Activities of Merja KYLLÖNEN related to 2014/0257(COD)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on veterinary medicinal products PDF (1 MB) DOC (1 MB)
Amendments (8)
Amendment 154 #
Proposal for a regulation
Recital 37
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; the decisive criteria should be that the antibiotic is used in human medicine when other antibiotic therapies are no longer effective and that there is evidence that resistance in human beings cannot be excluded by use in animals.
Amendment 156 #
Proposal for a regulation
Recital 37 a (new)
Recital 37 a (new)
(37a) As Antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide there must soon also action be taken in the field of human medicine for example in the form of an instrument incentivising the development of new antibiotics for human use similar to that already proposed within this regulation.
Amendment 282 #
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
3. Applications shall be submitted electronically using a single digital portal. For all applications submitted in accordance with the centralised marketing authorisation procedureunder this regulation, the formats made available by the Agency shall be used. (Identical to rapporteur’s AM21.)
Amendment 701 #
Proposal for a regulation
Article 107 – paragraph 2
Article 107 – paragraph 2
2. Persons qualified to prescribe veterinary medicinal products in accordance with applicable national law shall retail antimicrobialprescription only products only for animals which are under their careimmediate care, subject to a veterinary diagnosis based on clinical examination of the animals concerned or, exceptionally, frequent monitoring of its health, and only in the amount required for the treatment concerned.
Amendment 792 #
Proposal for a regulation
Article 111 – paragraph 2 a (new)
Article 111 – paragraph 2 a (new)
2a. Antimicrobial veterinary medicinal products must not be used on food- producing animals for prophylactic purposes, unless there is a high risk of infection. They must not under any circumstances be used to improve performance or compensate for poor animal husbandry.
Amendment 798 #
Proposal for a regulation
Article 111 a (new)
Article 111 a (new)
Amendment 803 #
Proposal for a regulation
Article 112 a (new)
Article 112 a (new)
Amendment 804 #
Proposal for a regulation
Article 112 b (new)
Article 112 b (new)
Article 112 b Reduction of therapy approaches based on antibacterial substances (1) In order to facilitate the effective reduction regarding the use of pharmaceuticals which contain antibacterial substances, anyone who engages in animal husbandry has to: 1. determine, respectively, two months after the disclosure of the key figures of the in accordance with paragraph 112b established therapy prevalence, if the biannual therapy prevalence concerning his reared animal species, and considering the type-of-use during the elapsed time frame, lies above the average therapy prevalence. 2. take immediate record of the results of the assessment under #1 (2) In a case where the operational, biannual therapy prevalence of the animal husbandman with respect to his business lies above the biannual average, the animal husbandman under consultation of a veterinarian has to assess the reasons that may have led to exceeding the average, and how the treatment of his cattle with pharmaceuticals containing antibacterial substances may be decreased. If the assessment of the animal husbandman comes to the result that a therapy by means of the concerned pharmaceuticals may be reduced, the husbandman has to take all necessary steps in order to accomplish the reduction. The husbandman has to consider the wellbeing of his cattle and guarantee the required medical care. (3) Member States may determine measures extending beyond the above mentioned requirements