The Human Medicines Regulations 2012 No. 1916

PART 3 U.K. [F1 Manufacture and distribution of medicinal products and active substances]

Textual Amendments

F1 Pt. 3 heading and Pt. 3 Ch. 1 inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 4

[F2 CHAPTER 2] U.K. Manufacturing and wholesale dealing

Textual Amendments

F2 Pt. 3 Ch. 2 heading inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 4

Conditions for holding a manufacturer's licence U.K.

Imports from states other than EEA States [F3 / countries other than approved countries for import] U.K.

38.—(1) This regulation applies in relation to a manufacturer's licence relating to the import of medicinal products.

(2) The licence holder must comply with the conditions set out in this regulation in relation to the import of medicinal products [F4 from—

(a) in the case of an import into Great Britain, a country other than an approved country for import, or

(b) in the case of an import into Northern Ireland, a country other than an EEA State].

(3) The licence holder must—

(a) comply with the principles and guidelines on good manufacturing practice in the Good Manufacturing Practice Directive in so far as they are relevant to the import of medicinal products; and

(b) ensure that active substances have been used as starting materials in the manufacture of medicinal products, other than special medicinal products, imported from [F5 , in the case of an import into Great Britain, a country other than an approved country for import and in the case of an import into Northern Ireland, a country other than an EEA State] only if those substances have been manufactured or assembled in accordance with [F6 good manufacturing practice for active substances].

Textual Amendments

F3 Words in reg. 38 heading inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 29(2) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 19(a)); 2020 c. 1, Sch. 5 para. 1(1)

F4 Reg. 38(2)(a)(b) substituted for words in reg. 38(2) (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 29(3) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 19(b)); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in reg. 38(3)(b) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 29(4) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 19(c)); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in reg. 38(3)(b) substituted (E.W.S.) (1.10.2015) by The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 4 and words in reg. 38(3)(b) substituted (N.I.) (1.10.2015) by The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 4