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Part IIIU.K. Further Provisions relating to Dealings with Medicinal Products

Modifications etc. (not altering text)

C1Part III (ss.51-68) modified (1.1.1995) by S.I. 1994/3144, reg. 9(9)

C2Pt. III amendment to earlier affecting provision SI 1994/3144 reg. 9 (30.10.2005) by Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005 (S.I. 2005/2759), regs. 1(a), 2(12)

Offences, and provision for disqualificationU.K.

[F167D.Defences under sections 67A, 67B and 67C: evidence etc.U.K.

(1)This section applies for the purposes of sections 67A to 67C.

(2)If evidence is adduced that is sufficient to raise an issue with respect to the doing of an act by a person in the course of his or her profession, the court must assume that the person did that act in the course of his or her profession unless the prosecution proves the contrary beyond reasonable doubt.

(3)The court must assume that the prosecution has proved the contrary beyond reasonable doubt if the prosecution proves beyond reasonable doubt that, in doing that act—

(a)the person used his or her professional skills for an improper purpose; or

(b)the person deliberately failed to have due regard for patient safety.

(4)Proof that a registrant failed to comply with a procedure established in relation to a registered pharmacy [F2or a relevant pharmacy service] does not of itself constitute proof that the registrant was not acting in the course of his or her profession.

(5)Knowledge acquired after a product is sold or supplied does not count if it is acquired only as a result of an investigation into whether an offence has been committed in respect of a product.

(6)If evidence is adduced that is sufficient to raise an issue with respect to doing of an act promptly, the court must assume that the act was done promptly unless the prosecution proves the contrary beyond reasonable doubt.

(7)A medicinal product is taken to be sold or supplied to a person in pursuance of a prescription or direction even if that person is not the person for whom it was dispensed in pursuance of the prescription or direction.]