OpenLegislation

Article 12 Right to reply

United Kingdom

Original text. Later amendments are not shown.

1.

When notifying the statement of objections, the Commission shall set a time-limit within which the marketing authorisation holder may submit to the Commission his written observations on the statement of objections.

That time-limit shall be at least four weeks.

The Commission shall not be obliged to take into account written observations received after the expiry of that time-limit.

2.

The marketing authorisation holder may annex to his written observations, statements from other persons who may corroborate any aspect of those written observations.

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)