Article 5: Recommendation on unforeseen variations

Location:
Chapter I
Source:
Eur-Lex

1.   Prior to the submission of a variation whose classification is not provided for in this Regulation, a holder may request a recommendation on the classification of the variation as follows:

(a) from the Agency, where the variation refers to a marketing authorisation granted under Regulation (EC) No 726/2004;
(b) from the competent authority of the Member State concerned, where the variation refers to a purely national marketing authorisation;
(c) from the competent authority of the reference Member State, in the other cases.

Where a recommendation is requested from the Agency as set out in the first subparagraph, point (a), it shall consult the coordination group if the recommendation is expected to result in a new classification of variation.

Where a recommendation is requested from the competent authority of the Member State concerned or of the reference Member State as set out in the first subparagraph, points (b) and (c), the relevant authority shall consult the coordination group and the Agency, if the recommendation is expected to result in a new classification of variation.

The recommendations shall be consistent with the guidelines referred to in Article 4(1). It shall be delivered within 60 days following receipt of the request and sent to the holder, the Agency, and the coordination group.

1a.   Prior to the examination of a variation whose classification is not provided for in this Regulation, a competent authority of a Member State may request a recommendation on the classification of the variation to the coordination group.

The recommendation referred to in the first subparagraph shall be consistent with the guidelines referred to in Article 4(1). It shall be delivered within 60 days following receipt of the request and sent to the holder, the Agency, and the competent authorities of all Member States.

2.   The Agency and the two coordination groups referred to in paragraph 1 shall cooperate to ensure the coherence of the recommendations delivered in accordance with that paragraph and publish those recommendations after deletion of all information of commercial confidential nature.

3.   The recommendation referred to in paragraph 1 that results in a new classification of variation shall be regularly integrated in the guidelines referred to in Article 4(1) in accordance with Article 4(2), third subparagraph.