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1. Marketing authorisation holders for medicinal products authorised in the Union shall provide the information for the purposes of Article 9(1), point (e), of this Regulation by 2 September 2022, in the form of an electronic submission to the database referred to in Article 57(1), point (l), of Regulation (EC) No 726/2004. Those marketing authorisation holders shall provide updates when necessary.

2. In order to facilitate the monitoring referred to in Article 7, the Agency may request marketing authorisation holders for medicinal products included on the critical medicines lists to submit the information referred to in Article 9(2) point (c). The marketing authorisation holders referred to in the first subparagraph of this paragraph shall submit the requested information by the deadline set by the Agency, through the single points of contact referred to in Article 9(2), point (a), using the monitoring and reporting methods and systems established pursuant to Article 9(1), points (b) and (c), respectively. Those marketing authorisation holders shall provide updates where necessary.

3. The marketing authorisation holders referred to in paragraphs 1 and 2 shall justify any failure to provide any requested information and any delays in providing requested information by the deadline set by the Agency.

4. Where the marketing authorisation holders referred to in paragraph 2 indicate that the information that they submitted at the request of the Agency or the national competent authorities for medicinal products contains information of a commercially confidential nature, they shall identify the relevant parts of that information having such nature and explain why that information is of a commercially confidential nature. The Agency shall assess the merits of each indication of information as being of a commercially confidential nature and protect such commercially confidential information against unjustified disclosure.

5. Where the marketing authorisation holders referred to in paragraph 2 or other relevant actors in the supply chain for medicinal products have any information in addition to that required under paragraph 2, second subparagraph, which provides evidence of an actual or potential shortage of medicinal products, they shall immediately provide such information to the Agency.

6. 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), the marketing authorisation holders referred to in paragraph 2 shall:

(a) provide any comments they have to the Agency;

(b) take into account any recommendations referred to in Article 8(3) and (4) and any guidelines referred to in Article 12, point (c);

(c) comply with any measures taken at Union or Member State level pursuant to Articles 11 and 12;

(d) inform the MSSG of any measures taken and report on the monitoring and results of those measures, including providing information on the resolution of the actual or potential shortage of medicinal products.