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The Medicines (Products for Human Use) (Fees) Regulations 2010

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Reduced registration application

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16.—(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.

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