Updated 18/09/2024
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Article 5 - Procedures for consultation

Article 5

Procedures for consultation

1.   The competent authorities shall communicate in relation to the request for consultation and the response using the most expeditious means from among those set out in Articles 2(1) and 4(1), taking due account of confidentiality considerations, correspondence times, the volume of material to be communicated and the ease of access to the information by the requesting competent authority. In particular, the requesting competent authority shall respond promptly to any clarifications requested by the competent authority receiving the request.

2.   If the information requested is or may be held by a competent authority of a Member State other than the competent authority of the same Member State receiving the request, the competent authority receiving the request shall collect the information promptly from the other competent authority and transmit it to the requesting competent authority in accordance with Article 4.

3.   The competent authorities shall cooperate to resolve any difficulties that may arise in executing a request.

4.   Where new information or a need for further information arises during the procedure for granting or refusing the authorisation, the competent authorities shall cooperate to ensure that all relevant information is exchanged. The forms set out in Annexes I and II shall be used for this purpose.

5.   By way of derogation from Articles 2(1) and 4(1), where the requesting competent authority makes request for consultation during the period of the last 30 working days before the end of the assessment of the application for authorisation, it may make that request verbally, provided that subsequent confirmation of the request for consultation is made in writing, unless the competent authority receiving the request agrees otherwise.