Guidelines
Article 4
1. The Commission shall, after consulting the Member States, the Agency and interested parties, draw up: (a) guidelines on the details of the various categories of variations; (b) guidelines on the operation of the procedures laid down in Chapters II, III and IV of this Regulation as well as on the documentation to be submitted pursuant to these procedures. 2. Guidelines referred to in point (a) of paragraph 1 shall be drawn up by the date referred to in the second subparagraph of Article 28 and shall be regularly updated, taking into account the recommendations delivered in accordance with Article 5 as well as scientific and technical progress.