21 Amendments of Peter JAHR related to 2014/0257(COD)
Amendment 44 #
Proposal for a regulation
Recital 17
Recital 17
(17) However, there may be situations where no suitable authorised veterinary medicinal product is available. In those situations, by way of exception, veterinarians should be allowed to prescribe other medicinal products to the animals under their responsibility in conformity with strict rules and in the interest of animal health or animal welfare only, whereby antimicrobial medicinal products for human use may be employed only subject to the issuing of a prescription by a vet and authorisation by the veterinary authority responsible for monitoring the work of the vet in question. In case of food-producing animals, veterinarians should ensure that an appropriate withdrawal period is prescribed, so that harmful residues of those medicinal products do not enter the food chain.
Amendment 63 #
Proposal for a regulation
Recital 38 a (new)
Recital 38 a (new)
(38a) Prudent use of antimicrobials is a cornerstone in addressing antimicrobial resistance. The Guidelines for prudent use, drafted by the Commission, need to be considered by Member States.
Amendment 80 #
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 professioveterinarian 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 should not affect any professional or ethical duty for dispensing professionals to refuse to dispense the medicine stated in the prescription.
Amendment 119 #
Proposal for a regulation
Recital 17
Recital 17
(17) However, there may be situations where no suitable authorised veterinary medicinal product is available. In those situations, by way of exception, veterinarians should be allowed to prescribe other medicinal products to the animals under their responsibility in conformity with strict rules and in the interest of animal health or animal welfare only; in such cases antimicrobial medicinal products for human use may be employed only subject to the issuing of a prescription by a veterinarian and the granting of authorisation by the veterinary authority responsible for monitoring the work of the veterinarian in question. In case of food-producing animals, veterinarians should ensure that an appropriate withdrawal period is prescribed, so that harmful residues of those medicinal products do not enter the food chain.
Amendment 135 #
Proposal for a regulation
Recital 27
Recital 27
(27) It is recognised that the potential effect of a product on the environment may depend on the volume used and the resulting amount of the pharmaceutical substance that may reach the environment. Therefore, where there is evidence that a constituent of a medicinal product for which a generic application for a marketing authorisation is submitted is a hazard for the environment, it is appropriate to require data on the potential effect on the environment in order to safeguard the environment. In such cases applicants should endeavour to join efforts in generating such data in order to reduce costs and to reduce testing on vertebrate animals. The current impact assessment system results in repetitive and potentially divergent assessments of substances' environmental properties. This can lead to divergent decisions being taken on products with similar effects on the environment, especially in the case of products authorised before the environmental impact assessment was carried out. The establishment of a single centralised assessment of the environmental properties of active substances for veterinary use by means of a monograph system could be a potential alternative. The Commission should therefore submit a report to Parliament and the Council examining the feasibility of monographs and potential alternative options as soon as possible.
Amendment 171 #
Proposal for a regulation
Recital 40
Recital 40
(40) There is still a lack of sufficiently detailed and comparable data at Union level to determine the trends and identify possible risk factors that could lead to the development of measures to limit the risk from antimicrobial resistance and to monitor the effect of measures already introduced. Therefore it is important to collect data on the sales and use of antimicrobials in animals, data on the use of antimicrobials in humans and data on antimicrobial resistant organisms found in animals, humans and food. To ensure that the information collected can be used effectively, appropriate rules should be laid down concerning the collection and the exchange of data. Veterinarians are already required to meet comprehensive documentation requirements in connection with the use of antibiotics. In keeping with the ‘one health’ approach, similar documentation requirements should be introduced in the area of human medicine. The Member States should be responsible for collecting data on the use of antimicrobials under the coordination of the Agency.
Amendment 360 #
Proposal for a regulation
Article 107 – paragraph 2
Article 107 – paragraph 2
2. PersoVeterinarians qualified to prescribe veterinary medicinal products in accordance with applicable national law shall retail antimicrobial products only for animals which are under their care and only after examination and diagnosis or recent animal health visit, and only in the amount required for the treatment concerned.
Amendment 375 #
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 lawof a veterinary medicinal product shall only be issued by a veterinarian for animals which are under their care and only after examination and diagnosis or recent animal health visit.
Amendment 399 #
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. Antimicrobial medicinal products for human use may only be employed, subject to the issuing of a prescription by a veterinarian and approval by the veterinary authority responsible for monitoring the work of the veterinarian in question, if treatment with a medicinal product as referred to in letter (a)(i) or (ii) is not possible; __________________ 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 408 #
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,. Antimicrobial medicinal products for human use may be employed, subject to the issuing of a prescription by a veterinarian and approval by the veterinary authority responsible for monitoring the work of the veterinarian in question, if treatment with a veterinary medicinal product as referred to in letter (a) or (b) is not possible; or
Amendment 426 #
Proposal for a regulation
Article 118 – paragraph 1
Article 118 – paragraph 1
1. Antimicrobial medicinal products shall only be used in accordance with Articles 115 and 116 to treat conditions for which there is no other treatment available, and the proper use of which would not present a risk to public or animal health.
Amendment 479 #
Proposal for a regulation
Article 51 – paragraph 8 a (new)
Article 51 – paragraph 8 a (new)
8a. Within 24 months of the date of entry into force of this regulation, the Commission shall submit a report to the European Parliament and the Council on the desirability and possible details of the creation of an environmental monograph system for the active substance to assess the environmental impact of veterinary medicinal products and potential alternatives, accompanied, if necessary, by a legislative proposal.
Amendment 518 #
Proposal for a regulation
Article 68 – paragraph 1
Article 68 – paragraph 1
1. A hHarmonised summary of product characteristicconditions of use and quality parts shall be prepared in accordance with the procedure laid down in Article 69 for groups of essentially 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 for which national marketing authorisations have been granted in different Member States before 1 January 2004 (‘similar products').
Amendment 534 #
Proposal for a regulation
Article 69 – paragraph 3
Article 69 – paragraph 3
3. Within 120 days of his appointment, the rapporteur shall present 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 characteristicproposing harmonisation of the conditions governing the use of the group of essentially similar veterinary medicinal products and of their quality parts.
Amendment 551 #
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 characteristicsation of conditions of use and of the quality part, each Member State shall vary athe marketing authorisations 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, and the quality part are in conformity with the agreement within 30 days of receipt of the information regarding the agreement from the rapporteur.
Amendment 554 #
Proposal for a regulation
Article 70 – paragraph 1
Article 70 – paragraph 1
1. By way of derogation from Article 69, the Committee may recommend to the Commission groups of similar veterinary medicinal products for which a scientific reassessment is necessary before a harmonised summary of the product characteristics isand quality part are prepared.
Amendment 559 #
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 foshall submit information concerning their products, included ing a gproup of similar products identifiedposal for a harmonisation of the quality part and summaries of the product characteristics shall submit information concerning their productsfor their medicines which belong to the group.
Amendment 819 #
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 or another Member State in accordance with Directive 2001/83/EC of the European Parliament and of the Council30 or Regulation (EC) No 726/2004. Antimicrobial medicinal products for human use may only be employed, subject to the issuing of a prescription by a veterinarian and approval by the veterinary authority responsible for monitoring the work of the veterinarian in question, if treatment with a medicinal product as referred to in point (a)(i) or (ii) is not possible; __________________ 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 829 #
Proposal for a regulation
Article 115 – paragraph 1 a (new)
Article 115 – paragraph 1 a (new)
1a. Homoeopathic veterinary medicinal products may be given to non-food producing animals by way of derogation from paragraph 1.
Amendment 849 #
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, o. Antimicrobial medicinal products for human use may be employed, subject to the issuing of a prescription by a veterinarian and approval by the veterinary authority responsible for monitoring the work of the veterinarian in question, if treatment with a veterinary medicinal product as referred to in point (a) or (b) is not possible. Or
Amendment 864 #
Proposal for a regulation
Article 116 – paragraph 3 a (new)
Article 116 – paragraph 3 a (new)
3a. By way of derogation from paragraphs 1 to 3, homoeopathic veterinary medicinal products may be administered to treat food-producing animals under the responsibility of the veterinarian provided that they exclusively contain active ingredients listed in Table 1 of Regulation (EU) No 37/2010 as substances for which no maximum limit needs to be set.