The Medicines (Exemption from Licences) (Assembly) Order 1979

Termination of exemption by the licensing authority

4.—(1) The licensing authority may direct that any exemption under the provisions of this Order shall cease to have effect, either wholly or to such extent as they consider appropriate, by giving notice in accordance with the provisions of paragraph (3) specifying the date from which and the extent to which that exemption shall cease to have effect, in any of the circumstances specified in paragraph (2).

(2) The circumstances specified for the purpose of paragraph (1) are—

(a) where it appears to the licensing authority at any time that on grounds of safety an exemption should cease to apply to a particular person either wholly or in respect of certain medicinal products; or

(b) where any person not being a member of a registering body has been requested in writing by the licensing authority to furnish particulars in writing of any medicinal products being assembled by him to which an exemption applies and has failed to furnish those particulars within 21 days of the date of such request or within such further time as the licensing authority may in a particular case allow; or

(c) where any person not being a member of a registering body has failed to notify the licensing authority in writing within 21 days of any change in the address at which he is assembling any medicinal product to which an exemption applies.

(3) Notice under paragraph (1) shall be given in writing to the person to whom exemption relates, save that where paragraph (2)(a) applies and that person is a member of a registering body notice in writing may be given instead to that body.