OpenLegislation

Regulation 6 Amendment of regulation 50

Original text. Later amendments are not shown.

(1)

Regulation 50 (material to accompany applications for UK marketing authorisations) is amended as follows.

(2)

After paragraph (1) insert—

“(1A)

An applicant for the grant of a parallel import licence for a relevant medicinal product must provide the material specified in Schedule 8A in relation to the product.”

(3)

In paragraph (4) after “application” insert “for a UK marketing authorisation”.

(4)

In paragraph (5) after “regulation” insert “for the purposes of a UK marketing authorisation”.

(5)

In paragraph (6) for “This” substitute “Unless the application is for a parallel import licence this”.