BETA

100 Amendments of Pavel POC related to 2014/0257(COD)

Amendment 136 #
Proposal for a regulation
Recital 27 a (new)
(27a) In accordance with Directive 2010/63/EU, it is necessary to replace, reduce or refine testing on vertebrate animals. Implementation of this Regulation should be based on the use of alternative test methods, suitable for the assessment of health and environmental hazards of products, wherever possible.
2015/06/17
Committee: ENVI
Amendment 204 #
Proposal for a regulation
Article 1 – paragraph 1
This Regulation lays down rules for the placing on the market, development, manufacture, import, export, wholesale distribution, retail supply, pharmacovigilance, control and use of veterinary medicinal products.
2015/06/17
Committee: ENVI
Amendment 212 #
Proposal for a regulation
Article 3 – paragraph 1
1. Where a veterinary medicinal product referIn cases of doubt, whered to in Article 2(1) also falls within the scope of Regulation (EU) No 528/2012 of the European Parliament and of the Council21 or Regulation (EC) No 1831/2003 of the European Parliament and of the Council, and there is a conflict between the provisaking into account all its characteristics, a product may fall within the definition of a "veterinary medicinal product" and within the definitions of this Regulation and the provisions of Regulation (EU) No 528/2012 or Regulation (EC) No 1831/2003a product covered by other Union legislation, the provisions of this Regulation shall prevailapply. __________________ 21 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).
2015/06/17
Committee: ENVI
Amendment 213 #
Proposal for a regulation
Article 4 – paragraph 1 – point 1 – point b
(b) its purpose is to may be used in, or administered to, animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis;
2015/06/17
Committee: ENVI
Amendment 214 #
Proposal for a regulation
Article 4 – paragraph 1 – point 1 – point c
(c) its purpose is to may be used for euthanasia ofin animals;
2015/06/17
Committee: ENVI
Amendment 219 #
Proposal for a regulation
Article 4 – paragraph 1 – point 2 – point c a (new)
(ca) fungal
2015/06/17
Committee: ENVI
Amendment 220 #
Proposal for a regulation
Article 4 – paragraph 1 – point 2 – point c b (new)
(cb) microbial
2015/06/17
Committee: ENVI
Amendment 233 #
Proposal for a regulation
Article 4 – paragraph 1 – point 8
(8) 'antimicrobial resistance' means the ability of microorganisms to survive or to grow in the presence of a concentrationbacteria to withstand the effects of an antimicrobial agent which is usually sufficient to inhibit or kill microorganisms of the same speciess that are intended to inhibit or kill them;
2015/06/17
Committee: ENVI
Amendment 234 #
Proposal for a regulation
Article 4 – paragraph 1 – point 8 a (new)
(8a) “antimicrobials” mean any compound with a direct action on micro- organisms used for treatment or prevention of infections. Antimicrobials include anti-bacterials, anti-virals, antifungals and anti-protozoals. Antibiotics are synonymous with anti- bacterials.
2015/06/17
Committee: ENVI
Amendment 235 #
Proposal for a regulation
Article 4 – paragraph 1 – point 9
(9) ‘clinical trial' means a study which aims to examcientific study not fallineg under field conditions the safety or efficacy of a veterinary medicinal product or boththe scope of Directive 2010/63/EU, conducted in a target species in accordance with good clinical practice under normalfield conditions of animal husbandry or as part of normal veterinary practiceto test at least one hypothesis relevant to efficacy claim or to in-use safety in the target animal for a veterinary medicinal product under investigation for the purpose of obtaining a marketing authorisation for a change thereofthe veterinary medicinal product concerned or variation thereof; in case of immunological veterinary medicinal product the study is a "field trial";
2015/06/17
Committee: ENVI
Amendment 239 #
Proposal for a regulation
Article 4 – paragraph 1 – point 10
(10) 'pre-clinical study' means a study not covered by the definition of clinical trial conducted in accordance with good laboratory practice 1 a, which aims to investigate the safety or efficacy of a veterinary medicinal product for the purpose of obtaining a marketing authorisation or a change thereof;a variation thereof __________________ 1a Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) and Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances
2015/06/17
Committee: ENVI
Amendment 241 #
Proposal for a regulation
Article 4 – paragraph 1 – point 11 – introductory part
(11) 'benefit-risk balance' means an evaluation of the positive therapeutic effects of the veterinary medicinal product in relation to the following risks relating to the use of that product:
2015/06/17
Committee: ENVI
Amendment 242 #
Proposal for a regulation
Article 4 – paragraph 1 – point 12
(12) 'common name' means the international non-proprietary name recommended by the World Health Organisation for a veterinary medicinal product, or, if one does not exist, the name generally usedusual common name;
2015/06/17
Committee: ENVI
Amendment 243 #
Proposal for a regulation
Article 4 – paragraph 1 – point 18
(18) 'package leaflet' means a documentn information leaflet on awhich attached to a veterinary medicinal product which is intended for a user of the veterinary medicinal product and which contains information to ensure its safe and efficacious use; which are compliant with the information provided for in the summary of product characteristics of the veterinary medicinal product;
2015/06/17
Committee: ENVI
Amendment 244 #
Proposal for a regulation
Article 4 – paragraph 1 – point 20 – introductory part
(20) ‘limited market' means a market for one of the following'veterinary medicinal product for limited market' means a veterinary medicinal product intended for a target species and/or therapeutic indication where the Union identifies a public interest to improve availability of authorised veterinary medicinal product types:s.
2015/06/17
Committee: ENVI
Amendment 245 #
Proposal for a regulation
Article 4 – paragraph 1 – point 20 – point a
(a) veterinary medicinal products for the treatment or prevention of diseases that occur infrequently or in limited geographical areas;deleted
2015/06/17
Committee: ENVI
Amendment 246 #
Proposal for a regulation
Article 4 – paragraph 1 – point 20 – point b
(b) veterinary medicinal products for animal species other than cattle, sheep, pigs, chickens, dogs and cats;deleted
2015/06/17
Committee: ENVI
Amendment 249 #
Proposal for a regulation
Article 4 – paragraph 1 – point 21
(21) 'pharmacovigilance' means the process of monitscientific, control and administrative activities relating to detection, reporting, and inssessment, understanding, prevesntigating adverse evenon and communication of adverse events which include continuous evaluation of the benefit risk balance of veterinary medicinal products;
2015/06/17
Committee: ENVI
Amendment 255 #
Proposal for a regulation
Article 4 – paragraph 1 – point 25
(25) 'withdrawal period' means the minimum period between the last administration of a veterinary medicinal product to an animal under normal conditions of use and in accordance with the provisions of this Regulation and the production of foodstuffs from that animal which under normal conditions of use is necessary to ensure that such foodstuffs do not contain residues in quantities harmful to public healthcomply with requirements laid down pursuant to Regulation (EC) 470/2009;
2015/06/17
Committee: ENVI
Amendment 256 #
Proposal for a regulation
Article 4 – paragraph 1 – point 26
(26) ‘making available on the market' means any supply of a veterinary medicinal product for distribution, consumption or use on the Union market of a Member State in the course of a commercial activity, whether in return for payment or free of charge;
2015/06/17
Committee: ENVI
Amendment 257 #
Proposal for a regulation
Article 4 – paragraph 1 – point 27
(27) 'placing on the market' means the first making available of a veterinary medicinal product on the UnionMember State market.
2015/06/17
Committee: ENVI
Amendment 266 #
Proposal for a regulation
Article 4 – paragraph 1 a (new)
'wholesale distribution' means all activities consisting of procuring, holding, supplying or exporting veterinary medicinal products, whether in return for payment or free of charge, apart from retail supply. Such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorized or entitled to supply medicinal products to the public in accordance with applicable national law;
2015/06/17
Committee: ENVI
Amendment 267 #
Proposal for a regulation
Article 4 – paragraph 1 b (new)
'name of veterinary medicinal product' means the name, which may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trademark or the name of the marketing authorisation holder;
2015/06/17
Committee: ENVI
Amendment 268 #
Proposal for a regulation
Article 4 – paragraph 1 c (new)
'pre-mix for medicated feedingstuffs' means any veterinary medicinal product prepared in advance with a view to the subsequent manufacture of medicated feeding stuffs according to the Regulation 2014/0255(COD) on the Manufacture, placing on the market and use of medicated feed and repealing Council Directive 90/167/EC
2015/06/17
Committee: ENVI
Amendment 269 #
Proposal for a regulation
Article 5 – paragraph 1
1. AWithout prejudice to other provisions of this Regulation, a veterinary medicinal product shall be placed on the market of a Member State only when a marketing authorisation has been granted in respect of the product by a the competent authority in accordance with Articles 44, 46 or 48of that Member State or by the Commission in accordance with Article 40this Regulation.
2015/06/17
Committee: ENVI
Amendment 275 #
Proposal for a regulation
Article 5 – paragraph 2
2. AWithout prejudice to Article (...references to be completed...), marketing authorisation for a veterinary medicinal product shall be valid for an unlimited period of time.
2015/06/17
Committee: ENVI
Amendment 278 #
Proposal for a regulation
Article 5 – paragraph 2 a (new)
2a. The marketing authorisation holder shall be responsible for marketing the medicinal product. The designation of a representative shall not relieve the marketing authorisation holder of his legal responsibility.
2015/06/17
Committee: ENVI
Amendment 279 #
Proposal for a regulation
Article 6 – paragraph 1 – point b
(b) the decentralised procedure laid down in Articles 45, 46 and 4657;
2015/06/17
Committee: ENVI
Amendment 280 #
Proposal for a regulation
Article 6 – paragraph 1 – point c
(c) the mutual recognition procedure laid down in Articles 47, 48 and 4857.
2015/06/17
Committee: ENVI
Amendment 281 #
Proposal for a regulation
Article 6 – paragraph 3
3. Applications shall be submitted electronically. For applications submitted or saved in exceptional circumstances and following accordance with the centralised marketing authorisation procedure, the formgreement with a competent authority, or, in case of central application, with the Agency. The Commission, in collaboration with the Member States made available byand with the Agency shall be usedadopt detailed guidelines for the format of electronic applications.
2015/06/17
Committee: ENVI
Amendment 283 #
Proposal for a regulation
Article 6 – paragraph 5
5. Within 15 days of receipt of the application, the competent authority or the Agency shall notify the applicant of whether all data required in accordance with Article 7 have been presout prejudice to specific provisions related to Mutual Recognition Procedure and Decentralised Procedure, the competent authority or the Agency shall, within 15 days of receipt of the application, notify the applicant of the formal requirements laid down in this Regulation for the application concerned have been met and whether the application can be subject to scientific assessmented.
2015/06/17
Committee: ENVI
Amendment 284 #
Proposal for a regulation
Article 7 – paragraph 1
1. An application for a marketing authorisation shall contain the following information: (a) the administrative information set out in Annex I; (b) technical documentation satisfying the requirements set out in Annex II; (c) the information to be provided in the immediate packaging, outer packaging and the package leaflet in accordance with Articles 9 to 14.deleted
2015/06/17
Committee: ENVI
Amendment 285 #
Proposal for a regulation
Article 7 – paragraph 1 a (new)
1a. The application for a marketing authorisation shall contain all administrative information and scientific documentation necessary for demonstrating the quality, safety and efficacy of the veterinary medicinal product in question. The dossier shall be submitted in accordance with Annex I and shall contain, in particular, the following information: (a) name or business name and permanent address or registered place of business of the person responsible for placing the product on the market and, if different, of the manufacturer or manufacturers involved and of the sites of manufacture; (b) name of veterinary medicinal product; (c) qualitative and quantitative particulars of all the constituents of the veterinary medicinal product, including its international non- proprietary name (INN) recommended by the WHO, where an INN exists, or its chemical name; (d) description of the method of manufacture; (e) therapeutic indications, contra- indications and adverse reactions; (f) dosage for the various species of animal for which the veterinary medicinal product is intended, its pharmaceutical form, method and route of administration and proposed shelf life; (g) reasons for any precautionary and safety measures to be taken when storing the veterinary medicinal product, administering it to animals and disposing of waste, together with an indication of potential risks that the veterinary medicinal product might pose to the environment, to human and animal health and to plants; (h) indication of the withdrawal period in the case of medicinal products intended for food-producing species; (i) description of the testing methods employed by the manufacturer; (j) results of: – pharmaceutical (physico-chemical, biological or microbiological) tests, – safety tests and residue tests, – pre-clinical and clinical trials; – tests assessing the potential risks posed by the medicinal product for the environment. This impact shall be studied and consideration shall be given on a case-by-case basis to specific provisions seeking to limit it. (k) proof of validity of the pharmacovigilance system master file; (l) a summary of product characteristics in accordance with Article 30 as well as the information to be provided in the immediate packaging, outer packaging and the package leaflet in accordance with Articles 9 to 14 (m) proof of a manufacturing authorisation for all
2015/06/17
Committee: ENVI
Amendment 290 #
Proposal for a regulation
Article 7 – paragraph 3
3. Where the application concerns a veterinary medicinal product intended for food-producing target species and containing pharmacologically active substances that are not listed in Table 1 of the Annex to Regulation (EU) No 37/2010 for the animal species in question, a document shall be submitted in addition to the information listed in paragraph 1 certifying that a valid application for the establishment of maximum residue limits has been submitted to the Agency in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council22 shall be submitted in addition to the information listed in paragraph 1. and that at least six months has elapsed from submission of such application __________________ 22 Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).
2015/06/17
Committee: ENVI
Amendment 293 #
Proposal for a regulation
Article 7 – paragraph 7
7. The Commission shall be empowered to adopt delegated acts in accordance with Article 146 in order to amend Annexes I and II to adapt the information and documentation requirements to technical and scientific progressAnnex I shall be adopted by the Council and European Parliament acting under the conditions provided for by the Treaty on a proposal from the Commission.
2015/06/17
Committee: ENVI
Amendment 322 #
Proposal for a regulation
Article 12 – paragraph 1 – introductory part
1. The package leaflet shall be available forttached to each veterinary medicinal product and shall contain at least the following information:
2015/06/17
Committee: ENVI
Amendment 372 #
Proposal for a regulation
Article 23 – paragraph 1 – introductory part
1. The competent authority or the AgencyCommittee for Medicinal Products for Veterinary Use set up by Article 139 ("Committee") to which the application has been submitted in accordance with Article 6 shall:
2015/06/17
Committee: ENVI
Amendment 375 #
Proposal for a regulation
Article 23 – paragraph 2
2. During the process of assessing applications for marketing authorisations for veterinary medicinal products containing or consisting of genetically modified organisms as referred to in Article 7(5), the necessary consultations shall be held by the AgencyCommittee with the bodies set up by the Union or Member States in accordance with Directive 2001/18/EC.
2015/06/17
Committee: ENVI
Amendment 376 #
Proposal for a regulation
Article 24 – paragraph 1 – introductory part
1. The competent authority or the AgencyCommittee examining the application may require an applicant to provide samples of the veterinary medicinal product to the Union reference laboratory, an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose to:
2015/06/17
Committee: ENVI
Amendment 379 #
Proposal for a regulation
Article 26 – paragraph 1
The competent authority or the AgencyCommittee to which the application has been submitted in accordance with Article 6 shall inform the applicant if the documentation submitted in support of the application is insufficient. The competent authority or the AgencyCommittee shall request the applicant to provide the documentation within a given deadline. In such case the time limits laid down in Articles 40, 44, 46 and 48 shall be suspended until the deadline has elapsed.
2015/06/17
Committee: ENVI
Amendment 380 #
Proposal for a regulation
Article 28 – paragraph 1 – introductory part
1. Inf case of favourable assessmentonditions to grant a marketing authorisation according to this Regulation have been met for the application concerned, the competent authority or the AgencyCommittee examining the application shall prepare an opinion including the following documents:
2015/06/17
Committee: ENVI
Amendment 385 #
Proposal for a regulation
Article 29 – paragraph 1 a (new)
1a. Member States may on their territories provide for additional legal subcategories in accordance with the respective national legislation.
2015/06/17
Committee: ENVI
Amendment 386 #
Proposal for a regulation
Article 29 – paragraph 1 b (new)
1b. Where the veterinary medicinal product authorised under Article 38 is classified as not subject to veterinary prescription, the Member State may, in order to safeguard animal health or welfare, public health or the environment, classify such product as subject to veterinary prescription in accordance with the respective national legislation.
2015/06/17
Committee: ENVI
Amendment 391 #
Proposal for a regulation
Article 29 – paragraph 3 – introductory part
3. By the way of derogation from paragraph 1, a competent authority or the AgencyCommission may not classify a veterinary medicinal product as subject to veterinary prescription if all of the following conditions are fulfilled:
2015/06/17
Committee: ENVI
Amendment 397 #
Proposal for a regulation
Article 29 – paragraph 3 – point h
(h) there is no risk to public or animal health as regards the development of resistance to anthelmintic subantimicrobial or antiparasitic resistances even where the veterinary medicinal products containing those substances are used incorrectly.
2015/06/17
Committee: ENVI
Amendment 426 #
Proposal for a regulation
Article 32 – paragraph 3
3. The Commission shall be empowered to adopt delegated acts in accordance with Article 146 in order to establishuncil and European Parliament acting under the conditions provided for by the Treaty on a proposal from the Commission shall be empowered to adopt 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.
2015/06/17
Committee: ENVI
Amendment 459 #
Proposal for a regulation
Article 38 – paragraph 2 – point c
(c) veterinary medicinal products containing an active substance which has not been authorised as a veterinary medicinal product within the Union at the date of the submission of the application;deleted
2015/06/17
Committee: ENVI
Amendment 462 #
Proposal for a regulation
Article 38 – paragraph 2 – point e
(e) generic veterinary medicinal products of reference veterinary medicinal products authorised under the centralised authorisation procedure.deleted
2015/06/17
Committee: ENVI
Amendment 464 #
Proposal for a regulation
Article 38 – paragraph 4
4. The Commission, taking into account the state of animal and public health in the Union, shall be empowered to adopt delegated acts in accordance with Article 146 in order to amend the list set out in paragraph 2.deleted
2015/06/17
Committee: ENVI
Amendment 466 #
Proposal for a regulation
Article 46 – paragraph 2
2. The application shall list Member States where the applicant seeks to obtain a marketing authorisation ('Member States concerned'). The applicant shall send application identical to that submitted to the reference Member State, including identical dossier as provided under Article 7, to all Member States concerned.
2015/06/17
Committee: ENVI
Amendment 468 #
Proposal for a regulation
Article 48 – paragraph 1
1. AIdentical applications for mutual recognition of marketing authorisations shall be submitted to the Member State that granted the first national marketing authorisation (‘reference"reference Member State") and the Member States where the applicant seeks to obtain recognition of the marketing authorisation ('concerned Member States').
2015/06/17
Committee: ENVI
Amendment 470 #
Proposal for a regulation
Article 48 – paragraph 3 – point c
(c) an information about the Member States in which an application for a marketing authorisation submitted by the applicant for the same veterinary medicinal product is under examinconsolidated dossier available to the reference Member State at the date of submission of the application;
2015/06/17
Committee: ENVI
Amendment 471 #
Proposal for a regulation
Article 48 – paragraph 4
4. Within 90 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 ofconcerned Member States whereand the applicant seeks to obtain recognition of the marketing authorisation (‘concerned Member States').
2015/06/17
Committee: ENVI
Amendment 499 #
Proposal for a regulation
Article 58
Variations to the terms of a marketing 1. Variation to the terms of a marketing authorisation means a change to the terms of the marketing authorisation for a veterinary medicinal product as referred to in Article 31 (‘variation'). 2. The Commission shall, by means of implementing acts, establish a list of variations to the terms of a marketing authorisation for a veterinary medicinal product requiring assessment (‘variations requiring assessment'). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). 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.Article 58 deleted authorisation
2015/06/17
Committee: ENVI
Amendment 503 #
Proposal for a regulation
Article 58 a (new)
Article 58a 1. Variation to the terms of a marketing authorisation (''variation') means an amendment to the contents of the particulars and documents and/or conditions referred to in Articles 7(1), 16, 17, 18, 19, 20 and 28: 2. The Commission shall adopt appropriate arrangements for the examination of variations to the terms of marketing authorisations granted in accordance with this Regulation. The Commission shall adopt these arrangements in the form of an implementing regulation. That measure, designed to amend non-essential elements of this Regulation, by supplementing it, shall be adopted in accordance with the examination procedure referred to in Article 145(2). 3. By (...insert date 12 months after this Regulation comes into force...), the Commission shall submit a report to the European Parliament and to the Council to review experience gained from application of Regulation 1234/2008. The report shall, if appropriate, be accompanied by relevant proposals to amend Regulation 1234/2008.
2015/06/17
Committee: ENVI
Amendment 504 #
Proposal for a regulation
Article 59
Where a variation entails consequential changes to the summary of the product characteristics, the labelling or the package leaflet, those changes shall be considered as part of that variation for the purposes of the examination of the application for a variation.Article 59 deleted Consequential changes to product information
2015/06/17
Committee: ENVI
Amendment 506 #
Proposal for a regulation
Article 60
Variations to the terms of a marketing 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 authorisation that do not require assessment
2015/06/17
Committee: ENVI
Amendment 507 #
Proposal for a regulation
Article 61
1. Marketing authorisation holder shall submit an application for a variation requiring assessment to a competent authority or to the Agency. 2. The application referred to in paragraph 1 shall contain: (a) a description of the variation; (b) reference to marketing authorisations affected by the application; (c) where the variation leads to other variations to the terms of the same marketing authorisation, a description of those other variations; (d) where the variation concerns marketing authorisations granted under the mutual recognition or decentralised procedures, a list of Member States which granted those marketing authorisations.Article 61 deleted Application for variations requiring assessment
2015/06/17
Committee: ENVI
Amendment 508 #
Proposal for a regulation
Article 62
When applying for several variations to the terms of the same marketing authorisation, a marketing authorisation holder may submit one application for allArticle 62 deleted Groups of variations.
2015/06/17
Committee: ENVI
Amendment 509 #
Proposal for a regulation
Article 63
1. When applying for variations to the terms of several marketing authorisations held by the same marketing authorisation holder and granted by different competent authorities and/or the Commission, the marketing authorisation holder shall submit an application to all competent authorities concerned and the Agency. 2. Where one of the marketing authorisations referred to in paragraph 1 is a centralised marketing authorisation, the Agency shall assess the application in accordance with the procedure laid down in Article 64. 3. Where none of the marketing authorisations referred to in paragraph 1 is a centralised marketing authorisation, the coordination group shall assign a competent authority among those having granted the marketing authorisations to assess the application in accordance with the procedure laid down in Article 64.Article 63 deleted Worksharing procedure
2015/06/17
Committee: ENVI
Amendment 510 #
Proposal for a regulation
Article 64
[...]deleted
2015/06/17
Committee: ENVI
Amendment 512 #
Proposal for a regulation
Article 65
Measures to close the procedures for variations requiring assessment 1. Within 30 days of the completion of the procedure laid down in Article 64(6) and (7) a competent authority or the Commission shall amend the marketing authorisation or reject the variation and inform the applicant of the grounds for the rejection. In case of centralised marketing authorisation, the Commission shall, by means of implementing acts, take a final decision amending the marketing authorisation or rejecting the variation. These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). 2. Where the draft decision is not in accordance with the opinion of the Agency, the Commission shall annex a detailed explanation of the reasons for not following the opinion of the Agency. 3. The competent authority or the Agency shall notify the marketing authorisation holder of the amended marketing authorisation without delay. 4. The product database shall be updated accordingly.Article 65 deleted
2015/06/17
Committee: ENVI
Amendment 513 #
Proposal for a regulation
Article 66
Where the opinion is prepared by a competent authority assigned in accordance with Article 63(3), each competent authority concerned shall amend the marketing authorisation granted by it or reject the variation in line with the opinion prepared by the competent authority assigned in accordance with Article 63(3). However, if a competent authority does not agree with the opinion, the coordination group review procedure laid down in Article 49 shall apply.Article 66 deleted Coordination group review
2015/06/17
Committee: ENVI
Amendment 514 #
Proposal for a regulation
Article 67
Implementation of variations requiring 1. A marketing authorisation holder may implement a variation requiring assessment only after a competent authority or the Commission has amended the decision granting the marketing authorisation in accordance with that variation and the holder has been notified thereof. 2. Where requested by a competent authority or the Agency, a marketing authorisation holder shall supply without delay any information related to a variation to the terms of a marketing authorisation.Article 67 deleted assessment
2015/06/17
Committee: ENVI
Amendment 515 #
Proposal for a regulation
Article 68
Preparatory phase of the harmonisation 1. A harmonised summary of product characteristics shall be prepared in accordance with the procedure laid down in Article 69 for veterinary medicinal products, other than homeopathic veterinary medicinal products, which have the same qualitative and quantitative composition of their active substances and the same pharmaceutical form and for which national marketing authorisations have been granted in different Member States before 1 January 2004 (‘similar products'). 2. For the purposes of determining qualitative and quantitative composition of the active substances, different salts, esters, ethers, isomers, mixtures of isomers, complexes and derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety or efficacy.Article 68 deleted exercise
2015/06/17
Committee: ENVI
Amendment 525 #
Proposal for a regulation
Article 68 a (new)
Article 68a 1. Harmonization should be based on individual products or closely related product (e.g. the same products authorized by different marketing authorization holders in different Member States considered to be "one entity" as defined in the Commission Communication 98/C 229/03), and it should not be based on groups of independent products which may differ significantly in terms of their quality, safety and efficacy 2. Harmonization shall be based on a consolidated dossier which shall be prepared by the marketing authorization holder – the SPC resulting from the harmonization exercise shall be based on the scientific evidence data for the respective product 3. The responsibility to propose the harmonized SPC shall rest with the marketing authorization holders 4. Where species/indications are not supported by scientific evidence in the dossier for the product, the Member States must not be forced to accept such indications 5. withdrawal periods must be based on product related residue depletion data and Member States must have the right to refuse withdrawal periods which are not justified due to public health protection as well as huge impacts on trade with animal products containing residues above the established maximum residue limits 6. As the dossiers for nationally authorized products are available to the national competent authorities, Committee for Veterinary Medicinal products should not be involved in identification of products which shall be subject to harmonization but this task should be conferred to the Co-ordination group 7. Rules need to be clear to ensure transparent and predictable legal environment 8. Regarding the regulatory procedure, a workable procedure shall be used for the harmonization exercise – e.g. Type II variation procedure 9. As a part of the harmonization procedure, the products shall be upgraded to the "MRP status" (products authorized under the Mutual Recognition Procedure) 10. Relationships between originators and generics, and responsibilities of marketing authorisation holders for both types of products, must be carefully balanced and in principle, where the originator product has been authorized, the generic product shall follow such harmonization.
2015/06/17
Committee: ENVI
Amendment 526 #
Proposal for a regulation
Article 69
summaries of products characteristics 1. By [12 months after the date of application of this Regulation for OP to insert the actual date] competent authorities shall provide the coordination group with lists of all products for which national marketing authorisations have been granted before 1 January 2004. 2. The coordination group shall establish groups of similar products. For each of the groups of similar products, the coordination group shall appoint one member to act as a rapporteur. 3. Within 120 days of his appointment, the rapporteur shall present the coordination group a report regarding possible harmonisation of summaries of product characteristics for the similar veterinary medicinal products in the group and propose a harmonised summary of products characteristics. 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. 5. Upon presentation of a report, the coordination group shall act by a majority of the votes cast by the members of the coordination group represented at the meeting. The rapporteur shall record the agreement, close the procedure and inform Member States and the marketing authorisation holders accordingly. 6. In the event of an opinion in favour of adopting a harmonised summary of the product characteristics, each Member State shall vary a marketing authorisation in conformity with the agreement within 30 days of receipt of the information regarding the agreement from the rapporteur. 7. In the event of an unfavourable opinion, the procedure referred to in Article 49 shall apply.Article 69 deleted Procedure for harmonisation of
2015/06/17
Committee: ENVI
Amendment 553 #
Proposal for a regulation
Article 70
Harmonisation of summary of products characteristics following reassessment 1. By way of derogation from Article 69, the Committee may recommend to the Commission groups of similar veterinary medicinal products for which a scientific reassessment is necessary before a harmonised summary of the product characteristics is prepared. 2. The Commission shall, by means of implementing acts, adopt decisions on groups of product for which a reassessment is necessary. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). 3. By way of derogation from Article 69, veterinary medicinal products authorised before 20 July 2000 as well as veterinary medicinal products authorised after that date but which were identified as potentially harmful to the environment in the course of the environmental risk assessment shall be reassessed before a harmonised summary of the product characteristics is prepared. 4. For the purposes of paragraphs 1 and 3, the procedure for a Union interest referral in accordance with Articles 84 to 87 shall apply accordingly.Article 70 deleted
2015/06/17
Committee: ENVI
Amendment 556 #
Proposal for a regulation
Article 71
Position of marketing authorisation Upon request from the coordination group or the Agency, holders of the marketing authorisations for products included in a group of similar products identified for a harmonisation of the summaries of the product characteristics shall submit information concerning their products.Article 71 deleted holder
2015/06/17
Committee: ENVI
Amendment 562 #
Proposal for a regulation
Article 72 – paragraph 1
1. Marketing authorisation holders shall elaborate and maintain a system for collectingnsure that benefit-risk balance of the authorised veterinary medicinal products is evaluated on a continuous basis and that appropriate measure are taken by the marketing authorisation holders in order ensure that the benefit-risk balance remains positive for the authorised veterinary medicinal products. To this end, the marketing authorisation holders elaborate and maintain a system for collecting, investigating, assessment and communicating of information on the risks of veterinary medicinal products as regards animal health, public health and the environment enabling them to fulfil their pharmacovigilance responsibilities listed in Articles 73, 76 and 77 ('pharmacovigilance system').
2015/06/17
Committee: ENVI
Amendment 564 #
Proposal for a regulation
Article 72 – paragraph 2
2. Competent authorities and the Agency, where the centrally authorised products are concerned, the Committee shall supervise the pharmacovigilance systems of marketing authorisation holders.
2015/06/17
Committee: ENVI
Amendment 569 #
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, on a continuous basis benefit-risk balance of authorised veterinary medicinal products, and enabling them to fulfil their responsibilities as listed in Articles 77 and 79 ('Union pharmacovigilance system').
2015/06/17
Committee: ENVI
Amendment 575 #
Proposal for a regulation
Article 73 – paragraph 2 – point a
(a) any response in an animal to a veterinary or human medicinal product, that is noxious and unintended;
2015/06/17
Committee: ENVI
Amendment 592 #
Proposal for a regulation
Article 73 – paragraph 2 a (new)
2a. Competent authorities and the Agency shall, in addition to the events provided under Paragraph 2, make available to healthcare professionals and animal holders different means of reporting to them any response in an animal to a human medicinal product.
2015/06/17
Committee: ENVI
Amendment 598 #
Proposal for a regulation
Article 74 – paragraph 2
2. The AgencyCommission shall, in collaboration with the Agency and with the Member States and the Commission, draw up the functional specifications for the pharmacovigilance database.
2015/06/17
Committee: ENVI
Amendment 603 #
Proposal for a regulation
Article 75 – paragraph 3 – point a
(a) the number of adverse events reported each year, broken down by type of product, animal species and type of adverse event;
2015/06/17
Committee: ENVI
Amendment 607 #
Proposal for a regulation
Article 76 – paragraph 1
1. Competent authorities shall record in the pharmacovigilance database all adverse events which were reported to them by healthcare professionals and animal holders and that occurred in the territory of their Member State, within 30 days following the receipt of the adverse event report. Serious adverse event in animals, noxious response in humans to a veterinary medicinal product and environmental incidents observed following administration of a veterinary medicinal product to an animal shall be reported within 15 days following the receipt of such adverse event report.
2015/06/17
Committee: ENVI
Amendment 611 #
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 healthcare professionals and animal holders and that occurred within the Union or in a third country with regard to their authorised veterinary medicinal products, within 30 days following the receipt of the adverse event report. Serious adverse event in animals, noxious response in humans to a veterinary medicinal product and environmental incidents observed following administration of a veterinary medicinal product to an animal shall be reported within 15 days following the receipt of such adverse event report.
2015/06/17
Committee: ENVI
Amendment 619 #
Proposal for a regulation
Article 77 – paragraph 1
1. The marketing authorisation holder shall be responsible for the pharmacovigilance of the products for which he holds a marketing authorisation. To this end, the holder of a marketing authorisation for a veterinary medicinal product shall establish a contact point for adverse events reporting in each Member State where the veterinary medicinal product is authorised to facilitate averse events reporting by the animal health professionals and animal owners in the official language in that Member State. Such contact point shall be a part of the marketing authorisation holder´s pharmacovigilance master file and shall be under the supervision of the competent authority in that Member State.
2015/06/17
Committee: ENVI
Amendment 621 #
Proposal for a regulation
Article 77 – paragraph 1 a (new)
1a. The Commission shall be empowered to adopt delegated acts in accordance with Article 146 in order to set up requirements for submission of reports provided under Par. 5, which shall include content, method of preparation, way of presentation and risk-based timelines for submission of the reports. The requirements should be such to make it possible to the competent authorities to decide on the benefit-risk balance of the concerned veterinary medicinal products and on the need to take any measure with respect to the product.
2015/06/17
Committee: ENVI
Amendment 627 #
Proposal for a regulation
Article 77 – paragraph 5
5. The marketing authorisation holder shall, bsubmit to the competent authorities, or, in cased on pharmacovigilance data and where necessary, submit changes to the terms of a marketing authorisation in accordance with Article 61f centrally authorised veterinary medicinal product, to the Agency, on a regular basis report on benefit-risk balance evaluation of the veterinary medicinal product. Where required in order to keep the benefit-risk balance positive, the marketing authorisation holder shall submit variation to the marketing authorisation.
2015/06/17
Committee: ENVI
Amendment 635 #
Proposal for a regulation
Article 78 – paragraph 1 – point e
(e) preparing the adverse event reports referred to in Article 76 and reports referred to in Article 77(5);
2015/06/17
Committee: ENVI
Amendment 661 #
Proposal for a regulation
Article 84 – paragraph 1
1. Where the interests of the Union are involved, and in particular the interests ofs regards public or animal health or of the environment related to the quality, safety or efficacy of veterinary medicinal products or the free movement of products within the Union, any Member State, or the Commission, may refer its concern to the Agency for the application of the procedure laid down in Article 85. The matter of concern shall be clearly identified.
2015/06/17
Committee: ENVI
Amendment 683 #
Proposal for a regulation
Article 98 – paragraph 1 – point c a (new)
(ca) comply with the rules good manufacturing practice for medicinal products established in the Union and use as starting materials only active substances which have been manufactured in accordance with the rules on good manufacturing practice for starting materials established in the Union;
2015/06/17
Committee: ENVI
Amendment 684 #
Proposal for a regulation
Article 98 – paragraph 1 – point d
(d) give prior notice to the competent authority of any changes which he may wish to make to any of the particulars supplied pursuant to Article 92 and inform the competent authority immediately if the qualified person referred to in Article 100 is replaced;
2015/06/17
Committee: ENVI
Amendment 686 #
Proposal for a regulation
Article 100 – paragraph 1
1. The holder of a manufacturing authorisation shall have permanently and continuously at his disposal the services of at least one qualified person who fulfils the conditions laid down in this Article and is responsible, in particular, for carrying out the duties specified in Article 101; the holder of the manufacturing authorisation may himself assume the responsibility referred to in this paragraph, if he personally fulfils conditions for qualified persons provided for by this Regulation.
2015/06/17
Committee: ENVI
Amendment 687 #
Proposal for a regulation
Article 100 – paragraph 2
2. The qualified person shall be in possession of a diploma, certificate or other evidence of appropriate qualification and shall have acquired sufficient experience in the field of manufacturing. The holder of the authorisation may himself assume the responsibility referred to in paragraph 1, iformal qualifications awarded on completion of a university course of study, or a course recognized as equivalent by the Member State concerned, extending over a period of at least four years of theoretical and practical study in one of the following scientific disciplines: pharmacy, medicine, veterinary science, chemistry, pharmaceutical chemistry and technology, biology. However, the minimum duration of the university course may be three and a half years where the course is followed by a period of theoretical and practical training of at least one year and includes a training period of at least six months in a pharmacy open to the public, corroborated by an examination at university level. Where two university or recognized equivalent courses coexist in a Member State and where one of these extends over four years and the other over three years, the diploma, certificate or other evidence of formal qualifications awarded on completion of the three-year university course or its recognized equivalent shall be considered to fulfil the condition of duration referred to in the first subparagraph in so far as the diplomas, certificates or other evidence of formal qualifications awarded on completion of both courses are recognized as equivalent by the Member State in question. The course shall include theoretical and practical tuition bearing upon at least the following basic subjects: – experimental physics, – general and inorganic chemistry, – organic chemistry, – analytical chemistry, – pharmaceutical chemistry, including analysis of medicinal products, – general and applied biochemistry (medical), – physiology, – microbiology, – pharmacology, – pharmaceutical technology, – toxicology, – pharmacognosy (study of the personally fulfils those condicomposition and effects of the active principles of natural substances of plant and animal origin). Tuition in these subjects should be so balanced as to enable the person concerned to fulfil the obligations as specified above. in this Regulation.
2015/06/17
Committee: ENVI
Amendment 688 #
Proposal for a regulation
Article 100 – paragraph 2 a (new)
2a. The qualified person shall have acquired practical experience over at least two years, in one or more undertakings which are authorized manufacturers, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of veterinary medicinal products. The duration of practical experience may be reduced by one year where a university course lasts for at least five years and by a year and a half where the course lasts for at least six years.
2015/06/17
Committee: ENVI
Amendment 718 #
Proposal for a regulation
Article 108 – paragraph 1
1. PWithout prejudice to national legislation prohibiting the offer for sale at a distance of prescription veterinary medicinal products to the public, persons permitted to supply veterinary medicinal products in accordance with Article 107(1) may offer veterinary medicinal products by means of information society services in the meaning of Directive 98/34/EC of the European Parliament and of the Council28 to natural or legal persons established in the Union under the condition that those medicinal products comply with the legislation of the destination Member State. __________________ 28 Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (OJ L 204, 21.7.1998, p. 37).
2015/06/17
Committee: ENVI
Amendment 726 #
Proposal for a regulation
Article 108 – paragraph 7
7. Members States may impose conditions, justified on grounds of public healthand animal health, animal welfare and environmental protection, for the retail on their territory of medicinal products offered for sale at a distance to the public by means of information society services.
2015/06/17
Committee: ENVI
Amendment 895 #
Proposal for a regulation
Article 123 – paragraph 1 a (new)
1a. Member States may provide for additional conditions in terms of advertising of veterinary medicinal products to protect public and animal health, animal welfare and the environment including conditions in terms of comparative and misleading advertising or unfair commercial practices.
2015/06/17
Committee: ENVI
Amendment 919 #
Proposal for a regulation
Article 136 – paragraph 1
1. Member States shall designate the competent authorities to carry out tasks under this Regulation. The competent authorities shall, inter alia, be responsible for providing the scientific expertise for assessment of all applications under this Regulation.
2015/06/17
Committee: ENVI
Amendment 920 #
Proposal for a regulation
Article 136 – paragraph 1 a (new)
1a. The management of funds intended for activities connected with requirements provided under this Regulation, the operation of communication networks and market surveillance shall be under the permanent control of the competent authorities in order to guarantee the independence of these authorities.
2015/06/17
Committee: ENVI
Amendment 922 #
Proposal for a regulation
Article 140 – paragraph 1
1. Each Member State shall be entitled to appoint a M, after consultation of the Management Board, appoint, for a three-year term which may be renewed, one member and anone alternate Member ofto the Committee. The alternates shall represent and vote for the Mmembers in their absence and may act as rapporteurs.
2015/06/17
Committee: ENVI
Amendment 924 #
Proposal for a regulation
Article 140 – paragraph 2
2. Members and alternate Members of the Committee shall be appointed on the basis ofs shall be chosen for their reolevant expertise and experience in the scientific evaluation of veterinary medicinal products for veterinary use, in order to guarantee the highest level of qualifications and a broad spectrum of relevant expertiseand shall represent the competent national authorities.
2015/06/17
Committee: ENVI
Amendment 925 #
Proposal for a regulation
Article 140 – paragraph 3
3. Member States shall submit relevant information to the Management Board of the Agency on expertise and experience in relation to the scientific profile established by the Committee of experts that the Member States consider for appointment for a position in the Committee.deleted
2015/06/17
Committee: ENVI
Amendment 926 #
Proposal for a regulation
Article 140 – paragraph 4
4. The Management Board shall evaluate information on the expert or experts submitted by the Member State and shall communicate its conclusions to the Member State and the Committee.deleted
2015/06/17
Committee: ENVI
Amendment 927 #
Proposal for a regulation
Article 140 – paragraph 5
5. Taking into account the conclusions referred to in paragraph 4, each Member State shall appoint one Member and one alternate to the Committee for a three- year term which may be renewed.deleted
2015/06/17
Committee: ENVI
Amendment 928 #
Proposal for a regulation
Article 140 – paragraph 7
7. The Committee may co-opt a maximum of five additional members chosen on the basis of their specific scientific competence. These members shall be appointed for a term of three years, which may be renewed, and shall not have alternates. The co-opted members may act as rapporteurs.
2015/06/17
Committee: ENVI
Amendment 935 #
Proposal for a regulation
Annex 2 – section 1 – part 1.1 – paragraph 7
Experiments on animals other than clinical triMember States shall ensure that all experiments on animals shall be conducted in accordance with Directive 2010/63/EU. As specified in the Directive 2010/63/EU, it is necessary to replace, reduce or refine testing on vertebrate animals. These methods shall be regularly reviewed and improved with a view to reducing testing on vertebrate animals and the number of animals involved.
2015/06/17
Committee: ENVI