S.L. 458.34 Art. 30Amendment of classification.

(1) When new facts are brought to its attention, the Authority shall examine and, as appropriate, amend the classification of a medicinal product by applying the criteria listed in regulation 27.

(2) Where a change of classification of a medicinal product has been authorised on the basis of significant pre-clinical tests or clinical trials, the Authority shall not refer to the results of those tests or trials when examining an application by another applicant or holder of marketing authorisation for a change of classification of the same substance for one year after the initial change was authorised.