17 Amendments of Gesine MEISSNER related to 2014/0257(COD)
Amendment 517 #
Proposal for a regulation
Article 68 – paragraph 1
Article 68 – paragraph 1
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 have been shown to be bioequivalent ('essentially similar products') and for which national marketing authorisations have been granted in different Member States before 1 January 2004 (‘similar products')and for which nationally approved summaries of product characteristics show an unacceptable divergence.
Amendment 524 #
Proposal for a regulation
Article 68 a (new)
Article 68 a (new)
Article 68a 1. A marketing authorisation holder may in accordance with Article 69 apply for a harmonisation of different national marketing authorisations that have been granted for the same veterinary medicinal product. 2. A single, approved Quality data set and a harmonised summary of product characteristics shall be prepared for veterinary medicinal products, other than homeopathic veterinary medicinal products, which have the same qualitative and quantitative composition of their active substances, the same pharmaceutical form and the same marketing authorisation holder ('same products') and for which national marketing authorisations have been granted in different Member States. The coordination group shall draw up detailed rules of procedure for harmonisation. 3. National marketing authorisations may be harmonised with decentralised and/or mutual recognition marketing authorisations if they are for the same product.
Amendment 527 #
Proposal for a regulation
Article 69 – paragraph 1
Article 69 – paragraph 1
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.
Amendment 529 #
Proposal for a regulation
Article 69 – paragraph 2
Article 69 – paragraph 2
2. The coordination group shall establish groups of essentially similar products according to article 68(1) where they consider there are unacceptable differences in SmPCs. For each of these groups of essentially similar products, the coordination group shall appoint one member to act as a rapporteur.
Amendment 530 #
Proposal for a regulation
Article 69 – paragraph 2 a (new)
Article 69 – paragraph 2 a (new)
2a. The marketing authorisation holders shall submit to the coordination group their requests to harmonise the marketing authorisations for a particular product. All registrations pertaining to the same product in the Union will be included in the harmonisation procedure, subject to Article 69(3). The coordination group shall appoint one member to act as a rapporteur and propose a start date for the procedure.
Amendment 532 #
Proposal for a regulation
Article 69 – paragraph 3
Article 69 – paragraph 3
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 characteristicproposing harmonisation of the conditions governing the use of the group of essentially similar veterinary medicinal products or of the marketing authorisations of same veterinary medicinal products.
Amendment 537 #
Proposal for a regulation
Article 69 – paragraph 4 – introductory part
Article 69 – paragraph 4 – introductory part
4. Harmonised summaries of product characteristics for veterinary medicinal productsconditions of use shall contain all oft least the following information:
Amendment 539 #
Proposal for a regulation
Article 69 – paragraph 4 – point a
Article 69 – paragraph 4 – point a
(a) all species mentioned in the marketing authorisations granted by Member States in respect of the essentially similar products in the group;
Amendment 541 #
Proposal for a regulation
Article 69 – paragraph 4 – point b
Article 69 – paragraph 4 – point b
(b) all therapeutic indications and dosages mentioned in the marketing authorisations granted by Member States in respect of the essentially similar products in the group;,
Amendment 544 #
Proposal for a regulation
Article 69 – paragraph 4 – point c
Article 69 – paragraph 4 – point c
(c) the shortesta withdrawal period of those stated in the summaries of the product characteristicswhich ensures that consumers are adequately protected.
Amendment 547 #
Proposal for a regulation
Article 69 – paragraph 5
Article 69 – paragraph 5
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(s) accordingly.
Amendment 549 #
Proposal for a regulation
Article 69 – paragraph 6
Article 69 – paragraph 6
6. In the event of an opinion in favour of adopting a harmonised summary of the product characteation of conditions of use or of harmonising a marketing authorisaticson, each Member State shall vary athe marketing authorisation in conformity with the agreement within 30 days of receipt of the information regarding the agreement from the rapporteuror authorisations of the products in their territory so that the elements listed in paragraph 4, where they are already included in the summaries of characteristics for a product belonging to that group, are in conformity with the agreement within 30 days of receipt of the information regarding the agreement from the rapporteur. Those marketing authorisations for the same product shall, be eligible to be considered to be mutual recognition marketing authorisations granted under this Regulation.
Amendment 558 #
Proposal for a regulation
Article 71 – paragraph 1
Article 71 – paragraph 1
Upon request from the coordination group or the Agency, holders of the marketing authorisations for products included in a group of essentially similar products identified for a harmonisation of the summaries of the product characteristics shall submit information concerning their productsor the holder of the marketing authorisations for a same product identified for harmonisation of marketing authorisations shall submit information concerning their products, including a proposal for harmonisation of the summaries of the product characteristics for their medicines which belong to the group.
Amendment 717 #
Proposal for a regulation
Article 108 – paragraph 1
Article 108 – paragraph 1
1. Persons permitted to supply veterinary medicinal products in accordance with Article 107(1) may offer veterinary medicinal productsprescription and non-prescription veterinary medicinal products, with the exception of antimicrobials, 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. Member States should be able to subject the supply of prescription medicinal products for food producing animals to conditions justified by the protection of public health. __________________ 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).
Amendment 730 #
Proposal for a regulation
Article 109 – title
Article 109 – title
Retail of prescription only veterinary medicinal products or active substances, with anabolic, anti-infectious, anti- parasitic, anti-inflammatory, hormonal or psychotropic veterinary medicinal productproperties
Amendment 734 #
Proposal for a regulation
Article 109 – paragraph 1
Article 109 – paragraph 1
1. Only manufacturers, wholesale distributors and retailers authorised specifically to do so in accordance with applicable national law shall be allowed to supply and purchase prescription only veterinary medicinal products which have anabolic, anti- infectious, anti-parasitic, anti- inflammatory, hormonal or psychotropic properties or substances which may be used as veterinary medicinal products having those properties.
Amendment 740 #
Proposal for a regulation
Article 109 – paragraph 3 – subparagraph 1 – introductory part
Article 109 – paragraph 3 – subparagraph 1 – introductory part
Those manufacturers and suppliers shall keep detailed records of the following information in respect of each purchase and sale transaction of prescription only veterinary medicinal products: