The Veterinary Medicines Regulations 2013

PART 2 U.K. Fees relating to marketing authorisations

Specified pharmaceutical applications U.K.

7.  The following table sets out the fees relating to a pharmaceutical veterinary medicinal product for—

(a) a national application for a marketing authorisation that is—

(i) a full application under Part 1 of Schedule 1;

(ii) a bibliographic application; or

(iii) an application based on pharmacological equivalence;

(b) an application for a marketing authorisation using the decentralised procedure where the United Kingdom is a concerned member State;

(c) an application for the mutual recognition of a product authorised in another member State.

Application		Full national application under Part 1 of Schedule 1 (£)	Bibliographic national application (£)	Pharmacologically equivalent national application		Decentralised application where the UK is a concerned member State or recognition of a product authorised in another member State (£)
				Reference product authorised in UK (£)	Reference product not authorised in UK (£)
Base Fee:		13,530	12,115	7,195	9,220	6,515
Additional fee if any of the target species is a food-producing animal:		3,905	3,585	2,155	2,760	1,415
Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom—
	food-producing animal:	7,465	6,595	5,885	7,495	2,630
	non-food-producing animal:	6,525	5,855	5,590	7,155	2,295
Additional fee for each additional pack type:		740	740	605	775	330
Additional fee for each additional active ingredient (food-producing animal):		6,465	6,125	4,040	5,165	2,085
Additional fee for each additional active ingredient (non-food-producing animal):		4,310	4,105	3,235	4,135	1,475
Additional fee if there is more than one target species, for each additional species (food-producing animal):		3,970	3,565	2,425	3,100	1,280 Applies for a maximum of 2 additional species
Additional fee if there is more than one target species, for each additional species (non- food-producing animal):		2,495	2,090	1,550	1,980	805 Applies for a maximum of 2 additional species
Additional fee for each additional recommended route of administration (food-producing animal):		2,695	2,490	1,620	2,070	940
Additional fee for each additional recommended route of administration (non- food-producing animal):		1,215	1,010	740	945	405
Simultaneous applications: fee for each additional product in the application:		2,895	2,895	2,895	3,705	1,685

Decentralised pharmaceutical application where the United Kingdom is the reference member State U.K.

8.  The fee for a decentralised application for a pharmaceutical product where the United Kingdom is the reference member State is the same as for a national application as set out in the table in paragraph 7, with the addition of the fees in the following table.

Fees for decentralised pharmaceutical application where the United Kingdom is the reference member State

Application		Additional fee for a pharmacologically equivalent product (£)	Additional fee otherwise (£)
Food-producing animal: one member State:		5,230	3,705
Non-food-producing animal: one member State:		3,985	3,220
Each additional member State:		530	530
Simultaneous application: fee for each additional product in the application:
	one member State:	6,670	6,670
	each additional member State:	120	120

Application for a marketing authorisation for an immunological or biosimilar product U.K.

9.—(1) The fee for a national application for a marketing authorisation relating to an immunological or biosimilar product, a decentralised application where the United Kingdom is the concerned member State or the mutual recognition of a product authorised in another member State is in accordance with the following table.

(2) In this paragraph a biosimilar application means an application made in accordance with Article 13(4) of Directive 2001/82/EC and a biosimilar product means a product which is the subject of such an application.

Fees for specified immunological and biosimilar applications

Application		National application for a marketing authorisation(£)	Decentralised application where the UK is a concerned member State or recognition of a product authorised in another member State (£)
1. Immunological or biosimilar product other than in paragraph 2 below: Base fee:		11,775	5,785
The following fees are in addition to the base fee—
	Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom, and for each new combination of active ingredients:	7,405	2,490
	Additional fee for each adjuvant or preservative not previously included in a veterinary medicinal product authorised in the United Kingdom and for each new combination of adjuvants or preservatives:	1,345	675
	More than one antigenic component – fee for each additional component:	1,350	405
	More than one species – fee for each additional species:	5,380	1,615 Applies for a maximum of 2 additional species
	More than one route of administration – fee for each additional route of administration:	5,380	1,615
	Simultaneous application - fee for each additional product in the application:	2,895	1,685
2. Immunological or product that is identical to a product already authorised in the United Kingdom but with a lesser number of antigens and that only contains antigens contained in that product:		10,430	5,380

Decentralised immunological application where the United Kingdom is the reference member State U.K.

10.  The fee for a decentralised application for a marketing authorisation for an immunological product where the United Kingdom is the reference member State is the same as for a national application set out in the previous table, with the addition of the fees in the following table—

Fees for decentralised immunological application where the United Kingdom is the reference member State

Application		Additional fee (£)
One member State:		3,470
Each additional member State:		530
Simultaneous applications: fee for each additional product in the application:
	one member State:	6,670
	each additional member State:	120

Applications for a marketing authorisation using data already assessed U.K.

11.  The fees for applications for marketing authorisations using identical data submitted simultaneously or on the basis of information provided under Article 13(c) of Directive 2001/82/EC are in accordance with the following table.

Fees for a marketing authorisation using data already assessed

Application		Fee (£)per authorisation
Decentralised application where the United Kingdom is the reference member State—
	one member State:	4,165
	each additional member State:	530
Any other application:		945

Application for an exceptional marketing authorisation (pharmaceutical) U.K.

12.  The fee for an application for an exceptional marketing authorisation for a pharmaceutical product is in accordance with the following table.

Fees for an exceptional marketing authorisation for a pharmaceutical product

Application		Provisional (£)	Limited (£)
Base Fee:		12,015	6,765
The following fees are in addition to the base fee—
Additional fee if any of the target species is a food-producing animal:		3,905	1,952
Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom—
	food-producing animal:	5,850	3,732
	non-food-producing animal:	4,910	3,262
Additional fee for each additional pack type:		710	370
Additional fee for each additional active ingredient (food-producing animal):		5,955	3,232
Additional fee for each additional active ingredient (non-food-producing animal):		3,800	2,155
Additional fee if there is more than one target species, for each additional species (food-producing animal):		2,965	1,985
Additional fee if there is more than one target species, for each additional species (non-food-producing animal):		1,485	1,247
Additional fee for each additional recommended route of administration (food-producing animal):		2,185	1,347
Additional fee for each additional recommended route of administration (non-food-producing animal):		710	608
Simultaneous applications— fee for each additional product in the application:		2,895	1,447

Fees for an application for an exceptional marketing authorisation (immunological) U.K.

13.  The fee for an application for an exceptional marketing authorisation for an immunological product is in accordance with the following table.

Fees for an exceptional marketing authorisation for an immunological product

Application	Provisional (£)	Limited (£)
Base fee:	10,810	5,887
The following fees are in addition to the base fee—
Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom, and for each new combination of active ingredients:	5,650	3,702
Additional fee for each adjuvant or preservative not previously included in a veterinary medicinal product authorised in the United Kingdom and for each new combination of adjuvants or preservatives:	1,350	672
More than one antigenic component – fee for each additional component:	1,190	675
More than one species – fee for each additional species:	4,060	2,690
More than one route of administration – fee for each additional route of administration:	4,060	2,690
Simultaneous application - fee for each additional product in the application:	2,895	1,447

Fee for the conversion from an exceptional to a full marketing authorisation U.K.

14.  The fee for the conversion of an exceptional marketing authorisation to a full marketing authorisation is £3,000.

Application for a marketing authorisation relating to a parallel import U.K.

15.  The fee for a marketing authorisation for a parallel import is in accordance with the following table.

Parallel imports

Application		Fee (£)
Application where the imported product has been authorised in accordance with the mutual recognition procedure or decentralised procedure, and the United Kingdom is included in these procedures—
	import from one or more member States:	1,755
Application to add an additional member State after the marketing authorisation has been granted – fee for each member State:		455
Application where the imported product has not been authorised in accordance with the mutual recognition procedure or the decentralised procedure but where the imported product originates from the same manufacturing site as the product authorised in the United Kingdom to which the imported product is considered to be essentially similar:		2,130
Any other application – fee for each member State from which the product is imported:		4,710

Application to change the distribution category of a product authorised through the centralised procedure U.K.

16.  The fee to change the distribution category of a product authorised through the centralised procedure is £3,135.

Application for a variation to a marketing authorisation dealt with under national or mutual recognition variation procedures. U.K.

17.—(1) This paragraph applies in relation to an application for a variation to one or more marketing authorisations except where paragraph 18, 19 or 21 applies.

(2) The fees for the variations to which this paragraph applies are set out in the following table.

(3) Where applications are made at the same time seeking an identical change to the terms of more than one marketing authorisation, and those applications are based on identical data, fees are payable as for a grouped variation.

(4) References in this paragraph to a grouped variation being “led” by a particular type of variation indicate that the principal variation in that group is a variation of that type.

Type of variation							National	UK is the reference member State	UK is a concerned member State
Single variations; one change for each product
	Extension:
			Change of strength or potency or the addition of a new strength or potency:				6,670	-	1,998
			Change of pharmaceutical form or the addition of a new pharmaceutical form:				8,415	-	2,301
			Change of route of administration, or the addition of a new one, of—					-
					(i) an immunological product, or a pharmaceutical product for a [F1 non-food-producing] animal:		5,390	-	1,737
					(ii) a pharmaceutical product for a food-producing animal:		7,135	-	2,058
			Change or addition of a food producing target species:				9,620	-	2,547
			Change of active substance, including:				8,415	-	2,301
						use of a different salt, ester, complex or derivative of the same therapeutic moiety:
						use of a different biologically active substance with a slightly different molecular structure:
						modification of the vector used to produce the antigen or the source material, including a new master cell bank from a different source:
						use of a new ligand or coupling mechanism for a radiopharmaceutical:
						change of the extraction solvent or change of the ratio of herbal drug to herbal drug preparation:
			Change of bioavailability:				8,415	-	2,301
			Change of pharmacokinetics:				8,415	-	2,301
			Simultaneous application: fee for each additional product in the application:				2,895	-	1,011
	Type II:						2,895	6,030	1,872
	Type IB:						885	1,325	531
	Type IA:						455	685	273
Grouped variations
		Extension-led:
		The fee for an application for an extension-led grouped variation is the fee for that extension as specified above plus —
				(a) if there is one variation in addition to the extension, the fee for that variation as specified above; or
				(b) if there is more than one variation in addition to the extension, the fee that would be payable for a grouped variation of that type as specified below.
		Type II led:
				For the first nine changes:			6,280	12,060	3,768
				For each subsequent group of up to ten changes:			4,500	4,500	2,700
		Type IB led:
				For the first nine changes:			1,770	2,650	1,062
				For each subsequent group of up to ten changes:			4,500	4,500	2,700
		Type IA led:
				For the first nine changes:			885	1,325	531
				For each subsequent group of up to ten changes:			4,500	4,500	2,700

Textual Amendments

F1 Words in Sch. 7 para. 17 substituted (14.4.2014) by The Veterinary Medicines (Amendment) Regulations 2014 (S.I. 2014/599), regs. 1, 4(2)

Application for a variation to a marketing authorisation dealt with under worksharing procedures U.K.

18.—(1) This paragraph applies in relation to an application for a variation to a marketing authorisation dealt with in accordance with worksharing procedures as set out in Article 20 of Commission Regulation (EC) No 1234/.

(2) The fee for a worksharing application, involving marketing authorisations obtained by a national procedure in the United Kingdom only, is the fee specified in the following table in the column headed “UK Only”.

(3) The fee for a worksharing application, involving marketing authorisations obtained through a national procedure in the United Kingdom and any other member State, is specified in the following table by reference to the United Kingdom’s role in the procedure, as “UK Reference Authority”, “UK Co-Reference Authority” or “Other”.

(4) The fee for a worksharing application, involving at least one marketing authorisation obtained through the mutual recognition or decentralised procedure, is specified in the following table by reference to the United Kingdom’s role in the procedure, as “UK Reference Authority”, “UK Co-Reference Authority” or “UK Concerned member State”.

(5) The fee for any kind of variation where the Agency co-ordinates worksharing is £455 for each marketing authorisation.

Type of application			UK Only	Where the application involves nationally authorised products in more than one member State			Application involves mutually recognised products
			UK Only	UK Reference Authority	UK Co-Reference Authority	Other	UK Reference Authority	UK Co-Reference Authority	UK Concerned member State
Worksharing applications The following fees apply for each change to each product:
	Type II
		For the first nine changes:	6,240	12,060	7,485	12,060	13,265	6,745	3,372
		For each subsequent group of up to ten changes:	4,500	4,500	4,500	4,500	4,500	4,500	2,700
	Type IB
		For the first nine changes:	1,770	2,650	2,120	2,650	2,915	1,905	954
		For each subsequent group of up to ten changes:	4,500	4,500	4,500	4,500	4,500	4,500	2,700

Application for an extension dealt with under the decentralised procedure where the United Kingdom is the reference member State U.K.

19.  The fee for a decentralised application for an extension where the United Kingdom is the reference member State is the same as for a national application as set out in the table in paragraph 17, with the addition of the supplementary fees in the following table (save that, where the application is for the addition of more than one species, only one supplementary fee applies).

Decentralised application for an extension where the United Kingdom is the reference member State

Application		Supplementary fee (£)
Pharmaceutical product for a food-producing animal – one member State:		3,705
Pharmaceutical product for a non-food-producing animal – one member State:		3,220
Immunological product – one member State:		3,460
Each additional member State:		530
Simultaneous application: fee for each additional product in the application:
	one member State:	6,670
	each additional member State:	120

Provision of information relating to the recognition of a United Kingdom marketing authorisation or an extension U.K.

20.—(1) Where an application is made for the Secretary of State to provide information to other member States to enable them to recognise a marketing authorisation already granted by the United Kingdom the following fees are payable.

(2) Those fees also apply where a marketing authorisation has been granted in more than one member State, the holder applies for an extension for that marketing authorisation and the United Kingdom acts as reference member State.

(3) Where a valid application to provide information to another member State is received within six months of the original grant of the marketing authorisation, or where the Secretary of State has already provided the information to a member State, and a further valid application is made to provide the information to an additional member State within six months of the date the last information was provided, the fees are—

Type of application	Fee for a pharmacologically equivalent product(a)			Fee (other products) (£)
(a) This fee is payable if the application for the marketing authorisation was on the basis that the product was pharmacologically equivalent to another veterinary medicinal product.
Pharmaceutical product for a food-producing animal – one member State:			3,940	2,440
Pharmaceutical product for a non-food-producing animal ‑ one member State:			2,645	1,895
Immunological product – one member State:			2,130	2,130
Each additional member State:			535	535

(4) Where the information to be provided relates to a product granted a marketing authorisation using identical data submitted simultaneously or on the basis of information provided under Article 13(c) of Directive 2001/82/EC the fees are—

Application		Fee (£)
Provision of information to—
	one member State:	4,165
	each additional member State:	530

(5) In any other case the fees are—

Type of application		Fee for a pharmacologically equivalent product (£)(a)	Fee (other products) (£)
(a) This fee is payable if the application for the marketing authorisation was on the basis that the product was pharmacologically equivalent to another veterinary medicinal product.
Pharmaceutical product for a food-producing animal – one member State:	12,015		10,515
Pharmaceutical product for a non-food-producing animal – one member State:	8,115		7,365
Immunological product – one member State:	8,940		8,940
Each additional member State:	535		535

(6) In the case of simultaneous applications, the above fees are payable for each additional product in the application for one member State, with a fee of £115 for each additional product for each additional member State.

Exception for a variation relating to animal testing U.K.

21.  If the only purpose of a variation is to remove animal testing or to reduce the numbers of animals used in testing, no fee is payable for the variation in the case of a national authorisation, and the United Kingdom element of the fee for the variation is not payable for an authorisation obtained through the mutual recognition procedure or the decentralised procedure.

Application for the renewal of a national marketing authorisation U.K.

22.—(1) The fee for an application for the renewal of a marketing authorisation is £1,360.

(2) The fee for the first reassessment of an exceptional marketing authorisation is £305, and the fee for each subsequent reassessment is £1,360.

Application for the renewal of a marketing authorisation obtained through mutual recognition or the decentralised procedure U.K.

23.  The fee for an application for the renewal of a marketing authorisation obtained through mutual recognition or the decentralised procedure is —

(a) £1,835 if the United Kingdom is the reference member State; and

(b) £1,225 if the United Kingdom is a concerned member State.

Registration of a homeopathic remedy U.K.

24.  The fee for an application for the registration of a homeopathic remedy is in accordance with the following table.

Fee for the registration of a homeopathic remedy

Type of application		Fees(£)
If all stocks and the formulation have already been assessed by the Secretary of State—
	not more than five stocks:	160
	more than five stocks:	375
If either all the stocks have already been assessed by the Secretary of State but there is a new formulation, or if the formulation has already been assessed by the Secretary of State but one or more of the stocks have not been already assessed—
	not more than five stocks:	455
	more than five stocks:	665
If the formulation and at least one of the stocks has not already been assessed by the Secretary of State—
	not more than five stocks:	760
	more than five stocks:	985
If the product is already authorised for human use in the United Kingdom, or for human or veterinary use in the United Kingdom or in another member State—
	not more than five stocks:	160
	more than five stocks:	375

Renewal of a homeopathic remedy U.K.

25.  The fee for the renewal of a homeopathic remedy is £320.

Annual fees for marketing authorisations U.K.

26.—(1) Within 30 days of receiving a written demand from the Secretary of State, a holder of a marketing authorisation must provide the Secretary of State with a statement of turnover for the previous calendar year.

(2) The annual fee, rounded to the next £1, is—

where—

(a)

T is the annual turnover in the previous calendar year;

(b)

and n is the number of active marketing authorisations held at any time during the previous calendar year.

(3) In the case of an authorisation holder with a turnover relating to all marketing authorisations held of less than £230,000, the annual fee, rounded to the next £1 is—

where—

(a)

T is the annual turnover in the previous calendar year;

(b)

and n is the number of active marketing authorisations held at any time during the previous calendar year.

(4) In this paragraph—

“turnover” means the sales value at manufacturers’ prices of all authorised veterinary medicinal products sold or supplied in the United Kingdom;

“manufacturers’ prices” means the prices charged (excluding value added tax) for authorised products by manufacturers to wholesalers, except to the extent that—

(a)

the products are supplied by manufacturers direct to retailers, in which case it means the prices charged for the products by the manufacturers to the retailers reduced by such sum as, in the opinion of the Secretary of State, represents the difference between the prices paid by the retailers and those which could be expected to be charged by the manufacturers to wholesalers according to the practice prevailing during the period in question with regard to such products;

(b)

a marketing authorisation holder sells or supplies products that the marketing authorisation holder has neither manufactured nor obtained from the manufacturer, in which case it means the prices paid by the marketing authorisation holder for those products.

Auditor’s certificate U.K.

27.—(1) The Secretary of State may at any time require an audit certificate in support of a statement of turnover.

(2) If the holder of the marketing authorisation does not provide an audit certificate before the date stipulated in the demand, an additional fee is payable for that year of £11,300 plus an additional £2,245 in respect of each marketing authorisation held.

(3) If the Secretary of State is not satisfied that the audit certificate provides sufficient assurance that the figures fairly present the financial records of the company, the Secretary of State may require the marketing authorisation holder to produce a further certificate and specify what further assurances are needed; and if these are not provided by the required date, the additional fee specified in sub-paragraph (2) is payable.

(4) Nothing in this paragraph limits the powers of an inspector to examine financial records.