Paragraph 7 F1

(1)

This paragraph applies for the purposes of the definition of “similar active substance” in relation to advanced therapy medicinal products.

(2)

In relation to cell-based advanced therapy medicinal products, these are not to be considered similar if—

(a)

there are differences in starting materials or the final composition of the product which have a significant impact on the biological characteristics or biological activity relevant for the intended therapeutic effect or safety attributes of the product, and the different source of the starting materials, such as in the case of autologous advanced therapy medicinal products, is not sufficient to support a claim that two products are not similar; or

(b)

there are differences in the manufacturing technology having a significant impact on the biological characteristics or the biological activity relevant for the intended therapeutic effect or safety attributes of the product.

(3)

In relation to gene therapy medicinal products—

(a)

two gene therapy medicinal products are not to be considered similar when there are differences in the therapeutic sequence, viral vector, transfer system, regulatory sequences or manufacturing technology which significantly affect the biological characteristics or biological activity relevant for the intended therapeutic effect or safety attributes of the product; and

(b)

differences in the therapeutic sequence with a significant impact on the intended therapeutic effect are not sufficient to support a claim that two gene therapy medicinal products are not similar.

(4)

The considerations in paragraphs (2) and (3) also apply in relation to genetically modified cells.

Annotations

Textual amendments

F1: Sch. 9A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 4 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 191); 2020 c. 1, Sch. 5 para. 1(1)