(a) the medicinal product is harmful in the normal conditions of use, or
(b) that its therapeutic efficacy is lacking or is insufficiently substantiated by the applicant, or
(c) that its qualitative and quantitative composition is not as declared.
Authorisation shall likewise be refused if the particulars and documents submitted in support of the application do not comply with Articles 8 and 10(1).
CHAPTER 4
Mutual recognition of authorizations