The Medicines (Products for Human Use) (Fees) Regulations 2016

Marketing authorisations U.K.

38.—(1) Unless sub-paragraph (2) or any of paragraphs 39 to 42 and 51 to 53 applies, the fee payable under regulation 19(1) in connection with an application for a variation to the terms of a marketing authorisation 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) This paragraph applies—

(a) to an application for a variation to the terms of a marketing authorisation of a kind described in item 1(c) or 2(c) in Table 1 or item 3 in Table 2; and

(b) where the application only concerns a new source or supply of a substance listed in Part 7 of this Schedule.

(3) If paragraph (2) applies, the appropriate fee for an application of the kind described—

(a) in item 1(c) of column 1 to Table 1, is the amount specified for an application of that type in item 1(b) of column 2;

(b) in item 2(c) of column 1 to Table 1, is the amount specified for an application of that type in item 2(b) of column 2;

(c) in item 3 of column 1 of Table 2, is the amount specified for item 2 in column 2 of Table 2.

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

(a) in respect of an application for a variation of a marketing authorisation which is within the scope of Chapter II (variations to marketing authorisations granted in accordance with Directive 87/22/EEC, Chapter 4 of Directive 2001/82/EC or Chapter 4 of Directive 2001/83/EC) of Commission Regulation (EC) No 1234/2008, Table 1;

(b) in respect of an application for a variation of a marketing authorisation which is within the scope of Chapter IIa (variations to purely national marketing authorisations) of Commission Regulation (EC) 1234/2008 F1 , Table 2;

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

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

(6) In Table 2 “UK national application” means an application for a variation to the terms of a UK national marketing authorisation within the meaning of Article 2(9) of Commission Regulation (EC) 1234/2008 F2 .

Table 1

Fees for applications for variations of marketing authorisations falling within the scope of Chapter II of Commission Regulation (EC) 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		£277
			(ii)	the UK is the reference member State or the licensing authority is the reference authority for work sharing		£550
		(b)	Type II Application where—
			(i)	the UK is a concerned member State		£734
			(ii)	the UK is the reference member State or the licensing authority is the reference authority for work sharing		£890
		(c)	Type II Complex Variation Application where—
			(i)	the UK is a concerned member State		£8,309
			(ii)	the UK is the reference member State or the licensing authority is the reference authority for work sharing		£14,406
		(d)	Extended Type II Complex Variation Application where—
			(i)	the UK is a concerned member State		£25,643
			(ii)	the UK is the reference member State or the licensing authority is the reference authority for work sharing		£35,846
2. Applications for a Group
		(a)	Minor Variation (Type IB) Group Application where—
			(i)	the UK is a concerned member State	£622
			(ii)	the UK is the reference member State or the licensing authority is the reference authority for work sharing	£1,225
		(b)	Major Variation (Type II) Group Application where—
			(i)	the UK is a concerned member State	£1,652
			(ii)	the UK is the reference member State or the licensing authority is the reference authority for work sharing	£1,996
		(c)	Major Variation (Type II) Complex Group Application where—
			(i)	the UK is a concerned member State	£9,010
			(ii)	the UK is the reference member State or the licensing authority is the reference authority for work sharing	£15,233
		(d)	Major Variation (Type II) Extended Complex Group Application where—
			(i)	the UK is a concerned member State	£26,276
			(ii)	the UK is the reference member State or the licensing authority is the reference authority for work sharing	£36,724

Table 2

Fees for applications for variations of marketing authorisations falling within the scope of Chapter IIa of Commission Regulation (EC) No 1234/2008

Column 1 Kind of national variation	Column 2 Fee payable
1. National Type 1B Application	£277
2. National Type II Application	£734
3. National Type II Complex Variation Application	£8,309
4. National Type II Extended Complex Variation Application	£25,643
5. National Type IB Minor Variation Group Application	£622
6. National Type II Major Variation Group Application	£1,652
7. National Type II Major Variation Complex Group Application	£9,010
8. National Type II Major Variation Extended Complex Group Application	£26,276

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)	£11,992
		(b)	paragraph 15(b)	£8,162

Textual Amendments

F1 Chapter IIa of the Regulation was inserted by Commission Regulation (EU) No 712/2012 (OJ No L 209, 4.8.2012, p4)

F2 Paragraph 9 of the Regulation was inserted by Commission Regulation (EU) No 712/2012 (OJ No L 209, 4.8.2012, p4).