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168.—(1) The prohibitions in regulation 46 (requirement for authorisation) do not apply to anything done in relation to a medicinal product if the following conditions are met.
(2) Condition A is that the medicinal product is not a prescription only medicine.
(3) Condition B is that the medicinal product is sold or supplied to a person who is a health care professional (“P”) exclusively for use by P—
(a)in the course of a business carried on by P, and
(b)for the purposes of administering it or causing it to be administered otherwise than by selling it.
(4) Condition C is that the medicinal product is—
(a)manufactured and assembled in accordance with the specification of P; and
(b)for use by a patient for whose treatment P is directly responsible in order to fulfil the special needs of that patient
(5) Condition D is that if sold or supplied through the holder of a wholesale dealer’s licence the medicinal product is sold or supplied to such a person and for such use as mentioned in condition B.
(6) Condition E is that no advertisement relating to the medicinal product is published by any person.
(7) Condition F is that the sale or supply of the medicinal product is in response to an unsolicited order.
(8) Condition G is that if the medicinal product is —
(a)manufactured or assembled in the United Kingdom or imported into the United Kingdom from a country other than an EEA State, it is manufactured, assembled or imported by the holder of a manufacturer’s licence that relates specifically to the manufacture, assembly or importation of special medicinal products; or
(b)imported from an EEA State, it is manufactured or assembled in that State by a person who is the holder of an authorisation in relation to its manufacture or assembly in accordance with the provisions of the 2001 Directive as implemented in that State.
(9) In this regulation “publish” has the meaning given in regulation 277(1) (interpretation: Part 14 advertising).
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