# The Veterinary Medicines (Amendment etc.) Regulations 2024, Regulation 37: New paragraph 12A


After paragraph 12 insert—
“Time limits – supplementary
12A. (1) Subject to sub-paragraph (3), a study, residue test or pre-clinical study in relation to the establishment of residue limits submitted by an applicant in relation to an application for a marketing authorisation or a variation of a marketing authorisation may not be used for any other such application or variation until the period of five years from that submission has elapsed.
(2) Subject to sub-paragraph (3), a study, residue test or preclinical study submitted by an applicant for a marketing authorisation or a variation in a marketing authorisation which demonstrates a reduction in antimicrobial resistance in relation to a reference product may not be used for any other such application until a period of four years in addition to the relevant protection period has elapsed.
(3) Sub-paragraphs (1) and (2) do not apply where an applicant has obtained a written authorisation to access a study, residue test or pre-clinical study mentioned in the relevant sub-paragraph.”.

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Source: https://www.legislation.gov.uk/uksi/2024/567/regulation/37 (the official version)
Page: https://openlegislation.uk/veterinary-medicines-amendment-etc-regulations-2024/regulation-37
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.