TITLE IIIPLACING ON THE MARKET
CHAPTER 3Procedures relevant to the marketing authorization
F1Article 26
1.
The marketing authorisation shall be refused if, after verification of the particulars and documents listed in Articles 8, 10, 10a, 10b and 10c, it is clear that:
(a)
the risk-benefit balance is not considered to be favourable; or
(b)
its therapeutic efficacy is insufficiently substantiated by the applicant; or
(c)
its qualitative and quantitative composition 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 Articles 8, 10, 10a, 10b and 10c.
3.
The applicant or the holder of a marketing authorisation shall be responsible for the accuracy of the documents and the data submitted.