BETA

42 Amendments of Ramón Luis VALCÁRCEL SISO related to 2014/0257(COD)

Amendment 111 #
Proposal for a regulation
Article 4 – paragraph 1 – point 20 – point b
(b) veterinary medicinal products for animal species other than cattle, sheep (only meat obtained from sheep), pigs, chickens, dogs and cats;
2015/05/07
Committee: AGRI
Amendment 119 #
Proposal for a regulation
Article 5 – paragraph 2
2. A marketing authorisation for a veterinary medicinal product shall be valid for an unlimited period of timefive years. The authorisation may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance. Once renewed, the marketing authorisation shall be valid for an unlimited period, unless the competent authority decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal.
2015/05/07
Committee: AGRI
Amendment 123 #
Proposal for a regulation
Article 5 – paragraph 2 a (new)
2a. When a previously authorised veterinary medicinal product has not been present on the market in a Member State for a period of three consecutive years, the authorisation granted for that veterinary medicinal product shall cease to be valid. The competent authority may, in exceptional circumstances, and on human or animal health grounds, grant exemptions from the previous paragraph. Such exemptions shall be duly justified.
2015/05/07
Committee: AGRI
Amendment 131 #
Proposal for a regulation
Article 8 – paragraph 2 – point a a (new)
(aa) the tested product is an unauthorised veterinary medicinal product, all the pharmacological active substances have a maximum residues limit, and the withdrawal period set by the veterinarian in accordance with Article 117 is respected, or
2015/05/07
Committee: AGRI
Amendment 133 #
Proposal for a regulation
Article 8 – paragraph 6 a (new)
6a. The holder of the clinical trial authorization shall notify the competent authority of every serious adverse events and all human adverse reactions shall be notified promptly and in any case not later than 15 days following receipt of the information.
2015/05/07
Committee: AGRI
Amendment 147 #
Proposal for a regulation
Article 12 – paragraph 1 – point m a (new)
(ma) Qualitative and quantitative composition.
2015/05/07
Committee: AGRI
Amendment 155 #
Proposal for a regulation
Article 16 – paragraph 6
6. A competent authority or the Agency may require the applicant to provide safety data concerning the potential risks posed by the generic veterinary medicinal product to the environment in case the marketing authorisation for the reference veterinary medicinal product was granted before 20 July 2000 or in case the second phase environmental risk assessment was required for the reference veterinary medicinal product.deleted
2015/05/07
Committee: AGRI
Amendment 168 #
Proposal for a regulation
Article 25
The competent authority shall ascertain that the manufacturers of veterinary medicinal products from third countries comply with EU legislation applicable and 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).
2015/05/07
Committee: AGRI
Amendment 211 #
Proposal for a regulation
Article 34 – paragraph 1 – point a
(a) 10 years for the veterinary medicinal products for cattle, sheep (only for meat), pigs, chickens, dogs and cats;.
2015/05/07
Committee: AGRI
Amendment 233 #
Proposal for a regulation
Article 35 – paragraph 3
3. The period of the protection of the first marketing authorisation shall not be prolonged by any additional periods of protection due to any variations or new authorisations belonging to the same marketing authorisation ('overall. The variations or new authorisation should have their own period of the protection of technical documenta. This protection') shall not exceed 18 yearsbe three years for each variation or new authorisation.
2015/05/07
Committee: AGRI
Amendment 252 #
Proposal for a regulation
Article 48 – paragraph 1
1. Applications and the dossier for mutual recognition of marketing authorisations shall be submitted to all the Member States. The Member State that granted the first national marketing authorisation is the (‘reference Member State').
2015/05/07
Committee: AGRI
Amendment 259 #
Proposal for a regulation
Article 49 – paragraph 2
2. Within the coordination group, a rapporteur shall be appointed in order to prepare a second assessment report for the veterinary medicinal product.deleted
2015/05/07
Committee: AGRI
Amendment 261 #
Proposal for a regulation
Article 50 – paragraph 1
1. Within 15 days after receipt of the assessment report referred to in Article 46(3) or in Article 48(4) the applicant may provide written notice to the AgencyCoordination group requesting a re-examination of the assessment report. In that case the applicant shall forward to the Agency detailed grounds for the request within 60 days of receipt of the assessment report. The application shall be accompanied by proof of payment of the fee payable to the Agency for the re-examination.
2015/05/07
Committee: AGRI
Amendment 280 #
Proposal for a regulation
Article 57 – paragraph 1 – point c
(c) a summary report on pharmacovigilance dataA bridging PSUR.
2015/05/07
Committee: AGRI
Amendment 285 #
Proposal for a regulation
Article 58 – paragraph 3
3. The Commission shall take account of the following criteria when adopting those implementing acts: (a) the need for a scientific assessment of changes in order to determine the risk to public health, animal health or the environment; (b) whether changes have an impact on the safety and efficacy of the veterinary medicinal product; (c) whether changes imply a significant alteration to the summary of product characteristics.deleted
2015/05/07
Committee: AGRI
Amendment 293 #
Proposal for a regulation
Article 60
Variations to the terms of a marketing authorisation that do not require 1. Where a variation does not appear in the list established in accordance with Article 58(2), the marketing authorisation holder shall record the change in the product database within 12 months following the implementation of the variation. 2. If necessary, competent authorities or, where the veterinary medicinal product is authorised under the centralised marketing authorisation procedure, the Commission shall amend the decision granting a marketing authorisation in accordance with the change.Article 60 deleted assessment
2015/05/07
Committee: AGRI
Amendment 304 #
Proposal for a regulation
Article 69 – paragraph 4
4. Harmonised summaries of product characteristics for veterinary medicinal products shall contain all of the following information: (a) all species mentioned in the marketing authorisations granted by Member States in respect of the similar products in the group; (b) all therapeutic indications mentioned in the marketing authorisations granted by Member States in respect of the similar products in the group; (c) the shortest withdrawal period of those stated in the summaries of the product characteristics.deleted
2015/05/07
Committee: AGRI
Amendment 307 #
Proposal for a regulation
Article 72 – paragraph 2
2. Competent authorities and the Agency shall supervise the pharmacovigilance systems of marketing authorisation holders and authorise them.
2015/05/07
Committee: AGRI
Amendment 308 #
Proposal for a regulation
Article 73 – paragraph 1
1. Member States, the Commission, the Agency and marketing authorisation holders shall collaborate in setting up and maintaining a system to monitor the safety and efficacy of authorised veterinary medicinal products, enabling them to fulfil their responsibilities as listed in Articles 77 and 79 (‘Union pharmacovigilance system').
2015/05/07
Committee: AGRI
Amendment 309 #
Proposal for a regulation
Article 73 – paragraph 2 – point b
(b) any observation of a lack of efficacy of a veterinary medicinal product following administration to an animal in accordance with the summary of product characteristics, including signs of antimicrobial resistance, following administration to an animal;
2015/05/07
Committee: AGRI
Amendment 314 #
Proposal for a regulation
Article 73 – paragraph 2 – point e
(e) any noxious responseaction in humans to a veterinary medicinal product;
2015/05/07
Committee: AGRI
Amendment 315 #
Proposal for a regulation
Article 73 – paragraph 2 – point f a (new)
(fa) any suspected transmission via a veterinary medicinal product of any infectious agent.
2015/05/07
Committee: AGRI
Amendment 321 #
Proposal for a regulation
Article 76 – paragraph 2
2. Marketing authorisation holders shall record in the pharmacovigilance database all adverse events which were reported to them by healthcnotify electronically all serious adverse events and human events relating to the use of veterinary medicinal products that are pbrofessionals and animal holders and that occurred within the Union or in a third country with regard to their authorised veterinary medicinal products, wiught to their attention or which they can reasonably be expected to have knowledge of to the competent authority of the Member State on whose territory the incident occurred and no later than 15 days following receipt of the information. The rest of adverse events relating to the use of veterinary medicinal products that are brought to the attention of the Marketing authorization holders or which they can reasonably be expected to have knowledge of, should be notified electronically to the pharmacovigilance database no later thian 30 days following the receipt of the adverse event report. information.
2015/05/07
Committee: AGRI
Amendment 326 #
Proposal for a regulation
Article 76 – paragraph 4
4. Within 15 days after receipt of the request referred to in paragraph 3, the marketing authorisation holder may give written notice to the competent authority that he wishes a re-examination of the request to collect additional specific pharmacovigilance data.deleted
2015/05/07
Committee: AGRI
Amendment 327 #
Proposal for a regulation
Article 76 – paragraph 5
5. Within 60 days following the receipt of the written notice, the competent authority shall re-examine the request and provide the marketing authorisation holder with its decision.deleted
2015/05/07
Committee: AGRI
Amendment 330 #
Proposal for a regulation
Article 77 – paragraph 6 – subparagraph 1
The marketing authorisation holder shall not communicate information regarding adverse events to the general public in relation to the veterinary medicinal product without giving prior notification of his intensending in advance a copy of that communication to the competent authority or authorities having granted the marketing authorisation or to the Agency where the marketing authorisation was granted in accordance with the centralised authorisation procedure.
2015/05/07
Committee: AGRI
Amendment 334 #
Proposal for a regulation
Article 78 – paragraph 1 – point j
(j) monitorcarrying out a Signal detection of adverse events included ing the pharmacovigilance system anddatabase to ensuringe that if needed, an appropriate corrective action plan is prepared and implemented;. The Signal detection should be made every six months during the first two years of effective commercialization of the product and afterwards yearly and the analysis and results should be sent to competent authorities.
2015/05/07
Committee: AGRI
Amendment 335 #
Proposal for a regulation
Article 78 – paragraph 1 – point l
(l) communicating any regulatory measure that is taken in a Member State or a third country and is based on pharmacovigilance data to the competent authorities and the Agency within 15 days of receipt of such information.
2015/05/07
Committee: AGRI
Amendment 336 #
Proposal for a regulation
Article 78 – paragraph 1 – subparagraph l a (new)
Unless other requirements have been laid down as a condition for the granting of the marketing authorisation or subsequently established by the competent authority, reports of all adverse reactions shall be submitted to the competent authorities in the form of a periodic safety report, immediately upon request or at least every six months after authorisation until the placing on the market. Periodic safety reports shall also be submitted immediately upon request or at least every six months during the first two years following the initial placing on the market, yearly for the following two years and thereafter at three-yearly intervals. The periodic safety reports shall include a scientific evaluation of the risk-benefit balance of the veterinary medicinal product. Unless other requirements have been laid down as a condition for the granting of the marketing authorisation or subsequently established by competent authority, reports of all adverse reactions shall be submitted to the competent authorities in the form of a periodic safety report, immediately upon request or at least every six months after authorisation until the placing on the market. Periodic safety reports shall also be submitted immediately upon request or at least every six months during the first two years following the initial placing on the market, yearly for the following two years and thereafter at three-yearly intervals. The periodic safety reports shall include a scientific evaluation of the risk-benefit balance of the veterinary medicinal product.
2015/05/07
Committee: AGRI
Amendment 337 #
Proposal for a regulation
Article 79 – paragraph 1
1. Competent authorities shall evaluate all adverse events reported to them by marketing authorisation holders, healthcare professionals and animal holders, manage risks and take the measures referred to in Articles 130 to 135 concerning marketing authorisations where necessary.
2015/05/07
Committee: AGRI
Amendment 338 #
Proposal for a regulation
Article 79 – paragraph 3
3. Competent authorities may impose specific requirements on marketing authorisation holders, veterinarians and other healthcare professionals in respect of the reporting of adverse events. The Agency and the competent authorities may organise meetings or a network for groups of veterinarians or other healthcare professionals, where there is a specific need for collecting, collating or analysing specific pharmacovigilance data.
2015/05/07
Committee: AGRI
Amendment 342 #
Proposal for a regulation
Article 81 – paragraph 2
2. Competent authorities and the Agency shall establish groups of veterinary medicinal products for which signal management process can be combined with a view of detecting risks to animal health, public health and protection of the environment.deleted
2015/05/07
Committee: AGRI
Amendment 343 #
Proposal for a regulation
Article 81 – paragraph 3
3. The Agency and the coordinationveterinary pharmacovigilance group shall agree on sharing of the monitoring of data on groups of veterinary medicinal products recorded in the pharmacovigilance database. For each group of veterinary medicinal products a competent authority or the Agency shall be appointed as responsible for the monitoring thereof (‘lead authority').
2015/05/07
Committee: AGRI
Amendment 344 #
Proposal for a regulation
Article 81 – paragraph 4
4. The results of the signal management process, except for nationally authorised products, shall be agreed upon by the competent authorities and, where appropriate, the Agency. The lead authority shall record the results in the pharmacovigilance database.
2015/05/07
Committee: AGRI
Amendment 384 #
Proposal for a regulation
Article 111 – paragraph 1
1. Veterinary medicinal products shall be used in accordance with the terms of the marketing authorisation. Nevertheless, the veterinarian should be able, in justified circumstances, to prescribe veterinary medicinal products in different terms to the ones authorised for the product.
2015/05/07
Committee: AGRI
Amendment 394 #
Proposal for a regulation
Article 115 – paragraph 1
1. By way of derogation from Article 111, whereMember States shall take the necessary measures to ensure that, if there is no authorised veterinary medicinal product in a Member State for a condition affecting a non- food producing animalspecies, by way of exception, the veterinarian responsible may, under his/her direct personal responsibility and in particular to avoid causing unacceptable suffering, exceptionally treat the animal concerned with the following: (a) a medicinal product: (i: (a) a veterinary medicinal product authorised under this Regulation in the Member State concerned under this Regulation for use with another animal species, or for another condition in the same species; (ii) a veterinary medicinal product authorised under this Regulation in another Member State for use in the same species or in another species, for the same condition or for another condition; (iior (b) if there is no product as referred to in point (a), either: (i) a medicinal product authorised for human use authorised in the Member State concerned in accordance with Directive 2001/83/EC of the European Parliament and of the Council30 or Regulation (EC) No 726/2004; (b) if there is no product as referred to in point (a), a veterinary medicinal product prepared extemporaneously in accordance, or (ii) in accordance with specific national measures, a veterinary medicinal product authorised in another Member State in accordance with this Regulation for use in the same species or in another species for the condition in question or for another condition; or (c) if there is no product as referred to in subparagraph (b), and within the terms of a veterinary prescriptionlimits of the law of the Member State concerned, a veterinary medicinal product prepared extemporaneously by a person authorised to do so under national legislation in accordance with the terms of a veterinary prescription. __________________ 30 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). (Point (iii) of Commission text has become point (i) in Parliament’s amendment. The word“or” has been added.)
2015/05/07
Committee: AGRI
Amendment 401 #
Proposal for a regulation
Article 116 – paragraph 1
1. By way of derogation from Article 111, whereMember States shall take the necessary measures to ensure that, if there is no authorised veterinary medicinal product in a Member State for a condition affecting a food-producing animal of a non-aquatic speciesspecies, by way of exception, the veterinarian responsible may, under his direct personal responsibility and in particular to avoid causing unacceptable suffering, exceptionally treat the animals concerned with any of the followingon a particular holding with: (a) a veterinary medicinal product authorised under this Regulation in the Member State concerned under this Regulation for use with another food-producing animal species, or for another condition in the same species; or (b) a veterinary medicinal product authorised under this Regulation in another Member State for use in the same species or in another food-producing species for the same condition or for another condition;if there is no product as referred to in point (a), either: (ci) a medicinal product for human use authorised in the Member State concerned in accordance with Directive 2001/83/EC or under Regulation (EC) No 726/2004, or (d) if there is no product as referred to in point (a), a veterinary medicinal product prepared extemp(ii) a veterinary medicinal product authorised in another Member State in accordance with this Regulation for use in the same species or in another food- producing species for the condition in question or for aneously in accordanceother condition; or (c) if there is no product as referred to in subparagraph (b), and within the terms of a veterinary prescription by a person authorised to do so under national legislation. (Point (b) of Commission text has become point (ii) in Parliament’s amendment and has beenlimits of the law of the Member State concerned, a veterinary medicinal product prepared extemporaneously by a person authorised to do so under national legislation in accordance with the terms of a veterinary prescription. modified.)
2015/05/07
Committee: AGRI
Amendment 412 #
Proposal for a regulation
Article 116 – paragraph 2
2. By way of derogation from Article 111, where there is no authorised veterinary medicinal product 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: (a) veterinary medicinal products authorised under this Regulation in the Member State concerned for use with another food-producing aquatic species, or for another condition in the same aquatic species; (b) veterinary medicinal products authorised under this Regulation in another Member State for use in the same aquatic species or in another food- producing aquatic species for the condition in question or for another condition.deleted
2015/05/07
Committee: AGRI
Amendment 416 #
Proposal for a regulation
Article 116 – paragraph 3
3. By way of derogation from paragraph 2, and until an implementing act referred to in paragraph 4 is established, if there is no product as referred to in subparagraphs (a) and (b) of paragraph 2, a veterinarian may, under his direct personal responsibility and in particular to avoid causing unacceptable suffering, exceptionally treat food-producing animals of an aquatic species on a particular holding with: (a) a veterinary medicinal product authorised under this Regulation in the Member State concerned or in another Member State for use with a food- producing non-aquatic species; (b) a medicinal product for human use authorised in the Member State concerned in accordance with Directive 2001/83/EC or under Regulation (EC) No 726/2004.deleted
2015/05/07
Committee: AGRI
Amendment 418 #
Proposal for a regulation
Article 116 – paragraph 4
4. 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. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). The Commission shall take account of the following criteria when adopting those implementing acts: (a) risks to the environment if aquatic animals are treated with these medicinal products; (b) impact on animal health and public health if the aquatic animal affected by the condition cannot receive treatment with the potential listed antimicrobial medicinal product; (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 concerned; (d) availability or lack of availability of other medicines, treatments or measures for prevention or treatment of diseases or certain conditions in aquatic animals.deleted
2015/05/07
Committee: AGRI
Amendment 423 #
Proposal for a regulation
Article 116 – paragraph 5
Use of antimicrobial veterinary medicinal products for species or indications outside the terms of the marketing authorisat(Does not affect the English version.)
2015/05/07
Committee: AGRI
Amendment 455 #
Proposal for a regulation
Article 144 – paragraph 1 – point b
(b) examine questions concerning pharmacovigilance of veterinary medicinal products authorised in Member States;deleted
2015/05/07
Committee: AGRI