OpenLegislation

Division II.4.3

United Kingdom

Original text. Later amendments are not shown.

Annexes to the detailed and critical summary shall include:

  1. (a)

    list of references — a list of all references shall be provided in accordance with internationally accepted standards. The references themselves shall be included in the dossier;

  2. (b)

    tabulated study reports — tabular summaries of study reports. In addition, a complete set of study reports shall be included in the dossier.