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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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“repeat stock” means—a homoeopathic stock which is identical to another homoeopathic stock which is used in the preparation of a product—in respect of which the applicant holds a certificate of registration or a homoeopathic marketing authorisation; orin respect of which another person holds a certificate of registration or a homoeopathic marketing authorisation to which, for the purposes of his application, the applicant has been authorised in writing to make reference by the person (or if more than one, each of the persons) who supplied information to the licensing authority in connection with the application for the certificate of registration or a homoeopathic marketing authorisation which relates to that product; orwhere more than one application is made by the applicant on the same occasion in respect of products prepared from identical homoeopathic stocks, for the purposes of the second and any subsequent of those applications which the licensing authority considers, the homoeopathic stock used in the preparation of the product to which the first of those applications which is considered by the licensing authority relates;

“safety development” means the toxicological and pharmacological testing necessary to demonstrate the safety of a relevant medicinal product, in accordance with module 4 of Part 1 of Annex 1 to the 2001 Directive;

“scientific advice” means advice in connection with the quality, safety or clinical development for a relevant medicinal product;

“special import notice” means a written notice given to the licensing authority in accordance with paragraph 22(2) (manufacturer's licence relating to the import of medicinal products from a state other than an EEA State) of or, paragraph 34 (wholesale dealer's licence relating to special medical imports) of Schedule 4 to the Human Medicines Regulations.

“special medicinal product” means a product within the meaning of regulation 167 of the Human Medicines Regulations or any equivalent legislation in an EEA State other than the United Kingdom;

“total value” means the gross amount of the total sales made during the period of 12 months preceding the date of the application;

“traditional herbal medicinal product” has the meaning given by Article 1(29) of the 2001 Directive;

“traditional herbal registration” means a traditional herbal registration granted by the licensing authority under Part 7 of the Human Medicines Regulations;

“turnover” in relation to wholesale dealing means the gross amount of the total sales made during the period of 12 months preceding the date of the application;

“under the unfettered access route” has the meaning given by regulation 8(1) of the Human Medicines Regulations;

“United Kingdom marketing authorisation” means a marketing authorisation granted by the licensing authority under—Part 5 of the Human Medicines Regulations; orChapter 4 of Title III to the 2001 Directive (mutual recognition and decentralised procedure);

“variation”—in relation to—a United Kingdom marketing authorisation; ora product licence which has effect as such a marketing authorisation by virtue of paragraphs 1 and 2 of Schedule 32 (transitional provisions and savings) to the Human Medicines Regulations,means “variation to the terms of a marketing authorisation” as defined in regulation 8(1) of the Human Medicines Regulations ;in relation to a traditional herbal registration, means a variation of the provisions of a traditional herbal registration;

“wholesale dealer's licence” means a wholesale dealer's licence within the meaning of regulation 18(1) (wholesale dealing in medicinal products) of the Human Medicines Regulations.

2

For the purposes of these Regulations, a clinical trial authorisation is in force unless the licensing authority has—

(a) received notification of the conclusion of the clinical trial to which the authorisation relates, in accordance with regulation 27 (conclusion of clinical trial) of the Clinical Trials Regulations; or

(b) suspended or terminated the trial at all sites at which that clinical trial was conducted, in accordance with regulation 31 (suspension or termination of clinical trial) of those Regulations .

3

In these Regulations any reference to an application for the variation of a marketing authorisation includes a reference to a notification of such a variation and any reference to an applicant for a variation to a marketing authorisation includes a reference to a person who submits such a notification.

4

In these Regulations any reference to an application to be included on the list of online sellers of medicines is a reference to a notification under regulation 256C of the Human Medicines Regulations (notification requirements for sellers of medicinal products at a distance) and any reference to an applicant to be included on the list of online sellers of medicines is a reference to a person who submits such a notification.

SCHEDULE 2 — Capital fees for applications for, and variations to, marketing authorisations, licences, registrations and certificates

PART 1 — General: interpretation and categories of applications and variations

Interpretation

1

In this Schedule—

“active ingredient from a new source” means an active ingredient in respect of which the application names as manufacturer a manufacturer not previously named as the manufacturer of that active ingredient included in a medicinal product in respect of which a marketing authorisation (other than a product licence of right) or a traditional herbal registration has previously been granted;

“EAMS scientific opinion” has the meaning given in regulation 8(1) of the Human Medicines Regulations;

“EU marketing authorisation” means—a marketing authorisation; oran authorisation issued by a competent authority of an EEA State other than the United Kingdom for the purposes of Article 6 of the 2001 Directive;

“the MHRA portal” means the internet-based hosted platform which enables persons to carry out business with the Medicines and Healthcare products Regulatory Agency of the Department of Health and Social Care electronically, known as the “the MHRA Portal”;

“new active ingredient” means an active ingredient that 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 previously been granted;

“new excipient” means—except in Part 2, paragraph 35 and Part 4, any ingredient of a medicinal product, other than an active ingredient, that has not previously been included in a medicinal product—which is intended to be administered by the same route of administration as the product in question; andin respect of which a marketing authorisation (other than a product licence of right), a certificate of registration or a traditional herbal registration has previously been granted,except that in the case of a medicinal product intended to be administered orally, the expression does not include any ingredient specified in any enactment (including an enactment comprised in subordinate legislation or in any Directive, Regulation or Decision of the European Union) as an approved ingredient or additive in food or in a food product;in Part 2, paragraph 35 and Part 4, any ingredient of a medicinal product, other than an active ingredient, that has not previously been included in a medicinal product which is intended to be administered by the same route of administration as the product in question and in respect of which a marketing authorisation (other than a product licence of right), a certificate of registration or a traditional herbal registration has previously been granted, except that—in the case of a medicinal product intended to be administered orally, the expression does not include any ingredient specified in any enactment (including an enactment comprised in subordinate legislation or in any Directive, Regulation or Decision of the European Union) as an approved ingredient or additive in food or in a food product; andin the case of a medicinal product intended for external use only, the expression does not include any ingredient specified in any enactment (including an enactment comprised in subordinate legislation or in any Directive, Regulation or Decision of the European Union) as an approved ingredient or additive in a cosmetic product;

“Phase I trial” means a clinical trial to study the pharmacology of a medicinal product when administered to humans, where the sponsor and investigator have no knowledge of any evidence that the product has effects likely to be beneficial to the subjects of the trial;

“Phase II or Phase III trial” means a clinical trial, other than a Phase I trial, where the medicinal product being tested—does not have an EU marketing authorisation; orhas an EU marketing authorisation, but—there has been a change—to the process of manufacture of the product or its active ingredient; orof manufacturer of that product, orthe product is to be used in the trial other than in accordance with the terms of the summary of product characteristics under that authorisation;

“Phase IV trial” means a clinical trial other than a Phase I trial or a Phase II or Phase III trial;

“Promising Innovative Medicines designation” means a designation issued by the licensing authority under the Early Access to Medicines Scheme in accordance with regulation 167C(2)(a) of the Human Medicines Regulations;

“TSE risk ingredient from a new source” and “TSE risk excipient from a new source” means an active ingredient or excipient, respectively, which has been manufactured from raw materials of ruminant origin or which has had raw materials of ruminant origin used in its manufacture and in respect of which—the application names as manufacturer, a manufacturer not previously named as the manufacturer of that ingredient or excipient included in a medicinal product in respect of which a marketing authorisation (other than a product licence of right), a certificate of registration or a traditional herbal registration has previously been granted; andno European Pharmacopoeia certificate of suitability covering the excipient has been submitted with the application;

“vitamin or mineral from a new source” means a vitamin or mineral in respect of which the application names as manufacturer a manufacturer not previously named as the manufacturer of that vitamin or mineral included in a medicinal product in respect of which a marketing authorisation (other than a product licence of right) or a traditional herbal registration has previously been granted.

General: categories of Applications and Variations

2

(1) In this Schedule, references to a particular type of application, variation or variation application shall be interpreted in accordance with this paragraph and paragraphs 3 to 23.

(2) A reference to a “European reference product application” means an application for a marketing authorisation to which the third sub-paragraph of Article 10(1) of the 2001 Directive applies.

Administrative variation application

3

An administrative variation application is an application by a traditional herbal registration holder to vary a traditional herbal registration where the variation applied for falls within one of the following sub-paragraphs—

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

(b) a change of either or both of the name and the address of a manufacturer, assembler, storer or distributor named in the registration 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; or

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

Extension application

4

An extension application is an application—

(a) for an extension of a marketing authorisation—

(i) in the case of a UKMA(NI) or UKMA(UK), within the meaning of Article 2(4) of Commission Regulation (EC) No 1234/2008; or

(ii) in the case of a UKMA(GB), within the meaning given in paragraph 1 of Schedule 10A to the Human Medicines Regulations; and

(b) which includes the result of pre-clinical tests or clinical trials as specified in Article 8(3)(i) of the 2001 Directive.

Complex application

5

A complex application is an application, other than a major application, for a marketing authorisation where the application falls within one or more of the following sub-paragraphs—

(a) the application relates to a medicinal product which is intended to be used in accordance with an indication for use in respect of a new category of patients or as treatment for a new category of disease;

(b) the application relates to a medicinal product containing a new combination of active ingredients that have not previously been included in that combination in a medicinal product in respect of which a marketing authorisation (other than a product licence of right) has previously been granted;

(d) the application relates to a medicinal product that is intended to be administered by a route of administration different from that used in relation to any medicinal product which contains the same active ingredient as the product in question and in respect of which a marketing authorisation (other than a product licence of right) has previously been granted;

(e) the application relates to a medicinal product containing an active ingredient the manufacture of which involves a route of synthesis (or, in the case of a medicinal product not synthetically produced, a method of manufacture) different from that used in the manufacture of the active ingredient of any medicinal product which contains the same active ingredient as the product in question and in respect of which a marketing authorisation (other than a product licence of right) has previously been granted;

(f) the application relates to a medicinal product which is a controlled release preparation and is not a simple application;

(g) the application relates to a sterile medicinal product the manufacture of which involves a method of sterilisation different from that used in the manufacture of any medicinal product which contains the same active ingredient as the product in question and in respect of which a marketing authorisation (other than a product licence of right) has previously been granted;

(h) the application relates to a sterile medicinal product the container of which is directly in contact with the medicinal product and is made from different material from the container of any medicinal product which contains the same active ingredient as the product in question and in respect of which a marketing authorisation (other than a product licence of right) has previously been granted;

(i) unless a European Pharmacopoeia certificate of suitability covering the active ingredient has been submitted with the application, the application names as manufacturer of the active ingredient of the medicinal product in question a different manufacturer from the manufacturer of that active ingredient included in a medicinal product in respect of which a marketing authorisation (other than a product licence of right) has previously been granted;

(j) the application relates to a medicinal product which is an influenza vaccine and in respect of which the manufacturer or the manufacturing process is different from that specified in any other marketing authorisation which the applicant holds in respect of that product;

(k) the application is for the grant of a marketing authorisation for a medicinal product which is an influenza vaccine, except where it relates only to an influenza vaccine containing a different strain or strains from that specified in any other marketing authorisation which the applicant holds;

(l) the application is for the grant of a marketing authorisation for a medicinal product which is to be delivered by way of a metered dose inhaler;

(m) the application is for the grant of a marketing authorisation for a medicinal product which is in a powdered form and is to be delivered by way of inhalation;

(n) the application relates to a medicinal product—

(i) which is administered to the site of action or absorption by a method which has not previously been authorised in relation to any authorised medicinal product which contains the same active ingredient as the product in question; and

(ii) in respect of that other product, a marketing authorisation (other than a product licence of right) has previously been granted;

(o) the application is an application for a marketing authorisation to which Article 10(3) of the 2001 Directive applies;

(p) the application is an application where the sole or primary evidence for the safety and efficacy of the medicinal product consists of published scientific literature;

(q) the application is an extension application;

(r) the application—

(i) is not an application in accordance with Article 10, 10a or 10c of the 2001 Directive; and

(ii) includes the results of pre-clinical tests or clinical trials as specified in Article 8(3)(i) of the 2001 Directive; or

(s) the application is an application for a marketing authorisation to which the first sub-paragraph of paragraph 3 of Part II of Annex I to the 2001 Directive applies.

Complex registration application

6

A complex registration application is an application for a traditional herbal registration relating to a medicinal product containing an active ingredient that 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) or a traditional herbal registration has previously been granted.

Complex variation application

7

A complex variation application is an application by a traditional herbal registration holder to vary a traditional herbal registration which relates to a change in the formulation of a medicinal product comprising one or more of the following changes—

(a) a change in that product's active ingredients which involves the addition of one or more active ingredients which are active ingredients from a new source;

(b) a change in that product's excipients which involves the addition of one or more TSE risk excipients from a new source; or

(c) a change which involves the addition of one or more vitamins or minerals which are vitamins or minerals from a new source where no European Pharmacopoeia certificate of suitability covering those vitamins or minerals has been submitted with the application.

Decentralised procedure application

8

A decentralised procedure application is a major application, a complex application, a standard application or a simple application for a marketing authorisation for a medicinal product in respect of which at the time of the application—

(a) a marketing authorisation has not been granted in any EEA State; and

(b) an application for a marketing authorisation has been made in more than one EEA State under the procedure in Title III, Chapter 4 of the 2001 Directive.

Extended Type II Complex Variation Application

9

An Extended Type II Complex Variation Application is an application by a marketing authorisation holder to vary a marketing authorisation (not being a parallel import licence) so that the medicinal product is indicated for use—

(a) in a therapeutic area for which the product was not previously indicated for use; or

(b) in respect of an organ, or any other part, of the human body for which the product was not previously indicated for use, if the application is supported by data which comprises or includes the results of clinical trials or physico-chemical, microbiological or pharmacological and toxicological tests.

Major application

10

A major application is an application for a marketing authorisation made to the licensing authority on the grounds that a medicinal product contains a new active ingredient.

Mutual recognition procedure incoming application

11

A mutual recognition procedure incoming application is a major application, a complex application or a standard application for a marketing authorisation for a medicinal product in respect of which—

(a) a marketing authorisation has already been granted in another EEA State; and

(b) recognition of that marketing authorisation is sought from the licensing authority by way of the grant of a marketing authorisation in the United Kingdom, under the procedure in Title III, Chapter 4 of the 2001 Directive.

New excipient variation application

12

A new excipient variation application is an application, other than a complex variation application, by a traditional herbal registration holder to vary a traditional herbal registration which relates to a change in the formulation of the medicinal product to add a new excipient.

New indication variation application

13

A new indication variation application is an application to vary a marketing authorisation for a national homoeopathic product, so that product is indicated for a therapeutic use not previously covered by that authorisation.

Parallel Import Licence application

14

(1) An application for a simple parallel import licence means an application for a parallel import licence in respect of a proposed importation of a medicinal product (“P”) which is similar to a medicinal product (“R”) in respect of which a marketing authorisation has already been granted in the United Kingdom.

(2) For the purposes of sub-paragraph (1) “similar” means—

(a) the manufacturer of P and the manufacturer of R are either the same company or belong to the same group of companies or, in the case of independent companies, agreements have been concluded with the same licensor; and

(b) product P and R are manufactured according to the same formulation, using the same active ingredients, have the same pharmaceutical form and have no differences that will result in a difference in the therapeutic effect.

(3) An application for a complex parallel import licence means an application for a parallel import licence which is not a simple parallel import licence and the application is in respect of a medicinal product—

(a) containing a new excipient;

(b) containing an active ingredient the manufacture of which involves a route of synthesis (or, in the case of a medicinal product not synthetically produced, a method of manufacture) different from that used in the manufacture of the active ingredient of any medicinal product which contains the same active ingredient as the product in question and in respect of which a marketing authorisation (other than a product licence of right) has previously been granted;

(d) which is a sterile medicinal product the manufacture of which involves a method of sterilisation different from that used in the manufacture of any medicinal product which contains the same active ingredient as the product in question and in respect of which a marketing authorisation (other than a product licence of right) has previously been granted;

(e) which is a sterile medicinal product the container of which is directly in contact with the medicinal product and is made from different material from the container of any medicinal product which contains the same active ingredient as the product in question and in respect of which a marketing authorisation (other than a product licence of right) has previously been granted;

(f) containing an active ingredient which, unless that active ingredient is covered by a European Pharmacopoeia certificate of suitability, is not manufactured by a manufacturer of the active ingredient which is included in the medicinal product in respect of which a marketing authorisation (other than a product licence of right) has previously been granted;

(g) which is an influenza vaccine;

(h) which is to be delivered by way of a metered dose inhaler;

(i) which is in powder form and is to be delivered by inhalation;

(j) which falls within the description of the medicinal product set out in Article 10(3) of the 2001 Directive;

(k) where the sole or primary evidence for the safety and efficacy of that product consists of published scientific literature;

(l) in respect of which a marketing authorisation has not been made under Article 10, 10a or 10c of the 2001 Directive by the competent authority in the member State of exportation, and the application includes the results of pre-clinical tests or clinical trials within the meaning of Article 8(3)(i) of the 2001 Directive; or

(m) in respect of which a marketing authorisation to which the first sub-paragraph of paragraph 3 of Part II of Annex I to the 2001 Directive applied in the member State of exportation.

(4) An application for a standard parallel import licence means an application for a parallel import licence which is not a complex parallel import licence or a simple parallel import licence.

(5) An application shall not fall within the meaning of sub-paragraph (1), (3) or (4) where the applicant and the holder of the marketing authorisation in the member State of exportation in respect of which the medicinal product in question relates are a parent undertaking and subsidiary undertaking within the meaning of section 1162 (taken together with section 1161 of, and Schedule 7 to) the Companies Act 2006 .

Reclassification variation application

15

A reclassification variation application is an application for variation of a marketing authorisation which has the effect that a medicinal product to which that authorisation relates—

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

(b) is to be available on general sale, where previously it was available only from a pharmacy.

Reduced registration application

16

(1) A reduced registration application category I is an application other than a complex registration application for a traditional herbal registration relating to a medicinal product which is presented in the form of a herbal tea.

(2) A reference to a reduced registration application category II means an application, other than a complex registration application, or a traditional herbal registration where the application falls within one of the descriptions specified in sub-paragraphs (a) to (d) as follows—

(a) the application relates to a medicinal product which is presented in the form of a herbal tincture;

(b) the application relates to a medicinal product which is presented in the form of an essential oil;

(d) the application relates to a medicinal product which contains only herbal substances in a capsule.

Simple application

17

A simple application is an application—

(a) for a marketing authorisation to which Article 10c of the 2001 Directive applies; or

(b) made no later than three months after the expiry of a marketing authorisation, which is for a marketing authorisation containing identical provisions to those contained in the expired authorisation and which is made by the person who held the expired authorisation.

Standard application

18

A standard application is any application for the grant of a marketing authorisation which is not a major application, a complex application, a simple application, a change of ownership application or an application for a parallel import licence.

Standard registration application

19

A standard registration application means any application for the grant of a traditional herbal registration which is not a complex registration application, a reduced registration application category I, a reduced registration application category II or a change of ownership application.

Standard variation application

20

A standard variation application is an application by a traditional herbal registration holder to vary a traditional herbal registration which is not a complex variation application, a new excipient variation application or an administrative variation application.

Standard variation application for a homoeopathic medicinal product

21

A standard variation application for a homoeopathic medicinal product is an application for a variation of a marketing authorisation for a national homoeopathic product which requires—

(a) the replacement of an excipient used in the manufacture of the product;

(b) the replacement of a reagent indirectly associated with the manufacturing process of the product or which disappears from that process with a comparable reagent;

(c) a change to the qualitative composition of the container or other form of packaging immediately in contact with the product;

(d) a change to the method of manufacture of a homoeopathic stock included in the product;

(e) a change to the specification of any reagent or excipient used in the manufacture of the product;

(f) a change to the finished product specification of the product;

(g) a change to the test procedure for any raw material used in the manufacture of the product;

(h) a change to the test procedure for the product;

(i) a change to the test procedure for the container or other form of packaging immediately in contact with the product;

(j) a change to comply with a supplement to the European Pharmacopoeia or any national pharmacopoeia of a member State;

(k) a change to the shape of the container in which the product may be placed on the market;

(l) an additional pack size in which the product may be placed on the market;

(m) a change to the approved storage conditions for the product;

(n) a change to the shelf life of an unopened container of the product after the container has been opened for the first time;

(o) a change to the dimensions of an approved dosage form of the product (for example, tablets); ...

(p) a change following modification to the manufacturing authorisation referred to in Article 40 of the 2001 Directive; or;

(q) a change to any packaging of the product, including the container or other form of packaging immediately in contact with the medicinal product, any packaging into which the container or other form of packaging immediately in contact with the product is placed, or to a leaflet that accompanies the product and contains information for the user of the product.

Type IB and Type II Applications

22

(1) A Type IB Application is an application by a marketing authorisation holder to vary a marketing authorisation (not being a parallel import licence) which is a “minor variation of type IB” within the meaning of

(a) in the case of a UKMA(NI) or UKMA(UK), Article 2(5) of Commission Regulation (EC) No 1234/2008;

(b) in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations

(2) A Type II Application is an application by a marketing authorisation holder to vary a marketing authorisation (not being a parallel import licence) which is not—

(a) a reclassification variation;

(b) a Type IA Application;

(d) a Type II Complex Variation Application;

(e) an Extended Type II Complex Variation Application; or

(f) an application for an extension of a marketing authorisation within the meaning of Article 2(4) of Commission Regulation (EC) No 1234/2008.

(a) in the case of a UKMA(NI) or UKMA(UK), Article 2(4) of Commission Regulation (EC) No 1234/2008;

(b) in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations

(3) For the purposes of sub-paragraph (2)(b), a “Type IA Application” means an application by a marketing authorisation holder to vary a marketing authorisation (not being a parallel import licence) which is a “minor variation of type IA” within the meaning of

(a) in the case of a UKMA(NI) or UKMA(UK), Article 2(2) of Commission Regulation (EC) No 1234/2008;

(b) in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations

Type II Complex Variation Application

23

A Type II Complex Variation Application is an application for a variation of a marketing authorisation, other than an Extended Type II Complex Variation Application, which relates to a change—

(a) in the formulation of a medicinal product comprising one or more of the following changes, other than a change to which in the case of a UKMA(NI) or UKMA(UK), paragraph 1 (changes to active substances) or paragraph 2 (changes to strength, pharmaceutical form and route of administration) of Annex I to Commission Regulation (EC) No 1234/2008 applies or, in the case of a UKMA(GB), sub-paragraph (a) (changes to active substances) or sub-paragraph (b) (changes to strength, pharmaceutical form and route of administration) of the definition of “extension of a UK marketing authorisation” in paragraph 1 of Schedule 10A to the Human Medicines Regulations applies —

(i) a change which necessitates in-vivo bioavailability studies to be performed on that product;

(ii) a change in that product's preservative system; or

(iii) a change in that product's excipients which significantly affects the pharmaceutical or the therapeutic properties of that product; or

(b) which is considered a “major variation of type II” within the meaning of in the case of a UKMA(NI) or UKMA(UK), Article 2(3) of Commission Regulation (EC) No 1234/2008 or, in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations and which is—

(i) supported by data which comprises or includes the results of clinical trials or physicochemical, biological, microbiological or pharmacological and toxicological tests; or

(ii) accompanied by evidence relating to post-marketing experience which is information of any type described in paragraph 5.2.6 of Part I of Annex I to the 2001 Directive (clinical documentation); or

(i) sub-paragraph (c), (e), (g), (h), (j) or (n) of the definition of complex application in paragraph 5 of this Schedule would apply where an application for a marketing authorisation is made in respect of a medicinal product; or

(ii) sub-paragraph (i) of that definition would so apply and the change is not a minor variation of type IA or a minor variation of type IB within the meaning of in the case of a UKMA(NI) or UKMA(UK), Commission Regulation (EC) No 1234/2008 or, in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations .

PART 2 — Capital Fees for Applications for Authorisations, Licences, Registrations and Certificates

Marketing authorisations

24

(1) Unless sub-paragraphs (2) or (4) or paragraphs 25, 26, 28 or 29 apply, the fee payable under regulation 12(1)(a) in connection with an application for a marketing authorisation 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.

(2) This paragraph applies—

(a) to a complex application for a marketing authorisation of a kind described in item 2 in column 1 of the following table; and

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

(3) If sub-paragraph (2) applies the appropriate fee is the amount specified for an application of the same type under item 3 of the following table.

(4) This paragraph applies—

(a) to a complex application for a parallel import licence of a kind described in item 5(c) in column 1 of the following table; and

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

(5) If sub-paragraph (4) applies the appropriate fee is the amount specified for item 5(b) in the following table.

Column 1Kind of application	Column 1Kind of application	Column 2Fee payable
1. Major Application	1. Major Application
(a)	in respect of an application relating to an orphan medicinal product to which point 6 of Part II of Annex 1 to the 2001 Directive applies	£39,811
(b)	which is a mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£83,580
(c)	which is a European reference product application in the case of a product for sale or supply in Northern Ireland	£83,580
(d)	which is a decentralised procedure application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for UKMA(GB)	£83,580
(e)	in respect of an application for a UKMA(GB) under the unfettered access route where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004	£24,688
. . .	. . .	. . .
. . .	. . .	. . .
(h)	in any other case	£124,194
2. Complex application	2. Complex application
(a)	which is a mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£23,205
(b)	which is a European reference product application in the case of a product for sale or supply in Northern Ireland	£23,205
(c)	which is a decentralised procedure application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£23,205
(d)	in respect of an application for a UKMA(GB) under the unfettered access route where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004	£13,983
. . .	. . .	. . .
. . .	. . .	. . .
(g)	in any other case	£34,335
3. Standard application	3. Standard application
(a)	which is a mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£8,503
(b)	which is a European reference product application in the case of a product for sale or supply in Northern Ireland	£8,503
(c)	which is a decentralised procedure application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£8,503
(d)	in respect of an application for a UKMA(GB) under the unfettered access route where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004	£7,743
. . .	. . .	. . .
. . .	. . .	. . .
(g)	in any other case	£12,589
4. Simple application	4. Simple application
(a)	which is a mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£3,433
(b)	which is a decentralised procedure application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£3,433
(c)	in respect of an application for a UKMA(GB) under the unfettered access route where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004	£3,433
. . .	. . .	. . .
. . .	. . .	. . .
(f)	in any other case	£3,433
5. Parallel import licence applications	5. Parallel import licence applications
(a)	in respect of a simple parallel import licence	£2,400
(b)	in respect of a standard parallel import licence	£10,617
(c)	in respect of a complex parallel import licence	£24,343
6. Change of ownership application	6. Change of ownership application	£592

(6) Each reference in paragraphs 25, 27 and 28 to an amount payable under paragraph 24 in respect of an application refers to the amount payable under this paragraph in respect of an application of the kind in question.

Fees where application includes reclassification

25

(1) Unless paragraph 27 applies, where an application, other than a major application, includes a reclassification element and—

(a) the reclassification falls within the category of application described in paragraph 15(a), an amount of £40,173 is payable in addition to the amount payable under paragraph 24 in respect of that application; or

(b) the reclassification falls within the category of application described in paragraph 15(b), an amount of £10,929 is payable in addition to the amount payable under paragraph 24 in respect of that application.

(2) For the purposes of this paragraph, an application includes a reclassification element if—

(a) in the case of an application falling within the category described in paragraph 15(a), the medicinal product in question is to be available in the United Kingdom only from a pharmacy, unless there is an analogous medicinal product available in the United Kingdom only from a pharmacy or on general sale; or

(b) in the case of an application falling within the category described in paragraph 15(b), the medicinal product in question is to be available in the United Kingdom on general sale, unless there is an analogous medicinal product also so available.

(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 application is made.

Fees where person holds clinical trial certificate

26

Where a major application is made by a person who holds a clinical trial certificate for a medicinal product which contains the same active ingredient as the medicinal product in respect of which the marketing authorisation is applied for, the fee payable under regulation 12(1)(a) in connection with the application is reduced by the amount of the application fee paid for the clinical trial certificate.

Joint development

27

(1) In this paragraph—

“joint development” means the development by two or more applicants for marketing authorisations relating to medicinal products—each of which contains the same new active ingredient or combination of new active ingredients but with different proprietary names and which does not require separate consideration by the Commission on Human Medicines, the Herbal Medicines Advisory Committee or the Advisory Board on the Registration of Homoeopathic Products;the development of which has been notified to the licensing authority at or before the time the application is submitted, as being a joint development undertaken by those applicants; andin respect of which applications for marketing authorisations have been received by the licensing authority within one month of each other;

“primary applicant” means—that party to a joint development who first makes an application for a marketing authorisation relating to a new active ingredient which was the subject of that joint development; orthat party to a joint development who first makes an application for a marketing authorisation relating to a different dosage form or strength of that new active ingredient;

“secondary applicant” means any party to a joint development, other than the primary applicant, who makes an application for a marketing authorisation relating to the same new active ingredient as that which was the subject of the application made by the primary applicant.

(2) Unless sub-paragraph (3) applies, where a joint development relates to a medicinal product and two or more applications for marketing authorisations are submitted to the licensing authority by parties to the joint development, the fee payable under regulation 12(1)(a) is the amount payable in respect of a major application under paragraph 24 plus—

(a) in respect of the first or only marketing authorisation applied for by that secondary applicant—

(i) in the case of an application relating to a medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £19,063; or

(ii) in any other case, the amount payable in respect of a complex application under paragraph 24;

(b) in respect of each additional marketing authorisation applied for by that secondary applicant which relates to a medicinal product of the same dosage form—

(i) in the case of an application relating to a medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £6,985; or

(ii) in any other case, the amount payable in respect of a standard application under paragraph 24;

(c) in respect of the first additional marketing authorisation applied for by that secondary applicant relating to that medicinal product which is of a different dosage form—

(i) in the case of an application relating to a medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £19,063; or

(ii) in any other case, the amount payable in respect of a complex application under paragraph 24;

(d) in respect of any other additional marketing authorisation applied for by that secondary applicant relating to that medicinal product which is of a different dosage form—

(i) in the case of an application relating to a medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £6,985; or

(ii) in any other case, the amount payable in respect of a standard application under paragraph 24.

(3) Where a joint development relates to a medicinal product and an application for an additional marketing authorisation is submitted by both the primary applicant and the secondary applicant, both or all of which applications relate to identical dosage forms and strengths of the product—

(a) where the amount payable by the primary applicant is that in respect of a complex application, the fee payable under regulation 12(1)(a) by the secondary applicant is—

(i) in the case of an application relating to a biological medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £6,985; or

(ii) in any other case, the amount payable in respect of a standard application under paragraph 24;

(b) where the amount payable by the primary applicant is that in respect of a standard application, the fee payable under regulation 12(1)(a) by the secondary applicant is that in respect of a simple application under paragraph 24.

Application for multiple authorisations

28

(1) Unless sub-paragraph (2), (3) or (4) applies, where an application for a marketing authorisation is for more than one such authorisation each relating to a medicinal product containing the same active ingredient or combination of ingredients, the fee payable under regulation 12(1)(a) is an amount equal to the total of the amounts payable under paragraph 24 in respect of a separate application for each such authorisation.

(2) If the application is a major application, the amount payable is the amount payable in respect of a major application under paragraph 24 and—

(a) in respect of each additional marketing authorisation applied for which relates to a medicinal product of a different dosage form with a different route of administration—

(i) in the case of an application relating to a medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £19,063; or

(ii) in any other case, the amount payable in respect of a complex application under paragraph 24;

(b) in respect of each additional marketing authorisation applied for which relates to a medicinal product of a different dosage form but with the same route of administration—

(i) in the case of an application relating to a medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £6,985; or

(ii) in any other case, the amount payable in respect of a standard application under paragraph 24; and

(c) in respect of each additional marketing authorisation applied for which relates to a medicinal product of the same dosage form but of a different strength of active ingredient or different combination of active ingredients—

(i) in the case of an application relating to a medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £6,985; or

(ii) in any other case, the amount payable in respect of a standard application under paragraph 24.

(3) If the application is a complex application, the amount payable is the amount payable in respect of a complex application under paragraph 24 plus—

(a) in respect of each additional marketing authorisation applied for which relates to a medicinal product of a different dosage form with a different route of administration, the amount payable in respect of a complex application under paragraph 24;

(b) in respect of each additional marketing authorisation applied for which relates to a medicinal product of a different dosage form but with the same route of administration—

(i) in the case of an application relating to a biological medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £6,985; or

(ii) in any other case, the amount payable in respect of a standard application under paragraph 24; and

(c) in respect of each additional marketing authorisation applied for which relates to a medicinal product of the same dosage form but of a different strength of active ingredient or different combination of active ingredients—

(i) in the case of an application relating to a biological medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £6,985; or

(ii) in any other case, the amount payable in respect of a standard application under paragraph 24.

(4) If the application includes any applications for marketing authorisations that include a reclassification element, the amount payable is the amount payable in accordance with sub-paragraphs (1) to (3) and—

(a) in respect of the first marketing authorisation applied for that includes a reclassification element, the additional amount payable in respect of the relevant category of reclassification variation application under paragraph 25(1); and

(b) in respect of each other marketing authorisation applied for that includes a reclassification element, £1,593.

(5) For the purposes of sub-paragraph (4), a “reclassification element” has the meaning given in paragraph 25(2).

Authorisation for a national homoeopathic product

29

(1) In this paragraph—

“formulation” does not include the formulation of a homoeopathic stock;

“identical” means—in relation to the formulation of the product, identical as regards the requirements in respect of composition, preparation and testing; andin relation to a homoeopathic stock, identical as regards the source, composition and preparation of the stock and the test which it is required to undergo;

“product” includes a series of products each of which is prepared from identical homoeopathic stocks.

(2) This paragraph does not apply to an application which is a mutual recognition procedure incoming application or a decentralised procedure application.

(3) In connection with an application for a marketing authorisation for a national homoeopathic product prepared from not more than 5 homoeopathic stocks, the fee payable under regulation 12(1)(a) is the amount set out in column 2 in the table below opposite the description in column 1 appropriate to that application.

(4) In connection with any other application for a marketing authorisation for a national homoeopathic product, the fee payable under regulation 12(1)(a) shall be the amount set out in column 3 in the table below opposite the description in column 1 appropriate to that application.

Column 1	Column 1	Column 1	Column 2	Column 3
Description of application	Description of application	Description of application	Fee for applications in respect of products prepared from not more than 5 homoeopathic stocks	Fee 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	1. An application in respect of a product which is both prepared solely from repeat stocks and is of a repeat formulation	1. An application in respect of a product which is both prepared solely from repeat stocks and is of a repeat formulation	£630	£892
2. An application in respect of a product which is either—	2. An application in respect of a product which is either—	2. An application in respect of a product which is either—	£984	£1,235
	(a)	prepared solely from repeat stocks; or
	(b)	is of a repeat formulation
3. Any other application	3. Any other application	3. Any other application	£1,325	£1,598

(5) Each reference in sub-paragraphs (6) to (8) to an amount payable under sub-paragraph (3) or (4) in respect of an application refers to the amount payable under that sub-paragraph in respect of an application of the kind in question.

(6) Where an application relates to a national homoeopathic product which is manufactured using a method of sterilisation—

(a) not used in the manufacture of a medicinal product in respect of which a marketing authorisation (other than a product licence of right), a certificate of registration or a traditional herbal registration has previously been granted; and

(b) not referred to in the European Pharmacopoeia or any national pharmacopoeia of a member State,

an amount of £2,622 is payable in addition to the amount payable under sub-paragraph (3) or (4) in respect of that application.

(7) Where an application relates to a national homoeopathic product which contains one or more new excipients, an amount of £8,746 is payable in addition to the amount payable under sub-paragraph (3) or (4) in respect of that application.

(8) Where an application relates to a national homoeopathic product which contains one or more TSE risk ingredients from a new source or TSE risk excipients from a new source, an amount of £773 is payable in addition to the amount payable under sub-paragraph (3) or (4) in respect of that application.

Manufacturer's licences and authorisations

30

(1) The fee payable under regulation 12(1)(a) in connection with an application for a manufacturer's licence or a manufacturing authorisation is—

(a) £245 in a case to which sub-paragraph (2) applies;

(b) £461 in the case of a change of ownership application; and

(2) This sub-paragraph applies to the case of an application for a manufacturer's licence which is limited solely to the manufacture or assembly of medicinal products which are to be sold or supplied in circumstances to which regulation 169 (mixing of general sale medicinal products) of the Human Medicines Regulations applies.

Wholesale dealer's licences

31

(1) Unless sub-paragraph (2) or (5) applies, the fee payable under regulation 12(1)(a) in connection with an application for a wholesale dealer's licence is £2,159.

(2) Where this sub-paragraph applies, the fee payable under regulation 12(1)(a) is £992.

(3) Subject to sub-paragraph (4), sub–paragraph (2) applies where an application for a 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 turnover of the sale of authorised medicinal products carried on at that pharmacy;

(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;

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