BETA

Activities of Soledad CABEZÓN RUIZ related to 2014/0257(COD)

Plenary speeches (1)

Veterinary medicinal products (A8-0046/2016 - Françoise Grossetête) ES
2016/11/22
Dossiers: 2014/0257(COD)

Amendments (5)

Amendment 157 #
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 prescribeVeterinarians are the only professional authorised to prescribe medicinal products to animals, 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 professionalveterinarians should be restricted to the amount required to continue the treatment until the medicinal product prescribed by the veterinarian is obtained by the farmer or by the owner and only for treatment of the animals under their care.
2015/06/17
Committee: ENVI
Amendment 253 #
Proposal for a regulation
Article 4 – paragraph 1 – point 24
(24) 'veterinary prescription‘ means any prescription for a veterinary or human medicinal product issued by a professional person qualified to do so veterinarian once a veterinary diagnosis has been established following accordance wi clinical examination of the applicable national lawnimal or in the light of continuous health checks on the animal;
2015/06/17
Committee: ENVI
Amendment 264 #
Proposal for a regulation
Article 4 – paragraph 1 – point 27 c (new)
(27c) "Adverse events" is any of the undesirable events described in art. 73 (2).
2015/06/17
Committee: ENVI
Amendment 265 #
Proposal for a regulation
Article 4 – paragraph 1 – point 27 d (new)
(27d) "Serious adverse events" is an adverse events which results in death, is life-threatening, results in significant disability or incapacity, is a congenital anomaly/birth defect, or which results in permanent or prolonged signs in the animals treated.
2015/06/17
Committee: ENVI
Amendment 343 #
Proposal for a regulation
Article 16 – paragraph 6
6. A competent authority or the Agency may require the applicant to provide safety data concerning the potential risks posed by the generic veterinary medicinal product to the environment in case the marketing authorisation for the reference veterinary medicinal product was granted before 20 July 2000 or in case the second phase environmental risk assessment was required for the reference veterinary medicinal product.deleted
2015/06/17
Committee: ENVI