal product authorised for human use in the Member State concerned in accordance with Directive 2001/83/EC of the European Parliament and of the Council or under Regulation (EC) No 726/2004, or
Amendment 827 #
Proposal for a regulation
Article 115 – paragraph 1 – point b – point ii (new)
Article 115 – paragraph 1 – point b – point ii (new)
(ii) in accordance with specific national measures, a veterinary medicinal product authorised in another Member State in accordance with this Regulation for use in the same species or in another species for the condition in question or for another condition; or
Amendment 828 #
Proposal for a regulation
Article 115 – paragraph 1 – point b a (new)
Article 115 – paragraph 1 – point b a (new)
(c) if there is no product as referred to in subparagraph (b), and within the limits of the law of the Member State concerned, a veterinary medicinal product prepared extemporaneously by a person authorised to do so under national legislation in accordance with the terms of a veterinary prescription. The veterinarian may administer the medicinal product personally or allow another person to do so under the veterinarian's responsibility.
Amendment 831 #
Proposal for a regulation
Article 116 – paragraph 1 – introductory part
Article 116 – paragraph 1 – introductory part
1. By way of derogation from Article 111, where1. Member States shall take the necessary measures to ensure that, if there is no authorised veterinary medicinal product in a Member State for a condition affecting a food-producing animal of a non-aquatic speciesspecies, by way of exception, the veterinarian responsible may, under his direct personal responsibility and in particular to avoid causing unacceptable suffering, exceptionally treat the animals concerned with any of the followingon a particular holding with:
Amendment 837 #
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 under this Regulation for use with another food-producing animal species, or for another condition in the same species; or
Amendment 840 #
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 Stateif there is no product as referred to in point (a), either: (i) a medicinal product for human use authorised in the Member State concerned in accordance with Directive 2001/83/EC or under Regulation (EC) No 726/2004, or (ii) a veterinary medicinal product authorised in another Member State in accordance with this Regulation for use in the same species or in another food- producing species for the same condition in question or for another condition; or
Amendment 846 #
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 accordance with Directive 2001/83/EC or under Regulation (EC) No 726/2004, orif there is no product as referred to in subparagraph (b), and within the limits of the law of the Member State concerned, a veterinary medicinal product prepared extemporaneously by a person authorised to do so under national legislation in accordance with the terms of a veterinary prescription. The veterinarian may administer the medicinal product personally or allow another person to do so under the veterinarian's responsibility.
Amendment 851 #
Proposal for a regulation
Article 116 – paragraph 1 – point d
Article 116 – paragraph 1 – point d
Amendment 860 #
Proposal for a regulation
Article 116 – paragraph 3 – introductory part
Article 116 – paragraph 3 – introductory part
Amendment 861 #
Proposal for a regulation
Article 116 – paragraph 3 – point a
Article 116 – paragraph 3 – point a
Amendment 862 #
Proposal for a regulation
Article 116 – paragraph 3 – point b
Article 116 – paragraph 3 – point b
Amendment 867 #
Proposal for a regulation
Article 116 – paragraph 4
Article 116 – paragraph 4
Amendment 870 #
Proposal for a regulation
Article 116 – paragraph 5
Article 116 – paragraph 5
5. For the purpose of treatment in accordance with paragraphs 1 to 3, the veterinarian may administer the medicinal product personally or allow another person to do so under the veterinarian's responsibility.