Paragraph 14 Applications for renewals of converted EU marketing authorisations made before IP completion dayF1
This paragraph applies where a holder of a converted EU marketing authorisation has, before IP completion day, made an application to the EMA for renewal of the EU marketing authorisation in accordance with Article 14 of Regulation (EC) No 726/2004 but no final decision has been made in relation to that application by the European Commission before IP completion day.
Where this paragraph applies—
the holder of the converted EU marketing authorisation must (subject to paragraph 18) submit the application for renewal to the licensing authority with the baseline data; and
the licensing authority must—
where before IP completion day the Committee for Medicinal Products for Human Use has given a positive final opinion in relation to the application with which the United Kingdom concurred, treat the renewal application as accepted for the purposes of regulation 66 (application for renewal of authorisation), or
where before IP completion day the Committee for Medicinal Products for Human Use has not given any opinion or has given a negative final opinion in relation to the application, or where a positive final opinion has been given but the United Kingdom recorded a divergent opinion, treat the application as an application made in relation to the converted EU marketing authorisation under regulation 66 and consider the application in accordance with that regulation.
Annotations
Textual amendments
- F1
Sch. 33A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 7 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 193); 2020 c. 1, Sch. 5 para. 1(1)