(Utkast) Kommisjonens gjennomføringsforordning (EU) .../... om format og innehold for søknad og anmodning om etablering av maksimale grenseverdier for reststoffer i samsvar med europaparlaments- og rådsforordning (EF) 470/2009
Restkonsentrasjoner av veterinærlegemidler i matvarer: gjennomføringsbestemmelser
(Draft) Commission Implementing Regulation (EU) .../... regarding the form and content of the applications and requests for the establishment of maximum residue limits in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 22.1.2025
Bakgrunn
(fra kommisjonsforordningen)
(1) Pharmacologically active substances are classified on the basis of opinions on maximum residue limits (MRLs) issued by the European Medicines Agency (EMA).
(2) An application for an opinion to establish the MRL is submitted to EMA. It is necessary to provide a standard format for submitting such applications and to list the information requested to accompany such applications.
(3) Under certain circumstances, the Commission, a Member State, an interested party or organisation may submit a request to EMA for an opinion to establish the MRL. It is necessary to provide a standard format for such requests and to list the information that should accompany them.
(4) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products