Regulation 59 Amendment of regulation 54 (applications relating to products in well-established medicinal use)I1

Regulation 54 is amended as follows.

In paragraph (1) before “European Union”, insert “ United Kingdom or the ”.

For paragraph (2), substitute—

“(2)

The applicant may, by way of derogation from paragraph 10 of Schedule 8, replace the results of pre-clinical tests or clinical trials with appropriate scientific literature.”.