13 Amendments of Renate SOMMER related to 2014/0257(COD)
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 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 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 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 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 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 865 #
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 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.