The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2006

Amendment of the General Fees Regulations

2.—(1) The General Fees Regulations are amended as follows.

(2) In each provision specified in the entries in column (1) of the Schedule to these Regulations (the content of which is described in column (2) of that Schedule), for the amount specified opposite that provision in column (3) of that Schedule substitute the amount specified opposite that provision in column (4) of that Schedule.

(3) In Part II of Schedule 1 (capital fees for applications for authorizations, licences and certificates) (1), in paragraph 5, omit sub-paragraphs (1)(aa) and (3).

(4) In Part III of Schedule 1 (capital fees for applications for variations of authorizations, licences and certificates) (2), in paragraph 7—

(a) in sub-paragraph (a), at the end, insert “and”; and

(b) omit sub-paragraph (aa).

(5) In Schedule 2 (fees for inspections) (3), in paragraph 2—

(a) in sub-paragraph (d), at the end, insert “and”; and

(b) omit sub-paragraph (e).

(6) In Part III of Schedule 3 (periodic fees for marketing authorizations and licences(4), for sub-paragraph (1) of paragraph 7, substitute—

“(1) The fee payable under regulation 14(3) in connection with the holding of a manufacturer’s licence shall be £356.”.

(1)

Sub-paragraphs (1)(aa) and (3) were inserted by S.I. 2005/2979.

(2)

Part III of Schedule 1 was amended by S.I.1996/683, 1998/574, 1999/566, 2000/592, 2001/795, 2002/236 and 542, 2003/625 and 2321, 2004/666 and 1157 and 2005/2979.

(3)

Sub-paragraph (e) was inserted by S.I. 2005/2979.

(4)

Paragraph 7 was substituted by S.I. 2005/2979.