Amendment of regulation 20 (authorisation procedure for clinical trials involving medicinal products with special characteristics) U.K.

9.  In regulation 20(1)(a), for paragraph (i) substitute—

“(i) which do not have a marketing authorization and are developed by means of one of the following biotechnological processes—

(aa) recombinant DNA technology,

(bb) controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells,

(cc) hybridoma and monoclonal antibody methods, or”.

Commencement Information

I1 Reg. 9 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1