Section 113 — Restrictions on transfer of pre-market approval

(1)Every pre‑market approval, and any rights, benefits or privileges under the pre‑market approval, are not transferable or assignable to any other person unless —

(a)the pre‑market approval contains a condition authorising the transfer or assignment; and

(b)the Agency consents in writing to the transfer or assignment.

(2)Any consent under subsection (1) may be given subject to compliance with any conditions that the Agency thinks fit to impose, which may include conditions modifying, or requiring or otherwise providing for the making of modifications to, the conditions of the pre‑market approval.

(3)A transfer or an assignment, or a purported transfer or assignment, of a pre‑market approval, or of any rights, benefits or privileges under the pre‑market approval, is void and of no effect —

(a)if the pre‑market approval is not capable of transfer or assignment;

(b)if the transfer or assignment, or purported transfer or assignment, is in breach of a condition of the pre‑market approval licence; or

(c)if there has, before the transfer or assignment or purported transfer or assignment, been a contravention of a condition imposed under subsection (2).