xmlns:atom="http://www.w3.org/2005/Atom" xmlns:atom="http://www.w3.org/2005/Atom"
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)
(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.]
Textual Amendments
F1Ss. 67A-67E inserted (16.4.2018) by The Pharmacy (Preparation and Dispensing Errors Registered Pharmacies) Order 2018 (S.I. 2018/181), arts. 1(3), 4 (with art. 2); S.I. 2018/402, art. 2