35 Amendments of Stanislav POLČÁK related to 2014/0257(COD)
Amendment 99 #
Proposal for a regulation
Article 4 – paragraph 1 – point 1 – point b
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;
Amendment 100 #
Proposal for a regulation
Article 4 – paragraph 1 – point 1 – point c
Article 4 – paragraph 1 – point 1 – point c
(c) its purpose is to may be used for euthanasia of animals;
Amendment 106 #
Proposal for a regulation
Article 4 – paragraph 1 – point 11 – introductory part
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:
Amendment 108 #
Proposal for a regulation
Article 4 – paragraph 1 – point 12
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;
Amendment 113 #
Proposal for a regulation
Article 4 – paragraph 1 – point 21
Article 4 – paragraph 1 – point 21
(21) ‘pharmacovigilance’ means the process of monitoring and investigating adverse evenscientific, control and administrative activities relating to detection, reporting, assessment, understanding, prevention and communication of adverse events which include continuous evaluation of the benefit-risk balance of veterinary medicinal products;
Amendment 115 #
Proposal for a regulation
Article 4 – paragraph 1 – point 27 a (new)
Article 4 – paragraph 1 – point 27 a (new)
(27a) '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;
Amendment 116 #
Proposal for a regulation
Article 4 – paragraph 1 – point 27 b (new)
Article 4 – paragraph 1 – point 27 b (new)
(27b) '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;
Amendment 117 #
Proposal for a regulation
Article 4 – paragraph 1 – point 27 c (new)
Article 4 – paragraph 1 – point 27 c (new)
(27c) ‘pre-mix for medicated feedingstuffs’ means any veterinary medicinal product prepared in advance with a view to the subsequent manufacture of medicated feedingstuffs according to the Regulation (...Regulation on medicated feedingstuffs...).
Amendment 240 #
Proposal for a regulation
Article 38 – paragraph 2 – point c
Article 38 – paragraph 2 – point c
Amendment 241 #
Proposal for a regulation
Article 38 – paragraph 2 – point e
Article 38 – paragraph 2 – point e
Amendment 244 #
Proposal for a regulation
Article 38 – paragraph 4
Article 38 – paragraph 4
Amendment 249 #
Proposal for a regulation
Article 46 – paragraph 2
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 an application identical to that submitted to the reference Member State, including an identical dossier as provided under Article 7, to all Member States concerned.
Amendment 251 #
Proposal for a regulation
Article 48 – paragraph 1
Article 48 – paragraph 1
1. Applications for mutual recognition of marketing authorisations shall be submitted to the Member State that granted the first national marketing authorisation (‘reference Member State'’) and the Member States where the applicant seeks to obtain recognition of the marketing authorisation (‘concerned Member States’).
Amendment 255 #
Proposal for a regulation
Article 48 – paragraph 3 – point c
Article 48 – paragraph 3 – point c
Amendment 257 #
Proposal for a regulation
Article 48 – paragraph 4
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 concerned Member States and the applicant. , together with the list of Member States where the applicant seeks to obtain recognition of the marketing authorisation (‘concerned Member States'’).
Amendment 283 #
Proposal for a regulation
Article 58 – paragraph 1
Article 58 – paragraph 1
1. Variation to the terms of a marketing authorisation means a change(‘variation') means an amendment to the termcontents of the mparketing authorisation for a veterinary medicinal product aticulars and documents and/or conditions referred to in Article 31 (‘variation')s 7(1) and 16.
Amendment 284 #
Proposal for a regulation
Article 58 – paragraph 2
Article 58 – paragraph 2
2. The Commission shall, by means of implementing acts, establish a list adopt appropriate arrangements for the examination of variations to the terms of a marketing authorisation for a veterinary medicinal product requiring assessment (‘variations requiring assessment')s granted in accordance with this Regulation. The Commission shall adopt these arrangements in the form of an implementing Regulation. Thoseat implementing acts, shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Amendment 286 #
Proposal for a regulation
Article 58 – paragraph 3 – introductory part
Article 58 – paragraph 3 – introductory part
3. The Commission shall take account of the following criteria wBy (...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 then adopting those implementing acts:pplication of Regulation 1234/2008. The report shall, if appropriate, be accompanied by relevant proposals to amend Regulation 1234/2008.
Amendment 287 #
Proposal for a regulation
Article 58 – paragraph 3 – point a
Article 58 – paragraph 3 – point a
Amendment 289 #
Proposal for a regulation
Article 58 – paragraph 3 – point b
Article 58 – paragraph 3 – point b
Amendment 290 #
Proposal for a regulation
Article 58 – paragraph 3 – point c
Article 58 – paragraph 3 – point c
Amendment 291 #
Proposal for a regulation
Article 59
Article 59
Amendment 292 #
Proposal for a regulation
Article 60
Article 60
Amendment 295 #
Proposal for a regulation
Article 61
Article 61
Amendment 296 #
Proposal for a regulation
Article 62
Article 62
Amendment 297 #
Proposal for a regulation
Article 63
Article 63
Amendment 299 #
Proposal for a regulation
Article 64
Article 64
Amendment 300 #
Proposal for a regulation
Article 65
Article 65
Amendment 302 #
Proposal for a regulation
Article 66
Article 66
Amendment 303 #
Proposal for a regulation
Article 67
Article 67
Amendment 352 #
Proposal for a regulation
Article 98 – paragraph 1 – point c a (new)
Article 98 – paragraph 1 – point c a (new)
(ca) comply with the rules on 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;
Amendment 353 #
Proposal for a regulation
Article 98 – paragraph 1 – point d
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;
Amendment 354 #
Proposal for a regulation
Article 100 – paragraph 1
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 the conditions for qualified persons provided for by this Regulation.
Amendment 355 #
Proposal for a regulation
Article 100 – paragraph 2
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, if he personally fulfils those conditions as specified above. he personally fulfils those conditions as specified above. The qualified person shall be in possession of a diploma, certificate or other evidence of formal 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 composition 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 specified in this Regulation.
Amendment 453 #
Proposal for a regulation
Article 136 – paragraph 1
Article 136 – paragraph 1
1. Member States shall designate the competent authorities to carry out tasks under this Regulation. The competent authorities shall be, inter alia, responsible for providing the scientific expertise for assessment of all applications under this Regulation.