Paragraph 3

A statement of the manufacturing, assembling or importation operations to which the authorisation is to relate, including a statement whether they include one or more of the following—

(a)

the manufacture of investigational medicinal products F1, including specifically MM investigational medicinal products or POC investigational medicinal products;

(b)

the assembly of investigational medicinal products F2, including specifically MM investigational medicinal products or POC investigational medicinal products; or

(c)

the importation of investigational medicinal products F3except for MM investigational medicinal products and POC investigational medicinal products.

Annotations

Textual amendments

F1: Words in Sch. 6 para. 3(a) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 51(3)(a)
F2: Words in Sch. 6 para. 3(b) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 51(3)(b)
F3: Words in Sch. 6 para. 3(c) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 51(3)(c)