Activities of Nicola CAPUTO related to 2014/0257(COD)
Plenary speeches (1)
Veterinary medicinal products (A8-0046/2016 - Françoise Grossetête) IT
Shadow opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council on veterinary medicinal products
Amendments (62)
Amendment 134 #
Proposal for a regulation
Article 9 – paragraph 1 – introductory part
Article 9 – paragraph 1 – introductory part
1. The immediate packaging of a veterinary medicinal product shall contain onlyat least the following information:
Amendment 139 #
Proposal for a regulation
Article 10 – paragraph 1 – introductory part
Article 10 – paragraph 1 – introductory part
1. The outer packaging of a veterinary medicinal product shall contain onlyat least the following information:
Amendment 158 #
Proposal for a regulation
Article 16 – paragraph 6
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 veterinaryIf there is evidence that a constituent of a medicinal product tois a hazard for 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 environm, a competent authority or the Agency shall require the safety data concerning the potential risk assessment was required for the reference veterinary medicinal products simultaneously from all the marketing authorisation holders concerned.
Amendment 201 #
Proposal for a regulation
Article 32 – paragraph 3
Article 32 – paragraph 3
3. The Commission shall be empowered to adopt delegated acts in accordance with Article 146 and taking into consideration the scientific advice of the Agency in order to establish rules for the designation of the antimicrobials which are to be reserved for treatment of certain infections in humans in order to preserve the efficacy of certain active substances in humans. The Commission, when establishing these rules, will make decisions on appropriate risk management measures at the class, substance or even the indication level and will consider also the route of administration.
Amendment 206 #
Proposal for a regulation
Article 32 – paragraph 4
Article 32 – paragraph 4
4. The Commission shall, by means of implementing acts and taking into consideration the scientific advice of the Agency, designate antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). The Commission, when establishing these rules, will make decisions on appropriate risk management measures at the class, substance or even the indication level and will consider also the route of administration.
Amendment 222 #
Proposal for a regulation
Article 35 – title
Article 35 – title
Amendment 224 #
Proposal for a regulation
Article 35 – paragraph 1
Article 35 – paragraph 1
1. Where a variation is approved in accordance with Article 65 extending the marketing authorisation to another species listed in Article 34(1)(a), the granted period of the protection provided for in that Article shall be prolonged by 1 year for each additional target species, provided that the variation has been submitted at least 3 years before the expiration of the protection period laid down in Article 34(1)(a).
Amendment 228 #
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 4 years.
Amendment 232 #
Proposal for a regulation
Article 35 – paragraph 3
Article 35 – paragraph 3
Amendment 236 #
Proposal for a regulation
Article 35 – paragraph 4 a (new)
Article 35 – paragraph 4 a (new)
4a. Any grant of periods for protection of technical documentation should also be equally applied to innovation performed to generic veterinary medicines, and not only to originators.
Amendment 253 #
Proposal for a regulation
Article 48 – paragraph 2
Article 48 – paragraph 2
Amendment 273 #
Proposal for a regulation
Article 54 – paragraph 2
Article 54 – paragraph 2
2. Member States shall send to the Agency data on the volume of sales and the use of veterinary antimicrobial medicinal products to the Agencyas well as data on how, when, where and why antimicrobials are being used. The Agency shall analyse the data and publish an annual report.
Amendment 302 #
Proposal for a regulation
Article 9 – paragraph 1 – introductory part
Article 9 – paragraph 1 – introductory part
1. The immediate packaging of a veterinary medicinal product shall contain onlyat least the following information:
Amendment 309 #
Proposal for a regulation
Article 10 – paragraph 1 – introductory part
Article 10 – paragraph 1 – introductory part
1. The outer packaging of a veterinary medicinal product shall contain onlyat least the following information:
Amendment 310 #
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, including signs of antimicrobial resistance, following administration to an animal in accordance with the summary of product characteristics;
Amendment 312 #
Proposal for a regulation
Article 73 – paragraph 2 – point c
Article 73 – paragraph 2 – point c
(c) any environmental incidents observed following administration of a veterinary medicinal product to an animal, including incidents of leakage of antibiotic residues into soil and water;
Amendment 316 #
Proposal for a regulation
Article 73 – paragraph 2 – point f a (new)
Article 73 – paragraph 2 – point f a (new)
(fa) any relevant documentation and data on the direct or indirect risks to the environment from the use of antimicrobial medicines in animals.
Amendment 344 #
Proposal for a regulation
Article 16 – paragraph 6
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 veterinaryIf there is evidence that a constituent of a medicinal product tois a hazard for 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 environm, a competent authority or the Agency shall require the safety data concerning the potential risk assessment was required for the reference veterinary medicinal products simultaneously to all the marketing authorisation holders concerned.
Amendment 358 #
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 not retail antimicrobial products only for animals which areand shall only be allowed to provide an emergency dosis after a proper diagnosis for the treatment of animals under their immediate care, and only in the amount required for the treatment concerned.
Amendment 366 #
Proposal for a regulation
Article 108 – paragraph 7 a (new)
Article 108 – paragraph 7 a (new)
7a. Strict control mechanisms, in particular regarding the control of cross- border veterinary prescriptions, shall be in place, leading to dissuasive penalties or prosecutions in case of illegal activity or failure to act according to the professional Code of Conduct. Member States shall develop a system of digital prescription at national level. The Commission shall promote the development of a harmonized system of digital prescription across Europe and assist Member States in its implementation. Delivering and control of prescriptions shall be at national level, at least until a European system enabling the control of cross border prescriptions is in place. A technology system of E- submission of prescriptions on a national database, directly linked to all pharmacies (shops and internet ones), national competent authorities and veterinarians shall be put in place as on-line cross checking by the pharmacy and the prescriber will prevent from frauds and abuse.
Amendment 382 #
Proposal for a regulation
Article 110 – paragraph 3
Article 110 – paragraph 3
3. Where a veterinary medicinal product is supplied on prescription, the quantity prescribed and supplied shall be restricted to the amount required for the treatment or therapy concerned. Preventive use of antimicrobials shall be prohibited.
Amendment 395 #
Proposal for a regulation
Article 115 – paragraph 1
Article 115 – paragraph 1
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 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: (in descending order of preference): (ia) a veterinary medicinal product authorised under this Regulation in the Member State concerned for use with another animal species, or for another condition in the same species; (iib) a veterinary medicinal product authorised under this Regulation in the Member State concerned for the same or another condition in a different species; (c) 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; (iiid) a medicinal product 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)e) only if there is no product as referred to in points (a) - (d), a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription by a person authorised to do so under national legislation. __________________ 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). (Points (i), (ii), (iii) and (b) of Commission text have become points (a), (c), (d), (e) in Parliament’s amendment. Besides point (b) (which has become point (e)) is modified.)
Amendment 403 #
Proposal for a regulation
Article 116 – paragraph 1 – introductory part
Article 116 – 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 food-producing animal of a non-aquatic species, the veterinarian responsible may, under his direct personal responsibility and in particular to avoid causing unacceptable suffering, exceptionally treat the animal concerned with any of the following (in descending order of preference):
Amendment 405 #
Proposal for a regulation
Article 116 – paragraph 1 – point a
Article 116 – paragraph 1 – point a
(a) a veterinary medicinal product authorised under this Regulation in the Member State concerned for use with another food-producing animal species, or for another condition in the same species;
Amendment 406 #
Proposal for a regulation
Article 116 – paragraph 1 – point b
Article 116 – paragraph 1 – point b
(b) a veterinary medicinal product authorised under this Rregulation in another Member State for use in the same species or in anotherconcerned for the same or another condition in a different food- producing species for the same condition or for another condition;
Amendment 407 #
Proposal for a regulation
Article 116 – paragraph 1 – point c
Article 116 – paragraph 1 – point c
(c) a veterinary medicinal product for human use authorisedauthorised under this Regulation in another Member State concerned in accordance with Directive 2001/83/EC or under Regulation (EC) No 726/2004, orfor use in the same species or in another food-producing species for the same condition or for another condition;
Amendment 410 #
Proposal for a regulation
Article 116 – paragraph 1 – point d
Article 116 – paragraph 1 – point d
(d) if there is no product as referred to in point (a), a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription by a person authorised to do so under national legislation.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
Amendment 411 #
Proposal for a regulation
Article 116 – paragraph 1 – point d a (new)
Article 116 – paragraph 1 – point d a (new)
(da) if there is no product as referred to in point (a), a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription by a person authorised to do so under national legislation.
Amendment 413 #
Proposal for a regulation
Article 116 – paragraph 2 – introductory part
Article 116 – paragraph 2 – introductory part
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 (in descending order of preference):
Amendment 414 #
Proposal for a regulation
Article 116 – paragraph 2 – point b
Article 116 – paragraph 2 – point b
(b) veterinary medicinal products authorised under this Regulation in another Member State for use in the same aquatic species or inconcerned for use with another food- producing aquatic species for the condition in question or for another condition.;
Amendment 415 #
Proposal for a regulation
Article 116 – paragraph 2 – point b a (new)
Article 116 – paragraph 2 – point b a (new)
(ba) 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.
Amendment 427 #
Proposal for a regulation
Article 32 – paragraph 3
Article 32 – paragraph 3
3. The Commission shall be empowered to adopt delegated acts in accordance with Article 146 and taking into consideration the scientific advice of the Agency in order to establish rules for the designation of the antimicrobials which are to be reserved for treatment of certain infections in humans in order to preserve the efficacy of certain active substances in humans. The Commission, when establishing these rules, will make decisions on appropriate risk management measures at the class, substance or even the indication level and will consider also the route of administration.
Amendment 429 #
Proposal for a regulation
Article 32 – paragraph 4
Article 32 – paragraph 4
4. The Commission shall, by means of implementing acts and taking into consideration the scientific advice of the Agency, designate antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). The Commission, when establishing these rules, will make decisions on appropriate risk management measures at the class, substance or even the indication level and will consider also the route of administration.
Amendment 445 #
Proposal for a regulation
Article 35 – title
Article 35 – title
Amendment 446 #
Proposal for a regulation
Article 35 – paragraph 1
Article 35 – paragraph 1
1. Where a variation is approved in accordance with Article 65 extending the marketing authorisation to another species listed in Article 34(1)(a), the periogranted of the protection provided for in that Article shall be prolonged by 1 year for each additional target species, provided that the variation has been submitted at least 3 years before the expiration of the protection period laid down in Article 34(1)(a).
Amendment 449 #
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 4 years.
Amendment 453 #
Proposal for a regulation
Article 35 – paragraph 3
Article 35 – paragraph 3
Amendment 457 #
Proposal for a regulation
Article 35 – paragraph 4 a (new)
Article 35 – paragraph 4 a (new)
4a. Any grant of periods for protection of technical documentation should also the equally applied to innovation performed to generic veterinary medicines, and not only to originators.
Amendment 469 #
Proposal for a regulation
Article 48 – paragraph 2
Article 48 – paragraph 2
Amendment 490 #
Proposal for a regulation
Article 54 – paragraph 2
Article 54 – paragraph 2
2. Member States shall send to the Agency data on the volume of sales and the use of veterinary antimicrobial medicinal products to the Agencyas well as data on how, when, where and why antimicrobials are being used. The Agency shall analyse the data and publish an annual report.
Amendment 577 #
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, including signs of antimicrobial resistance, following administration to an animal in accordance with the summary of product characteristics;
Amendment 578 #
Proposal for a regulation
Article 73 – paragraph 2 – point c
Article 73 – paragraph 2 – point c
(c) any environmental incidents observed following administration of a veterinary medicinal product to an animal, including incidents of leakage of antibiotic residues into soil and water;
Amendment 586 #
Proposal for a regulation
Article 73 – paragraph 2 – point f a (new)
Article 73 – paragraph 2 – point f a (new)
(fa) any relevant documentation and data on the direct or indirect risks to the environment of use of antimicrobial medicines in animals;
Amendment 697 #
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 not retail antimicrobial products and shall only be allowed to provide an emergency doses after a proper diagnosis for the treatment of animals only for animals which are under their immediate care, and only in the amount required for the treatment concerned.
Amendment 727 #
Proposal for a regulation
Article 108 – paragraph 7 a (new)
Article 108 – paragraph 7 a (new)
7a. Strict control mechanisms, in particular regarding the control of cross- border veterinary prescriptions, shall be in place, leading to dissuasive penalties or prosecutions in case of illegal activity or failure to act according to the professional Code of Conduct. Member States shall develop a system of digital prescription at national level. The Commission shall promote the development of a harmonized system of digital prescription across Europe and assist Member States in its implementation. Delivering and control of prescriptions shall be at national level, at least until a European system enabling the control of cross border prescriptions is in place. A technology system of E- submission of prescriptions on a national database, directly linked to all pharmacies (shop and internet ones), national competent authorities and veterinarians shall be put in place as on-lime cross checking by the pharmacy and the prescriber will prevent from frauds and abuse.
Amendment 763 #
Proposal for a regulation
Article 110 – paragraph 3
Article 110 – paragraph 3
3. Where a veterinary medicinal product is supplied on prescription, the quantity prescribed and supplied shall be restricted to the amount required for the treatment or therapy concerned. Preventive use of antimicrobials shall be prohibited.
Amendment 808 #
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 responsible may, under his/her direct personal responsibility and in particular to avoid causing unacceptable suffering, exceptionally treat the animal concerned with the following (in descending order of preference):
Amendment 809 #
Proposal for a regulation
Article 115 – paragraph 1 – point a
Article 115 – paragraph 1 – point a
Amendment 811 #
Proposal for a regulation
Article 115 – paragraph 1 – point a – point i
Article 115 – paragraph 1 – point a – point i
Amendment 813 #
Proposal for a regulation
Article 115 – paragraph 1 – point a – point ii
Article 115 – paragraph 1 – point a – point ii
Amendment 816 #
Proposal for a regulation
Article 115 – paragraph 1 – point a – point iii
Article 115 – paragraph 1 – point a – point iii
Amendment 822 #
Proposal for a regulation
Article 115 – paragraph 1 – point a a (new)
Article 115 – paragraph 1 – point a a (new)
(aa) (a) a veterinary medicinal product authorised under this Regulation in the Member State concerned for use with another animal species, or for another condition in the same species; (b) a veterinary medicinal product authorised under this regulation in the Member State concerned for the same or another condition in a different species; (c) 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; (d) a medicinal product for human use authorised in the Member State concerned in accordance with Directive 2001/83/EC of the European Parliament and of the Council or Regulation (EC) No 726/2004; (e) only if there is no products as referred to in points (a) -(d), a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription by a person authorised to do so under national legislation.
Amendment 823 #
Proposal for a regulation
Article 115 – paragraph 1 – point b
Article 115 – paragraph 1 – point b
Amendment 833 #
Proposal for a regulation
Article 116 – paragraph 1 – introductory part
Article 116 – 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 food-producing animal of a non-aquatic species, the veterinarian responsible may, under his direct personal responsibility and in particular to avoid causing unacceptable suffering, exceptionally treat the animal concerned with any of the following (in descending order of preference):
Amendment 838 #
Proposal for a regulation
Article 116 – paragraph 1 – point a
Article 116 – paragraph 1 – point a
(a) a veterinary medicinal product authorised under this Regulation in the Member State concerned for use with another food-producing animal species, or for another condition in the same species;
Amendment 841 #
Proposal for a regulation
Article 116 – paragraph 1 – point b
Article 116 – paragraph 1 – point b
(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 conditionconcerned for the same or another condition or for another condition in different food-producing species;
Amendment 845 #
Proposal for a regulation
Article 116 – paragraph 1 – point c
Article 116 – paragraph 1 – point c
(c) a veterinary medicinal product for human use authorisedauthorised under this Regulation in another Member State concerned in accordance with Directive 2001/83/EC or under Regulation (EC) No 726/2004, orfor use in the same species or in another food-producing species for the same condition or for another condition;
Amendment 852 #
Proposal for a regulation
Article 116 – paragraph 1 – point d
Article 116 – paragraph 1 – point d
(d) if there is no product as referred to in point (a), a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription by a person authorised to do so under national legislation.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
Amendment 854 #
Proposal for a regulation
Article 116 – paragraph 1 – point d a (new)
Article 116 – paragraph 1 – point d a (new)
(da) (e) if there is no product as referred to in point (a), a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription by a person authorised to do so under national legislation.
Amendment 857 #
Proposal for a regulation
Article 116 – paragraph 2 – introductory part
Article 116 – paragraph 2 – introductory part
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 (in descending order of preference):
Amendment 858 #
Proposal for a regulation
Article 116 – paragraph 2 – point b
Article 116 – paragraph 2 – point b
(b) veterinary medicinal products authorised under this Regulation in another Member State for use in the same aquatic species or inconcerned for use with another food- producing aquatic species for the condition in question or for another condition.;
Amendment 859 #
Proposal for a regulation
Article 116 – paragraph 2 – point b a (new)
Article 116 – paragraph 2 – point b a (new)
(ba) (c) 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.