SCHEDULES
SCHEDULE 10National homoeopathic products
General requirements for application
2
1
An application for the grant of a UK marketing authorisation for a national homoeopathic product does not need be made in accordance with, and an applicant for such an authorisation does not need to comply with—
a
paragraphs (b) and (c) of paragraph 10 of Schedule 8 (requirement to submit results of pre-clinical tests and clinical trials);
b
the guidance referred to in paragraph (1) in the “Introduction and general principles” of Annex 1 to the 2001 Directive in so far as it relates to the requirement to submit the results of pre-clinical tests and clinical trials; or
c
the following provisions of Part 1 of that Annex—
i
sections 2.4 to 2.7 (non-clinical and clinical overview and non-clinical and clinical summaries),
ii
section 4 (Module 4: non-clinical reports), or
iii
section 5 (Module 5: clinical study reports).
2
The applicant must submit with the application—
a
particulars and documents relating to the safety of the product in accordance with paragraph 3 (subject to paragraph 4); and
b
particulars and documents relating to the efficacy of the product in accordance with paragraph 5.
3
References in Annex 1 to the 2001 Directive to non-clinical reports, non-clinical documentation and non-clinical data apply in relation to the application as if they were references to the particulars and documents referred to in paragraph 3.
4
References in that Annex to clinical study reports, clinical documentation and clinical data apply in relation to the application as if they were references to the particulars and documents referred to in paragraph 5.