3.

The information referred to in paragraph 2, point (c), shall include at least: the name of the marketing authorisation holder of the medicinal product; the name of the medicinal product; the identification of active manufacturing sites for finished products and active substances of the medicinal product; the Member State in which the marketing authorisation is valid and the marketing status of the medicinal product in each Member State; 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; sales and market share data of the medicinal product; available stocks of the medicinal product; the forecast of supply for the medicinal product, including information on potential vulnerabilities in the supply chain, quantities already delivered and projected deliveries; demand forecasts for the medicinal product; details of available alternative medicinal products; 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.

← art_9__para_2__point_d__text_1 · All articles · art_9__para_3__text_1 →

Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.