# 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 9

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

In addition to the requirements set out in Articles 8 and 10(1), an application for authorization to market a radionuclide generator shall also contain the following information and particulars:
a general description of the system together with a detailed description of the components of the system which may affect the composition or quality of the daughter nucleid preparation,
qualitative and quantitative particulars of the eluate or the sublimate.

---
Source: https://www.legislation.gov.uk/eudr/2001/83/article/9 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/article-9
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.