105 Amendments of Martin HÄUSLING related to 2014/0257(COD)
Amendment 111 #
Proposal for a regulation
Recital 7
Recital 7
(7) This Regulation should set high standards of quality, safety and efficacy for veterinary medicinal products in order to meet common concerns as regards the protection of public and animal health and the environment. At the same time, this Regulation should harmonise the rules for the authorisation of veterinary medicinal products and the placing of them on the Union market.
Amendment 120 #
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 temporarily 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 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 123 #
Proposal for a regulation
Recital 18
Recital 18
(18) Member States should be able to temporarily allow exceptional use of veterinary medicinal products without a marketing authorisation where it is necessary to respond to Union listed diseases and where the health situation in a Member State so requires.
Amendment 132 #
Proposal for a regulation
Recital 26 a (new)
Recital 26 a (new)
(26a) The potential risk to the environment needs to be assessed for all veterinary medicinal products. Marketing authorisation holders should therefore provide an environmental risk assessment within two years after the entry into force of this Regulation.
Amendment 133 #
Proposal for a regulation
Recital 26 b (new)
Recital 26 b (new)
(26b) The establishment of a single decentralised assessment of the environmental properties of active substances for veterinary use by means of a monograph system should be established in the future. The Commission should therefore submit a report to Parliament and the Council as soon as possible, as well as a legislative proposal, if appropriate.
Amendment 134 #
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 afor all veterinary medicinal products 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.
Amendment 138 #
Proposal for a regulation
Recital 30
Recital 30
Amendment 140 #
Proposal for a regulation
Recital 30 a (new)
Recital 30 a (new)
(30a) In the interest of safety and public, animal and environmental health, the approval period for pharmaceutical substances and veterinary medicinal products should be limited in time. At the time of subsequent approvals, any developments in science and technology should be taken into account when any decision regarding the renewal of an approval is taken. The renewal of the approval should be for a period not exceeding 15 years.
Amendment 142 #
Proposal for a regulation
Recital 32
Recital 32
(32) In certain circumstances where a significant animal, environmental or public health concern exists but scientific uncertainty persists, appropriate measures can be adopted taking into account Article 5(7) of the WTO Agreement on the Application of Sanitary and Phytosanitary Measures which has been interpreted for the Union in the Communication from the Commission on the precautionary principle17 . In such circumstances, Member States or the Commission should seek to obtain additional information necessary for a more objective assessment of the particular concern and should review the measure accordingly within a reasonable period of time. __________________ 17 Communication from the Commission on the precautionary principle, COM (2000) 1 (final).
Amendment 144 #
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 veterinary antimicrobials should be tightened, and the authorisation requirements should sufficiently address the risks and benefits of antimicrobial veterinary medicinal products.
Amendment 150 #
Proposal for a regulation
Recital 35
Recital 35
(35) The combined use of several antimicrobial active substances may represent a particular risk with respect to the development of antimicrobial resistance. Combinations of antimicrobial substances should therefore only be authorised exceptionally where evidence is provided that the long-term benefit-risk balance of the combination is favourable.
Amendment 153 #
Proposal for a regulation
Recital 37
Recital 37
(37) In order to preserve as long as possible the efficacy of certain antimicrobials in the treatment of infections in humans, it may beis necessary to reserve those antimicrobials for humans only. ThereforeAs a baseline, this should apply for the highest priority critically important antimicrobials identified by the WHO. Moreover, it should be possible to decide that certainother critically important antimicrobials, following the scientific recommendations of the Agency, should not be available on the market in the veterinary sector.
Amendment 169 #
Proposal for a regulation
Recital 39
Recital 39
(39) It is important to consider the international dimension of the development of antimicrobial resistance when assessing the benefit-risk balance of certain veterinary antimicrobials in the Union. Any measure restricting the use of those products may affect the trade of products of animal origin or the competitiveness of certain animal production sectors in the Union. Moreover, antimicrobial resistant organisms can spread to humans and animals in the Union through consumption of products of animal origin imported from third countries, from direct contact with animals or humans in third countries or by other means. Therefore, measures restricting the use of veterinary antimicrobials in the Union should be based on scientific advice and should be consideredtake into account scientific advice. The Union should actively promote its policies in the context of cooperation with third countries and international organisations addressing antimicrobial resistance in order the ensure consistency with their activities and policies.
Amendment 177 #
Proposal for a regulation
Recital 49
Recital 49
(49) It is necessary, in specific cases, orn specific cases it is necessary, from a public health and, animal health or environmental perspective, to complement the safety and efficacy data available at the time of authorisation with additional information following the placing of the product on the market. Therefore the obligation to conduct post-authorisation studies should be imposed on the marketing authorisation holder.
Amendment 197 #
Proposal for a regulation
Recital 65
Recital 65
(65) The verification of compliance with the legal requirements through controls is of fundamental importance to ensure that the objectives of the Regulation are effectively achieved across the Union. Therefore the competent authorities of the Member States should have the power to perform inspections at all stages of production, distribution and use of veterinary medicinal products and publish annual inspection reports. In order to preserve the effectiveness of the inspections, authorities should have the possibility to performll inspections should be unannounced inspections.
Amendment 198 #
Proposal for a regulation
Recital 67
Recital 67
(67) In certain cases failures in Member States' control system can substantially hinder the achievement of the objectives of this Regulation and may lead to the emergence of risks to public and animal health and the environment. Tohe Commission should ensure a harmonised approach to inspections throughout the Union, the Commissionand should be able to carry out audits in the Member States to verify the functioning of national control systems.
Amendment 199 #
Proposal for a regulation
Recital 70
Recital 70
(70) Companies and authorities are frequently confronted with the need to distinguish between veterinary medicinal products, feed additives, biocidal products and other products. In order to avoid inconsistencies in the treatment of such products, to increase legal certainty, and to facilitate the decision process by Member States, a coordination group of Member States should be established, and among other tasks it should. This coordination group should also include an appropriate number of members with comprehensive expertise in complementary and alternative therapies. Members of the coordination group should, among other tasks, provide on a case-by- case basis a recommendation whether a product falls within the definition of a veterinary medicinal product and whether alternative treatments are available. In order to ensure legal certainty the Commission may decide whether a specific product is a veterinary medicinal product.
Amendment 200 #
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. Furthermore, it is desirable to generally allow the use of homeopathic medicinal products designed for human use, including immunological homeopathic products, that have a potency starting from D4, on all animals, including food producing animals, under certain conditions.
Amendment 202 #
Proposal for a regulation
Recital 71 a (new)
Recital 71 a (new)
Amendment 211 #
Proposal for a regulation
Article 2 – paragraph 4 a (new)
Article 2 – paragraph 4 a (new)
4a. Substances or preparations of substances that are only intended to be applied externally on the animal for cleaning or care, or for influencing the appearance or body odour, as far as no substances or preparations are added which are excluded from marketing outside pharmacies.
Amendment 222 #
Proposal for a regulation
Article 4 – paragraph 1 – point 2 – point d a (new)
Article 4 – paragraph 1 – point 2 – point d a (new)
(da) mineral;
Amendment 225 #
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 principles.
Amendment 236 #
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 238 #
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 272 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
2. An initial marketing authorisation for a veterinary medicinal product shall be valid for an unlimited period of timefive years.
Amendment 276 #
Proposal for a regulation
Article 5 – paragraph 2 a (new)
Article 5 – paragraph 2 a (new)
2a. The authorisation may be renewed after five years on the basis of a re- evaluation of the risk-benefit balance based on the latest state of scientific knowledge, taking into account adverse effects reported under Article 76. The renewal of an authorisation shall be limited to periods not exceeding 15 years.
Amendment 286 #
Proposal for a regulation
Article 7 – paragraph 2 – point a
Article 7 – paragraph 2 – point a
(a) documentation on the direct or indirect risks to public or, animal health and the environment of use of the antimicrobial veterinary medicinal product in animals,
Amendment 289 #
Proposal for a regulation
Article 7 – paragraph 2 – point b
Article 7 – paragraph 2 – point b
(b) information about risk mitigation measures to limit antimicrobial resistance development related to the use of veterinary medicinal product, in particular when used for control treatment (metaphylaxis).
Amendment 291 #
Proposal for a regulation
Article 7 – paragraph 5
Article 7 – paragraph 5
Amendment 292 #
Proposal for a regulation
Article 7 – paragraph 5 a (new)
Article 7 – paragraph 5 a (new)
5a. When applying for renewal, publically available, peer-reviewed scientific literature on the active pharmaceutical substance and its relevant metabolites dealing with side-effects on human health, the environment and non-target species and published within the last 10 years before the date of submission of the dossier shall be added by the applicant to the dossier.
Amendment 319 #
Proposal for a regulation
Article 11 – paragraph 1 – point b
Article 11 – paragraph 1 – point b
(b) the quantitative particulars of the active substances, unless the product exists in only one concentration or the concentration is reflected in the brand name;
Amendment 328 #
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 may be supplemented by a brand name in the label;
Amendment 330 #
Proposal for a regulation
Article 13 – paragraph 1 – point d
Article 13 – paragraph 1 – point d
Amendment 333 #
Proposal for a regulation
Article 13 – paragraph 1 – point g
Article 13 – paragraph 1 – point g
(g) target species, and the dosage for each species, where applicable;
Amendment 335 #
Proposal for a regulation
Article 13 – paragraph 1 – point i
Article 13 – paragraph 1 – point i
Amendment 361 #
Proposal for a regulation
Article 21 – paragraph 3
Article 21 – paragraph 3
3. Where a medicinal product has been granted a marketing authorisation in accordance with this Article, the summary of product characteristics shall clearly state that only a limited assessment of quality and/or efficacy has been conducted due to the lack of comprehensive efficacy and/or quality data. The packaging shall bear a warning with the same information.
Amendment 370 #
Proposal for a regulation
Article 22 – paragraph 3
Article 22 – paragraph 3
3. Where a medicinal product has been granted a marketing authorisation in accordance with this Article, the summary of product characteristics shall clearly state that only a limited assessment of quality, safety and/or efficacy has been conducted due to the lack of comprehensive quality, safety and/or efficacy data. The packaging shall bear a warning with the same information.
Amendment 373 #
Proposal for a regulation
Article 23 – paragraph 1 – point b
Article 23 – paragraph 1 – point b
(b) assess the veterinary medicinal product as such as well as in comparison to the standard reference treatment regarding the quality, safety and efficacy documentation provided.
Amendment 374 #
Proposal for a regulation
Article 23 – paragraph 2
Article 23 – paragraph 2
Amendment 378 #
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 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) and that they minimize environmental pollution.
Amendment 381 #
Proposal for a regulation
Article 28 – paragraph 3
Article 28 – paragraph 3
3. Where the application concerns an antimicrobial veterinary medicinal product, the competent authority or the Commission mayshall require the marketing authorisation holder to conduct post-authorisation studies in order to ensure that the benefit- risk balance remains positive with a view to the possible development of antimicrobial resistance.
Amendment 395 #
Proposal for a regulation
Article 29 – paragraph 3 – point f
Article 29 – paragraph 3 – point f
Amendment 403 #
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 specifying that the product is not to be used as a preventive measure in food producing animals, or in group treatments where there has been no diagnosis of disease
Amendment 408 #
Proposal for a regulation
Article 30 – paragraph 1 – point e a (new)
Article 30 – paragraph 1 – point e a (new)
(ea) Information from the environmental risk assessment of the product, in particular environmental endpoints and risk characterisation data, including ecotoxicological information on effects on non-target species and persistence of active substances and active metabolites in soil and water
Amendment 413 #
Proposal for a regulation
Article 32 – paragraph 1 – point d
Article 32 – paragraph 1 – point d
(d) the product is an antimicrobial veterinary medicinal product presented for use as performance enhancer in order to promote the growth of treated animals, or to increase yields from treated animals;
Amendment 415 #
Proposal for a regulation
Article 32 – paragraph 1 – point d a (new)
Article 32 – paragraph 1 – point d a (new)
(da) the product is intended for preventive purposes for food producing animals, or for group treatment of food producing animals without any diagnosis of disease;
Amendment 419 #
Proposal for a regulation
Article 32 – paragraph 1 – point h a (new)
Article 32 – paragraph 1 – point h a (new)
(ha) the product poses significantly higher risks to the treated animal, public health or the environment compared to the standard reference treatment;
Amendment 420 #
Proposal for a regulation
Article 32 – paragraph 1 – point i a (new)
Article 32 – paragraph 1 – point i a (new)
(ia) the product contains or consists of genetically modified organisms within the meaning of Article 2 of Directive 2001/18/EC of the European Parliament and of the Council.
Amendment 424 #
Proposal for a regulation
Article 32 – paragraph 2
Article 32 – paragraph 2
2. A marketing authorisation for an antimicrobial veterinary medicinal product shall be refused if the antimicrobial is reserved for treatment of certain infections in humans. Fluoroquinolones, 3rd and 4th generation cephalosporins, macrolides and glycopeptides shall be considered as reserved for treatment of certain infections in humans. Member States may consider further antimicrobials as reserved for treatment of certain infections in humans.
Amendment 428 #
Proposal for a regulation
Article 32 – paragraph 3
Article 32 – paragraph 3
3. The Commission shall be empowered to adopt delegated acts in accordance with Article 146 in order to establish rules for the further designation of the antimicrobials which are to be reserved for treatment of certain infections in humans in order to preserve the efficacy of certain active substances in humans. The Commission shall, when establishing these rules, draw on the scientific opinions of the Agency, not least in respect of species of animals, indications and routes of administration.
Amendment 430 #
Proposal for a regulation
Article 32 – paragraph 4
Article 32 – paragraph 4
4. The Commission shall, by means of implementing acts and drawing on the scientific recommendations made by the Agency, designate further antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans, in accordance with the rules under paragraph 3. Thoese implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Amendment 436 #
Proposal for a regulation
Article 33 – paragraph 3 a (new)
Article 33 – paragraph 3 a (new)
3a. Safety information with regard to the environmental effects of veterinary medicinal products shall not be protected.
Amendment 458 #
Proposal for a regulation
Article 38 – paragraph 2 – point b
Article 38 – paragraph 2 – point b
Amendment 480 #
Proposal for a regulation
Article 51 a (new)
Article 51 a (new)
Article 51a Feasibility study for monograph review system By the 1st June 2018, the Commission shall present a report to the European Parliament and the Council on the establishment of a substance-based review system (monographs) for the environmental risk assessment of veterinary medicinal products, to be accompanied by a legislative proposal, if appropriate.
Amendment 484 #
Proposal for a regulation
Article 54 – title
Article 54 – title
Collection of data on the sales and use of antimicrobial veterinary medicinal products
Amendment 486 #
Proposal for a regulation
Article 54 – paragraph 1
Article 54 – paragraph 1
1. 1. Member States shall collect relevant and comparable data on the volume of sales and the use of veterinary antimicrobial medicinal products on a yearly basis. These data shall include: (a) the volume of sales in terms of weight and monetary value for each antimicrobial type at national level; (b) the quantity of antimicrobials used, the species treated, the disease or infection being treated, and method of treatment, at per farm-level.
Amendment 493 #
Proposal for a regulation
Article 54 – paragraph 3 a (new)
Article 54 – paragraph 3 a (new)
Amendment 502 #
Proposal for a regulation
Article 58 – paragraph 3 – point b a (new)
Article 58 – paragraph 3 – point b a (new)
(ba) whether changes have an impact on route of administration
Amendment 546 #
Proposal for a regulation
Article 69 – paragraph 4 – point c a (new)
Article 69 – paragraph 4 – point c a (new)
(ca) all relevant impacts on the environment.
Amendment 555 #
Proposal for a regulation
Article 70 – paragraph 3
Article 70 – paragraph 3
3. By way of derogation from Article 69, veterinary medicinal products authorised before 230 JulyOctober 20005 as well as veterinary medicinal products authorised after that date but which were identified as potentially harmful to the environment in the course of the environmental risk assessment shall be reassessed in line with Annex II before a harmonised summary of the product characteristics is prepared. For that purpose, marketing authorisation holders shall submit an environmental risk assessment within 24 months after entry into force of this Regulation.
Amendment 566 #
Proposal for a regulation
Article 72 – paragraph 2
Article 72 – paragraph 2
2. Competent authorities and the Agency shall supervise the pharmacovigilance systems of marketing authorisation holders. The supervisors shall not have any conflicts of interest with regard to the marketing authorisation holder.
Amendment 572 #
Proposal for a regulation
Article 73 – paragraph 2 – introductory part
Article 73 – paragraph 2 – introductory part
2. Competent authorities, the Agency and marketing authorisation holders shall make available to healthcare professionals and, animal holders and environmental scientists different means of reporting to them the following events whether or not the event is considered to be product- related (‘adverse events'):
Amendment 580 #
Proposal for a regulation
Article 73 – paragraph 2 – point c
Article 73 – paragraph 2 – point c
(c) any environmental incidents observedadverse or unintended reaction observed in the environment following administration of a veterinary medicinal product to an animal;
Amendment 614 #
Proposal for a regulation
Article 76 – paragraph 3
Article 76 – paragraph 3
3. Competent authorities may, on their own initiative or on request from the Agency, request the marketing authorisation holder to collect specific pharmacovigilance data, in particular regarding the use of a veterinary medicinal product in specified animal species, in the context of public and animal health, safety of the persons administering the product, and the protection of the environment. The authority shall state in detail the reasons for the request and inform other competent authorities and the Agency thereof.
Amendment 634 #
Proposal for a regulation
Article 78 – paragraph 1 – point d
Article 78 – paragraph 1 – point d
(d) establishing and maintaining a system which ensures that all adverse events, including on non-target species and the environment, which are brought to the attention of the marketing authorisation holder are collected and recorded in order to be accessible at least at one site in the Union;
Amendment 666 #
Proposal for a regulation
Article 88 – paragraph 1 a (new)
Article 88 – paragraph 1 a (new)
1a. By way of derogation from the requirements laid down in the first paragraph, Member States may exempt minor remedies from registration.
Amendment 670 #
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 medicinal product shall not contain more than one part per 10 000 of the mother tincture;, unless the ingredients of the medicinal product are included in Table 1 of Regulation (EU) No. 37/2010 with the comment "No maximum residue level (MRL) required".
Amendment 673 #
Proposal for a regulation
Article 90 – paragraph 1 – point a
Article 90 – paragraph 1 – point a
(a) scientific name or other name given in a pharmacopoeia or documented in a monograph of the homeopathic stock or stocks, together with a statement of the various routes of administration, pharmaceutical forms and degree of dilution to be registered;
Amendment 674 #
Proposal for a regulation
Article 91 – paragraph 1 – point a
Article 91 – paragraph 1 – point a
(a) to produce or import veterinary medicinal products; or
Amendment 676 #
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 678 #
Proposal for a regulation
Article 92 – paragraph 2 – point c
Article 92 – paragraph 2 – point c
(c) details about the manufacturing site where the veterinary medicinal products are to be manufactured or tested, including data about emissions, discharges and losses of the active substance and its precursors to the environment;
Amendment 681 #
Proposal for a regulation
Article 93 – paragraph 5
Article 93 – paragraph 5
5. A manufacturing authorisation may be granted conditionally, subject to a requirement for the applicant to undertake actions or introduce specific procedures within a given time period. The manufacturing authorisation may be suspended if these requirements are not complied with. The manufacturing authorisation shall be refused if manufacturing causes unacceptable risks to the environment.
Amendment 706 #
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 retail antimicrobial products only for animals which are under their care, subject to a veterinary diagnosis based on clinical examination of the animal concerned, and only in the amount required for the treatment concerned.
Amendment 752 #
Proposal for a regulation
Article 110 – paragraph 1 – point f a (new)
Article 110 – paragraph 1 – point f a (new)
(fa) the condition which is being treated,
Amendment 778 #
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 785 #
Proposal for a regulation
Article 111 – paragraph 1 a (new)
Article 111 – paragraph 1 a (new)
1a. Antimicrobials may only be administered under prescription by a veterinary doctor or a suitably qualified animal health professional for group treatment of food producing animals after all the preventive measures listed under Annex IIIa have been taken.
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 856 #
Proposal for a regulation
Article 116 – paragraph 2 – introductory part
Article 116 – paragraph 2 – introductory part
2. By way of derogation from Article 111, where there is no authorised veterinary medicinal product or any other treatment in a Member State for a condition affecting a food-producing aquatic species, the veterinarian responsible may, under his direct personal responsibility and in particular to avoid causing unacceptable suffering, treat the animals concerned with any of the following medicinal products:
Amendment 866 #
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, homeopathic veterinary medicinal products may be administered to food- producing species under the responsibility of a veterinarian the active constituents of which appear in Table 1 of the Regulation (EU) No. 37/2010 with the classification "No maximum residue level (MRL) required".
Amendment 868 #
Proposal for a regulation
Article 116 – paragraph 4 – subparagraph 1
Article 116 – paragraph 4 – subparagraph 1
The Commission may, by means of implementing acts, establish a list of veterinary medicinal products authorised in the Union for use in terrestrial animals which can be used for treatment of food- producing animals of an aquatic species in accordance with paragraph 1. This provision is strictly limited to closed aquatic systems with specific waste water treatment facilities. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Amendment 869 #
Proposal for a regulation
Article 116 – paragraph 4 – subparagraph 2 – point c
Article 116 – paragraph 4 – subparagraph 2 – point c
(c) impact on the competitiveness of certain sectors in aquaculture in the Union if the animal affected by the condition cannot receive treatment with the antimicrobial medicinal product concernedfishermen whose preys can be significantly affected by use of medicines in open-water aquaculture;
Amendment 883 #
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 use of which would not present a risk to public or animal healthprovided that the measures referred to in Annex IIIa have been taken for food- producing animals, and the use of which would not present a risk to public or animal health and the environment. Prophylactic use, as well as control treatment without any diagnosis of disease, shall not be allowed.
Amendment 885 #
Proposal for a regulation
Article 118 – paragraph 1 a (new)
Article 118 – paragraph 1 a (new)
1a. Articles 115 and 116 do not apply to critically important antimicrobials as referred to in Article 32(2).
Amendment 890 #
Proposal for a regulation
Article 118 – paragraph 2 – subparagraph 2 – point c a (new)
Article 118 – paragraph 2 – subparagraph 2 – point c a (new)
(ca) availability of other farming methods that could prevent the outbreak of the disease
Amendment 891 #
Proposal for a regulation
Article 118 – paragraph 2 – subparagraph 2 – point e
Article 118 – paragraph 2 – subparagraph 2 – point e
Amendment 898 #
Proposal for a regulation
Article 125 – paragraph 1
Article 125 – paragraph 1
1. Competent authorities shall perform controls of manufacturers, importers, marketing authorisation holders, wholesale distributors and suppliers of the veterinary medicinal products as well as animals and foodstuff regularly, on a risk- basis, in order to verify that the requirements as set out in this Regulation are complied with.
Amendment 899 #
Proposal for a regulation
Article 125 – paragraph 1 a (new)
Article 125 – paragraph 1 a (new)
1a. The Commission shall ensure a harmonised approach to inspections and controls of veterinary medicines throughout the Union.
Amendment 901 #
Proposal for a regulation
Article 125 – paragraph 4 – subparagraph 2
Article 125 – paragraph 4 – subparagraph 2
Amendment 904 #
Proposal for a regulation
Article 125 – paragraph 6
Article 125 – paragraph 6
6. Inspection reports shall be uploaded to the appropriate database, with continuous access for all competent authorities. A summary of the inspection results shall be made publicly available.
Amendment 905 #
Proposal for a regulation
Article 128 – paragraph 3 a (new)
Article 128 – paragraph 3 a (new)
3a. The Agency and the Commission shall ensure a harmonised approach to veterinary medicine inspections.
Amendment 923 #
Proposal for a regulation
Article 140 – paragraph 1 a (new)
Article 140 – paragraph 1 a (new)
Amendment 932 #
Proposal for a regulation
Article 141 – paragraph 1 – point h a (new)
Article 141 – paragraph 1 – point h a (new)
(ha) provide guidance on the contribution of farming practices to reduce the development of antimicrobial resistance, building on the existing action plans of the European Commission and Member States, specifically by developing guidance on the reduction of overall use of antimicrobials.
Amendment 934 #
Proposal for a regulation
Annex 2 – section 1 – part 1.1 – paragraph 1
Annex 2 – section 1 – part 1.1 – paragraph 1
The technical documentation shall include a detailed and full description of the tests, studies and trials conducted or referred to, including the methods used. The data shall be relevant and of sufficient quality to demonstrate the quality, safety and efficacy of the veterinary product. The technical documentation shall contain data on the quality, safety and efficacy of the standard reference treatment.
Amendment 936 #
Proposal for a regulation
Annex 2 – section 1 – part 1.3 – subpart 1.3.1 – paragraph 1 – point d
Annex 2 – section 1 – part 1.3 – subpart 1.3.1 – paragraph 1 – point d
(d) the potential risks for the environment resulting from the production of use of the veterinary medicinal product;
Amendment 937 #
Proposal for a regulation
Annex 2 – section 1 – part 1.3 – subpart 1.3.1 – paragraph 1 – point e
Annex 2 – section 1 – part 1.3 – subpart 1.3.1 – paragraph 1 – point e
(e) the potential risks relating to the development of antimicrobial resistance during production and use.
Amendment 938 #
Proposal for a regulation
Annex 2 – section 1 – part 1.3 – subpart 1.3.1 – paragraph 6
Annex 2 – section 1 – part 1.3 – subpart 1.3.1 – paragraph 6
An environmental risk assessment shall be submitted regarding any undesirable effects which the production or use of the veterinary medicinal product may have on the environment and the risk of such effects. The assessment shall also identify any precautionary measures which may be necessary to reduce such risk.
Amendment 939 #
Proposal for a regulation
Annex 2 – section 1 – part 1.3 – subpart 1.3.1 – paragraph 7 – introductory part
Annex 2 – section 1 – part 1.3 – subpart 1.3.1 – paragraph 7 – introductory part
This assessment shall normally be conducted in two phases. All available data of sufficient reliability and relevance shall be considered, including information gained during the drug discovery process. The first phase of the assessment shall always be performed and the second phase shall be performed if necessary. The details of the assessment shall be provided in accordance with accepted guidance. The assessment shall indicate the potential exposure of the environment to the product and the level of risk associated with any such exposure taking into account in particular the following items:
Amendment 940 #
Proposal for a regulation
Annex 2 – section 1 – part 1.3 – subpart 1.3.1 – paragraph 7 – point c a (new)
Annex 2 – section 1 – part 1.3 – subpart 1.3.1 – paragraph 7 – point c a (new)
(ca) An assessment of potential mixture effects including an estimate of the total environmental exposure to the active ingredient from different products and other active ingredients that act via a similar mode of action.
Amendment 941 #
Proposal for a regulation
Annex 2 – section 1 – part 1.3 – subpart 1.3.1 – paragraph 8
Annex 2 – section 1 – part 1.3 – subpart 1.3.1 – paragraph 8
In the second phase, further specific investigation of the fate and effects of the product on particular ecosystems shall be conducted, in accordance with established guidance, and taking into account the pharmacological effect of the product as well as any relevant side effects. The extent of exposure of the product to the environment, and the available information about the physical/chemical, pharmacological and/or toxicological properties of the substance(s) concerned, including metabolites, shall be taken into consideration.
Amendment 942 #
Proposal for a regulation
Annex 2 – section 1 – part 1.3 – subpart 1.3.1 – paragraph 8 a (new)
Annex 2 – section 1 – part 1.3 – subpart 1.3.1 – paragraph 8 a (new)
The environmental risk assessment shall be updated when new information becomes available that would change the estimation of the risk.
Amendment 943 #
Proposal for a regulation
Annex 2 – section 1 – part 1.3 – subpart 1.3.1 – paragraph 8 b (new)
Annex 2 – section 1 – part 1.3 – subpart 1.3.1 – paragraph 8 b (new)
A follow up assessment shall always be performed within two years of market introduction that provides an assessment of the emissions from all manufacturing sites (API production and formulation). For each manufacturing site, the assessment should include: 1. A description of how solid and liquid waste is managed, including volumes discharged to water and land per year, treatment technologies used in relation to best available technologies, and estimated yearly average dilution of treated wastewater in the recipient. If waste is treated by third parties, a similar assessment shall be performed and reported for these sites. 2. MEC/PNEC ratios of the active pharmaceutical ingredient (API) (MEC= measured environmental concentrations; PNEC= predicted no effect concentrations) in the recipient for algae, daphnia and fish as well as for antimicrobial resistance during production when discharges are most likely to occur. The MEC shall be derived by analyses of whole effluent and a calculated dilution in the recipient, rather than direct measures in the recipient. In case no APIs are detected, the applicant shall show that the level of quantification of the validated analytical method is applied is at least 100 times below the lowest PNEC or if that is not possible show that the best available analytical technology has been used. 3. A measure of the toxicity of the treated effluent (dilution causing 50% effect) to algae and daphnia according to OECD guidelines. 4. In case of antibiotic production, measures taken to avoid environmental discharges of antibiotic-resistance bacteria from the production chain shall be described.
Amendment 944 #
Proposal for a regulation
Annex 2 – section 2 – part 2.3 – subpart 2.3.1 – paragraph 5
Annex 2 – section 2 – part 2.3 – subpart 2.3.1 – paragraph 5
The environmental risk assessment shall evaluate the potential harmful effects, which the production or use of the product may cause to the environment and identify any precautionary measures, which may be necessary to reduce such risks.
Amendment 945 #
Proposal for a regulation
Annex 3 – part 4 – paragraph 2 a (new)
Annex 3 – part 4 – paragraph 2 a (new)
For combinations of antimicrobial substances, the risks and benefits need to be assessed for the long term.
Amendment 946 #
Proposal for a regulation
Annex 3 a (new)
Annex 3 a (new)
Preventative measures to be used before resorting to antimicrobial treatment of entire groups (metaphylaxis) of food producing animals: – using good healthy breeding stock that grows naturally, with suitable genetic diversity – conditions that respect the behavioural needs of the species, including social interactions/hierarchies – stocking densities that do not increase risk of disease transmission – isolation of sick animals away from the rest of the group – (for chickens and smaller animals) subdivision of flocks into smaller, physically separated groups – Implementation of existing animal welfare rules already in cross compliance under the Common Agricultural Policy's horizontal Regulation 1306/2013, annex II, SMRs 11, 12, 13 (Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes (OJ L 221, 8.8.1998, p. 23) Council Directive 91/630/EEC of 19 November 1991 laying down minimum standards for the protection of pigs (OJ L 340, 11.12.1991, p. 33), Council Directive 91/629/EEC of 19 November 1991 laying down minimum standards for the protection of calves (OJ L 340, 11.12.1991, p. 28))