114

1

Regulation 128 (accompanying material) is amended as follows.

2

For paragraph (1) substitute—

128

1

The applicant for the grant of a traditional herbal registration other than a THR(GB) under the unfettered access route must provide the material specified in Schedule 12 in relation to the product.

1A

The applicant for the grant of a THR(GB) under the unfettered access route must provide—

a

the application form submitted in connection with the granting of the THR(NI) which authorises the sale or supply of the product in Northern Ireland;

b

a copy of all material submitted in support of the application for the THR(NI) which authorises the sale or supply of the product in Northern Ireland; and

c

a copy of the THR(NI) which authorises the sale or supply of the medicinal product in Northern Ireland,

together with any material specified in Schedule 12 which is not included in the material specified in sub-paragraphs (a) to (c) in relation to the product.

3

In paragraph (3), after “of the 2001 Directive” insert “ where the application is for a THR(NI) or THR(UK), or the list established under regulation 126A where the application is for a THR(GB) ”.