Veterinary medicinal products

Draft Resolution of the Cabinet of Ministers of Ukraine "On the Approval of the Procedure for Establishing Maximum Residue Limits of Active Substances Contained in Veterinary Medicinal Products". Language(s): Ukrainian. Number of pages: 13

The draft Resolution provides for the approval of the Procedure for establishing maximum residue limits of active substances contained in veterinary medicinal products, in particular:

•   establishing the procedure for submitting application for the setting of maximum residue limits and the list of documents to be attached thereto;

•   defining the requirements for the content and structure of the dossier on a pharmacologically active substance, including the scientific data necessary for conducting a safety assessment;

•   establishing a mechanism for conducting scientific risk assessment for human health, taking into account internationally recognized approaches;

•   defining the criteria for decision-making on the establishment, amendment, provisional establishment or withdrawal of maximum residue limits;

•   defining the powers of the competent authority with regard to organizing the expert evaluation of submitted materials, adopting relevant decisions and maintaining a list of established maximum residue limits.

This Procedure lays down rules and procedures for establishing:

·      maximum residue limits of active substances that may be permitted in food of animal origin;

·      the level of a residue of a pharmacologically active substance established for control reasons in the case of certain substances for which a maximum residue limit has not been established under this Procedure.

This Procedure shall not apply to biologically derived active components intended to induce active or passive immunity or to diagnose the state of immunity, used in immunological veterinary medicinal products, nor to substances unintentionally added to food that are present in such food as a result of the production process.

The provisions of this Procedure shall apply in compliance with the legislation prohibiting the use of certain substances having hormonal or thyrostatic effects and beta-agonists.

Maximum residue limits shall be established for pharmacologically active substances used or intended for use in veterinary medicinal products prior to their authorization.

The draft Procedure also stipulates that it shall be prohibited to impede the import or placing on the market of food products of animal origin on grounds related to maximum residue limits or reference points for action, provided that this Procedure and its implementing measures have been complied with.