Refusal of a Marketing Authorisation
The MA will be refused if after verification of the particulars and documents listed in Articles 8, 10, 10a, 10b and 10c, Directive 2001/83/EC, it is clear that:
• The benefit-risk balance is not considered to be favourable,
or
• its therapeutic efficacy is insufficiently substantiated by the applicant,
or
• its qualitative and quantitative composition is not as declared.
The MA is also to be refused if any particulars or documents submitted with the application do not comply with the legislation, e.g., the product information such as SmPC, labelling or Package leaflet.
The applicant or MA holder is responsible for the accuracy of the documents and the data submitted.
Legal basis: Article 26, Directive 2001/83/EC