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Paragraph 16 Reduced registration application

Original text. Later amendments are not shown.

(1)

A reduced registration application category I is an application other than a complex registration application for a traditional herbal registration relating to a medicinal product which is presented in the form of a herbal tea.

(2)

A reference to a reduced registration application category II means an application, other than a complex registration application, or a traditional herbal registration where the application falls within one of the descriptions specified in sub-paragraphs (a) to (d) as follows—

(a)

the application relates to a medicinal product which is presented in the form of a herbal tincture;

(b)

the application relates to a medicinal product which is presented in the form of an essential oil;

(c)

the application relates to a medicinal product which is presented in the form of a fatty oil; or

(d)

the application relates to a medicinal product which contains only herbal substances in a capsule.