31 Amendments of Matthias GROOTE related to 2014/0257(COD)
Amendment 110 #
Proposal for a regulation
Recital 6
Recital 6
(6) Animals may suffer from a broad range of diseases which can be prevented or treated. The impact of animal diseases and the measures necessary to control them can be devastating for individual animals, animal populations, animal keepers and the economy. Animal diseases transmissible to humans may also have a significant impact on public health. Therefore sufficient and effective veterinary medicinal products should be available in the Union in order to ensure high standards of animal and public health, and for the development of the agriculture and aquaculture sectors. To this end, good husbandry and management practices have to be put place in order to improve animal welfare, limit the spread of diseases, prevent antimicrobial resistance and ensure proper nutrition of livestock.
Amendment 146 #
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 and human antimicrobials. Use not covered by the terms of the marketing authorisation of certain new or critically important antimicrobials for humans should be restricted 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 170 #
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 considered in the context of cooperation with third countries and international organisations addressing antimicrobial resistance in order the ensure consistency with their activities and policies. To this end, it is necessary to develop an international strategy to combat antimicrobial resistance.
Amendment 182 #
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, except for antimicrobials, via the Internet to buyers in their own or other Member States.
Amendment 191 #
Proposal for a regulation
Recital 57
Recital 57
(57) The illegal sale of veterinary medicinal products to the public via the Internet may represent a threat to public and animal health, as falsified or substandard medicines may reach the public in this way. It is necessary to address this threat. Account should be taken of the fact that specific conditions for the supply of medicinal products to the public have not been harmonised at Union level and, therefore, Member States may impose conditions for supplying medicinal products to the public within the limits of the Treaty. The online sale of antibiotics should be prohibited.
Amendment 226 #
Proposal for a regulation
Article 4 – paragraph 1 – point 7
Article 4 – paragraph 1 – point 7
Directive 2001/82/EC
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 234 #
Proposal for a regulation
Article 4 – paragraph 1 – point 8 a (new)
Article 4 – paragraph 1 – point 8 a (new)
(8a) “antimicrobials” mean any compound with a direct action on micro- organisms used for treatment or prevention of infections. Antimicrobials include anti-bacterials, anti-virals, antifungals and anti-protozoals. Antibiotics are synonymous with anti- bacterials.
Amendment 347 #
Proposal for a regulation
Article 17 – paragraph 1 – introductory part
Article 17 – paragraph 1 – introductory part
By way of derogation from Article 7(1)(b) an application for a marketing authorisation for a veterinary medicinal product containing a combination of active substances that have each already been used in authorised veterinary medicinal products, but have not hitherto been authorised in that combination (‘combination veterinary medicinal product') shall satisfy the following criteria:
Amendment 431 #
Proposal for a regulation
Article 32 – paragraph 4
Article 32 – paragraph 4
4. The Commission shall, by means of implementing acts, designate antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). When adopting those implementing acts, the Commission shall take into account the work of EU agencies, as well as existing lists published by WHO and the OIE. The Commission should prioritize the evaluation of certain antibiotics such as modern cephalosporins and fluoroquinolones.
Amendment 433 #
Proposal for a regulation
Article 32 – paragraph 4 a (new)
Article 32 – paragraph 4 a (new)
4a. The rules and criteria to be used by the European Commission for determining which antimicrobials are to be reserved for treatment of specific infections in humans should not interfere with Member States' right to restrict the use of certain antimicrobials in livestock. The EU list should not constrain Member State(s) that implement or wish to implement stricter rules, or have restricted/prohibited the use of some antimicrobials in certain species.
Amendment 475 #
Proposal for a regulation
Article 50
Article 50
Amendment 478 #
Proposal for a regulation
Article 51 – paragraph 2 – point a
Article 51 – paragraph 2 – point a
(a) veterinary medicinal products authorised within the Union by the Commission and by the competent authorities, together with their summaries of product characteristics, package leaflets, and lists of sites where each product is manufactured and reference numbers to the pharmacovigilance system master file;
Amendment 485 #
Proposal for a regulation
Article 54 – paragraph 1
Article 54 – paragraph 1
1. Member States shall collect relevant and comparable data on the volume of sales and, the use of veterinary antimicrobial medicinal products including species treated, reason for use and method of treatment.
Amendment 494 #
Proposal for a regulation
Article 54 – paragraph 4 a (new)
Article 54 – paragraph 4 a (new)
4a. Data requirements for adopting those implementing acts shall include animal species, the dose, the duration and type of treatment, the number of animals treated and the administration route(s). In addition any off-label use of antimicrobials should be mandatorily reported to national authorities.
Amendment 495 #
Proposal for a regulation
Article 54 – paragraph 4 b (new)
Article 54 – paragraph 4 b (new)
4b. The use of antibiotics in drinking water should be restricted to cases where most of the animals or the whole herd are sick. Five years after the entry into force of this Regulation, the European Commission shall publish a report examining the different routes used to administer antibiotics to food-producing animals, and in particular the oral routes used through feed and water, and their subsequent impact on antimicrobial resistance.
Amendment 520 #
Proposal for a regulation
Article 68 – paragraph 1 a (new)
Article 68 – paragraph 1 a (new)
1a. The marketing authorisation holder could in accordance with Article 69 apply for a harmonisation of different national marketing authorisations that have been granted for the same veterinary medicinal product. A single, approved quality data set and a harmonised summary of product characteristics shall be prepared for such products. The coordination group shall draw up detailed rules of procedure for the harmonisation of 'same products' from the same marketing authorisation holder.
Amendment 528 #
Proposal for a regulation
Article 69 – paragraph 1
Article 69 – paragraph 1
1. By [12 months after the date of application of this Regulation for OP to insert the actual date] competent authorities shall provide the coordination group with lists of all products for which national marketing authorisations have been granted before 1 January 2004.
Amendment 531 #
Proposal for a regulation
Article 69 – paragraph 2 a (new)
Article 69 – paragraph 2 a (new)
2a. The marketing authorisation holders shall submit to the coordination group their requests to harmonise the marketing authorisations for a particular product. All registrations pertaining to the same product in the Union will be included in the harmonisation procedure, subject to Article 69(3). The coordination group shall appoint one member to act as a rapporteur and propose a start date for the procedure.
Amendment 533 #
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 similar veterinary medicinal products and (if it is the case) of the marketing authorisations of the same veterinary medicinal products.
Amendment 542 #
Proposal for a regulation
Article 69 – paragraph 4 – point b
Article 69 – paragraph 4 – point b
(b) all therapeutic indications and posology mentioned in the marketing authorisations granted by Member States in respect of the similar products in the group;
Amendment 548 #
Proposal for a regulation
Article 69 – paragraph 5
Article 69 – paragraph 5
5. Upon presentation of a report, the coordination group shall act by a majority of the votes cast by the members of the coordination group represented at the meeting. The rapporteur shall record the agreement, close the procedure and inform Member States and the marketing authorisation holders(s) accordingly.
Amendment 550 #
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 characteation of the conditions of use and (if relevant) of harmonising a marketing authorisaticson, each Member State shall vary athe marketing authorisation in conformity with the agreement within 30 days of receipt of the information regarding the agreement from the rapporteur. or 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, are in conformity with the agreement within 30 days of receipt of the information regarding the agreement from the rapporteur. Those marketing authorisations for the same product shall, henceforth be considered to be mutual recognition marketing authorisations granted under this Regulation.
Amendment 595 #
Proposal for a regulation
Article 74 – paragraph 1
Article 74 – paragraph 1
1. The Agency shall establish and maintain a Union database on pharmacovigilance of veterinary medicinal products (the ‘"pharmacovigilance database'"). The pharmacovigilance database shall be the only data entry point for adverse events reported by the holders of marketing authorisations.
Amendment 602 #
Proposal for a regulation
Article 75 – paragraph 3 – point a
Article 75 – paragraph 3 – point a
(a) the number of adverse events reported each year, broken down by product and active substance, animal species and type of adverse event;
Amendment 612 #
Proposal for a regulation
Article 76 – paragraph 3
Article 76 – paragraph 3
3. Competent authorities may, on their own initiative or on a request from the Agency, request the marketing authorisation holder to collectprovide 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 629 #
Proposal for a regulation
Article 78 – paragraph 1 – introductory part
Article 78 – paragraph 1 – introductory part
Qualified persons responsible for pharmacovigilance as referred to in Article 77(3) shall carry ouensure that the following tasks are carried out:
Amendment 672 #
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 735 #
Proposal for a regulation
Article 109 – paragraph 1
Article 109 – paragraph 1
1. Only manufacturers, wholesale distributors and retailers authorised specifically to do so in accordance with applicable national law shall be allowed to supply and purchase veterinary medicinal products which have anabolic, anti- infectious, anti-parasitic, anti- inflammatory, hormonal or psychotropic properties or substances which may be used as veterinary medicinal products having those properties. In the case of non-food producing animals (i.e. companion and small animals) all retailers – ranging from supermarkets, pet stores, to traditional and online (veterinary) pharmacies – should be allowed to sell anti-parasitic and anti- inflammatory products, without the need to be specifically authorised to do so.
Amendment 876 #
Proposal for a regulation
Article 117 – paragraph 5 – subparagraph 2 a (new)
Article 117 – paragraph 5 – subparagraph 2 a (new)
Data on the use of antibiotics outside the terms of authorisation should be collected and mandatorily reported to national authorities in accordance with article 54 of this Regulation.
Amendment 881 #
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 health. Antimicrobial products shall not be used as a routine preventive measure.
Amendment 930 #
Proposal for a regulation
Article 141 – paragraph 1 – point f
Article 141 – paragraph 1 – point f