In order to, inter alia, adapt this Regulation to the scientific developments of the sector, to exercise the supervisory powers of the Commission effectively, and to introduce harmonised standards within the Union, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of establishing the criteria for the designation of the antimicrobials which are to be reserved for treatment of certain infections in humans; establishing the requirements for collection of data as regards the antimicrobial medicinal products, rules on the methods of collection and quality assurance; establishing the rules to ensure the effective and safe use of veterinary medicinal products authorised and prescribed for oral administration via routes other than medicated feed; providing details on content and format of the information as regards equine species in the single lifetime identification document; amending the rules on withdrawal period in the light of new scientific evidence; providing the necessary detailed rules on the application, by operators in third countries, of the provisions on the prohibition of the use of antimicrobial medicinal products in animals for the purpose of promoting growth or increase yield and the prohibition of the use of designated antimicrobials; laying down the procedure for the imposition of fines or periodic penalty payments as well as the conditions and methods for their collection; and amending Annex II in order to (i) adapt the requirements regarding the technical documentation on the quality, safety and efficacy of veterinary medicinal products to technical and scientific progress and (ii) achieve a sufficient level of detail that ensures legal certainty and harmonisation as well as any necessary updating.
Zaradi, med drugim, prilagoditve te uredbe znanstvenemu razvoju sektorja, za učinkovito izvajanje nadzornih pooblastil Komisije, za uvedbo harmoniziranih standardov v Uniji bi bilo treba na Komisijo prenesti pooblastila za sprejemanje aktov v skladu s členom 290 PDEU v zvezi z določitvijo meril za opredelitev protimikrobnih snovi, ki jih je treba rezervirati za zdravljenje nekaterih okužb pri ljudeh; z določitvijo zahtev za zbiranje podatkov o uporabi protimikrobnih zdravil, pravil o metodah zbiranja in zagotavljanje kakovosti; z določitvijo pravil za zagotovitev učinkovite in varne uporabe zdravil za uporabo v veterinarski medicini, ki so odobrena in predpisana za peroralno uporabo na način, ki ni medicirana krma, z zagotavljanjem podatkov glede vsebine in oblike informacij v zvezi z družino enoprstih kopitarjev iz enotnega identifikacijskega dokumenta za celotno življenjsko dobo; s spreminjanjem pravil o karenci na podlagi novih znanstvenih dokazov; z določitvijo potrebnih natančnih pravil o uporabi za izvajalce dejavnosti v tretjih državah določb o prepovedi uporabe protimikrobnih zdravil pri živalih z namenom spodbujanja rasti ali povečanja donosa ter prepovedi uporabe določenih protimikrobnih snovi; z določitvijo postopka za uvedbo glob ali periodičnih denarnih kazni ter pogojev in načinov njihove izterjave; in za spremembo Priloge II za (i) prilagoditev zahtev glede tehnične dokumentacije o kakovosti, varnosti in učinkovitosti zdravil za uporabo v veterinarski medicini tehničnemu in znanstvenemu napredku ter (ii) doseganje ustrezne raveni podrobnosti za zagotovitev pravne varnosti in harmonizacijo ter potrebne posodobitve.