18 Amendments of Daniel BUDA related to 2014/0255(COD)
Amendment 56 #
Proposal for a regulation
Recital 13
Recital 13
(13) Labelling of medicated feed should comply with the general principles laid down in Regulation (EC) No 767/2009 and be subject to specific labelling requirements, contain concise, clear and easily understandable information in order to provide the end user with the information necessary to correctly administer the medicated feed. Similarly, limits for the deviations of the labelled content of medicated feed from the actual content should be established.
Amendment 64 #
Proposal for a regulation
Recital 17
Recital 17
(17) In order to ensure the safe use of medicated feed, its supply and use should be subject to presentation of a valid veterinary prescription which has been issued after examination and after a veterinary diagnosis has been established, or following a regular visit for checking the health of the animals to be treated. However, the possibility to manufacture medicated feed before a prescription is presented to the manufacturer should not be excluded.
Amendment 70 #
Proposal for a regulation
Recital 18
Recital 18
(18) In order to ensure a particularly prudent use of medicated feed for food- producing animals and, therefore provide the basis for the assurance of a high level of protection of public health, specific conditions concerning the use and the validity of the prescription, compliance with the withdrawal period and record- keeping by the animal holder should be provided for.
Amendment 72 #
Proposal for a regulation
Recital 19
Recital 19
(19) Taking into account the serious public health risk posed by resistance to antimicrobials, it is appropriate to limit the use of medicated feed containing antimicrobials for food-producing animals. Preventive use, with the exception of situations when such medication is required for preventing the outbreak of epizootics, or use to enhance the performance of food-producing animals should in particular not be allowed.
Amendment 82 #
Proposal for a regulation
Recital 19 b (new)
Recital 19 b (new)
(19b) In accordance with Regulation (EC) No 1831/2003, the ban on the use of antibiotics as growth promoting agents as of 1 January 2006 should be strictly adhered to and properly enforced.
Amendment 117 #
Proposal for a regulation
Article 2 – paragraph 2 – point i a (new)
Article 2 – paragraph 2 – point i a (new)
(ia) ‘antimicrobials’: a general term for any compound with a direct action on micro-organisms used for treatment or prevention of infections;
Amendment 119 #
Proposal for a regulation
Article 2 – paragraph 2 – point i c (new)
Article 2 – paragraph 2 – point i c (new)
(ic) ‘anti-parasites’: medicine substance used in the treatment of parasitic diseases of varied aetiology;
Amendment 121 #
Proposal for a regulation
Article 2 – paragraph 2 – point i e (new)
Article 2 – paragraph 2 – point i e (new)
(ie) 'preventive treatment (prophylaxis)': treatment of an animal or a group of animals before the emergence of clinical signs of a disease, in order to prevent the occurrence of a disease or an infection;
Amendment 126 #
Proposal for a regulation
Article 2 – paragraph 2 – point i f (new)
Article 2 – paragraph 2 – point i f (new)
(if) 'control treatment (metaphylaxis)': treatment of a group of animals, after a diagnosis of a clinical disease in part of the group has been made, with the aim of treating the clinically sick animals and controlling the spread of disease to animals in close contact and at risk which may already be (sub-clinically) infected;
Amendment 131 #
Proposal for a regulation
Article 2 – paragraph 2 – point i g (new)
Article 2 – paragraph 2 – point i g (new)
(ig) 'curative (therapeutic) treatment': treatment of an ill animal or group of animals, when a diagnosis of a disease or an infection has been made;
Amendment 214 #
Proposal for a regulation
Paragraph 15 – subparagraph 1
Paragraph 15 – subparagraph 1
1. The supply of medicated feed to animal holders shall be subject to the presentation and, in case of manufacturing by on-farm mixers, the possession of a veterinary prescription issued after the veterinary examination and the establishment of a veterinary diagnosis, or following a regular animal health check visit, and to the conditions laid down in paragraphs 2 to 6.
Amendment 218 #
Proposal for a regulation
Article 15 – paragraph 2
Article 15 – paragraph 2
2. The prescription shall contain the information set out in Annex V. The original prescription shall be kept by the manufacturer or, where appropriate, the distributor. The personveterinarian or another professional person qualified to do so in accordance with applicable national law issuing the prescription and the animal holder shall keep a copy of the prescription. The original and copies shall be kept for three years from the date of issuance. (N.B. horizontal amendment to replace relevant wording throughout the proposal)
Amendment 235 #
Proposal for a regulation
Paragraph 15 – subparagraph 5
Paragraph 15 – subparagraph 5
5. The prescribed medicated feed may be used only for animals examined by the authorised person who issued the prescription and only for a diagnosed disease. The person who issued the prescription shall verify that this medication is justified for the target animals on veterinary grounds. Furthermore he shall ensure that the administration of the veterinary medicinal product concerned is not incompatible with another treatment or use and that there is no contra-indication or interaction where several medicinal products are used.
Amendment 239 #
Proposal for a regulation
Paragraph 15 – subparagraph 6
Paragraph 15 – subparagraph 6
6. The prescription shall, in line with the summary of the product characteristics of the veterinary medicinal product, indicate the inclusion rate of the veterinary medicinal product calculated on the basis of the relevant parameters taking into account the product characteristics and, where appropriate, the geographical or season-related circumstances.
Amendment 259 #
Proposal for a regulation
Article 16 – paragraph 1 – point b
Article 16 – paragraph 1 – point b
(b) the quantities required for one month' s treatment or two weeks in case of medicated feed containing antimicrobial veterinary medicinal products, unless the summary of product characteristics of the prescribed antimicrobial veterinary medicinal product establishes a treatment period of a duration longer than one week.
Amendment 309 #
Proposal for a regulation
Annex 3 – introductory part
Annex 3 – introductory part
The label of medicated feed and intermediary products shall include the following particula, in accordance with the requirements of this Annex and of Regulation (EC) No 767/2009 the following particulars, in a simple, clear and easily understandable manner for the end users:
Amendment 321 #
Proposal for a regulation
Annex 3 – point 9
Annex 3 – point 9
(9) a recommendation to read the package leaflet of the veterinary medicinal products, including a hyperlink where it can be found, a warning that the product is only for the treatment of animals, as well as another warning that the product must be kept out of the sight and reach of children;, as well as another warning that people in the proximity of animals treated with medicated feed may be contaminated.
Amendment 327 #
Proposal for a regulation
Annex 3 – point 15
Annex 3 – point 15
(15) the instructions for use, in accordance with the veterinary prescription and with the summary of product characteristics referred to in Article 14 of Directive 2001/82/EC;, or with the veterinary prescription, if available at the time of manufacture.