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 (b), 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.

← art_10__para_1__text_1 · All articles · art_10__para_2__text_1 →

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