S.L. 458.34 Art. 21Refusal of marketing authorisation.

(1) The marketing authorisation of a medicinal product shall be refused if, after verification of the particulars and documents listed in regulations 5 and 7 it is clear that:

(a) the risk-benefit balance is not considered to be favourable, or

(b) the therapeutic efficacy of the medicinal product is insufficiently substantiated by the applicant, or

(c) the qualitative and quantitative composition of the medicinal product is not as declared.

(2) Authorisation shall likewise be refused if any particulars or documents submitted in support of the application do not comply with the provisions of regulations 5 and 7.

(3) The applicant or the holder of a marketing authorisation shall be responsible for the accuracy of the documents and the data submitted.