Activities of Miguel VIEGAS related to 2014/0257(COD)
Plenary speeches (1)
Veterinary medicinal products (A8-0046/2016 - Françoise Grossetête) PT
Shadow opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council on veterinary medicinal products
Amendments (24)
Amendment 79 #
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 memberveterinarian, ofr a regulated animal health professionn equivalent professional as defined in the laws of Member States, 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. 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 121 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
2. A marketing authorisation for a veterinary medicinal product shall be valid for an unlimited period of time, except where new scientific knowledge gives grounds for reassessment.
Amendment 140 #
Proposal for a regulation
Article 10 – paragraph 1 – point d
Article 10 – paragraph 1 – point d
Amendment 142 #
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 productsin accordance with the law in force;
Amendment 152 #
Proposal for a regulation
Article 14 – paragraph 3 a (new)
Article 14 – paragraph 3 a (new)
3a. The information on the labelling shall be provided in the national language of every Member State where the veterinary medicinal product is made available on the market.
Amendment 173 #
Proposal for a regulation
Article 29 – paragraph 3 – introductory part
Article 29 – paragraph 3 – introductory part
3. By the way of derogation fromNotwithstanding paragraph 1, a competent authority or the Agency may not classify a veterinary medicinal product as subject to veterinary prescription if all of the following conditions are fulfilled:
Amendment 213 #
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 218 #
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 220 #
Proposal for a regulation
Article 34 – paragraph 1 – point d
Article 34 – paragraph 1 – point d
(d) 140 years for veterinary medicinal products for animal species other than listed in paragraph 1(a) and (c).
Amendment 229 #
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 234 #
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 185 years.
Amendment 239 #
Proposal for a regulation
Article 38 – paragraph 1
Article 38 – paragraph 1
1. Centralised marketing authorisations shall be granted by the Commission in accordance with this Section. They shall be valid throughout the Union and considered the priority procedure.
Amendment 254 #
Proposal for a regulation
Article 48 – paragraph 2
Article 48 – paragraph 2
2. A minimum of 64 months shall elapse between the decision granting the first national marketing authorisation and the submission of the application for mutual recognition of the national marketing authorisation.
Amendment 256 #
Proposal for a regulation
Article 48 – paragraph 4
Article 48 – paragraph 4
4. Within 9045 days of receipt of a valid application, the reference Member State shall prepare an updated assessment report for the veterinary medicinal product. The updated assessment report together with the approved summary of the product characteristics and the text to appear in the labelling and package leaflet shall be forwarded to all Member States and the applicant, together with the list of Member States where the applicant seeks to obtain recognition of the marketing authorisation (‘concerned Member States’).
Amendment 305 #
Proposal for a regulation
Article 69 – paragraph 4 – point c
Article 69 – paragraph 4 – point c
(c) the shortest withdrawal period deemed appropriate in the light of the most recent scientific studies, out of those stated in the summaries of the product characteristics.
Amendment 328 #
Proposal for a regulation
Article 77 – paragraph 2
Article 77 – paragraph 2
2. Where the pPharmacovigilance tasks havemay not, under any circumstances, been contracted out by the marketing authorisation holder to a third party, those arrangements shall be set out in details in the pharmacovigilance system master file.
Amendment 329 #
Proposal for a regulation
Article 77 – paragraph 4
Article 77 – paragraph 4
Amendment 341 #
Proposal for a regulation
Article 80 – paragraph 1
Article 80 – paragraph 1
1. A competent authority may delegate any of the tasks entrusted to it as referred to in Article 79 to a competent public authority in another Member State subject to the written agreement of the latter.
Amendment 362 #
Proposal for a regulation
Article 107 – paragraph 2
Article 107 – paragraph 2
2. Persons qualiVeterinarians, or equivalent professionals as defined toin the laws of Member States, prescribeing 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 372 #
Proposal for a regulation
Article 110 – paragraph 1 – point d
Article 110 – paragraph 1 – point d
(d) full name and contact details, qualifications and professional membership number of the personveterinarian, or equivalent professional as defined in the laws of Member States, writing the prescription;
Amendment 373 #
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 personveterinarian, or equivalent professional as defined in the laws of Member States, writing the prescription;
Amendment 376 #
Proposal for a regulation
Article 110 – paragraph 2
Article 110 – paragraph 2
2. A veterinary prescription shall only be issued by a persoveterinarian, or an equaliivalent professional as defined to do soin the laws of Member States, recognised by the appropriate professional association in accordance with applicable national law.
Amendment 396 #
Proposal for a regulation
Article 115 – paragraph 1 – introductory part
Article 115 – paragraph 1 – introductory part
1. By way of derogation from Article 111, where there is no authorised veterinary medicinal product in a Member State for a condition affecting a non-food producing animal, the veterinarian responsiblethe veterinarian responsible, or the equivalent professional as defined in the laws of Member States, may, under his/her direct personal responsibility and in particular to avoid causing unacceptable suffering, exceptionally treat the animal concerned with the following:
Amendment 436 #
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 regularly, at predetermined intervals laid down in Member States, and on a risk- basis, in order to verify that the requirements as set out in this Regulation are complied with.