The Veterinary Medicines Regulations 2013

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

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 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