Activities of Bolesław G. PIECHA related to 2014/0257(COD)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on veterinary medicinal products PDF (1 MB) DOC (1 MB)
Amendments (12)
Amendment 128 #
Proposal for a regulation
Recital 23
Recital 23
(23) Companies have less interest in developing veterinary medicinal products for markets of a limited size. In order to promote the availability of veterinary medicinal products within the Union for those markets, in someexceptional cases it should be possible to grant marketing authorisations without a complete application dossier having been submitted, on the basis of a benefit-risk assessment of the situation and, where necessary, subject to specific obligations. In particular, this should be possible in the case of veterinary medicinal products for use in minor species or for the treatment or prevention of diseases that occur infrequently or in limited geographical areas. Such products should only be used on the basis of a prescription.
Amendment 161 #
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 professveterinarians or other persons authorised under nationals law should be restricted to the amount required for treatment of the animals under their care.
Amendment 185 #
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 veterinarians or other persons authorised to do so by the Member State where they are established; however, countries which do not allow prescriptions to be issued by persons other than veterinarians may refuse to recognise such prescriptions issued in other countries in accordance with those countries’ national laws. 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.
Amendment 196 #
Proposal for a regulation
Recital 62
Recital 62
(62) Where medicinal products are authorised within a Member State and have been prescribed in that Member State by a member of a regulated animal health professionveterinarian or other persons authorised to do so under national law for an individual animal or group of animals, it should in principle be possible for that veterinary prescription to be recognised and for the medicinal product to be dispensed in another Member State, provided that that Member State authorises persons with similar qualifications to issue prescriptions. The removal of regulatory and administrative barriers to such recognition should not affect any professional or ethical duty for dispensing professionals to refuse to dispense the medicine stated in the prescription.
Amendment 363 #
Proposal for a regulation
Article 21 – paragraph 3 a (new)
Article 21 – paragraph 3 a (new)
3a. A veterinary medicinal product that has been granted marketing authorisation in accordance with this article may only be issued on the basis of a prescription.
Amendment 371 #
Proposal for a regulation
Article 22 – paragraph 3 a (new)
Article 22 – paragraph 3 a (new)
3a. A veterinary medicinal product that has been granted marketing authorisation in accordance with this article may only be issued on the basis of a prescription.
Amendment 398 #
Proposal for a regulation
Article 29 – paragraph 3 – point h
Article 29 – paragraph 3 – point h
(h) there is no risk to public or animal health as regards the development of resistance to antimicrobial or anthelmintic substances even where the veterinary medicinal products containing those substances are used incorrectly.
Amendment 411 #
Proposal for a regulation
Article 30 – paragraph 1 – point j a (new)
Article 30 – paragraph 1 – point j a (new)
(ja) information as to whether the veterinary medicinal product is only available on prescription.
Amendment 691 #
Proposal for a regulation
Article 104 – paragraph 3
Article 104 – paragraph 3
3. Supplies of small quantities of veterinary medicinal products required for courses of treatment lasting a week or longer, if the characteristics of the medicinal product thus dictate, from one retailer to another shall not be regarded as wholesale distribution.
Amendment 694 #
Proposal for a regulation
Article 105 – paragraph 3 – point a
Article 105 – paragraph 3 – point a
(a) has at his disposal technically competent staff, including at least one veterinarian or person authorised to issue prescriptions in line with national rules, and suitable and sufficient premises complying with the requirements laid down by the Member State concerned as regards the storage and handling of veterinary medicinal products;
Amendment 759 #
Proposal for a regulation
Article 110 – paragraph 2
Article 110 – paragraph 2
2. A veterinary prescription shall only be issued by a veterinarian or other person qualified to do so in accordance with applicable national law.
Amendment 774 #
Proposal for a regulation
Article 110 – paragraph 4 a (new)
Article 110 – paragraph 4 a (new)
4a. The provisions of paragraph 4 shall not apply to prescriptions issued by anyone other than a veterinarian. In cases where someone other than a veterinarian has issued a prescription, Member States may refuse to recognise it if their national systems do not allow for the possibility of prescriptions being issued by anyone other than a veterinarian. If the Member States take steps in accordance with this paragraph, they shall immediately notify the Commission, which shall forward this information to all of the Member States.