Medicines Act 1968 (c. 67)

Part III U.K. Further Provisions relating to Dealings with Medicinal Products

Modifications etc. (not altering text)

C1 Part III (ss.51-68) modified (1.1.1995) by S.I. 1994/3144, reg. 9(9)

C2 Pt. 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 disqualification U.K.

[F1 67A. Defence to offence of contravening section 63(a) or (b): product not sold or supplied U.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—

[F2 (a) the adulteration took place—

(i) at a registered pharmacy, or

(ii) in the course of the provision of a relevant pharmacy service;]

(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—

[F3 (a) the adulteration took place—

(i) at a registered pharmacy, or

(ii) in the course of the provision of a relevant pharmacy service;]

(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

F1 Ss. 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

F2 S. 67A(2)(a) substituted (1.12.2022) by The Pharmacy (Preparation and Dispensing Errors – Hospital and Other Pharmacy Services) Order 2022 (S.I. 2022/851), arts. 1(3), 5(2) (with art. 3); S.I. 2022/1024, art. 2

F3 S. 67A(3)(a) substituted (1.12.2022) by The Pharmacy (Preparation and Dispensing Errors – Hospital and Other Pharmacy Services) Order 2022 (S.I. 2022/851), arts. 1(3), 5(3) (with art. 3); S.I. 2022/1024, art. 2