BETA

57 Amendments of Momchil NEKOV related to 2014/0257(COD)

Proposal for a regulation
Recital 6

(6) Animals may suffer from a broad range of diseases which can be prevented or treated. The impact of animal diseases and the measures necessary to control them can be devastating for individual animals, animal populations, animal keepers and the economy. Animal diseases transmissible to humans may also have a significant impact on public health. Therefore sufficient and effective veterinary medicinal products should be available in the Union in order to ensure high standards of animal and public health, and for the development of the agriculture and aquaculture sectors.Does not affect the English version.)

2015/05/07
Committee: AGRI

Proposal for a regulation
Recital 7

(7) This Regulation should set high standards of quality, safety and efficacy for veterinary medicinal products in order to meet common concerns as regards the protection of public and animal health. At the same time, this Regulation should harmonise the rules for the authorisation of veterinary medicinal products and the placing of them on the Union market.Does not affect the English version.)

2015/05/07
Committee: AGRI

Proposal for a regulation
Recital 33

(33) Antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide. Many of the antimicrobials used in animals are also used in humans. Some of those antimicrobials are critical for preventing or treating life-threatening infections in humans. In order to fight antimicrobial resistance a number of measures should be taken. It needs to be ensured that appropriate warnings and guidance are included on the labels of veterinary antimicrobials. Use not covered by the terms of the marketing authorisation of certain new or critically important antimicrobials for humans should be restricted in the veterinary sector. The rules for advertising veterinary antimicrobials should be tightened, and the authorisation requirements should sufficiently address the risks and benefits of antimicrobial veterinary medicinal products.Does not affect the English version.)

2015/05/07
Committee: AGRI

Proposal for a regulation
Recital 34

(34) It is necessary to mitigate the risk of development of antimicrobial resistance to human and veterinary medicinal products. Therefore, an application for an antimicrobial veterinary medicinal product should contain information about the potential risks that use of the product may lead to the development of antimicrobial resistance in humans or animals or in organisms associated with them. In order to ensure a high level of public and animal health, veterinary antimicrobials should only be authorised following a careful scientific benefit-risk assessment. If necessary, conditions should be laid down in the marketing authorisation in order to restrict the use of the product. This should include restrictions on the use of the veterinary medicinal product not in accordance with the terms of the marketing authorisation, in particular the summary of product characteristics of the veterinary medicinal product.Does not affect the English version.)

2015/05/07
Committee: AGRI

Proposal for a regulation
Recital 35

(35) The combined use of several antimicrobial active substances may represent a particular risk with respect to the development of antimicrobial resistance. Combinations of antimicrobial substances should therefore only be authorised where evidence is provided that the benefit-risk balance of the combination is favourable.Does not affect the English version.)

2015/05/07
Committee: AGRI

Proposal for a regulation
Recital 36

(36) The development of new antimicrobials has not kept pace with the increase of resistance to existing antimicrobials. Given the limited innovation in developing new antimicrobials it is essential that the efficacy of existing antimicrobials is maintained for as long as possible. The use of antimicrobials in veterinary medicinal products may accelerate the emergence and spread of resistant micro-organisms and may compromise the effective use of the already limited number of existing antimicrobials to treat human infections. Therefore the misuse of antimicrobials should not be allowed.Does not affect the English version.)

2015/05/07
Committee: AGRI

Proposal for a regulation
Recital 37

(37) In order to preserve as long as possible the efficacy of certain antimicrobials in the treatment of infections in humans, it may be necessary to reserve those antimicrobials for humans only. Therefore it should be possible to decide that certain antimicrobials, following the scientific recommendations of the Agency, should not be available on the market in the veterinary sector.Does not affect the English version.)

2015/05/07
Committee: AGRI

Proposal for a regulation
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 professionals should be restricted to the amount required for treatment of the animals under their care.Does not affect the English version.)

2015/05/07
Committee: AGRI

Proposal for a regulation
Recital 39

(39) It is important to consider the international dimension of the development of antimicrobial resistance when assessing the benefit-risk balance of certain veterinary antimicrobials in the Union. Any measure restricting the use of those products may affect the trade of products of animal origin or the competitiveness of certain animal production sectors in the Union. Moreover, antimicrobial resistant organisms can spread to humans and animals in the Union through consumption of products of animal origin imported from third countries, from direct contact with animals or humans in third countries or by other means. Therefore, measures restricting the use of veterinary antimicrobials in the Union should be based on scientific advice and should be considered in the context of cooperation with third countries and international organisations addressing antimicrobial resistance in order the ensure consistency with their activities and policies.Does not affect the English version.)

2015/05/07
Committee: AGRI

Proposal for a regulation
Recital 40

(40) There is still a lack of sufficiently detailed and comparable data at Union level to determine the trends and identify possible risk factors that could lead to the development of measures to limit the risk from antimicrobial resistance and to monitor the effect of measures already introduced. Therefore it is important to collect data on the sales and use of antimicrobials in animals, data on the use of antimicrobials in humans and data on antimicrobial resistant organisms found in animals, humans and food. To ensure that the information collected can be used effectively, appropriate rules should be laid down concerning the collection and the exchange of data. The Member States should be responsible for collecting data on the use of antimicrobials under the coordination of the Agency.Does not affect the English version.)

2015/05/07
Committee: AGRI

Proposal for a regulation
Recital 75

(75) In order to adapt this Regulation to the scientific developments of the sector, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of the use of a product outside the terms of the granted marketing authorisation, in particular regarding establishing a list of antimicrobial veterinary medicinal products for which such use should be prohibited.Does not affect the English version.)

2015/05/07
Committee: AGRI

Proposal for a regulation
Recital 77

(77) In order to adapt this Regulation to the scientific developments of the sector, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of establishing detailed rules on the principles for the refusal or restriction of marketing authorisations of antimicrobial veterinary medicinal products, in particular with a view to preserving the efficacy of certain active substances in treating infections in humans.Does not affect the English version.)

2015/05/07
Committee: AGRI

Proposal for a regulation
Recital 79

(79) In order to introduce harmonised standards within the Union for the methods of gathering data on the use of antimicrobials and the methods of transferring of these data to the Commission, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of establishing rules on these methods.Does not affect the English version.)

2015/05/07
Committee: AGRI

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 concentration of an antimicrobial agent which is usually sufficient to ~~inhibit~~halt the growth of or kill microorganisms of the same species;

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 4 – paragraph 1 – point 11 – point c

(~~c) any risk relating to the development of antimicrobial resistance;~~Does not affect the English version.)

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 7 – paragraph 2 – point а

(~~а) documentation on the direct or indirect risks to public or animal health of use of the antimicrobial veterinary medicinal product in animals,~~Does not affect the English version.)

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 7 – paragraph 2 – point b

(~~b) information about risk mitigation measures to limit antimicrobial resistance development related to the use of veterinary medicinal product.~~Does not affect the English version.)

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 9 – paragraph 1 – point b a (new)

(bа) an indication of the presence of genetically modified organisms where the product contains or consists of such organisms;

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 9 – paragraph 1 – point f

(~~f) the expiry date, in the format: "mm/yyyy , preceded by the abbreviation "Exp." ;~~Does not affect the English version.)

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 11 – paragraph 1 – point b a (new)

(bа) an indication of the presence of genetically modified organisms where the product contains or consists of such organisms;

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 11 – paragraph 1 – point d

(~~d) the expiry date, in the format: "mm/yyyy , preceded by the abbreviation "Exp." .~~Does not affect the English version.)

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 12 – paragraph 1 – point i a (new)

(iа) in the case of veterinary medicinal products which include or consist of genetically modified organisms, information to that effect;

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 13 – paragraph 1 – point d

(d) the expiry date, in the format: " mm/yyyy " , preceded by the abbreviation " Exp.iry date " ;

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 13 – paragraph 1 – point h

(h) a special warning if necessary for the medicinal product (e.g. presence of genetically modified organisms);

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 21 – paragraph 1 – point а

(а) the benefit of the immediate availability on the market of the veterinary medicinal product to ~~the~~ animal or public health outweighs the risk inherent in the fact that certain documentation has not been provided;

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 22 – paragraph 1 – introductory part

1. By way of derogation from Article 7(1)(b), in exceptional circumstances related to animal or public health, where the applicant has demonstrated that for objective, verifiable reasons he is unable to provide the quality, safety and/or efficacy documentation required in accordance with Part 1, Part 2 and Part 3 of Annex II, a marketing authorisation may be granted subject to any of the following:(Does not affect the English version)

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 28 – paragraph 3

3. Where the application concerns an antimicrobial veterinary medicinal product, the competent authority or the Commission may require the marketing authorisation holder to conduct post-authorisation studies in order to ensure that the benefit- risk balance remains positive with a view to the possible development of antimicrobial resistance.(Does not affect the English version)

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 29 – paragraph 1 – point c

(~~c) antimicrobial veterinary medicinal products;~~Does not affect the English version)

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 29 – paragraph 3 – point h

(g) there is no risk to public or animal health as regards the development of resistance to anthelmintic substances even where the veterinary medicinal products containing those substances are used incorrectly.Does not affect the English version)

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 30 – paragraph 1 – point c – point xii

(~~xii) where appropriate, an indication of classification of an antimicrobial regarding its strategic use,~~Does not affect the English version)

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 30 – paragraph 1 – point c – point xiii

(~~xiii) special conditions for use, including restrictions on the use of antimicrobials in order to limit the risk of development of antimicrobial resistance,~~Does not affect the English version)

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 32 – paragraph 1 – point g

(~~g) risk for public health in case of development of antimicrobial resistance outweighs the benefits of the product to animal health;~~Does not affect the English version)

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 32 – paragraph 2

~~2. A marketing authorisation for an antimicrobial veterinary medicinal product shall be refused if the antimicrobial is reserved for treatment of certain infections in humans.~~(Does not affect the English version)

2015/05/07
Committee: AGRI

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 establish 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.(Does not affect the English version)

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 32 – paragraph 4

4. The Commission shall, by means of implementing acts, designate antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans. These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).(Does not affect the English version)

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 34 – paragraph 1 – point b

(b) 14 years for antimicrobial veterinary medicinal products for cattle, sheep, pigs, chickens, dogs and cats containing an antimicrobial active substance which has not been an active substance in a veterinary medicinal product authorised within the Union on the date of the submission of the application;Does not affect the English version)

2015/05/07
Committee: AGRI

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(Does not affect the English version).

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 54 – title

~~Collection of data on the sales and use of antimicrobial veterinary medicinal products~~(Does not affect the English version)

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 54 – paragraph 1

~~1. Member States shall collect relevant and comparable data on the volume of sales and the use of veterinary antimicrobial medicinal products.~~(Does not affect the English version)

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 54 – paragraph 2

~~2. Member States shall send data on the volume of sales and the use of veterinary antimicrobial medicinal products to the Agency. The Agency shall analyse the data and publish an annual report.~~(Does not affect the English version)

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 54 – paragraph 3

3. The Commission shall be empowered to adopt delegated acts in accordance with Article 146 in order to establish detailed rules on the methods of gathering data on the use of antimicrobials and the method of transfer of these data to the Agency.(Does not affect the English version)

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 58 – paragraph 3 – point а

(~~а) the need for a scientific assessment of changes in order to determine the risk to public health, animal health or the environment;~~Does not affect the English version)

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 76 – paragraph 3

3. Competent authorities may, on their own initiative or on request from the Agency, request the marketing authorisation holder to collect specific pharmacovigilance data, in particular regarding the use of a veterinary medicinal product in specified animal species, in the context of public and animal health, safety of the persons administering the product, and the protection of the environment. The authority shall state in detail the reasons for the request and inform other competent authorities and the Agency thereof.(Does not affect the English version)

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 84 – paragraph 1

1. Where the interests of the Union are involved, and in particular the interests of 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.(Does not affect the English version)

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 107 – paragraph 2

2. Persons qualified to prescribe veterinary medicinal products in accordance with applicable national law shall retail antimicrobial products only for animals which are under their care, and only in the amount required for the treatment concerned.(Does not affect the English version.)

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 116 – paragraph 4 – subparagraph 2 – point b

(~~b) impact on animal health and public health if the aquatic animal affected by the condition cannot receive treatment with the potential listed antimicrobial medicinal product;~~Does not affect the English version.)

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 118 – paragraph 1

1. Antimicrobial medicinal products shall only be used in accordance with Articles 115 and 116 to treat conditions for which there is no other treatment available, and the use of which would not present a risk to public or animal health.(Does not affect the English version.)

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 118 – paragraph 2 – subparagraph 1

The Commission may, by means of implementing acts in accordance with the examination procedure referred to in Article 145(2), and taking into consideration scientific advice of the Agency, establish a list of antimicrobial medicinal products that cannot be used in accordance with paragraph 1, or which can only be used for treatment in accordance with paragraph 1 subject to certain conditions.(Does not affect the English version.)

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 118 – paragraph 2 – subparagraph 2 – point a

(~~а) risks to public health if the antimicrobial product is used in accordance with paragraph 1;~~Does not affect the English version.)

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 118 – paragraph 2 – subparagraph 2 – point b

(~~b) risk for human health in case of development of antimicrobial resistance;~~Does not affect the English version.)

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 118 – paragraph 2 – subparagraph 2 – point d

(~~d) availability of other antimicrobial treatments for humans;~~Does not affect the English version)

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 119 – paragraph 1

1. By way of derogation from Article 111, a competent authority may allow the use in its territory of veterinary medicinal products not authorised in that Member State, where the situation of animal or public health so requires, and the marketing of those veterinary medicinal products is authorised in another Member State.(Does not affect the English version)

2015/05/07
Committee: AGRI

Proposal for a regulation
Article 125 – paragraph 2 – point d

(~~d) the potential impact of non-compliance with the requirements on public health, animal health and the environment.~~Does not affect the English version)

2015/05/07
Committee: AGRI

Proposal for a regulation
Annex 2 – part 1 – section 1.1 – paragraph 4

Where relevant, studies shall be submitted providing information on the direct or indirect risks to human health, food safety or animal health of the use of the antimicrobial product in animals, as well as an assessment of the effects of risk mitigation measures proposed by the applicant to limit antimicrobial resistance development.(Does not affect the English version)

2015/05/07
Committee: AGRI

Proposal for a regulation
Annex 2 – part 1 – section 1.3 – subsection 1.3.1 – paragraph 1 – point e

(~~e) the potential risks relating to the development of antimicrobial resistance.~~Does not affect the English version)

2015/05/07
Committee: AGRI

Proposal for a regulation
Annex 2 – part 1 – section 1.3 – subsection 1.3.2 – point А – point А.4 – point А.4.3

~~А.4.3. Development of resistance~~(Does not affect the English version)

2015/05/07
Committee: AGRI

Proposal for a regulation
Annex 2 – part 1 – section 1.4 – subsection 1.4.2 – point А – point А.5

~~А.5. Studies investigating resistance.~~(Does not affect the English version)

2015/05/07
Committee: AGRI