Paragraph 19
Where an authorisation for the medicinal product to be placed on the market has been granted by F1, in the case of a medicinal product for sale or supply in Northern Ireland, a member State or by a country other than an EEA State, or in the case of a medicinal product for sale or supply in Great Britain, by a country other than the United Kingdom or by the European Commission—
a copy of that authorisation;
a summary of the safety data, including the data contained in the periodic safety update reports, where available; and
any suspected adverse reaction reports.
Annotations
Textual amendments
- F1
Words in Sch. 8 para. 19 substituted (31.12.2020) by S.I. 2019/775, reg. 50(4) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 38(c))