Regulation 3 Fees

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

reg. 3(2)(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 12(4)(b)(i)
reg. 3(2)(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 12(4)(b)(ii)
reg. 3(3)(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 12(4)(c)(i)
reg. 3(3)(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 12(4)(c)(ii)
reg. 3(4)(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 12(4)(d)(i)
reg. 3(2)(b) sum substituted by Medical Devices (Fees Amendment) 2010 reg. 2(2)(b)(ii)
reg. 3(3)(a) sum substituted by Medical Devices (Fees Amendment) 2010 reg. 2(2)(c)(i)
reg. 3(3)(b) sum substituted by Medical Devices (Fees Amendment) 2010 reg. 2(2)(c)(ii)
reg. 3(4)(a) sum substituted by Medical Devices (Fees Amendment) 2010 reg. 2(2)(d)(i)
reg. 3(4)(b) sum substituted by Medical Devices (Fees Amendment) 2010 reg. 2(2)(d)(ii)
reg. 3(5)(a) sum substituted by Medical Devices (Fees Amendment) 2010 reg. 2(2)(e)(i)
reg. 3(1)(a) sum substituted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 3(a)
reg. 3(1)(b) sum substituted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 3(b)
reg. 3(2)(a) sum substituted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 3(c)
reg. 3(2)(b) sum substituted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 3(d)
reg. 3(3)(a) sum substituted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 3(e)
reg. 3(3)(b) sum substituted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 3(f)
reg. 3(4)(a) sum substituted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 3(g)
reg. 3(4)(b) sum substituted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 3(h)
reg. 3(5)(a) sum substituted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 3(i)
reg. 3(5)(b) sum substituted by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2000 reg. 3(j)
reg. 3(3)(a) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 3(e)
reg. 3(3)(b) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 3(f)
reg.3(1)(a)(b)(2)(a)(b)(3) (a)(b)(4)(a)(b)(5)(a)(b) amended by Medical Devices (Consultation Requirements) (Fees) 1996 reg.2
reg 3 am by Medicines for Human Use and Medical Devices(Fees Amendments) 2003 reg 3
reg 3 am by Medicines for Human Use and Medical Devices (Fees Amendments) 2006 reg 4
reg.3 amended by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 1999 reg.3
reg 3 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2001 reg 4
reg.3(1)-(5) amended by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 1998 reg.3
reg. 3(1)(a) word substituted by Medical Devices (Fees Amendments) 2009 reg. 2(2)(a)(i)
reg. 3(1)(b) word substituted by Medical Devices (Fees Amendments) 2009 reg. 2(2)(a)(ii)
reg. 3(2)(a) word substituted by Medical Devices (Fees Amendments) 2009 reg. 2(2)(b)(i)
reg. 3(2)(b) word substituted by Medical Devices (Fees Amendments) 2009 reg. 2(2)(b)(ii)
reg. 3(3)(a) word substituted by Medical Devices (Fees Amendments) 2009 reg. 2(2)(c)(i)
reg. 3(3)(b) word substituted by Medical Devices (Fees Amendments) 2009 reg. 2(2)(c)(ii)
reg. 3(4)(a) word substituted by Medical Devices (Fees Amendments) 2009 reg. 2(2)(d)(i)
reg. 3(4)(b) word substituted by Medical Devices (Fees Amendments) 2009 reg. 2(2)(d)(ii)
reg. 3(5)(a) word substituted by Medical Devices (Fees Amendments) 2009 reg. 2(2)(e)(i)
reg. 3(5)(b) word substituted by Medical Devices (Fees Amendments) 2009 reg. 2(2)(e)(ii)
reg. 3(1)(a) sum substituted by Medical Devices (Fees Amendment) 2010 reg. 2(2)(a)(i)
reg. 3(1)(b) sum substituted by Medical Devices (Fees Amendment) 2010 reg. 2(2)(a)(ii)
reg. 3(2)(a) sum substituted by Medical Devices (Fees Amendment) 2010 reg. 2(2)(b)(i)
reg. 3(5)(b) sum substituted by Medical Devices (Fees Amendment) 2010 reg. 2(2)(e)(ii)
reg. 3(1)(a) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 3(a)
reg. 3(1)(b) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 3(b)
reg. 3(2)(a) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 3(c)
reg. 3(2)(b) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 3(d)
reg. 3(4)(a) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 3(g)
reg. 3(4)(b) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 3(h)
reg. 3(5)(a) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 3(i)
reg. 3(5)(b) sum substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2004 reg. 3(j)
reg. 3(1)(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 12(4)(a)(i)
reg. 3(1)(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 12(4)(a)(ii)
reg. 3(2)(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 12(4)(b)(i)
reg. 3(2)(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 12(4)(b)(ii)
reg. 3(3)(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 12(4)(c)(i)
reg. 3(3)(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 12(4)(c)(ii)
reg. 3(4)(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 12(4)(d)(i)
reg. 3(4)(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 12(4)(d)(ii)
reg. 3(5)(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 12(4)(e)(i)
reg. 3(5)(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 12(4)(e)(ii)
reg. 3(1)(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 12(4)(a)(i)
reg. 3(1)(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 12(4)(a)(ii)
reg. 3(4)(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 12(4)(d)(ii)
reg. 3(5)(a) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 12(4)(e)(i)
reg. 3(5)(b) word substituted by Medicines for Human Use and Medical Devices (Fees Amendments) 2007 reg. 12(4)(e)(ii)
reg. 3(1)(a) word substituted by Medical Devices (Fees Amendments) 2008 reg. 2(2)(a)(i)
reg. 3(1)(b) word substituted by Medical Devices (Fees Amendments) 2008 reg. 2(2)(a)(ii)
reg. 3(2)(a) word substituted by Medical Devices (Fees Amendments) 2008 reg. 2(2)(b)(i)
reg. 3(2)(b) word substituted by Medical Devices (Fees Amendments) 2008 reg. 2(2)(b)(ii)
reg. 3(3)(a) word substituted by Medical Devices (Fees Amendments) 2008 reg. 2(2)(c)(i)
reg. 3(3)(b) word substituted by Medical Devices (Fees Amendments) 2008 reg. 2(2)(c)(ii)
reg. 3(4)(a) word substituted by Medical Devices (Fees Amendments) 2008 reg. 2(2)(d)(i)
reg. 3(4)(b) word substituted by Medical Devices (Fees Amendments) 2008 reg. 2(2)(d)(ii)
reg. 3(5)(a) word substituted by Medical Devices (Fees Amendments) 2008 reg. 2(2)(e)(i)
reg. 3(5)(b) word substituted by Medical Devices (Fees Amendments) 2008 reg. 2(2)(e)(ii)
reg. 3(1)(a) word substituted by Medicines (Products for Human Use) (Fees) 2016 reg. 60(2)(a)(i)
reg. 3(1)(b) word substituted by Medicines (Products for Human Use) (Fees) 2016 reg. 60(2)(a)(ii)
reg. 3(2)(a) word substituted by Medicines (Products for Human Use) (Fees) 2016 reg. 60(2)(b)(i)
reg. 3(2)(b) word substituted by Medicines (Products for Human Use) (Fees) 2016 reg. 60(2)(b)(ii)
reg. 3(3)(a) word substituted by Medicines (Products for Human Use) (Fees) 2016 reg. 60(2)(c)(i)
reg. 3(3)(b) word substituted by Medicines (Products for Human Use) (Fees) 2016 reg. 60(2)(c)(ii)
reg. 3(4)(a) word substituted by Medicines (Products for Human Use) (Fees) 2016 reg. 60(2)(d)(i)
reg. 3(4)(b) word substituted by Medicines (Products for Human Use) (Fees) 2016 reg. 60(2)(d)(ii)
reg. 3(5)(a) word substituted by Medicines (Products for Human Use) (Fees) 2016 reg. 60(2)(e)(i)
reg. 3(5)(b) word substituted by Medicines (Products for Human Use) (Fees) 2016 reg. 60(2)(e)(ii)
reg 3 am by Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) 2002 reg 4

(1)

Subject to regulation 2(2) and the following paragraphs of this regulation, in respect of a consultation in relation to a medical device which incorporates a medicinal substance manufactured by—

(a)

an approved manufacturer of that substance, the fee shall be £2,500;

(b)

any other manufacturer, the fee shall be £7,000.

(2)

Subject to the following paragraphs of this regulation, in respect of a further consultation in relation to a medical device which incorporates a medicinal substance manufactured by—

(a)

an approved manufacturer of that substance, the fee shall be £625;

(b)

any other manufacturer, the fee shall be £1,750.

(3)

Subject to regulation 2(2) and the following paragraphs of this regulation, in respect of a consultation in relation to a medical device which incorporates more than one medicinal substance,—

(a)

if each medicinal substance is manufactured by an approved manufacturer of that substance, the fee shall be £2,500;

(b)

if any of those medicinal substances is not manufactured by an approved manufacturer of that substance, the fee shall be £7,000.

(4)

Subject to the following paragraphs of this regulation, in respect of a further consultation in relation to a medical device which incorporates more than one medicinal substance,—

(a)

if each medicinal substance is manufactured by an approved manufacturer of that substance, the fee shall be £625;

(b)

if any of those medicinal substances is not manufactured by an approved manufacturer of that substance, the fee shall be £1,750.

(5)

Subject to paragraph (6), in respect of a consultation in relation to a medical device which incorporates any new medicinal substance—

(a)

where the competent body has not previously been consulted in relation to a medical device which incorporates that substance, the fee shall be £32,000;

(b)

where it has previously been so consulted, the fee shall be £8,000.

(6)

Subject to regulation 2(2), where the same notified body consults the competent body on the same occasion in relation to a number of devices which—

(a)

are of similar construction and are designed to perform similar functions;

(b)

incorporate medicinal substances of the same specification which are manufactured by the same manufacturer or manufacturers; and

(c)

do not incorporate any other medicinal substance;

the amount of the fee in respect of that consultation shall be equal to the amount of the fee which would, but for this paragraph, be payable under the preceding paragraphs of this regulation for a consultation in relation to one of those devices. Payment and recovery of fees