3 Amendments of Albert DESS related to 2014/0257(COD)
Amendment 104 #
Proposal for a regulation
Article 4 – paragraph 1 – point 8 b (new)
Article 4 – paragraph 1 – point 8 b (new)
(8b) ‘antimicrobial substance’ means a compound with a direct action on microorganisms used for treatment or prevention of infections. Antimicrobial substances include antibacterials, antivirals, antifungals and antiprotozoals; in the context of this Regulation, antimicrobial substance refers to an antibacterial.
Amendment 157 #
Proposal for a regulation
Article 16 – paragraph 6
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 phasef a potential environmental risk hassessment was required for the reference veterinary medicinal been identified for that product.
Amendment 381 #
Proposal for a regulation
Article 110 – paragraph 3
Article 110 – paragraph 3
3. Where a veterinary medicinal product is supplied on prescription, the quantity prescribed and supplied shall be restricted to the amount required for the treatment or therapy concerned. The prophylactic use of antibiotics shall be permissible only in certain cases specified by the Agency.