21 Amendments of Lampros FOUNTOULIS related to 2014/0257(COD)
Amendment 108 #
Proposal for a regulation
Recital 2
Recital 2
(2) In the light of the experience acquired and following the assessment by the Commission of the functioning of the market for veterinary medicinal products, the legal framework for veterinary medicinal products should be adapted to scientific progress, the current market conditions and economic reality, with respect for animals, nature and their interaction with man.
Amendment 113 #
Proposal for a regulation
Recital 9
Recital 9
(9) The scope of the mandatory use of a centralised authorisation procedure under which the authorisations are valid throughout the Union should cover inter alia products containing new active substances and products which contain or consist of engineered tissues or cells. Thought should also be given to medicinal products that may be developed in the future and care should be taken to lay down, in advance, a legal framework to support their development and, at the same time, ensure that they comply with Union regulations. At the same time, in order to ensure the widest possible availability of veterinary medicinal products in the Union, the centralised authorisation procedure should be extended to allow for applications for authorisations under that procedure to be submitted for any veterinary medicinal product, including for generics of nationally authorised veterinary medicinal products. Particular care must be taken in all cases to control generics, in order to ensure that they meet high quality standards.
Amendment 114 #
Proposal for a regulation
Recital 10
Recital 10
(10) The national procedure for authorising veterinary medicinal products should be maintained because of varying needs in different geographical areas of the Union as well as the business models of small and medium sized enterprises (SMEs). It should be ensured that marketing authorisations granted in one Member State are recognised in other Member States.
Amendment 116 #
Proposal for a regulation
Recital 12
Recital 12
(12) In order to avoid unnecessary administrative and financial burdens for applicants and competent authorities, a full in-depth assessment of an application for the authorisation of a veterinary medicinal product should be carried out only once. It is appropriate therefore to lay down special procedures for the mutual recognition of national authorisations.
Amendment 117 #
Proposal for a regulation
Recital 17
Recital 17
(17) However, there may be situations where no suitable authorised veterinary medicinal product is available. In those situations, by way of exception, veterinarians should be allowed to prescribe other medicinal products to the animals under their responsibility in conformity with strict rules and in the interest of animal health or animal welfare only. In case of food-producing animals, veterinarians should ensure that an appropriate withdrawal period is prescribed, so that harmful residues of those medicinal products do not enter the food chain, and particular care must therefore be taken when administering antibiotics to food- producing animals.
Amendment 121 #
Proposal for a regulation
Recital 18
Recital 18
Amendment 124 #
Proposal for a regulation
Recital 19
Recital 19
(19) Taking into account the need for simple rules on changes to the marketing authorisations of veterinary medicinal products, only changes that may affect animalpublic health, publicanimal health or the environment should require a scientific assessment. That scientific assessment should be carried out as quickly as possible, in order to prevent problems to the business of undertakings and livestock holdings.
Amendment 127 #
Proposal for a regulation
Recital 23
Recital 23
(23) Companies have less interest in developing veterinary medicinal products for markets of a limited size. In order to promote the availability of veterinary medicinal products within the Union for those markets, in some cases it should be possible to grant marketing authorisations without a complete application dossier having been submitted, on the basis of a benefit-risk assessment of the situation and, where necessary, subject to specific obligations. In particular, this should be possible in the case of veterinary medicinal products for use in minor species or for the treatment or prevention of diseases that occur infrequently or in limited geographical areas. Any such authorisation should be revoked if a full dossier is not submitted within a short space of time.
Amendment 131 #
Proposal for a regulation
Recital 26
Recital 26
(26) Certain particulars and documents that are normally to be submitted with an application for a marketing authorisation shoulneed not be required if a veterinary medicinal product is a generic medicinal product of a veterinary medicinal product that is authorised or has been authorised in the Union. However, care should be taken to ensure that the medicinal product meets European standards.
Amendment 139 #
Proposal for a regulation
Recital 30
Recital 30
(30) In order to avoid unnecessary administrative and financial burdens both for the competent authorities and for the pharmaceutical industry, as a general rule a marketing authorisation for a veterinary medicinal product should be granted for an unlimiappropriated period of time. Conditions for renewing the approval of a marketingAll authorisations should be imposed only exceptionally and should be duly justifiedreviewed, especially if new scientific data come to light.
Amendment 141 #
Proposal for a regulation
Recital 31
Recital 31
(31) It is recognised that, in some cases, a scientific risk assessment alone cannot provide all the information on which a risk management decision should be based, and other relevant factors should also be taken into account including societal, economical, ethical, environmental and welfare factors and the feasibility of controls.
Amendment 159 #
Proposal for a regulation
Recital 38
Recital 38
(38) If an antimicrobial is administered and used incorrectly, this presents a risk to public or animal health. Therefore antimicrobial veterinary medicinal products should only be available on veterinary prescription. Persons having the right to prescribe have a key role in ensuring prudent use of antimicrobials and consequently they should not be influenced, directly or indirectly, by economic incentives when prescribing those products. Therefore the supply of veterinary antimicrobials by those health professionalsem should be restricted to the amount required for treatment of the animals under their care.
Amendment 173 #
Proposal for a regulation
Recital 41
Recital 41
(41) The majority of the veterinary medicinal products on the market have been authorised under national procedures. The lack of harmonisation of summary of product characteristics for veterinary medicinal products authorised nationally in more than one Member State creates additional and unnecessary barriers for the circulation of veterinary medicinal products within the Union. It is necessary to harmonise those summaries of product characteristics. In order to avoid unnecessary costs and burdens for the Member States, the Commission and the pharmaceutical industry, and in order to increase the availability of veterinary medicinal products as fast as possible, it should be possible to harmonise summaries of the products characteristics for certain veterinary medicinal products in accordance with an administrative procedure, while taking on board the risk to public and animal health and to the environment. This harmonisation exercise should cover veterinary medicinal products authorised before 200418. __________________ 18 Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products (OJ L 136, 30.4.2004, p. 58).
Amendment 174 #
Proposal for a regulation
Recital 42
Recital 42
(42) In order to reduce administrative burden and maximise the availability of veterinary medicinal products in the Member States, simplified rules should be laid down as to how their packaging and labelling are to be presented. The textual information provided should be reduced and, if possible, replaced by pictograms and abbreviations. Pictograms and abbreviations should be standardised across the Union. Care should be taken so that those rules do not jeopardise public and animal health and environmental safety. Care should also be taken to ensure that the new, simplified presentation does not result in deliberate concealment of important information on the medicinal product.
Amendment 175 #
Proposal for a regulation
Recital 44
Recital 44
Amendment 176 #
Proposal for a regulation
Recital 47
Recital 47
(47) Holders of marketing authorisations should be responsible for continuously carrying out pharmacovigilance of the veterinary medicinal products they place on the market. They should collect reports on adverse events relating to their products, including those concerning use outside the terms of the granted marketing authorisation. However, final responsibility and competence for pharmacovigilance must rest in all cases with the Member States.
Amendment 178 #
Proposal for a regulation
Recital 49
Recital 49
(49) It is necessary, in specific cases, or from a public health and animal health perspective, to complement the safety and efficacy data available at the time of authorisation with additional information following the placing of the product on the market. Therefore the obligation to finance the conduct of post-authorisation studies under the supervision of the authorities should be imposed on the marketing authorisation holder.
Amendment 180 #
Proposal for a regulation
Recital 51
Recital 51
(51) It is necessary to exercise control over the entire chain of distribution of veterinary medicinal products, from manufacture or import into the Union through supply to the end-user. Veterinary medicinal products from third countries should comply with the same requirements which apply to products manufactured in the Union, or with requirements which are recognised to be at least equivalent thereto.
Amendment 184 #
Proposal for a regulation
Recital 56
Recital 56
(56) The conditions governing the supply of veterinary medicinal products to the public should be harmonised in the Union. Veterinary medicinal products should only be supplied by persons authorised to do so by the Member State where they are established. At the same time, in order to improve access to veterinary medicinal products in the Union, retailers that are authorised to supply veterinary medicinal products by the competent authority in the Member State where they are established should be allowed to sell prescription and non-prescription veterinary medicinal products, depending on the type of medicinal product, via the Internet to buyers in other Member States.
Amendment 190 #
Proposal for a regulation
Recital 57
Recital 57
(57) The illegal sale of veterinary medicinal products to the public via the Internet may represent a threat to public and animal health, as falsified or substandard medicines may reach the public in this way. It is necessary to address this threat. Account should be taken of the fact that specific conditions for supply of medicinal products to the public have not been harmonised at Union level and, therefore, Member States mayust impose conditions for supplying medicinal products to the public within the limits of the Treaty.
Amendment 193 #
Proposal for a regulation
Recital 58
Recital 58
(58) When examining the compatibility with Union law of the conditions for the supply of medicinal products, the Court of Justice of the European Union has recognised, in the context on medicinal products for human use, the very particular nature of medicinal products whose therapeutic effects distinguish them substantially from other goods. The Court of Justice has also held that health and life of humans rank foremost among the assets and interests protected by the Treaty and that it is for Member States to determine the level of protection which they wish to afford to public health and the way in which that level has to be achieved. Since that level may vary from one Member State to another, Member States must be allowed some discretion as regards the conditions for the supply on their territory of medicinal products to the public. Therefore Member States should be able to subject the supply of medicinal products offered for sale at a distance by means of information societyonline services to conditions justified by the protection of public health. Such conditions should not unduly restrict the functioning of the internal market.