SCHEDULES

SCHEDULE 11Advice and representations

PART 4Exceptions to Schedule

39

This Schedule does not apply if—

a

the licensing authority refuse to grant an application for a traditional herbal registration;

b

the application was referred to the Committee for Herbal Medicinal Products in accordance with Article 16c(4) of the 2001 Directive; and

c

the Committee for Herbal Medicinal Products did not support the grant of the application.