Article 9 Right to be heard
United Kingdom
Before adoption of the report provided for in Article 10, the Agency shall invite the marketing authorisation holder to submit written observations.
It shall do so in writing, indicating a time-limit for the submission of those observations, which shall be at least four weeks.
Notes on the whole EU Regulation
Textual amendments
- F1
Regulation revoked in part (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 9 para. 1(n) (subject to transitional provisions in S.I. 2012/1916, Sch. 33A); 2020 c. 1, Sch. 5 para. 1(1)