# Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, Article 26

Extent: E+W+S+N.I.

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.

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Source: https://www.legislation.gov.uk/eudr/2001/83/article/26 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/article-26
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.