S.L. 439.20 Art. 39Retrospective assessment.

(1) In accordance with regulation 38(2)(f), the retrospective assessment shall be carried out by the competent authority which shall, on the basis of the necessary documentation submitted by the user, evaluate the following:

(a) whether the objectives of the project were achieved;

(b) the harm inflicted on animals, including the numbers and species of animals used, and the severity of the procedures; and

(c) any elements that may contribute to the further implementation of the requirement of replacement, reduction and refinement.

(2) All projects using non-human primates and projects involving procedures classified as ‘severe’, including those referred to in regulation 15(2), shall undergo a retrospective assessment.

(3) Without prejudice to sub-regulation (2) and by way of derogation from regulation 38(2)(f), the competent authority in Malta may exempt projects involving only procedures classified as ‘mild’ or ‘non-recovery’ from the requirement for a retrospective assessment.