20 Amendments of Biljana BORZAN related to 2014/0257(COD)
Amendment 160 #
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 and only once a veterinary diagnosis has been established following a clinical examination of the animals concerned, or in the light of regular health visits of the animal(s) concerned.
Amendment 165 #
Proposal for a regulation
Recital 38 a (new)
Recital 38 a (new)
(38a) In order to facilitate responsible use, there is an imperative need for rapid, reliable and efficacious veterinary diagnostics both to identify the cause of disease as to perform antibiotic sensitivity testing. This will facilitate correct diagnosis, allow for a targeted use of antibiotics, support using as little as possible critically important antibiotics and therefore restrain from the development of antibiotic resistance. There is clear need for future innovation specifically for pen-site diagnosis, and a need to consider carefully whether there is a case for more harmonisation and regulation in this sector.
Amendment 183 #
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, with the exception of antimicrobials, via the Internet to buyers in other Member States.
Amendment 254 #
Proposal for a regulation
Article 4 – paragraph 1 – point 24
Article 4 – paragraph 1 – point 24
(24) 'veterinary prescription‘ means any prescription for a veterinary medicinal product issued by a professional person qualified to do so in accordance with applicable national law;veterinarian to the owner or the person taking care of the animal(s), only after diagnosis or in the light of a regular animal health visit.
Amendment 384 #
Proposal for a regulation
Article 29 – paragraph 1 – introductory part
Article 29 – paragraph 1 – introductory part
1. A competent authority or the Commission shall classify the following veterinary medicinal products as subject to mandatory veterinary prescription:
Amendment 388 #
Proposal for a regulation
Article 29 – paragraph 2 – introductory part
Article 29 – paragraph 2 – introductory part
2. A competent authority or the Commission may classify a veterinary medicinal product as subject to mandatory veterinary prescription where special precautions are contained in the summary of product characteristics referred to in Article 30, and in particular potential risks to:
Amendment 392 #
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 not classify a veterinary medicinal product as subject to mandatory veterinary prescription if all of the following conditions are fulfilled:
Amendment 423 #
Proposal for a regulation
Article 32 – paragraph 2
Article 32 – paragraph 2
2. A marketing authorisation for an antimicrobial veterinary medicinal product or a group of antimicrobial veterinary medicinal products shall be refused if the antimicrobial is reserved for treatment of certain infections in humans.
Amendment 571 #
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 authorities different means of reporting to them the following events whether or not the event is considered to be product- related (‘adverse events'):
Amendment 588 #
Proposal for a regulation
Article 73 – paragraph 2 – point f a (new)
Article 73 – paragraph 2 – point f a (new)
(fa) Detection of a substance in the environment, especially in ground water or surface water.
Amendment 594 #
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') that is linked with the Product database.
Amendment 690 #
Proposal for a regulation
Article 104 – paragraph 3
Article 104 – paragraph 3
3. Supplies of small quantities of veterinary medicinal products from one retailer to another shall not be regarded as wholesale distribution. The Commission shall define the maximum scope of "small quantities" of veterinary medicinal products in retail through delegated acts.
Amendment 703 #
Proposal for a regulation
Article 107 – paragraph 2
Article 107 – paragraph 2
2. PersoVeterinarians qualified to prescribe veterinary medicinal products in accordance with applicable national law shall retail antimicrobial products only for animals which are under their care, and only in the amount required for the treatment concerned.
Amendment 712 #
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, with the exception of antimicrobials, by means of information society services in 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 713 #
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 by means of information society services in 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. Member States should be able to subject the supply of prescription medicinal products for food producing animals to conditions justified by the protection of public health. __________________ 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 749 #
Proposal for a regulation
Article 110 – paragraph 1 – point e
Article 110 – paragraph 1 – point e
(e) signature or an equivalent electronic form of identification of the person writissuing the prescription;
Amendment 760 #
Proposal for a regulation
Article 110 – paragraph 2
Article 110 – paragraph 2
2. A veterinary prescription shall only be issued by a persoveterinarian qualified to do so in accordance with applicable national law.
Amendment 771 #
Proposal for a regulation
Article 110 – paragraph 4
Article 110 – paragraph 4
4. Veterinary prescriptions, including in electronical format, shall be recognised throughout the Union. A veterinary medicinal product prescribed shall be supplied in accordance with applicable national law.
Amendment 917 #
Proposal for a regulation
Article 133 a (new)
Article 133 a (new)
Article 133a Prohibiting supply of antimicrobials reserved for humans 1. Veterinary medicinal products containing antimicrobial agents that are classified as reserved for the treatment of certain infections of humans by the Commission are prohibited. 2. Veterinary medicinal products referred to in paragraph 1 that are approved for use at the time of entry into force of this Regulation shall be withdrawn from the market by the respective authorisation holders.
Amendment 929 #
Proposal for a regulation
Article 140 a (new)
Article 140 a (new)