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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.

[F167A.Defence to offence of contravening section 63(a) or (b): product not sold or suppliedU.K.

(1)This section applies in a case where—

(a)a person (“the defendant”) is charged with an offence under section 67(2) of contravening section 63(a) or (b) in respect of a medicinal product; and

(b)the product is not sold or supplied in its adulterated state.

(2)Where the defendant is charged with contravening section 63(a), it is a defence for the defendant to prove that—

(a)the adulteration took place at a registered pharmacy;

(b)the defendant—

(i)was a registrant acting in the course of his or her profession, or

(ii)was acting under the supervision of a person who was a registrant acting in the course of his or her profession; and

(c)at the time of the alleged contravention, the defendant did not know that the product was being adulterated.

(3)Where the defendant is charged with contravening section 63(b), it is a defence for the defendant to prove that—

(a)the adulteration took place at a registered pharmacy;

(b)the person who adulterated the product—

(i)was a registrant acting in the course of his or her profession, or

(ii)was acting under the supervision of a person who was a registrant acting in the course of his or her profession; and

(c)at the time of the alleged contravention, the defendant did not know that the product had been adulterated.]