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Working methods and provision of information on medicinal products

1. In order to prepare for the fulfilment of the tasks referred to in Articles 4 to 8, the Agency, shall:

(a) specify the procedures and criteria for establishing and reviewing the critical medicines lists;

(b) specify the methods of and criteria for the monitoring, data collection and reporting provided for in Articles 4, 7 and 8, with a basic minimum data set;

(c) develop streamlined IT monitoring and reporting systems, in coordination with the relevant national competent authorities, that facilitate interoperability with other existing IT systems and IT systems under development until the ESMP is fully functional, on the basis of data fields that are harmonised across Member States;

(d) establish the working party referred to in Article 3(6) and ensure that each Member State is represented on that working party;

(e) establish and maintain a list of single points of contact for marketing authorisation holders for all medicinal products authorised in the Union, through the database provided for in Article 57(1), point (l), of Regulation (EC) No 726/2004;

(f) specify the methods for the provision of recommendations referred to in Article 5(2) and Article 8(3) and (4) and for the coordination of measures referred to in Article 8(5);

(g) publish information covered by points (a), (b) and (f) on a dedicated webpage on its web portal.

For the purposes of the first subparagraph, point (a), Member States, marketing authorisation holders, other relevant actors in the supply chain for medicinal products and representatives of healthcare professionals, of patients and consumers, may be consulted as necessary.

2. Following the recognition of a public health emergency or the recognition of a major event in accordance with Article 4(3), the Agency shall:

(a) establish a list of single points of contact for the marketing authorisation holders for the medicinal products included on the critical medicines lists;

(b) maintain the list of single points of contact referred to in point (a) for the duration of the public health emergency or major event;

(c) request relevant information on medicinal products on the critical medicines lists from the single points of contact referred to in point (a) and set a deadline for the submission of that information, if that information is not available in the ESMP;

(d) request information on medicinal products on the critical medicines lists from the single points of contact referred to in Article 3(6), second subparagraph, on the basis of the set of information referred to in Article 6(4), and set a deadline for the submission of that information, if that information is not available in the ESMP.

3. The information referred to in paragraph 2, point (c), shall include at least:

(a) the name of the marketing authorisation holder of the medicinal product;

(b) the name of the medicinal product;

(c) the identification of active manufacturing sites for finished products and active substances of the medicinal product;

(d) the Member State in which the marketing authorisation is valid and the marketing status of the medicinal product in each Member State;

(e) details of the actual or potential shortage of the medicinal product, such as actual or estimated start and end dates and suspected or known cause;

(f) sales and market share data of the medicinal product;

(g) available stocks of the medicinal product;

(h) the forecast of supply for the medicinal product, including information on potential vulnerabilities in the supply chain, quantities already delivered and projected deliveries;

(i) demand forecasts for the medicinal product;

(j) details of available alternative medicinal products;

(k) shortage prevention and mitigation plans that include, at a minimum, information on production and supply capacity and approved production sites of the finished medicinal product and of active substances, potential alternative production sites and minimum stock levels of the medicinal product.

4. In order to supplement the shortage prevention and mitigation plans for critical medicinal products referred to in paragraph 3, point (k), the Agency and national competent authorities for medicinal products may request information from wholesale distributors and other relevant actors regarding any logistical challenges incurred in the wholesale supply chain.