Paragraph 7 F1
If requested by the licensing authority, the risk management plan, together with a summary, that—
(a)
describes the risk management system which the applicant will introduce for the medicinal product concerned; and
(b)
shall be proportionate to the identified risks and the potential risks of the medicinal product, and the need for post-authorisation safety data.
Annotations
Textual amendments
- F1
Sch. 8A inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 26 and Sch. 8A inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 26