63 Amendments of Eleonora EVI related to 2014/0257(COD)
Amendment 107 #
Proposal for a regulation
Citation 5 a (new)
Citation 5 a (new)
– having regard to the European Parliament resolution of 19 May 2015 on safer healthcare in Europe: improving patient safety and fighting antimicrobial resistance (A8-0142/2015 - 2014/2207(INI);
Amendment 109 #
Proposal for a regulation
Recital 5
Recital 5
(5) The provisions of this act aim to reduce administrative burden, enhance the internal market and increase the availability of veterinary medicinal products, while guaranteeing the highest level of public and animal health and environmental protection. In line with the precautionary principle the pharmaceuticals industry should be required to demonstrate that veterinary medicines produced or placed on the market have neither a harmful effect on human or animal health nor an unsustainable environmental impact.
Amendment 118 #
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; however, the administration to animals of off-label antimicrobials authorised solely for human use should be prohibited. 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 126 #
Proposal for a regulation
Recital 20
Recital 20
(20) Directive 2010/63/EU of the European Parliament and of the Council15 lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Clinical trials for veterinary medicinal products are exempted from that Directive. The design and performance of clinical trials, which provide essential information on the safety and efficacy of a veterinary medicinal product, should be such as to provide the most satisfactory results whilst using the minimum number of animals, the procedures should be the least likely todesigned to avoid causeing pain, suffering or distress to animals and should take into account the principles established by Directive 2010/63/EU. __________________ 15 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).
Amendment 137 #
Proposal for a regulation
Recital 29
Recital 29
(29) Differences in the manufacturing process of biological products or a change in the excipient used may lead to differences in the generic product characteristics. In an application for generic biological veterinary medicinal product the bioequivalence should be demonstrated in order to ensure, based on the existing knowledge, that quality, safety and efficacy are similar.
Amendment 143 #
Proposal for a regulation
Recital 33
Recital 33
(33) Antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide. Many of the antimicrobials used in animals are also used in humans. Some of those antimicrobials are critical for preventing or treating life-threatening infections in humans. In order to fight antimicrobial resistance a number of measures should be taken. It needs to be ensured that appropriate warnings and guidance are included on the labels of veterinary antimicrobials. Use not covered by the terms of the marketing authorisation of certain new or critically important antimicrobials for humans should be restricprohibited in the veterinary sector. The rules for advertising of veterinary antimicrobials should be tightenedgeared solely to the provision of scientific information, and the authorisation requirements should sufficiently address the risks and benefits of antimicrobial veterinary medicinal products.
Amendment 152 #
Proposal for a regulation
Recital 36 a (new)
Recital 36 a (new)
(36a) The use of antimicrobial veterinary medicinal products should be reduced by phasing out their use for prophylactic purposes and minimising their metaphylactic use in treating diseased animals and preventing healthy animals in the same group from becoming infected.
Amendment 162 #
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 prescribe 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. Veterinarians should not be allowed to sell antimicrobial veterinary medicinal products, as this could result in conflicts of interest that give rise to over-prescription of such products.
Amendment 186 #
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. In order to minimise the risk to animal and human health, online sales of antimicrobials should be prohibited.
Amendment 195 #
Proposal for a regulation
Recital 61
Recital 61
(61) Advertising, even on non-prescription medicinal products, could affect public and animal health and distort competition. Therefore, advertising of veterinary medicinal products should satisfy certain criteria. Persons qualified to prescribe or supply can properly evaluate the information available in advertising because of their knowledge, training and experience in animal health. The advertising of veterinary medicinal products to persons who cannot properly appreciate the risk associated with their use may lead to medicine misuse or overconsumption which is liable to h arm public or animal health, or the environment. Comparative advertising should be allowed only for non- prescription products, in accordance with the rules laid down by Member States.
Amendment 201 #
Proposal for a regulation
Recital 71
Recital 71
(71) Having regard to the special characteristics of homeopathic veterinary medicinal products, especially the constituents of these products, it is desirable to establish a special, simplified registration procedure and to provide specific provisions for labelling for certain homeopathic veterinary medicinal products which are placed on the market without therapeutic indications. Immunological homeopathic products cannot follow the simplified registration procedure as immunologicals may initiate a response at a high dilution rate. The quality aspect of a homeopathic medicinal product is independent of its use so no specific provisions should apply with regard to the necessary quality requirements and rules.
Amendment 203 #
Proposal for a regulation
Recital 71 a (new)
Recital 71 a (new)
(71a) "The usual rules governing the authorisation to market veterinary medicinal products must be applied to homeopathic veterinary medicinal products marketed with therapeutic indications or in a form which may present risks which must be balanced against the desired therapeutic effect. Member States should be able to apply particular rules for the evaluation of the results of tests and trials intended to establish the safety and efficacy of these medicinal products, provided that they notify them to the Commission."
Amendment 215 #
Proposal for a regulation
Article 4 – paragraph 1 – point 2 – introductory part
Article 4 – paragraph 1 – point 2 – introductory part
(2) ‘sSubstance' means as: Any matter of the following originirrespective of origin which may be:
Amendment 216 #
Proposal for a regulation
Article 4 – paragraph 1 – point 2 – point a
Article 4 – paragraph 1 – point 2 – point a
(a) human, e.g. human blood and human blood products;
Amendment 217 #
Proposal for a regulation
Article 4 – paragraph 1 – point 2 – point b
Article 4 – paragraph 1 – point 2 – point b
(b) animal, e.g. micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products;
Amendment 218 #
Proposal for a regulation
Article 4 – paragraph 1 – point 2 – point c
Article 4 – paragraph 1 – point 2 – point c
(c) vegetable, e.g. micro-organisms, plants, parts of plants, vegetable secretions, extracts;
Amendment 221 #
Proposal for a regulation
Article 4 – paragraph 1 – point 2 – point d
Article 4 – paragraph 1 – point 2 – point d
(d) chemical;, e.g. elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis
Amendment 227 #
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 also contain a number of principles.
Amendment 228 #
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;
Amendment 230 #
Proposal for a regulation
Article 4 – paragraph 1 – point 7 a (new)
Article 4 – paragraph 1 – point 7 a (new)
(7a) Herbal medicinal products are medicinal products containing as the sole active pharmaceutical ingredient one or more vegetable substances or one or more vegetable preparations or one or more such vegetable substances in combination with one or more such vegetable preparations.
Amendment 237 #
Proposal for a regulation
Article 4 – paragraph 1 – point 9
Article 4 – paragraph 1 – point 9
(9) ‘clinical trial' means a study which aims to examine under field conditions the safety or efficacy of a veterinary medicinal product or both under normal conditions of animal husbandry or as part of normal veterinary practice for the purpose of obtaining a marketing authorisation or a change thereof;
Amendment 240 #
Proposal for a regulation
Article 4 – paragraph 1 – point 10
Article 4 – paragraph 1 – point 10
(10) 'pre-clinical study' means a study not covered by the definition of clinical trial which aims to investigate the safety or efficacy of a veterinary medicinal product for the purpose of obtaining a marketing authorisation or a change thereof;
Amendment 304 #
Proposal for a regulation
Article 9 – paragraph 1 – point g a (new)
Article 9 – paragraph 1 – point g a (new)
(ga) details of take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and precautions regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products;
Amendment 312 #
Proposal for a regulation
Article 10 – paragraph 1 – point f
Article 10 – paragraph 1 – point f
(f) requirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and, if appropriate, additional precautions as regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products;
Amendment 318 #
Proposal for a regulation
Article 11 – paragraph 1 – point b
Article 11 – paragraph 1 – point b
Amendment 320 #
Proposal for a regulation
Article 11 – paragraph 1 – point d
Article 11 – paragraph 1 – point d
(d) the expiry date, in the format: ‘mm/yyyy', preceded by the abbreviation ‘Exp.'"for use by"; .
Amendment 321 #
Proposal for a regulation
Article 11 – paragraph 1 – point d a (new)
Article 11 – paragraph 1 – point d a (new)
(da) (e) route of administration
Amendment 324 #
Proposal for a regulation
Article 12 – paragraph 1 – point j
Article 12 – paragraph 1 – point j
(j) requirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and, if appropriate, additional precautions regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products;
Amendment 329 #
Proposal for a regulation
Article 13 – paragraph 1 – point a
Article 13 – paragraph 1 – point a
(a) the scientific name of the stock or stocks followed by the degree of dilution, using the symbols of the European Pharmacopoeia or, in the absence thereof, of the pharmacopoeias currently used officially in Member States; If the homeopathic veterinary medicinal product is composed of more than one stock, the scientific names of the stocks can be supplemented by a brand name in the labelling;
Amendment 331 #
Proposal for a regulation
Article 13 – paragraph 1 – point d
Article 13 – paragraph 1 – point d
Amendment 334 #
Proposal for a regulation
Article 13 – paragraph 1 – point g
Article 13 – paragraph 1 – point g
(g) target species and dosage levels for the different target species;
Amendment 336 #
Proposal for a regulation
Article 13 – paragraph 1 – point i
Article 13 – paragraph 1 – point i
Amendment 337 #
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. The language or languages of the information on the labelling shall be determined by the Member State where the veterinary medicinal product is made available on the market, with due regard for the rights of linguistic minorities.
Amendment 338 #
Proposal for a regulation
Article 14 – paragraph 3
Article 14 – paragraph 3
3. Veterinary medicinal products may be labelled in several languagesfor export shall be labelled in the languages of the Member States in which they will be placed on the market.
Amendment 390 #
Proposal for a regulation
Article 29 – paragraph 3 – introductory part
Article 29 – paragraph 3 – introductory part
3. By the way of derogation from paragraph 1, a competent authority or the Agency may notshall classify a veterinary medicinal product as not subject to veterinary prescription if all of the following conditions are fulfilled:
Amendment 393 #
Proposal for a regulation
Article 29 – paragraph 3 – point a
Article 29 – paragraph 3 – point a
(a) the administration of the veterinary medicinal product is restricted to pharmaceutical forms requiring no particular knowledge or skill in using the products (e.g. s.c. injection);
Amendment 396 #
Proposal for a regulation
Article 29 – paragraph 3 – point f
Article 29 – paragraph 3 – point f
Amendment 405 #
Proposal for a regulation
Article 30 – paragraph 1 – point c – point xiii
Article 30 – paragraph 1 – point c – point xiii
(xiii) special conditions for use, including restrictions on the use of antimicrobials in order to limit the risk of development of antimicrobial resistance and the prohibition of off-label use,
Amendment 439 #
Proposal for a regulation
Article 34 – paragraph 1 – point b
Article 34 – paragraph 1 – point b
(b) 140 years for antimicrobial veterinary medicinal products for cattle, sheep, pigs, chickens, dogs and cats containing an antimicrobial active substance which has not been an active substance in a veterinary medicinal product authorised within the Union on the date of the submission of the application;
Amendment 441 #
Proposal for a regulation
Article 34 – paragraph 1 – point c
Article 34 – paragraph 1 – point c
(c) 180 years for veterinary medicinal products for bees;
Amendment 450 #
Proposal for a regulation
Article 35 – paragraph 2
Article 35 – paragraph 2
2. Where a variation is approved in accordance with Article 65 extending the marketing authorisation to a another species not listed in Article 34(1)(a), the period of the protection provided for in Article 34 shall be prolonged by 42 years.
Amendment 455 #
Proposal for a regulation
Article 35 – paragraph 3
Article 35 – paragraph 3
3. The period of the protection of the first marketing authorisation prolonged by any additional periods of protection due to any variations or new authorisations belonging to the same marketing authorisation ( ' 'overall period of the protection of technical documentation ' ') shall not exceed 184 years.
Amendment 663 #
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.
Amendment 665 #
Proposal for a regulation
Article 88 – paragraph 1
Article 88 – paragraph 1
1. By way of derogation from Article 5 paragraph 1, 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.
Amendment 667 #
Proposal for a regulation
Article 88 – paragraph 2 a (new)
Article 88 – paragraph 2 a (new)
2a. Each member state shall ensure that reports of suspected serious adverse events, and suspected adverse events in humans, that have occurred within its territory are communicated to the Agency and to the other member states without delay, at the latest within 15 calendar days of becoming known.
Amendment 668 #
Proposal for a regulation
Article 88 – paragraph 2 b (new)
Article 88 – paragraph 2 b (new)
2b. The veterinary homeopathic medicinal products not subject to Article 89 paragraph 1 shall be authorised in accordance with the general regulations. For the safety tests, preclinical and clinical trials of veterinary homeopathic medicinal products not subject to Article 89 paragraph 1 a Member State may introduce or retain on its territory specific rules in accordance with the principles and characteristics as practised in that Member State.
Amendment 669 #
Proposal for a regulation
Article 89 – paragraph 1 – point b
Article 89 – paragraph 1 – point b
(b) there is a sufficient degree of dilution to guarantee the safety of the medicinal product; in particular, the ingredients of the medicinal product shall not contain more than one part per 10 000 of the mother tincture;must be included in Tab. 1 of the Regulation (EU) No. 37/2010 with the comment "No maximum residue level (MRL) required".
Amendment 677 #
Proposal for a regulation
Article 91 – paragraph 2
Article 91 – paragraph 2
2. Notwithstanding paragraph 1, a manufacturing authorisation shall not be required for preparation, dividing up, changes in packaging or presentation where these processes are carried out solely for retail in accordance with Articles 107 and 108. A manufacturing authorisation shall also not be required for preparation, filling or changes in packaging or presentation where these processes are carried out solely for dispensing by pharmacists in a pharmacy or by veterinarians in a veterinary practice;
Amendment 693 #
Proposal for a regulation
Article 104 – paragraph 5
Article 104 – paragraph 5
5. A wholesale distributor shall supply veterinary medicinal products only to persons permitted to carry out retail activities in the Member States in accordance with Article 107(1), other wholesale distributors and exporters of veterinary medicinal products.
Amendment 699 #
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 law shall not retail antimicrobial products only for animals which are under their care, and only in the amount required for the treatment concerned.
Amendment 709 #
Proposal for a regulation
Article 107 – paragraph 2 a (new)
Article 107 – paragraph 2 a (new)
2a. Given the risks associated with antimicrobial resistance, no economic incentives may be provided in any form, directly or indirectly, by pharmaceutical companies to persons who prescribe veterinary medicinal products.
Amendment 715 #
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 other than products containing 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 722 #
Proposal for a regulation
Article 108 – paragraph 5 – subparagraph 1 – point c a (new)
Article 108 – paragraph 5 – subparagraph 1 – point c a (new)
(ca) information on procedures for the safe disposal of medicinal products, specifying the public or private body responsible at national or local level for the disposal of veterinary medicine residues and the collection points for disposal free of charge.
Amendment 723 #
Proposal for a regulation
Article 108 – paragraph 5 – subparagraph 1 – point c b (new)
Article 108 – paragraph 5 – subparagraph 1 – point c b (new)
(cb) Member States’ websites shall also contain hyperlinks to the web pages of the bodies responsible in Member States for listing authorised national retailers.
Amendment 724 #
Proposal for a regulation
Article 108 – paragraph 6
Article 108 – paragraph 6
6. The Agency shall set up a website providing information on the common logo. The Agency’s website shall explicitly mention that the websites of Member States contain information on persons authorised to offer veterinary medicinal products for sale at a distance to the public by means of information society services in the Member State concerned. The Agency’s website shall be linked to the web pages of the appropriate Member State bodies listing authorised retailers in Member States.
Amendment 729 #
Proposal for a regulation
Article 108 – paragraph 7 a (new)
Article 108 – paragraph 7 a (new)
7a. Each Member State shall authorise national online retailers and carry out appropriate checks to ensure that their operations are valid. Member States shall respond without delay to concerns raised by other Member States regarding online retailers authorised on their national territory.
Amendment 739 #
Proposal for a regulation
Article 109 – paragraph 1 – subparagraph 1 (new)
Article 109 – paragraph 1 – subparagraph 1 (new)
Member States may decide, in addition, to authorise the sale of anti-parasitic and anti-inflammatory medicinal products for pets through ordinary distribution channels.
Amendment 779 #
Proposal for a regulation
Article 111 – paragraph 1
Article 111 – paragraph 1
1. VNotwithstanding Art. 115 and 116, veterinary medicinal products shall be used in accordance with the terms of the marketing authorisation. or registration within the right of the veterinarian for free choice of therapeutic method;
Amendment 821 #
Proposal for a regulation
Article 115 – paragraph 1 – point a – point iii a (new)
Article 115 – paragraph 1 – point a – point iii a (new)
Amendment 844 #
Proposal for a regulation
Article 116 – paragraph 1 – point c
Article 116 – paragraph 1 – point c
Amendment 863 #
Proposal for a regulation
Article 116 – paragraph 3 – point b – point 1 (new)
Article 116 – paragraph 3 – point b – point 1 (new)
(1) By way of a derogation from paragraphs 1 to 3, homeopathic veterinary medicinal products may be administered to food-producing species under the responsibility of a veterinarian the active constituents of which appear in Tab. 1 of the Regulation (EU) No. 37/2010 with the classification "No maximum residue level (MRL) required"
Amendment 875 #
Proposal for a regulation
Article 117 – paragraph 4
Article 117 – paragraph 4
4. With regard to homeopathic veterinary medicinal products the withdrawal period shall be established at zero days.The withdrawal period shall be established at zero days for homeopathic veterinary medicinal products containing solely active substances listed in Table 1 of Regulation (EU) No. 37/2010 with the classification "No maximum residue level (MRL) required"
Amendment 903 #
Proposal for a regulation
Article 125 – paragraph 6
Article 125 – paragraph 6
6. IFinal inspection reports shall be uploaded to the appropriate database, with continuous access for all competent authorities, and made public.