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

Type Statutory-Instrument

Publication 2016-02-11

Last updated 2025-04-01

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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(b) does not relate to anything done in a registered pharmacy but where the total turnover of the sale by way of wholesale dealing of authorised medicinal products does not exceed £35,000; or

(c) relates only to medicinal products classified as subject to general sale under regulation 5(1) (classification of medicinal products) or paragraph 3(5) of Schedule 32 (transitional provisions and savings: product licences of right) to the Human Medicines Regulations.

(4) Sub-paragraph (2) does not apply where the applicant has not held a wholesale dealer's licence during the 12 month period preceding the date of the application unless at the time of making the application it is reasonable for the applicant to believe—

(a) in the case of an application for a wholesale dealer's licence which relates to anything done in a registered pharmacy by or under the supervision of a pharmacist and which amounts to wholesale dealing, that such dealing will constitute no more than 15% of the gross amount of the total sales of authorised medicinal products likely to be made in the period of 12 months following the grant of the licence, or

(b) in the case of an application for a wholesale dealer's licence which does not relate to anything done in a registered pharmacy, that the gross amount of total sales of authorised medicinal products likely to be made in the period of 12 months following the grant of the licence will not exceed £35,000,

and that applicant so informs the licensing authority when the application is made.

(5) The fee payable under regulation 12(1)(a) in connection with a change of ownership application is £478.

Broker's registrations

32

(1) The fee payable under regulation 12(1)(a) in connection with an application for a broker's registration is £1,983.

(2) The fee payable under regulation 12(1)(a) in connection with a change of ownership application is £439.

Active substance registrations

33

(1) The fee payable under regulation 12(1)(a) in connection with an application for an active substance registration is—

(a) £3,763 where the application includes the manufacture of active substances; or

(b) £2,159 where the application only concerns the importation or distribution of active substances.

(2) The fee payable under regulation 12(1)(a) in connection with a change of ownership application is £439.

Clinical trial authorisations

34

The fee payable under regulation 12(1)(a) in connection with an application for a clinical trial authorisation is—

(a) £4,656, where the application is for a product that is not marketed; or

(b) £343, where the application is for a product that is marketed.

Traditional herbal registrations

35

(1) Subject to sub-paragraphs (3) to (6), the fee payable under regulation 12(1)(a) in connection with an application for a traditional herbal registration of a kind described in column 1 of the following table is the fee specified in the corresponding entry in column 2 of that table.

Column 1	Column 1	Column 1	Column 1	Column 2
Kind of application	Kind of application	Kind of application	Kind of application	Fee payable
1. Complex registration application	1. Complex registration application	1. Complex registration application	1. Complex registration application
	(a)	(a)	in respect of a medicinal product containing a single active ingredient	£5,899
	(b)	(b)	in any other case	£8,848
2. Standard registration application	2. Standard registration application	2. Standard registration application	2. Standard registration application
	(a)	(a)	in respect of a medicinal product containing 3 or fewer active ingredients	£2,950
	(b)	(b)	in any other case	£4,424
3. Reduced registration application category II	3. Reduced registration application category II	3. Reduced registration application category II	3. Reduced registration application category II
		(a)	in respect of a medicinal product containing 3 or fewer active ingredients	£983
		(b)	in any other case	£1,476
4. Reduced registration application category I	4. Reduced registration application category I	4. Reduced registration application category I	4. Reduced registration application category I
		(a)	in respect of a medicinal product containing 3 or fewer active ingredients	£657
		(b)	in any other case	£983
5. Change of ownership application	5. Change of ownership application	5. Change of ownership application	5. Change of ownership application	£592

(2) Each reference in sub-paragraphs (3) to (6) to an amount payable under sub-paragraph (1) in respect of an application refers to the amount payable under that sub-paragraph in respect of an application of the kind in question.

(3) Where an application relates to a medicinal product which contains one or more vitamins or minerals which are vitamins or minerals from a new source, a fee of—

(a) £1,311, if European Pharmacopoeia certificates of suitability covering all the vitamins or minerals which are a vitamin or mineral from a new source have been submitted with the application; or

(b) £2,622, in any other case,

is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.

(4) Where an application relates to a medicinal product which contains one or more new excipients, an amount of £8,748 is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.

(5) Where an application relates to a medicinal product which contains one or more TSE risk excipients from a new source, an amount of £777 is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.

(6) Where an application relates to a medicinal product which is a sterile medicinal product, an amount of £2,622 is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.

Online sellers of medicines

36

The fee payable under regulation 13 in connection with an application to be included on the list of online sellers of medicines is £100.

PART 3 — Capital Fees for Assistance in Obtaining Marketing Authorisations in Other EEA States

Outgoing mutual recognition applications

37

(1) The fee payable for regulatory assistance under regulation 17 is the fee specified in sub-paragraphs (2) to (5).

(2) In the case where the application to the licensing authority relates to a medicinal product for which a marketing authorisation was granted in the United Kingdom (the application relating to that authorisation is referred to in this paragraph as the “original application”) and the original application had been a major application or would fall within the meaning of a major application, in respect of—

(a) the first application for regulatory assistance (“the first application”), the fee is £41,573;

(b) any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as the first application, the fee is £2,564;

(d) any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as any subsequent application, the fee is £2,564.

(3) In the case where the application to the licensing authority relates to a medicinal product for which a marketing authorisation was granted in the United Kingdom and the original application had been a complex application or would fall within the meaning of a complex application, in respect of—

(a) the first application for regulatory assistance (“the first application”), the fee is £10,753;

(b) any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as the first application, the fee is £2,564;

(d) any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as any subsequent application, the fee is £2,564.

(4) In the case where the application to the licensing authority relates to a medicinal product for which a marketing authorisation was granted in the United Kingdom and the original application had been a standard application or would fall within the meaning of a standard application, in respect of—

(a) the first application for regulatory assistance (“the first application”), the fee is £4,282;

(b) any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as the first application, the fee is £2,564;

(d) any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as any subsequent application, the fee is £2,564.

(5) In the case where the application to the licensing authority relates to a medicinal product for which a marketing authorisation was granted in the United Kingdom and the original application had been a simple application or would fall within the meaning of a simple application, in respect of—

(a) the first application for regulatory assistance (“the first application”), the fee is £2,564;

(b) any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as the first application, the fee is £2,564;

(d) any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as any subsequent application, the fee is £2,564.

(6) The condition referred to in sub-paragraphs (2) to (5) is that all applications fall within the meaning given to a “set of applications” in regulation 16.

PART 4 — Capital Fees for Applications for Variations of Authorisations, Licences and Registrations

Marketing authorisations

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;

(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 and of marketing authorisations in force in Great Britain, Table 2;

(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.

Column 1Kind of variation	Column 1Kind of variation	Column 2Fee payable
1. Application for a single kind variation	1. Application for a single kind variation
(a)	Type IB Application	£419
(b)	Type II Application	£419
(c)	Type II Complex Variation Application	£3,338
(d)	Extended Type II Complex Variation Application	£10,301
2. Applications for a Group	2. Applications for a Group
(a)	Minor Variation (Type IB) Group Application	£419
(b)	Major Variation (Type II) Group Application	£1,528
(c)	Major Variation (Type II) Complex Group Application	£3,619
(d)	Major Variation (Type II) Extended Complex Group Application	£10,555
Column 1Kind of national variation	Column 2Fee payable
---	---
1.National Type 1B Application	£419
2. National Type II Application	£1,593
3. National Type II Complex Variation Application	£11,126
4. National Type II Extended Complex Variation Application	£40,173
5. National Type IB Minor Variation Group Application	£833
6. National Type II Major Variation Group Application	£2,212
7. National Type II Major Variation Complex Group Application	£12,065
8. National Type II Major Variation Extended Complex Group Application	£35,184
9 Variation of a UKMA(GB) which was granted following an application made under the unfettered access route, provided a corresponding variation has been approved to the related UKMA(NI) for the same product	£nil
10 Variation of a UKMA(GB) which was granted following an application made under the unfettered access route, provided a corresponding variation has been approved to the related European Union marketing authorisation for the same product	Apply fees and fee categories in Table 1
11 Variation of a UKMA(UK) or a UKMA(GB) which was granted following an application other than an application made under the unfettered access route, where the medicinal product concerned has already been granted a marketing authorisation by a competent authority of an EEA State under Article 28 of the 2001 Directive, provided a corresponding variation has been approved to the related marketing authorisation or UKMA(NI) for the same product	Apply fees and fee categories in Table 1
12 Variation of a UKMA(GB) which was granted following an application where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application), provided a corresponding variation has been approved to the related European Union marketing authorisation or UKMA(NI) for the same product	Apply fees and fee categories in table 1
Column 1Kind of reclassification variation	Column 1Kind of reclassification variation	Column 1Kind of reclassification variation
---	---	---
Application falling within the category described in—	Application falling within the category described in—	Application falling within the category described in—
		(a)
		(b)

Variation of marketing authorisations

39

(1) Subject to sub-paragraph (3) and paragraph 39A , if an application to vary a marketing authorisation of a kind described in sub-paragraph (2) is—

(a) the first application to vary a marketing authorisation;

(b) made within 5 years of the date of grant of the marketing authorisation; and

the fee payable for that application is the fee payable under regulation 19(1) together with the difference between that fee and the fee which would have been payable if the application had been a major application.

(2) In this paragraph a marketing authorisation is one which has been granted in accordance with an application to which point 6 of Part II of Annex I to the 2001 Directive applies or which is an orphan marketing authorisation.

(3) Sub-paragraph (1) and (2) shall not apply where the first application for variation of the marketing authorisation relates to a therapeutic area, in respect of which the applicant would be entitled (had the applicant not already held a marketing authorisation) to apply for a marketing authorisation to which point 6 of Part II of Annex I to the 2001 Directive applies or which is in respect of a medicinal product which meets the orphan criteria listed in regulation 50G(2) of the Human Medicines Regulations.

Reclassification of marketing authorisations

40

(1) Where an application is a reclassification variation application to which this paragraph applies, the fee payable under regulation 19(1) in connection with the application for variation of a marketing authorisation is £1,593.

(2) This paragraph applies to a reclassification variation application which would have the effect that a medicinal product to which the marketing authorisation relates—

(a) is to be available only from a pharmacy (where previously it was available only on prescription), if an analogous medicinal product is available only from a pharmacy or on general sale; or

(b) is to be available on general sale (where previously it was available only on prescription or only from a pharmacy), if an analogous medicinal product is available on general sale.

(3) For the purposes of this paragraph, an analogous medicinal product is a medicinal product which has a United Kingdom marketing authorisation or a European Union marketing authorisation and which—

(a) has the same active ingredient, route of administration and use;

(b) has the same strength or a higher strength;

(d) is for sale or supply at the same quantity or a greater quantity,

as the medicinal product in relation to which the variation application is made.

Variation of marketing authorisation: national homoeopathic products

41

The fee payable under regulation 19(1) in connection with an application for a variation of a marketing authorisation in respect of a national homoeopathic product is—

(a) £296 where the application is a standard variation application for a homoeopathic medicinal product;

(b) £456 where the application is a new indication variation application; and

Variation of parallel import licence

42

(1) The fee payable under regulation 19(1) in connection with an application for variation of a parallel import licence is—

(a) £40,173 if, were the marketing authorisation not a parallel import licence, the application for the variation would be a reclassification variation application falling within paragraph 15(a) and to which paragraph 38 of this Schedule does not apply;

(b) £10,929 if, were the marketing authorisation not a parallel import licence, the application for the variation would be a reclassification variation application falling within paragraph 15(b) and to which paragraph 38 of this Schedule does not apply; and

(2) For the purposes of sub-paragraph (1)(c) an application for an administrative variation is where the variation applied for falls within one of the following paragraphs—

(a) a change of either or both of the name and the address of the holder of the licence;

(b) a change of either or both of the name and the address of a manufacturer, assembler, storer or distributor named in the licence where the change has been occasioned by the taking over of an existing business, whether by purchase, merger or otherwise, and any change of address does not involve a change of the site of manufacture, assembly or storage or of the site from which distribution takes place;

(c) the removal from the licence of details of one or more of the sites of manufacture, assembly or storage or of the sites from which distribution takes place;

(d) the removal from the licence of details of any of the activities to which the licence relates;

(e) the removal from the licence of details of any of the medicinal products which the holder of the licence is authorised to import;

(f) the addition or deletion of the name and address of the suppliers of the medicinal product to which the licence relates, or a change in the name, the address, or both the name and address, of the suppliers of that product; or

(g) unless paragraph 9 of Schedule 7 applies, a change consequential upon any or any combination of the following—

(i) a change of ownership of the United Kingdom marketing authorisation in respect of which the parallel import licence was granted,

(ii) a change to the number of the United Kingdom marketing authorisation in respect of which the parallel import licence was granted,

(iii) a change to the name of the holder of the United Kingdom marketing authorisation in respect of which the parallel import licence was granted,

(iv) a change to the address of the holder of the United Kingdom marketing authorisation in respect of which the parallel import licence was granted,

(v) a change to the number of the marketing authorisation for the product in the country where the product originates,

(vi) a change of ownership of the marketing authorisation for the product in the country where the product originates,

(vii) a change to the name of the holder of the marketing authorisation for the product in the country where the product originates, or

(viii) a change to the address of the holder of the marketing authorisation for the product in the country where the product originates,

where the change has been occasioned by the taking over of an existing business, whether by purchase, merger or otherwise, if the marketing authorisation was not a parallel import licence, the application for that variation would be a reclassification variation application to which paragraph 40 of this Schedule applies.

Manufacturer's authorisations and licences

43

Unless the fee in paragraph 44 is payable or paragraph 51 applies, the fee payable under regulation 19(1) in connection with an application for variation of a manufacturing authorisation or a manufacturer's licence is—

(a) £345 in the case of a manufacturer's licence referred to in paragraph 30(2); and

(b) £688 in any other case.

Variation of manufacturer's authorisations and licences

44

The fee payable under regulation 19(1) in connection with an application for variation of a manufacturing authorisation or a manufacturer's licence is £345 in respect of each variation applied for which constitutes a change to the authorisation or licence not requiring an inspection or medical, scientific or pharmaceutical assessment.

Wholesale dealer's licences

45

Unless the fee in paragraph 46 is payable or paragraph 51 applies, the fee payable under regulation 19(1) in connection with an application for a variation of a wholesale dealer's licence is £652.

Variation of wholesale dealer's licence

46

The fee payable under regulation 19(1) in connection with an application for variation of a wholesale dealer's licence is £345 in respect of each variation applied for which consists of a change to the licence not requiring an inspection or medical, scientific or pharmaceutical assessment.

Variation of a broker's registration

47

The fee payable under regulation 19(1) in connection with an application for variation of a broker's registration is £345 in respect of each variation applied for which consists of a change to the registration not requiring an inspection.

Variation of an active substance registration

48

The fee payable under regulation 19(1) in connection with an application for variation of an active substance registration is £309 in respect of each variation applied for which consists of a change to the registration not requiring an inspection.

Clinical trial authorisations

49

(1) A fee of £302 is payable under regulation 20(2)(a) in connection with a notice of amendment relating to an amendment to the dossier, or to the protocol, related to a request for authorisation to conduct a clinical trial.

Traditional herbal registrations

50

Unless paragraph 51 applies, the fee payable under regulation 19(1) in connection with an application for variation of a traditional herbal registration is—

(a) £293 if the application is a standard variation application;

(b) £773 if the application is a complex variation application;

(d) £186 if the application is an administrative variation application.

Identical variations

51

(1) Unless paragraph 52 or 53 applies, where more than one application—

(a) of a type referred to in sub-paragraph (2) is made at the same time by the same marketing authorisation holder and all of the applications are for identical kinds of variations; or

(b) by the same applicant is made at the same time for a traditional herbal registration, a manufacturer's licence, or a wholesale dealer's licence and where the applications are for identical variations,

the fee payable under regulation 19(1) is that specified in sub-paragraph (3).

(2) The type of application referred to in sub-paragraph (1) is a—

(a) Type IB Application;

(b) Type II Application;

(d) Major Variation (Type II) Group Application.

(3) The fee referred to in sub-paragraph (1)—

(a) in connection with the first application considered by the licensing authority is the appropriate amount specified in this Part of this Schedule; and

(b) in connection with each of the other applications is 50% of that amount.

Complex Variation Applications

52

(1) Where more than one application of a type referred to in sub-paragraph (2) is made at the same time by the same marketing authorisation holder and all of the applications are for identical kinds of variations, the fee payable under regulation 19(1)—

(a) in connection with the first application considered by the licensing authority is the appropriate amount specified in this Part of the Schedule; and

(b) in connection with each of the other applications in respect of which no further medical, scientific or pharmaceutical assessment is required, is the amount which would be payable if the application was a Type II Application.

(2) The type of application referred to in sub-paragraph (1) is a—

(a) Type II Complex Variation Application;

(b) Extended Type II Complex Variation Application;

(d) Major Variation (Type II) Extended Complex Group Application.

Multiple reclassification variation applications

53

Where more than one reclassification variation application is made at the same time by the same applicant, each relating to medicinal products which have the same active ingredient or combination of ingredients, the fee payable under regulation 19(1)—

(a) if one or more of the applications is an application to which paragraph 40 does not apply—

(i) in connection with the first application to which paragraph 40 does not apply, is the appropriate amount specified in this Part of the Schedule;

(ii) in connection with each other application to which paragraph 40 does not apply, the fee payable is £1,308; and

(iii) in connection with each other application to which paragraph 40 does apply, the fee payable is £367; and

(b) in any other case—

(i) in connection with the first application, is the appropriate amount specified in this Part of the Schedule; and

(ii) in connection with each other application, the fee payable is £367.

PART 5 — Capital Fees for Assessment of Labels and Leaflets

A set of changes

54

(1) Unless paragraph 55 applies, the fee payable under regulation 25(1) in connection with a set of proposed changes to the labelling or the package leaflet of a medicinal product is—

(a) £992, in respect of a product which is the subject of a United Kingdom marketing authorisation (other than a parallel import licence); and

(b) £440, in respect of a product which is the subject of a parallel import licence.

(2) If the proposed changes in respect of a product to which the fee in sub-paragraph (1)(a) applies are submitted in accordance with the National Guidance on labels and leaflets self-certification, the fee payable under regulation 25(1) is £224.

(3) For the purpose of this paragraph—

(a) changes are submitted in accordance with the National Guidance on labels and leaflets self-certification if they are of a type described in the National Guidance on labelling and patient information leaflets for self-certification and comply with the conditions set out in relation to those changes in that Guidance; and

(b) the “National Guidance on labelling and patient information leaflets for self-certification” means the documents entitled “Guidance on changes to labelling and patient information for self-certification” and “Guidance on changes to labelling for self certification – compliance with Article 56(a) of the 2001 Directive – inclusion of Braille on the labelling” published by the licensing authority and available on its website .

More than one set of changes proposed

55

(1) In this paragraph, “clinical particulars” means the clinical particulars contained in the Summary of Product Characteristics for that product as specified in of Article 11 of the 2001 Directive.

(2) This paragraph applies where more than one set of proposed changes falling within regulation 25(1) is submitted by the same marketing authorisation holder at the same time and where—

(a) the sets of proposed changes consist of identical changes to the labelling or package leaflets of products with the same active ingredient or combination of ingredients, dosage form and clinical particulars; or

(b) the sets of proposed changes consist of identical changes to different versions of the labelling or package leaflet of the same product.

(3) Where this paragraph applies, the fee payable under regulation 25(1) is—

(a) in connection with the first set of proposed changes considered by the licensing authority, the appropriate amount specified in paragraph 54; and

(b) in connection with each of the other sets of proposed changes, 50% of that amount.

PART 6 — Capital Fee for the Renewal of a Marketing Authorisation

Regulatory assistance

56

Unless paragraph 57 applies, the fee payable under regulation 27A in connection with an application for the renewal of a United Kingdom marketing authorisation is—

(a) in respect of an application for renewal of a UKMA(GB) granted under the unfettered access route, £1,239;

(b) in respect of an application for renewal of a UKMA(GB) where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application), £1,239;

Regulatory assistance – same manufacturer

57

(1) This sub-paragraph applies if more than one application falling within regulation 27A is made by the same applicant at the same time, each of which relates to medicinal products which have the same active ingredient or combination of ingredients, dosage form and therapeutic indications, and the marketing authorisations for those products have the same date for renewal.

(2) The fee payable under regulation 27A for applications to which sub-paragraph (1) applies is—

(a) in respect of applications for renewal of more than one UKMA(GB) granted under the unfettered access route or UKMA(GB) where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application), and provided a corresponding renewal application has been made to the related European Union marketing authorisation or UKMA(NI) for the same product—

(i) £1,239 for the first application considered by the licensing authority; and

(ii) £1,239 for each other application;

(b) in all other cases—

(i) £16,042 for the first application considered by the licensing authority; and

(ii) £822 for each other application.

PART 7 — Relevant Substances

Substances listed for the purposes of paragraph 24(2)(b) and (4)(b) and 38(2)(b)

58

(1) The substances listed for the purposes of paragraphs 24(2)(b) and (4)(b) and 38(2)(b) (fees payable where the application concerns certain substances) are—

— Acetic Acid

— Aluminium Chloride

— Aluminium Hydroxide

— Aluminium Sulfate

— Ammonia

— Ammonium Bicarbonate

— Ammonium Chloride

— Ascorbic Acid

— Barium Sulfate

— Benzoic Acid

— Benzoyl Peroxide

— Benzyl Alcohol

— Benzyl Benzoate

— Bismuth Subgallate

— Calamine

— Calcium Acetate

— Calcium Carbonate

— Calcium Chloride

— Calcium Gluconate

— Calcium Glycerophosphate

— Calcium Hydroxide

— Calcium Lactate

— Calcium Phosphate

— Charcoal

— Chlorobutanol

— Chlorocresol

— Citric Acid

— Coal Tar

— Ethanol

— Ethanolamine

— Ferric Chloride

— Ferrous Fumarate

— Ferrous Gluconate

— Ferrous Sulfate

— Formaldehyde Solution

— Glucose

— Glycine

— Hydrogen Peroxide

— Iodine

— Isopropyl Alcohol

— Isopropyl Myristate

— Kaolin

— Lactic Acid

— Lactose

— Lactulose

— Lithium Carbonate

— Lithium Citrate

— Magnesium Acetate

— Magnesium Carbonate

— Magnesium Chloride

— Magnesium Hydroxide

— Magnesium Oxide

— Magnesium Sulfate

— Magnesium Trisilicate

— Malic Acid

— Manganese Sulfate

— Oleic Acid

— Paraffin

— Phenol

— Phosphoric Acid

— Potassium Acetate

— Potassium Bicarbonate

— Potassium Chloride

— Potassium Citrate

— Potassium Dihydrogen Phosphate

— Potassium Hydrogen Tartrate

— Potassium Hydroxide

— Potassium Iodate

— Potassium Iodide

— Potassium Nitrate

— Silver Nitrate

— Sodium Acetate

— Sodium Ascorbate

— Sodium Bicarbonate

— Sodium Carbonate

— Sodium Chloride

— Sodium Citrate

— Sodium Dihydrogen Phosphate

— Sodium Fluoride

— Sodium Hydroxide

— Sodium Iodide

— Sodium Lactate

— Sodium Sulfate

— Sorbic Acid

— Sucrose

— Sulpher

— Tar

— Tartaric Acid

— Undecenoic Acid

— Urea

— Wool Alcohols

— Wool Fat

— Zinc Acetate

— Zinc Chloride

— Zinc Oxide

— Zinc Sulfate

— Zinc Undecenoate

(2) The list of substances under this Part includes any dried, anhydrous, hydrate, hydrous, activated, strong, light, heavy and coloured forms of substances listed under paragraph (1) that are the subject of a pharmacopoeial monograph of the European Pharmacopoeia or the British Pharmacopoeia.

SCHEDULE 3 — Fees for inspections

General provisions relating to fees for inspections

1

(1) In this Schedule, a reference to 1 day means a period of 7 hours.

(2) For the purposes of paragraphs 3(2)(c), 4(2)(c), 6(2)(c) and 8, in calculating the number of days taken to make an inspection, any part day shall be calculated as a whole day.

(3) Where an inspection is made at a site which is outside the United Kingdom, the fee for the inspection shall be increased by an amount equal to the travelling and subsistence costs of the inspector relating to the inspection and any additional costs (such as interpreters' fees) reasonably incurred by the inspector in respect of that inspection as a result of its being at a site outside the United Kingdom.

(4) If an inspection is made by more than one inspector, the time taken by the licensing authority to make an inspection is the total amount of time spent by each inspector in making the inspection.

Fees: general

2

(1) The fee for an inspection made at a site is—

(a) £5,251, if the time taken to make the inspection is not more than 1 day; and

(b) thereafter, £2,625 for every additional period of 3 hours and 30 minutes or less taken to make the inspection.

(2) Sub-paragraph (1) does not apply if the inspection is one for which a fee is payable under paragraphs 3 to 7.

Traditional herbal medicinal products

3

(1) Sub–paragraph (2) applies if the site inspected is wholly concerned with the manufacture, assembly or import from a third country of traditional herbal medicinal products.

(2) If this sub-paragraph applies, the fee payable in respect of an inspection of a site in connection with the grant, variation or renewal of a manufacturer's licence or during the currency of such a licence, is—

(a) £994 if the time taken to make the inspection is not more than 3 hours;

(b) £1,615 if the time taken to make the inspection is more than 3 hours but not more than 1 day; and

(c) if the time taken to make the inspection is more than 1 day, the amount calculated by multiplying the total number of days taken to make the inspection by £1,615.

Sites concerned with starting materials for traditional herbal medicinal products

4

(1) Sub-paragraph (2) applies if the site inspected is wholly concerned with the manufacture or assembly of starting material for use in the manufacture of traditional herbal medicinal products.

(2) If this sub-paragraph applies, the fee payable in respect of an inspection of an API manufacturer under Article 111(1g)(a) of the 2001 Directive, is—

(a) £994 if the time taken to make the inspection is not more than 3 hours;

(b) £1,615 if the time taken to make the inspection is more than 3 hours but not more than 1 day; and

(c) if the time taken to make the inspection is more than 1 day, the amount calculated by multiplying the total number of days to make the inspection by £1,615.

Wholesale dealer's licence: general

5

Except in the case of an inspection falling within paragraphs 6 or 7, the fee for an inspection of a site made in connection with the grant or variation of a wholesale dealer's licence or during the currency of such a licence, is—

(a) if the time taken to make the inspection is not more than 1 day, £4,136; and

(b) if the time taken is 1 day or more, £4,136 for the first day and £2,068 for every subsequent period of 3 hours and 30 minutes or less taken to make the inspection.

Wholesale dealer's licence: traditional herbal medicinal products

6

(1) Sub–paragraph (2) applies if the site inspected is wholly concerned with the wholesale dealing of traditional herbal medicinal products.

(2) If this sub-paragraph applies, the fee payable in respect of an inspection of a site in connection with the grant, variation or renewal of a wholesale dealer's licence or during the currency of such a licence is—

(a) £1,114 if the time taken to make the inspection is not more than 3 hours;

(b) £2,047 if the time taken to make the inspection is more than 3 hours but not more than 1 day; and

(c) if the time taken to make the inspection is more than 1 day, the amount calculated by multiplying the total number of days taken to make the inspection by £2,047.

Wholesale dealer's licences: inspection of short duration

7

(1) Sub-paragraph (3) applies if the time taken to make the inspection is not more than 3 hours and 30 minutes, and

(a) the site is that of a wholesale dealer whose licence is limited to dealing only in medicinal products classified as subject to general sale under regulation 5(1) of the Human Medicines Regulations;

(b) the site relates to a registered pharmacy as referred to in paragraph 31(3) of Part 2 of Schedule 2; or

(c) the total turnover in respect of sales by way of wholesale dealing in authorised medicinal products of the wholesale dealer does not exceed £35,000.

(2) If paragraph (c) of sub-paragraph (1) applies because the applicant has not held a wholesale dealer's licence during the 12 month period preceding the date of the application, sub–paragraph (1) does not apply unless at the time of making the application—

(a) it is reasonable for the applicant to believe that the gross amount of total sales of authorised medicinal products likely to be made in the period of 12 months following the grant of the licence will not exceed £35,000; and

(b) the applicant so informs the licensing authority.

(3) If this sub-paragraph applies, the fee payable in respect of an inspection of a site made in connection with the grant, variation or renewal of a wholesale dealer's licence is £2,068.

Broker's registrations

8

(1) Except in the case of an inspection where sub–paragraph (2) applies, the inspection fee payable in connection with the grant, variation or review of a broker's registration is—

(a) £3,241 if the time taken to make the inspection is not more than 1 day; and

(b) if the time taken is 1 day or more, £3,241 for the first day and £1,621 for every subsequent period of 3 hours and 30 minutes or less taken to make the inspection.

(2) This paragraph applies where an application or variation of a broker's registration is considered under paragraph 10 but it is necessary to carry out a site inspection before the registration is granted or varied.

(3) If sub-paragraph (2) applies, a fee of £780 is payable in addition to any fee under paragraph 10.

Active substance registrations

9

(1) Except in the case of an inspection where sub–paragraph (2) applies, the fee payable in connection with the grant, variation or review of an active substance registration where the inspection relates to—

(a) a manufacturer of an active substance, is—

(i) £3,975 if the time taken to make the inspection is not more than 1 day; and

(ii) if the time taken is 1 day or more, £3,975 for the first day and £1,988 for every subsequent period of 3 hours and 30 minutes or less taken to make the inspection;

(b) an importer or distributor of an active substance, is—

(i) £2,898 if the time taken to make the inspection is not more than 1 day; and

(ii) if the time taken is 1 day or more, £2,898 for the first day and £1,449 for every subsequent period of 3 hours and 30 minutes or less taken to make the inspection.

(2) This paragraph applies where an application or variation of an active substance registration is considered under paragraph 10 but it is necessary to carry out a site inspection before the registration is granted or varied.

(3) If sub-paragraph (2) applies—

(a) a fee of £949 is payable in addition to any fee under paragraph 10 where the inspection relates to a manufacturer of an active substance;

(b) a fee of £697 is payable in addition to any fee under paragraph 10 where the inspection relates to an importer or distributor of an active substance.

Office-based inspections

10

The fee for an inspection comprising an office-based evaluation and risk assessment of documentation but not involving inspection of a site, in connection with the monitoring of—

(a) good manufacturing practice, good clinical practice or good pharmacovigilance practice, is £4,924 per day;

(b) good distribution practice, is £3,810 per day.

SCHEDULE 4 — Periodic fees for licences

PART 1 — Interpretation

1

In this Schedule—

“anthroposophic product” means a medicinal product prepared in accordance with the methods of anthroposophic medicine which is sold or supplied as an anthroposophic product and is so described by the person who sells or supplies that medicinal product;

“derivative”, in relation to a limited use drug or a new active substance, means a medicinal product—which contains the same active ingredient or combination of active ingredients as that drug or substance but which is either—a different dosage form of that drug or substance; orof the same dosage form as, but of a different strength of active ingredient to, or of a different combination of active ingredients to, that drug or substance; andin respect of which an application for a marketing authorisation was made before the determination of the application for the marketing authorisation for that drug or substance;

“general sale list medicine” means a medicinal product (not being an anthroposophic product, a herbal remedy or a homoeopathic medicinal product) classified as subject to general sale within the meaning of regulation 5(1) of the Human Medicines Regulations;

“limited use drug” means a medicinal product in respect of which an application for a marketing authorisation has been submitted, to which point 6 of Part II of Annex I to the 2001 Directive applies or in respect of which an orphan marketing authorisation has been granted;

“lower fee” means the periodic fee payable—where the medicinal product has not been manufactured or imported into the United Kingdom during the period of 12 months preceding the commencement of the relevant fee period; orin relation to a medicinal product that has been manufactured or imported into the United Kingdom during the period referred to in (a) above, where the value of the product sold or supplied during that period did not exceed £1,000; andin relation to a prescription only product, where the authorisation holder has notified the licensing authority that the medicinal product to which the marketing authorisation relates, is not expected to be manufactured, or imported into the United Kingdom during the relevant fee period; orin relation to a pharmacy medicine or a general sale list medicine, the periodic fee payable during the relevant fee period;

“new active substance” means a medicinal product which is not a limited use drug and which contains an active ingredient which has not previously been included as an active ingredient in a medicinal product in respect of which a marketing authorisation (other than a product licence of right) has been granted in the five years preceding 31st December in the fee period preceding the relevant fee period;

“pharmacy medicine” means a medicinal product (not being an anthroposophic product, a herbal remedy or a homoeopathic medicinal product) classified as a pharmacy medicine within the meaning of regulation 5(5) of the Human Medicines Regulations;

“prescription only medicine” means a medicinal product (not being an anthroposophic product, a herbal remedy, a homoeopathic medicinal product, a new active substance or a derivative of a new active substance) classified as a prescription only medicine within the meaning of regulation 5(3) of the Human Medicines Regulations;

“reduced rate fee” means the periodic fee payable in relation to a prescription only medicine where the total value of the product which is sold or supplied in the relevant fee period does not exceed £35,000;

“standard fee” means the periodic fee payable in relation to a prescription only medicine where the total value of the product which is sold or supplied in the relevant fee period exceeds £35,000; and

“total value of the product” means the amount calculated in accordance with Part 2 of this Schedule.

PART 2 — Value of the Product Sold or Supplied

Determining the total value of the product

2

For the purposes of this Schedule, the “total value of the product” means, the gross value at manufacturer's prices of all medicinal products to which the authorisation relates that are sold or supplied in the United Kingdom by the holder of that authorisation during a period of 12 months preceding the commencement of the relevant fee period.

Manufacturer's prices

3

For the purposes of paragraph 2 manufacturer's prices means—

(a) for products manufactured or obtained, sold or supplied by the authorisation holder to wholesalers or to distributors or assemblers named in the marketing authorisation, which that holder has manufactured or obtained from the manufacturer, the prices charged for the supply;

(b) for products sold or supplied by the authorisation holder to retailers, which that holder has manufactured or obtained from the manufacturer, the prices which, in the opinion of the licensing authority, the authorisation holder would have charged, in accordance with the practice prevailing during the relevant year, to a wholesaler of the product; or

(c) for products sold or supplied by the authorisation holder which that holder has neither manufactured nor obtained from the manufacturer, the price which the authorisation holder paid for the supply.

Information requirements

4

(1) The authorisation holder shall determine the total value of product sold or supplied in accordance with paragraphs 2 and 3 and provide such information to the licensing authority if required to do so.

(2) The licensing authority may additionally require an auditor's certificate verifying the authorisation holder's determination of the value of products sold or supplied.

(3) If an auditor's certificate has not been provided to the licensing authority within one month of it being required, or such longer period that the authority may allow, the periodic fee shall be calculated in accordance with sub-paragraph (4).

(4) The periodic fees for the relevant fee period in question shall be equal to the fee provided for in paragraphs 10 and 13 of Part 3 of this Schedule or, such lesser sum as the licensing authority may specify in a written notice served on the authorisation holder.

PART 3 — Periodic Fees for Marketing Authorisations and Licences

Marketing authorisations

5

Unless paragraphs 6 to 10 apply, the fee payable under regulation 38(1) in connection with the holding of a marketing authorisation relating to a medicinal product of a kind described in column 1 of the following table is the applicable fee specified in the corresponding entry in column 2 of that table.

Marketing authorisation: where Part 2 of the Act applies

6

In the case of an article or substance to which Part 2 of the Act applies by virtue of the Medicines (Surgical Materials) Order 1971 , the fee payable under regulation 38(1) in connection with the holding of a marketing authorisation or licence is £368.

Marketing authorisation: derivatives

7

Unless paragraph 8 applies, where a marketing authorisation is held in respect of a derivative of a new active substance, the fee payable under regulation 38(1) is—

(a) £11,627 where the medicinal product to which the authorisation relates has a different route of administration from that of the new active substance; or

(b) £7,847 in any other case.

Number of fee periods

8

(1) The fee specified in—

(a) paragraph 5 for a new active substance; and

(b) in paragraph 7 for a derivative of a new active substance,

is only payable for the five relevant fee periods following that in which the marketing authorisation is granted.

(2) The fee payable in accordance with entry 3(a) of the table set out in paragraph 5 is only payable for the three relevant fee periods following the year beginning 1st April during which the marketing authorisation is granted.

(3) Where a marketing authorisation is surrendered and at the same time another marketing authorisation held by the authorisation holder is varied so as to include in that other authorisation the provisions of the first authorisation, the fee payable—

(a) for the five relevant fee periods following the fee period during which the marketing authorisation is granted is the fee specified at entry 1 of the table set out in paragraph 5, where the first authorisation relates to a new active substance;

(b) in all other cases, for each fee period mentioned in sub-paragraph (2), is the fee specified at entry 3(a) of that table.

(4) In respect of fee periods following those referred to in sub-paragraphs (1) to (3) of this paragraph, the periodic fees are the appropriate fees for the kind of medicinal product in question specified in entries 3(b), (c) or (d) of the table set out in paragraph 5.

(5) In connection with the holding of a marketing authorisation in respect of a limited use drug or a derivative of a limited use drug—

(a) where the total value of the product sold or supplied exceeds £200,000, until the expiry of the five relevant fee periods following the fee period during which the marketing authorisation was granted, the periodic fee payable is the fee that would be payable if the drug were, respectively, a new active substance or a derivative of a new active substance;

(b) where the total value of the product sold or supplied does not exceed £200,000 or where a periodic fee has been payable in respect of the limited use drug or derivative of a limited use drug for five relevant fee periods following the fee period during which the marketing authorisation was granted, the periodic fee payable is the fee payable in respect of a prescription only medicine in accordance with entry 3(b)(i) of the table set out in paragraph 5.

Authorisation for two or more kinds of medicinal product

9

Where a marketing authorisation relates to any two or more medicinal products of a kind described in entries 3(b), (c) or (d) of column 1 of the table in paragraph 5, the fee payable under regulation 38(1) shall be the lower of the fee specified as corresponding to those entries in column 2 of that table.

Reduced fees

10

Where a reduced rate fee or a lower fee may be payable in respect of any relevant fee period and an authorisation holder does not submit information about the total value of the product sold or supplied in relation to the relevant calendar year to the satisfaction of the licensing authority, the periodic fee payable shall, where applicable, be the standard fee for each description of medicinal product in respect of which a marketing authorisation is held by the authorisation holder.

Manufacturer's licences or manufacturing authorisations

11

(1) Unless sub-paragraph (3) applies, the fee payable under regulation 38(1) in connection with the holding of a manufacturer's licence is £561.

(2) The fee payable under regulation 38(1) in connection with the holding of a manufacturing authorisation is £561.

(3) The fee payable under regulation 38(1) in connection with the holding of a manufacturer's licence which relates to the import of special medicinal products from a third country is the fee payable in accordance with sub-paragraph (1) and an additional amount calculated in accordance with paragraph 15.

Wholesale dealer's licences

12

(1) Subject to sub-paragraph (2) and to paragraphs 13 and 16, the fee payable under regulation 38(1) in connection with the holding of a wholesale dealer's licence is £346.

(2) The fee payable under regulation 38(1) is £206 where the wholesale dealer's licence—

(a) relates to anything done in a registered pharmacy by or under the supervision of a pharmacist and amounts to wholesale dealing, where such dealing constitutes no more than 15% of the total value of the sale of authorised medicinal products carried on at that pharmacy;

(b) does not relate to anything done in a registered pharmacy, where the total value of the sale by way of wholesale dealing in authorised medicinal products does not exceed £35,000; or

(3) For the purposes of sub-paragraph (2), the total value shall be calculated in accordance with Part 2 of this Schedule and the references to “marketing authorisation” and “authorisation holder” in Part 2 shall be interpreted as if they were references to “wholesale dealer's licence” and “licence holder”, respectively.

Wholesale dealer's licences: evidence

13

Where in respect of any relevant fee period, the holder of a wholesale dealer's licence does not submit evidence of turnover in relation to the relevant fee period to the satisfaction of the licensing authority, the periodic fee payable shall be the fee prescribed in paragraph 12(1).

Wholesale dealer's licences: special medicinal products

14

The fee payable under regulation 38(1) in connection with the holding of a wholesale dealer's licence which relates to special medicinal products imported from another EEA member State is the fee payable in accordance with paragraphs 12 and 13 and an additional amount calculated in accordance with paragraph 15.

Additional amount for manufacturer's licences and wholesale dealer's licences which relate to special medicinal products

15

(1) The additional amount referred to in paragraphs 11(3) and 14 in relation to any fee period is—

(a) the fee specified in the entry in column 2 of Table 1 (additional periodic fee in connection with notices for imported special medicinal products) corresponding to the estimated number of special import notices for that fee period specified in column 1, and

(b) the fee specified in the entry in column 2 of Table 2 (additional periodic fee in connection with the number of different special medicinal products imported) corresponding to the estimated number of different special medicinal products imported for that fee period specified in column 1.

Column 1	Column 2
Number of special import notices	Additional amount
1 to 20	£86
21 to 100	£427
101 to 500	£2,131
501 to 1,000	£4,261
1,001 to 2,000	£8,521
2,001 to 5,000	£17,042
5,001 to 10,000	£34,083
10,001 to 15,000	£51,125
15,001 to 20,000	£68,166
20,001 to 25,000	£85,208
25,001 to 30,000	£102,249
30,001 to 35,000	£119,291
35,001 to 40,000	£136,333
40,001 to 45,000	£153,375
45,001 to 50,000	£170,417
Each additional 5,000 above 50,000	£170,417 plus £17,042 for each additional 5,000 special import notices
Column 1	Column 2
---	---
Number of different special medicinal products notified for import	Additional amount
1 to 5	£122
6 to 10	£244
11 to 20	£487
21 to 50	£1,218
51 to 100	£2,435
101 to 200	£,4,869
For each additional 100 special medicinal products notified for import above 200	£4,869 plus £2,435 for each additional 100 special medicinal products notified for import

(2) For the purposes of this paragraph, the estimated number of special import notices for any fee period shall be the number notified in writing to the licence holder by the licensing authority before the start of that fee period as the number of such notices which the authority estimate will be given by the holder during the fee period.

(3) For the purposes of this paragraph, the estimated number of different special medicinal products notified for import for any fee period shall be the number notified in writing to the licence holder by the licensing authority before the start of that fee period as the number of such notices which the authority estimate will be given by the holder during the fee period.

Traditional herbal registrations

16

The fee payable under regulation 38(1) in connection with the holding of a traditional herbal registration is £92.

Online sellers of medicines

17

(1) Subject to sub-paragraph (2), the fee payable under regulation 39(1) by a person included on the list of online sellers of medicines is £97.

(2) For the fee period beginning with 1st April 2016 and ending with 31st March 2017, the fee payable under regulation 39(1) by a person included on the list of online sellers of medicines is the fee payable in accordance with sub-paragraph (1) and an additional amount of £100.

(3) The fee payable in accordance with sub-paragraph (2) is payable on invoice.

PART 4 — Types of Marketing Authorisation for which only One Periodic Fee is Payable

Parallel import licences

18

In a case where a parallel import licence has been granted by the licensing authority the periodic fee relating to that licence is payable once only.

SCHEDULE 5 — Fees for certificates of registration

Column 1	Column 1	Column 1	Column 2	Column 2	Column 3	Column 3
Type of application	Type of application	Type of application	Fees for applications in respect of products prepared from not more than 5 homoeopathic stocks	Fees for applications in respect of products prepared from not more than 5 homoeopathic stocks	Fees for other applications	Fees for other applications
1	An application in respect of a product which is both prepared solely from repeat stocks and is of a repeat formulation.	An application in respect of a product which is both prepared solely from repeat stocks and is of a repeat formulation.	An application in respect of a product which is both prepared solely from repeat stocks and is of a repeat formulation.	£194	£194	£479
2	An application in respect of a product which is either—	An application in respect of a product which is either—	An application in respect of a product which is either—	£582	£582	£857
	(a)	prepared solely from repeat stocks; or	prepared solely from repeat stocks; or
	(b)	is of a repeat formulation.	is of a repeat formulation.
3	A mutual recognition procedure incoming application.	A mutual recognition procedure incoming application.	A mutual recognition procedure incoming application.	£610	£610	£777
4	A mutual recognition outgoing application (regulatory assistance).	A mutual recognition outgoing application (regulatory assistance).	A mutual recognition outgoing application (regulatory assistance).	£287	£287	£374
5	A decentralised procedure application where the UK is a concerned member State.	A decentralised procedure application where the UK is a concerned member State.	A decentralised procedure application where the UK is a concerned member State.	£524	£524	£686
6	A decentralised procedure application where the UK is the reference member State.	A decentralised procedure application where the UK is the reference member State.	A decentralised procedure application where the UK is the reference member State.	£813	£813	£1,063
7	Any other application.	Any other application.	Any other application.	£962	£962	£1,259

SCHEDULE 6 — Time for payment of capital fees: small companies

Interpretation

1

In this Schedule a reference to an application is to an application made by or on behalf of a small company.

Major application

2

In connection with a major application for a marketing authorisation for which the fee payable is that specified in entry 1(h) of the table in paragraph 24 of Part 2 of Schedule 2, the fee payable under regulation 12(1)(a) shall, if the applicant so requests in writing, be payable as to 25% at the time of the application and as to 75% within 30 days following written notice from the licensing authority that the application has been determined.

Complex application

3

In connection with a complex application for a marketing authorisation, the fee payable under regulation 12(1)(a) shall, if the applicant so requests in writing, be payable—

(a) as to 50% at the time of the application; and

(b) as to 50% within 30 days following written notice from the licensing authority that the application has been determined.

Multiple application

4

In connection with an application to which paragraph 28 of Part 2 of Schedule 2 applies, the fee payable under regulation 12(1)(a) shall, if the applicant so requests in writing, be payable—

(a) as to 50% of the total payable in accordance with that paragraph at the time of the application; and

(b) as to 50% of that total within 30 days following written notice from the licensing authority that the application has been determined.

Outgoing mutual recognition application

5

As regards the fee payable under regulation 17 in connection with an application—

(a) to which paragraph 36(2) of Part 3 of Schedule 2 applies—

(i) 25% of that fee shall be payable at the time when, in connection with the application or set of applications for regulatory assistance, a request is made under the second sub-paragraph of Article 28(1) of the 2001 Directive for an assessment report to be prepared or updated; and

(ii) 75% of that fee shall become payable within 30 days following written notice from the licensing authority that the regulatory assistance is at an end;

(b) to which paragraph 36(3), (4) or (5), of Part 3 of Schedule 2 applies—

(i) 50% of that fee shall be payable at the time when, in connection with the application or set of applications for regulatory assistance, a request is made under the second sub-paragraph of Article 28(1) of the 2001 Directive for an assessment report to be prepared or updated, and

(ii) 50% of that fee shall become payable within 30 days following written notice from the licensing authority that the regulatory assistance is at an end,

if the applicant so requests in writing.

Application for traditional herbal registration

6

In connection with an application for a traditional herbal registration, the fee payable under regulation 12(1)(a) shall, if the applicant so requests in writing, be payable as to 50% at the time of the application and as to 50% within 12 months after that time.

Traditional herbal registration: complex variation

7

In connection with a complex variation application or a new excipient variation application to vary a traditional herbal registration, the fee payable under regulation 19(1) shall, if the applicant so requests in writing, be payable as to 50% at the time of the application and as to 50% within 12 months after that time.

Application for manufacturer's licence, manufacturing authorisation or wholesale dealer's licence

8

In connection with an application for a manufacturer's licence, manufacturing authorisation, or a wholesale dealer's licence, the fee payable under regulation 12(1)(a) shall, if the applicant so requests in writing, be payable as to 50% at the time of the application and as to 50% within 12 months after that time.

Inspection fees in connection with applications

9

In connection with an application for a marketing authorisation, traditional herbal registration, manufacturer's licence or manufacturing authorisation, the fee payable in respect of an inspection at any site other than one named as a possible site for manufacture of a medicinal product by three or more applicants shall, if the applicant so requests in writing, be payable as to 50% within the period of 14 days referred to in regulation 50(1)(b) and as to 50% within 12 months after that date.

SCHEDULE 7 — Waiver, reduction or refund of capital fees

Interruptions of manufacture, assembly, sale or supply

1

Where the manufacture, assembly, sale or supply of medicinal products of a particular class or description will be, or is likely to be, interrupted for a period and in consequence thereof the health of the community will be, or is likely to be, put at risk, any capital fees payable under these Regulations in connection with an application for the grant of a marketing authorisation or a manufacturer's licence relating to a medicinal product falling within that class or description and made during that period or, if the period will, or is likely to, exceed 3 months of that period, shall be waived.

Reclassification

2

(1) Where—

(a) an application for a marketing authorisation includes a reclassification element within the meaning of paragraph 25 of Part 2 of Schedule 2; and

(b) the licensing authority is satisfied that the reclassification element does not require consideration by the Commission on Human Medicines, the Herbal Medicines Advisory Committee or the Advisory Board on the Registration of Homoeopathic Products,

50% of the additional amount payable under paragraph 25(1)(a) or (b) or 28(4)(a) of Part 2 of that Schedule shall be refunded, or if it has not yet been paid, shall be waived.

(2) Where—

(a) an application for variation of a marketing authorisation is a reclassification variation application (not being an application falling within paragraph 40 of Part 4 of Schedule 2); and

(b) the licensing authority is satisfied that the application does not require consideration by the Commission on Human Medicines, the Herbal Medicines Advisory Committee or the Advisory Board on the Registration of Homoeopathic Products,

50% of the fee payable under paragraph 38 of Schedule 2 and entry 1(c)(i) of Table 1 referred to in that paragraph or of the fee payable under paragraph 53 (a)(i) of Part 4 of Schedule 2 shall be refunded, or if it has not yet been paid, shall be waived.

(3) Where—

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