39 Amendments of Norbert LINS 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 64 #
Proposal for a regulation
Recital 38 a (new)
Recital 38 a (new)
(38a) In order to facilitate prudent use, there is an imperative need for rapid, reliable and efficacious veterinary diagnostics both to identify the cause of disease as to perform antibiotic sensitivity testing. This will facilitate correct diagnosis, allow for a targeted use of antibiotics, avoiding the use of critically important antibiotics, and therefore restrain from the development of antibiotic resistance. There is clear need for future innovation specifically for on- site diagnostics, and a need to reflect whether more harmonisation or EU regulation in this sector is needed.
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 156 #
Proposal for a regulation
Recital 37 a (new)
Recital 37 a (new)
(37a) As Antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide there must soon also action be taken in the field of human medicine for example in the form of an instrument incentivising the development of new antibiotics for human use similar to that already proposed within this regulation.
Amendment 164 #
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 207 #
Proposal for a regulation
Article 2 – paragraph 4 – point e a (new)
Article 2 – paragraph 4 – point e a (new)
(ea) substances or preparations which are intended exclusively for external use in animals, to clean or groom them or to alter their appearance or body odour, provided that no substances or preparations subject to veterinary prescription have been added to them.
Amendment 209 #
Proposal for a regulation
Article 2 – paragraph 4 – point e b (new)
Article 2 – paragraph 4 – point e b (new)
(eb) feedingstuffs as defined in Regulation (EU) No 767/2009 of the European Parliament and of the Council.
Amendment 224 #
Proposal for a regulation
Article 4 – paragraph 1 – point 7
Article 4 – paragraph 1 – point 7
(7) ‘homeopathic veterinary medicinal product’ means a veterinary medicinal product prepared from homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias used officially in Member States; a homeopathic veterinary medicinal product may contain a number of active ingredients.
Amendment 229 #
Proposal for a regulation
Article 4 – paragraph 1 – point 7 a (new)
Article 4 – paragraph 1 – point 7 a (new)
(7a) ‘herbal medicinal product’ means any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations;
Amendment 232 #
Proposal for a regulation
Article 4 – paragraph 1 – point 7 b (new)
Article 4 – paragraph 1 – point 7 b (new)
(b) ‘anthroposophic medicinal product’ means a medicinal product which has been developed in accordance with the anthroposophic approach to human life and the natural world, using a homeopathic procedure described by the European Pharmacopeia or, in the absence thereof, by the pharmacopoeias used officially in Member States, or using a special anthroposophic procedure, and which are intended to be used in accordance with anthroposophic principles.
Amendment 252 #
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 medicinal product issued by a veterinarian or another professional person qualified to do so in accordance with applicable national law; ("if adopted, modification needed throughout the whole text")
Amendment 270 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
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 29 – paragraph 3 a (new)
Article 29 – paragraph 3 a (new)
3a. In contrast to paragraph 1, medicinal products for veterinary use shall be without prescription if: (a) they are registered as single homeopathic products and released for sale in pharmacies, have a dilution of not less than D4 (1:10 000) and are not produced using alcohol. (b) they are registered as complex homeopathic products, contain no individual components below a dilution of D4, are released for sale in pharmacies and are not produced using alcohol.
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 461 #
Proposal for a regulation
Article 38 – paragraph 2 – point e
Article 38 – paragraph 2 – point e
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 654 #
Proposal for a regulation
Article 81 a (new)
Article 81 a (new)
Article 81a (a) Marketing authorisations shall be valid for five years. (b) An authorisation may be renewed after five years on the basis of a re- evaluation of the risk-benefit balance. An authorisation holder seeking such renewal shall submit all requisite documentation concerning the quality, safety and effectiveness of the product in question at least six months before expiry of the existing authorisation. (c) Once renewed, the marketing authorisation shall be valid for an unlimited period, unless the competent authority decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal in accordance with subparagraph (b).
Amendment 664 #
Proposal for a regulation
Article 88 – paragraph 1
Article 88 – paragraph 1
1. By way of derogation from Article 5, homeopathic veterinary medicinal products that satisfy the requirements set out in Article 89 and are not immunological homeopathic veterinary medicinal products shall be registered in accordance with Article 90. Veterinary medicinal products registered or approved in accordance with national rules before 31 December 1993 shall not be affected by the provisions of this Article.
Amendment 671 #
Proposal for a regulation
Article 89 – paragraph 1 a (new)
Article 89 – paragraph 1 a (new)
1a. Registration shall not be required in the case of medicinal products placed on the market by a pharmaceutical business in volumes of up to 1 000 packets in a year unless: (a) they contain preparations made from the bodies of animals, including living animals, human or animal body parts, components or metabolites in processed or unprocessed form, or micro-organisms, including viruses, or components or metabolites thereof; (b) they contain more than the one- hundredth part of the minimum dose of a non-homeopathic medicine subject to prescription; (c) any of the following apply: – the medicinal product does not meet recognised pharmaceutical quality standards, – there is reason to suspect that, when used according to the instructions, the medicinal product may have harmful effects to a degree that is medically unacceptable, – the specified withdrawal period is insufficient, – the medicinal product is subject to medical prescription, except in the case of products containing exclusively substances listed in the Annex to Regulation (EU) No 37/2010 as substances for which no maximum limits need to be set, – the medicinal product has not been produced in accordance with a process described in the homeopathic section of the pharmacopoeia, – marketing the medicinal product or using it on animals would be unlawful.
Amendment 711 #
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 not subject to veterinary prescription as referred to in Article 29, in particular no antimicrobials, by means of information society services within 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 776 #
Proposal for a regulation
Article 111 – paragraph 1
Article 111 – paragraph 1
1. Veterinary medicinal products shall be used in accordance with the terms of the marketing authorisation or registration.
Amendment 789 #
Proposal for a regulation
Article 111 – paragraph 2 a (new)
Article 111 – paragraph 2 a (new)
2a. Antibiotic veterinary medicinal products shall not be used for preventive treatment (prophylaxis), unless the risk for infection is very high and the consequences are severe. Prophylactic use has to be applied for individual treatment and has to be carefully scrutinized to ensure that the intended use complies with prudent use principles. Prophylaxis with antimicrobials shall never be applied routinely nor to compensate for poor hygiene or for inadequate husbandry conditions.
Amendment 803 #
Proposal for a regulation
Article 112 a (new)
Article 112 a (new)
Amendment 804 #
Proposal for a regulation
Article 112 b (new)
Article 112 b (new)
Article 112 b Reduction of therapy approaches based on antibacterial substances (1) In order to facilitate the effective reduction regarding the use of pharmaceuticals which contain antibacterial substances, anyone who engages in animal husbandry has to: 1. determine, respectively, two months after the disclosure of the key figures of the in accordance with paragraph 112b established therapy prevalence, if the biannual therapy prevalence concerning his reared animal species, and considering the type-of-use during the elapsed time frame, lies above the average therapy prevalence. 2. take immediate record of the results of the assessment under #1 (2) In a case where the operational, biannual therapy prevalence of the animal husbandman with respect to his business lies above the biannual average, the animal husbandman under consultation of a veterinarian has to assess the reasons that may have led to exceeding the average, and how the treatment of his cattle with pharmaceuticals containing antibacterial substances may be decreased. If the assessment of the animal husbandman comes to the result that a therapy by means of the concerned pharmaceuticals may be reduced, the husbandman has to take all necessary steps in order to accomplish the reduction. The husbandman has to consider the wellbeing of his cattle and guarantee the required medical care. (3) Member States may determine measures extending beyond the above mentioned requirements
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.