PART 5Amendment of Part 5 (marketing authorisations)
Amendment of regulation 54 (applications relating to products in well-established medicinal use)59
1
Regulation 54 is amended as follows.
2
In paragraph (1) before “European Union”, insert “United Kingdom or the”.
3
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.