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Regulation 32 Amendment to paragraph 8

Original text. Later amendments are not shown.

In paragraph 8 (application for a product using a new combination of active substances)—

(a)

renumber the existing text as sub-paragraph (1);

(b)

after that text insert—

“(2)

Notwithstanding sub-paragraph (1) the applicant must provide a sound scientific justification based on valid therapeutic principles for the combination of active substances, including clinical data, which demonstrates the need for and contribution of all active substances at the moment of treatment.”.