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.”.