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1. In order to facilitate the monitoring referred to in Article 7, unless the information concerned is available on the ESMP, the Agency may request a Member State to:

(a) submit the set of information referred to in Article 9(2), point (d), including available and estimated data on volume of demand and demand forecasts, through the single point of contact referred to in Article 3(6), second subparagraph, using the reporting methods and systems established pursuant to Article 9(1), points (b) and (c), respectively;

(b) indicate the existence of any commercially confidential information and explain why that information is of a commercially confidential nature, in accordance with Article 10(4);

(c) indicate any failure to provide requested information, and whether there are any delays in providing that information by the deadline set by the Agency in accordance with Article 10(3). Member States shall comply with the Agency’s request by the deadline set by the Agency.

2. For the purposes of paragraph 1, wholesale distributors and other persons or legal entities that are authorised or entitled to supply medicinal products included on the critical medicines lists to the public shall provide that Member State with relevant information and data, including information and data on the levels of stock of those medicinal products at the request of that Member State.

3. Where Member States have any information in addition to the information to be provided in accordance with paragraphs 1 and 2 of this Article on volumes of sales of and volumes of prescriptions for medicinal products which provides evidence of an actual or potential shortage of a medicinal product included on the critical medicines lists, including data referred to in Article 23a, third paragraph, of Directive 2001/83/EC, they shall immediately provide such information to the MSSG through their respective single points of contact referred to in Article 3(6), second subparagraph, of this Regulation.

4. Following the reporting on the results of the monitoring referred to in Article 7 and any recommendations on preventive or mitigating measures provided in accordance with Article 8(3) and (4), Member States shall:

(a) take into account any recommendations and guidelines referred to in Article 12, point (c), and coordinate their actions in relation to any actions taken at Union level pursuant to Article 12, point (a);

(b) inform the MSSG of any measures taken and report on the results of the actions referred to in point (a), including providing information on the resolution of the actual or potential shortage of medicinal products. For the purposes of the first subparagraph, points (a) and (b), Member States that take an alternative course of action at national level shall share the reasons for doing so with the MSSG in a timely manner. The recommendations, guidelines and actions referred to in the first subparagraph, point (a), and a summary report of the lessons learned, shall be made publicly available via the web portal referred to in Article 14.