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Regulation 60 Amendment of regulation 55 (applications relating to new combinations of active substances)

Original text. Later amendments are not shown.

(1)

Regulation 55 is amended as follows.

(2)

In paragraph (1)(a), omit “, the 2001 Directive or Regulation (EC) No 726/2004”.

(3)

For paragraph (2), substitute—

“(2)

The applicant must provide the results of new pre-clinical tests or new clinical trials relating to that combination in accordance with paragraph 10 of Schedule 8, but does not need to provide scientific references relating to each individual active substance.”.