Article 21 Access to the file
United Kingdom
Following notification under Article 7, the marketing authorisation holder shall have the right, on request, to access the documents and other materials compiled by the Agency and the Commission which serve as evidence of an alleged infringement.
Documents obtained through access to the file shall be used only for the purposes of judicial or administrative proceedings for the application of this Regulation.
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)