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

Traditional herbal registrations

33.—(1) Subject to sub-paragraphs (3) to (6), the fee payable under regulation 12(1)(a) in connection with an application for a traditional herbal registration of a kind described in column 1 of the following table is the fee specified in the corresponding entry in column 2 of that table—

Fee for application for traditional herbal registration

Column 1				Column 2
Kind of application				Fee payable
1. Complex registration application
	(a)		in respect of a medicinal product containing a single active ingredient	£5,237
	(b)		in any other case	£7,857
2. Standard registration application
	(a)		in respect of a medicinal product containing 3 or fewer active ingredients	£2,619
	(b)		in any other case	£3,928
3. Reduced registration application category II
		(a)	in respect of a medicinal product containing 3 or fewer active ingredients	£873
		(b)	in any other case	£1,310
4. Reduced registration application category I
		(a)	in respect of a medicinal product containing 3 or fewer active ingredients	£583
		(b)	in any other case	£873
5. Change of ownership application				£478

(2) Each reference in sub-paragraphs (3) to (6) to an amount payable under sub-paragraph (1) in respect of an application refers to the amount payable under that sub-paragraph in respect of an application of the kind in question.

(3) Where an application relates to a medicinal product which contains one or more vitamins or minerals which are vitamins or minerals from a new source, a fee of—

(a) £1,164, if European Pharmacopoeia certificates of suitability covering all the vitamins or minerals which are a vitamin or mineral from a new source have been submitted with the application; or

(b) £2,328, in any other case,

is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.

(4) Where an application relates to a medicinal product which contains one or more new excipients, an amount of £7,767 is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.

(5) Where an application relates to a medicinal product which contains one or more TSE risk excipients from a new source, an amount of £690 is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.

(6) Where an application relates to a medicinal product which is a sterile medicinal product, an amount of £2,328 is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.