# 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 78

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

Member States shall ensure that the time taken for the procedure for examining the application for the distribution authorization does not exceed 90 days from the day on which the competent authority of the Member State concerned receives the application.
The competent authority may, if need be, require the applicant to supply all necessary information concerning the conditions of authorization. Where the authority exercises this option, the period laid down in the first paragraph shall be suspended until the requisite additional data have been supplied.

---
Source: https://www.legislation.gov.uk/eudr/2001/83/article/78 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/article-78
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.