PART 7Traditional herbal registrations
Validity of traditional herbal registration
Application for renewal of registration133
1
An application for the renewal of a traditional herbal registration must be made to the licensing authority.
2
The applicant must be established in the European Union.
3
The application must be—
a
made in writing;
b
signed by or on behalf of the applicant; and
c
unless the licensing authority directs otherwise, accompanied by any fee payable in connection with the application.
4
An application is treated as signed for the purposes of paragraph (3)(b) if it is signed with an electronic signature.
5
The application must be made so that it is received by the licensing authority before the beginning of the period of nine months ending with the expiry of the period mentioned in paragraph (1)(a) or (3)(a) of regulation 132 (initial and further period of validity), as the case may be.
6
The holder must provide a consolidated version of the file in respect of quality, safety and efficacy including—
a
the evaluation of data contained in suspected adverse reaction reports and periodic safety update reports submitted in accordance with Part 11; and
b
all variations introduced since the traditional herbal registration was granted.
7
The licensing authority may renew a traditional herbal registration only if, having considered the application and the material accompanying it, the authority thinks that the positive therapeutic effects of the product to which the registration relates outweigh the risks of the product to the health of patients or of the public.
8
Schedule 11 makes provision about advice and representations in relation to an application for the renewal of a traditional herbal registration.