76 Amendments of Pilar AYUSO related to 2014/0257(COD)
Amendment 111 #
Proposal for a regulation
Article 4 – paragraph 1 – point 20 – point b
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;
Amendment 119 #
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 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.
Amendment 123 #
Proposal for a regulation
Article 5 – paragraph 2 a (new)
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.
Amendment 131 #
Proposal for a regulation
Article 8 – paragraph 2 – point a a (new)
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
Amendment 133 #
Proposal for a regulation
Article 8 – paragraph 6 a (new)
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.
Amendment 147 #
Proposal for a regulation
Article 12 – paragraph 1 – point m a (new)
Article 12 – paragraph 1 – point m a (new)
(ma) Qualitative and quantitative composition.
Amendment 155 #
Proposal for a regulation
Article 16 – paragraph 6
Article 16 – paragraph 6
Amendment 168 #
Proposal for a regulation
Article 25
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).
Amendment 208 #
Proposal for a regulation
Article 2 – paragraph 4 – point e a (new)
Article 2 – paragraph 4 – point e a (new)
(ea) medicated feed and intermediate products as defined in article 2.2 a) and b) of Regulation YYYY/XXX on medicated feed.
Amendment 211 #
Proposal for a regulation
Article 34 – paragraph 1 – point a
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;.
Amendment 233 #
Proposal for a regulation
Article 35 – paragraph 3
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.
Amendment 252 #
Proposal for a regulation
Article 48 – paragraph 1
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'’).
Amendment 259 #
Proposal for a regulation
Article 4 – paragraph 1 – point 27 a (new)
Article 4 – paragraph 1 – point 27 a (new)
(27a) "Marketing authorisation holder": the holder of an authorisation granted in accordance with the legislation.
Amendment 259 #
Proposal for a regulation
Article 49 – paragraph 2
Article 49 – paragraph 2
Amendment 261 #
Proposal for a regulation
Article 50 – paragraph 1
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.
Amendment 263 #
Proposal for a regulation
Article 4 – paragraph 1 – point 27 b (new)
Article 4 – paragraph 1 – point 27 b (new)
(27b) "Periodic safety update report" is the report that collect all adverse events known by the marketing authorisation holder of a product that shall be submitted to the competent authorities.
Amendment 271 #
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 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.
Amendment 277 #
Proposal for a regulation
Article 5 – paragraph 2 a (new)
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.
Amendment 280 #
Proposal for a regulation
Article 57 – paragraph 1 – point c
Article 57 – paragraph 1 – point c
(c) a summary report on pharmacovigilance dataA bridging PSUR.
Amendment 285 #
Proposal for a regulation
Article 58 – paragraph 3
Article 58 – paragraph 3
Amendment 293 #
Proposal for a regulation
Article 60
Article 60
Amendment 299 #
Proposal for a regulation
Article 8 – paragraph 6 a (new)
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
Amendment 304 #
Proposal for a regulation
Article 69 – paragraph 4
Article 69 – paragraph 4
Amendment 307 #
Proposal for a regulation
Article 72 – paragraph 2
Article 72 – paragraph 2
2. Competent authorities and the Agency shall supervise the pharmacovigilance systems of marketing authorisation holders and authorise them.
Amendment 308 #
Proposal for a regulation
Article 73 – paragraph 1
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').
Amendment 309 #
Proposal for a regulation
Article 73 – paragraph 2 – point b
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;
Amendment 314 #
Proposal for a regulation
Article 73 – paragraph 2 – point e
Article 73 – paragraph 2 – point e
(e) any noxious responseaction in humans to a veterinary medicinal product;
Amendment 315 #
Proposal for a regulation
Article 73 – paragraph 2 – point f a (new)
Article 73 – paragraph 2 – point f a (new)
(fa) any suspected transmission via a veterinary medicinal product of any infectious agent.
Amendment 321 #
Proposal for a regulation
Article 76 – paragraph 2
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.
Amendment 326 #
Proposal for a regulation
Article 76 – paragraph 4
Article 76 – paragraph 4
Amendment 327 #
Proposal for a regulation
Article 76 – paragraph 5
Article 76 – paragraph 5
Amendment 330 #
Proposal for a regulation
Article 77 – paragraph 6 – subparagraph 1
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.
Amendment 334 #
Proposal for a regulation
Article 78 – paragraph 1 – point j
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.
Amendment 335 #
Proposal for a regulation
Article 78 – paragraph 1 – point l
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.
Amendment 336 #
Proposal for a regulation
Article 78 – paragraph 1 – subparagraph l a (new)
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.
Amendment 337 #
Proposal for a regulation
Article 79 – paragraph 1
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.
Amendment 338 #
Proposal for a regulation
Article 79 – paragraph 3
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.
Amendment 342 #
Proposal for a regulation
Article 81 – paragraph 2
Article 81 – paragraph 2
Amendment 343 #
Proposal for a regulation
Article 81 – paragraph 3
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'’).
Amendment 344 #
Proposal for a regulation
Article 81 – paragraph 4
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.
Amendment 359 #
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 retailsupply antimicrobial products only for animals which are under their careimmediate care after appropriate examination and diagnosis, and only in the amount required for the treatment concerned.
Amendment 377 #
Proposal for a regulation
Article 110 – paragraph 2
Article 110 – paragraph 2
2. A veterinary prescription shall only be issued by a person qualified to do so in accordance with applicable national lawmedicinal product should only be prescribed by a veterinarian.
Amendment 384 #
Proposal for a regulation
Article 111 – paragraph 1
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.
Amendment 394 #
Proposal for a regulation
Article 115 – paragraph 1
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.)
Amendment 401 #
Proposal for a regulation
Article 116 – paragraph 1
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.)
Amendment 412 #
Proposal for a regulation
Article 116 – paragraph 2
Article 116 – paragraph 2
Amendment 416 #
Proposal for a regulation
Article 116 – paragraph 3
Article 116 – paragraph 3
Amendment 418 #
Proposal for a regulation
Article 116 – paragraph 4
Article 116 – paragraph 4
Amendment 423 #
Proposal for a regulation
Article 116 – paragraph 5
Article 116 – paragraph 5
Amendment 454 #
Proposal for a regulation
Article 35 – paragraph 3
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.
Amendment 455 #
Proposal for a regulation
Article 144 – paragraph 1 – point b
Article 144 – paragraph 1 – point b
Amendment 473 #
Proposal for a regulation
Article 49 – paragraph 2
Article 49 – paragraph 2
Amendment 476 #
Proposal for a regulation
Article 50 – paragraph 1
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.
Amendment 481 #
Proposal for a regulation
Article 52 – paragraph 2
Article 52 – paragraph 2
2. Marketing authorisation holders shall have full access to the information in the product database concerning their own marketing authorisations and limited access to other products.
Amendment 496 #
Proposal for a regulation
Article 56
Article 56
Amendment 497 #
Proposal for a regulation
Article 57 – paragraph 1 – point c
Article 57 – paragraph 1 – point c
(c) a summary report on pharmacovigilance dataA bridging PSUR.
Amendment 501 #
Proposal for a regulation
Article 58 – paragraph 3
Article 58 – paragraph 3
Amendment 505 #
Proposal for a regulation
Article 60
Article 60
Amendment 511 #
Proposal for a regulation
Article 64 – paragraph 1
Article 64 – paragraph 1
1. If a variation application fulfils the requirements laid down in Article 61, the competent authority or the Agency, or a competent authority assigned in accordance with Article 63(3) shall acknowledge receipt of a complete application in 15 days.
Amendment 536 #
Proposal for a regulation
Article 69 – paragraph 4
Article 69 – paragraph 4
Amendment 565 #
Proposal for a regulation
Article 72 – paragraph 2
Article 72 – paragraph 2
2. Competent authorities and the Agency shall supervise the pharmacovigilance systems of marketing authorisation holders and authorise them.
Amendment 568 #
Proposal for a regulation
Article 73 – paragraph 1
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').
Amendment 583 #
Proposal for a regulation
Article 73 – paragraph 2 – point d
Article 73 – paragraph 2 – point d
(d) any infringements of withdrawal period following administration to an animal of a veterinary or human medicinal product;
Amendment 584 #
Proposal for a regulation
Article 73 – paragraph 2 – point e
Article 73 – paragraph 2 – point e
(e) any noxious responseaction in humans to a veterinary medicinal product;
Amendment 604 #
Proposal for a regulation
Article 75 – paragraph 3 – point b a (new)
Article 75 – paragraph 3 – point b a (new)
(ba) Information about incidence of adverse events.
Amendment 625 #
Proposal for a regulation
Article 77 – paragraph 3
Article 77 – paragraph 3
3. The marketing authorisation holder shall permanently have at his disposal one or more appropriately qualified persons responsible for pharmacovigilance. Those persons shall reside and operate in the Union. Only one qualified personof them shall be designated by the marketing authorisation holder as the qualified person per pharmacovigilance system master file.
Amendment 628 #
Proposal for a regulation
Article 77 – paragraph 6 – subparagraph 1
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.
Amendment 639 #
Proposal for a regulation
Article 78 – paragraph 1 – point l
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.
Amendment 642 #
Proposal for a regulation
Article 79 – paragraph 3
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.
Amendment 645 #
Proposal for a regulation
Article 79 – paragraph 5
Article 79 – paragraph 5
5. Competent authorities shall verify by means of inspections referred to in Article 125 or any other way that marketing authorisation holders comply with the requirements relating to pharmacovigilance laid down in this Section.
Amendment 648 #
Proposal for a regulation
Article 81 – paragraph 2
Article 81 – paragraph 2
Amendment 649 #
Proposal for a regulation
Article 81 – paragraph 3
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').
Amendment 651 #
Proposal for a regulation
Article 81 – paragraph 4
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.
Amendment 777 #
Proposal for a regulation
Article 111 – paragraph 1
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.
Amendment 871 #
Proposal for a regulation
Article 117 – paragraph 1 – point b – point i
Article 117 – paragraph 1 – point b – point i
(i) the longest withdrawal period provided in the summary of the product characteristics for any milk producing speciesmilk multiplied by factor 1.5;
Amendment 933 #
Proposal for a regulation
Article 144 – paragraph 1 – point b
Article 144 – paragraph 1 – point b