Article 4: Guidelines

Location:

Chapter I

Source:

1. The Commission shall, after consulting the Member States and the Agency, draw up guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of this Regulation, and on the documentation to be submitted pursuant to those procedures.

2. The guidelines referred to in paragraph 1 shall be regularly updated.

The Agency, in cooperation with the competent authorities of the Member States, shall report annually to the Commission on recommendations on unforeseen variations referred to in Article 5 that result in new classification of variations and provide information on necessary updates to be included in the guidelines referred to in paragraph 1.

The Commission shall without undue delay consider the report and integrate new classification of variations and necessary updates to the guidelines.

3. The Commission may publish the electronic version of the guidelines on its website. This electronic version may include new classification of variations and necessary updates to the guidelines before the regular update pursuant to paragraph 2.