# 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, Division 1.3.4: Summaries of product characteristics already approved in the Member States

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

Annexed to the administrative data of the application form shall be copies of all the summaries of product characteristics in accordance with Articles 11 and 21 as approved by Member States, where applicable and a list of countries in which an application has been submitted.

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Source: https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/I/division/1/division/1.3/division/1.3.4 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/annex-I/part-I/division-1/division-1.3/division-1.3.4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.