Paragraph 20
Where F1, in the case of a medicinal product for sale or supply in Northern Ireland, an authorisation for the medicinal product to be placed on the market has been granted by a member State in accordance with the 2001 Directive, a copy of—
(a)
the summary of the product characteristics approved by the competent authority of the member State; and
(b)
the package leaflet approved by that competent authority.
Annotations
Textual amendments
- F1
Words in Sch. 8 para. 20 inserted (31.12.2020) by S.I. 2019/775, reg. 50(5) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 38(d))