The Medicines (Products for Human Use) (Fees) Regulations 2012

Marketing authorizations

35.—(1) Subject to paragraphs 36 to 39 and 46 to 48, the fee payable under regulation 18(1) in connection with an application for a variation to the terms of a marketing authorization of a kind described in column 1 of the appropriate table is the fee specified in the corresponding entry in column 2 of the appropriate table.

(2) In sub-paragraph (1), the appropriate table is—

(a) in respect of an application for a variation of a marketing authorization which is within the scope of EC Regulation No. 1234/2008(1), Table 1;

(b) in respect of a UK national variation application, Table 2;

(c) in respect of a reclassification variation application, Table 3.

(3) In Table 1, “reference authority” has the meaning given in Article 20(2)(b) of EC Regulation No. 1234/2008.

(4) In Table 2, “UK national variation application” means a variation to a notification of, or an application for, a variation to the terms of a marketing authorization which is not within the scope of EC Regulation No. 1234/2008 and which—

(a) is a change set out in the document entitled “UK National MA Variations Guidance” published by the licensing authority and available on its website on 30th November 2009(2); and

(b) complies with the procedures and conditions to be fulfilled as set out in that document,

and the expressions “National Type 1B Application”, “National Type II Application”, “National Type II Complex Variation Application”, “National Type II Extended Complex Variation Application”, “National Type IB Minor Variation Group Application”, “National Type II Major Variation Group Application” and “National Type II Major Variation Complex Group Application” shall be interpreted accordingly.

Table 1

Fees for applications for variations of marketing authorizations falling within the scope of EC Regulation No. 1234/2008

Column 1 Kind of variation						Column 2 Fee payable
1. Application for a single kind variation
		(a)	Type IB Application where—
			(i)	the UK is a concerned Member State		£300
			(ii)	the UK is the reference Member State or the licensing authority is the reference authority for work sharing		£594
		(b)	Type II Application where—
			(i)	the UK is a concerned Member State		£794
			(ii)	the UK is the reference Member State or the licensing authority is the reference authority for work sharing		£962
		(c)	Type II Complex Variation Application where—
			(i)	the UK is a concerned Member State		£8,981
			(ii)	the UK is the reference Member State or the licensing authority is the reference authority for work sharing		£15,571
		(d)	Extended Type II Complex Variation Application where—
			(i)	the UK is a concerned Member State		£27,716
			(ii)	the UK is the reference Member State or the licensing authority is the reference authority for work sharing		£38,744
2. Applications for a Group
		(a)	Minor Variation (Type IB) Group Application where—
			(i)	the UK is a concerned Member State	£672
			(ii)	the UK is the reference Member State or the licensing authority is the reference authority for work sharing	£1,324
		(b)	Major Variation (Type II) Group Application where—
			(i)	the UK is a concerned Member State	£1,786
			(ii)	the UK is the reference Member State or the licensing authority is the reference authority for work sharing	£2,158
		(c)	Major Variation (Type II) Complex Group Application where—
			(i)	the UK is a concerned Member State	£9,738
			(ii)	the UK is the reference Member State or the licensing authority is the reference authority for work sharing	£16,465
		(d)	Major Variation (Type II) Extended Complex Group Application where—
			(i)	the UK is a concerned Member State	£28,401
			(ii)	the UK is the reference Member State or the licensing authority is the reference authority for work sharing	£39,693

Table 2

Fees for UK national variation applications

Column 1 Kind of national variation	Column 2 Fee payable
1. National Type 1B Application	£300
2. National Type II Application	£794
3. National Type II Complex Variation Application	£8,981
4. National Type II Extended Complex Variation Application	£27,716
5. National Type IB Minor Variation Group Application	£672
6. National Type II Major Variation Group Application	£1,786
7. National Type II Major Variation Complex Group Application	£9,738
8. National Type II Major Variation Extended Complex Group Application	£28,401

Table 3

Fees for reclassification variation applications

Column 1 Kind of reclassification variation				Column 2 Fee payable
Application falling within the category described in—
		(a)	paragraph 15(a)	£12,961
		(b)	paragraph 15(b)	£8,822

(1)

See Article 1 of the Regulation.

(2)

A copy of the guidance can be downloaded from the licensing authority’s website at www.mhra.gov.uk or obtained by writing to the licensing authority at 151 Buckingham Palace Road, London, SW1W 9SZ or by sending an email to [e-mail].