The Medicines (Products for Human Use) (Fees) Regulations 2012

PART 1General

Citation and commencement

1.  These Regulations may be cited as the Medicines (Products for Human Use) (Fees) Regulations 2012 and come into force on 1st April 2012.

Interpretation

2.  These Regulations shall be interpreted in accordance with Schedule 1.

PART 2Capital Fees for Pre-Application Meetings

Interpretation of Part 2

3.  In this Part—

“EU marketing authorization” means—

“relevant medicinal product” means a medicinal product for human use to which the provisions of the 2001 Directive apply.

Fee for scientific advice: application for, or variation to, EU marketing authorization

4.  Unless regulation 5 applies, the fee payable by a person with whom the licensing authority holds a meeting in order to provide scientific advice with a view to that person making an application for an EU marketing authorization or an application for the variation of an EU marketing authorization, is—

(a)£2,378, if the advice provided at that meeting consists of advice in connection with—

(i)quality development only; or

(ii)safety development only;

(b)£2,986, if the advice provided at that meeting consists only of advice in connection with clinical development;

(c)£3,309, if the advice provided at that meeting consists only of advice in connection with quality and safety development;

(d)£3,917, if the advice provided at that meeting consists of advice in connection with—

(i)quality and clinical development; or

(ii)safety and clinical development;

(e)£4,849, if the advice provided at that meeting consists of advice in connection with quality, safety and clinical development.

Fee for scientific advice: classification of a medicinal product

5.—(1) The fee payable by a person with whom the licensing authority holds a meeting to provide scientific advice in connection with the classification of a relevant medicinal product, is—

(a)£2,986, if the advice relates to a product which, if reclassified, will be available on general sale; and

(b)£3,917, if the advice relates to a product which, if reclassified, will be available without a prescription from a pharmacy.

(2) For the purposes of this regulation, a product is on general sale if it is a medicinal product of a description or falling within a class specified in an Order made under section 51 (general sale lists) of the Act(1).

Fee for advertising advice

6.  The fee payable by the holder of a marketing authorization with whom the licensing authority holds a meeting in order to provide advice before the publication of advertising of a medicinal product by that holder’s undertaking on whether that advertising conforms to the requirements of Title VIII of the 2001 Directive, is £2,378.

Fee for pharmacovigilance advice

7.—(1) The fee payable by a person with whom the licensing authority holds a meeting in order to provide pharmacovigilance advice is—

(a)£3,917, in a case where the time taken by the licensing authority to prepare for and attend the meeting is more than six hours;

(b)£3,308, in any other case.

(2) The time taken by the licensing authority for the purposes of paragraph (1) shall be the total time spent by each individual engaged in preparing for or attending the meeting on behalf of the licensing authority.

Fee for advice on labelling or leaflets

8.  The fee payable by the holder of one or more marketing authorizations with whom the licensing authority holds a meeting in order to provide advice on proposed changes to the labelling or the package leaflets of the medicinal products to which those authorizations relate, is £2,378.

Fee for regulatory advice

9.  The fee payable by the holder of a marketing authorization with whom the licensing authority holds a meeting in order to provide regulatory advice to that person, is £2,986.

Fee for advice for other purposes

10.—(1) Unless paragraph (4) applies, the fee payable by a person specified in paragraph (2) with whom the licensing authority holds a meeting for a purpose specified in paragraph (3) is £4,810.

(2) A person who—

(a)is, or is to be, a sponsor of a clinical trial;

(b)manufactures medicinal products;

(c)is, or is to be, responsible for placing medicinal products on the market; or

(d)acts on behalf of, or provides advice or assistance to, a person referred to in sub-paragraphs (a) to (c),

is a specified person for the purpose of paragraph (1).

(3) A meeting referred to in paragraph (1) is for a specified purpose if it is held to provide advice in relation to—

(a)scientific or regulatory issues relating to the development of a medicinal product or a type of medicinal product;

(b)the design of pharmaceutical or pre-clinical tests, or clinical trials, for a medicinal product or a type of medicinal product;

(c)the management of risk in relation to a medicinal product or a type of medicinal product which is under development, or is being marketed in the European Union; or

(d)other scientific or regulatory issues relating to a medicinal product or a type of medicinal product after an EU marketing authorization has been granted for that product or a product of that type.

(4) Paragraph (1) does not apply in the case of a meeting where the purpose of such a meeting is to provide only advice specified in regulations 4 to 9.

(5) In this regulation—

“Directive 93/42/EEC” means Council Directive 93/42/EEC concerning medical devices(2);

“medical device” has the same meaning as in Article 1(2)(a) of Directive 93/42/EEC;

“medicinal product” includes a substance incorporated in a medical device which, if used separately, may be considered to be a medicinal product as defined in Article 1(2) of the 2001 Directive;

“regulatory issues” means issues relating to the application of any EU instrument relating to EU marketing authorizations or to medical devices, or any enactment which implements such an instrument;

“risks” means any risk relating to the quality, safety or efficacy of a medicinal product as regards patients’ health or public health, or any risk of undesirable effects on the environment;

“sponsor” shall be interpreted in accordance with regulation 3 (sponsor of a clinical trial) of the Clinical Trials Regulations(3);

and a reference to the development of a medicinal product or a type of medicinal product is a reference to development for the purposes of—

(a)obtaining an EU marketing authorization, or making a variation to an EU marketing authorization, for that product or a product of that type; or

(b)obtaining a design-examination certificate of the type mentioned in paragraph 4.3 of Annex II to Directive 93/42/EEC or a type-examination certificate of the type mentioned in paragraph 5 of Annex III to that Directive, for a medical device incorporating that product or a product of that type.

Time for payment of fees under regulations 4 to 10

11.  All sums payable by way of fees under regulations 4 to 10 must be paid within a period of 14 days, commencing on the date of the written notice issued by the licensing authority requiring payment of those fees.

PART 3Capital Fees for Applications for Authorizations, Registrations, Licences, Certificates or Authorisations and for Associated Inspections

Fees for applications for authorizations, licences or certificates etc.

12.—(1) Unless Part 16 of these Regulations (revocations and savings) applies, the application fee for a marketing authorization (other than a European Union marketing authorization), a traditional herbal registration, a manufacturer’s licence, a manufacturing authorisation, a wholesale dealer’s licence or a clinical trial authorisation is—

(a)the fee prescribed for that application in Part 2 of Schedule 2; and

(b)in respect of an inspection of a site made in connection with that application, the fee payable in accordance with regulations 27 to 32.

(2) Unless regulation 28 applies, the fee in paragraph (1) is payable by the applicant.

Fee for applications for copy certificates of good manufacturing practice

13.  The fee payable by an applicant for a certified copy of a certificate of good manufacturing practice issued pursuant to Article 111(5) of the 2001 Directive is £67.

Fees for applications for certificates and copy certificates by exporters of medicinal products

14.—(1) The fee payable by an applicant for a certificate issued under section 50 (export certificates) of the Act(4), is—

(a)£148, if the applicant requests the certificate to be issued within 24 hours of receipt of the application; and

(b)£67 in any other case.

(2) The fee in paragraph (1)(a) and (b) is for three identical signed certificates.

(3) The fee payable by the applicant for a certified copy of the certificate referred to in paragraph (1) is £33.

PART 4Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States

Meaning of “set of applications”

15.  For the purposes of this Part, a “set of applications” means—

(a)a number of applications to the licensing authority for regulatory assistance in connection with obtaining recognition according to the procedure laid down in Title III, Chapter 4 of the 2001 Directive of a single United Kingdom marketing authorization in other EEA States, but only if all the applications relate to applications for marketing authorizations in other EEA States that have the same 90 day assessment period for the purposes of Article 28(4) of the 2001 Directive; or

(b)a number of applications to competent authorities of other EEA States for marketing authorizations relating to a single United Kingdom marketing authorization, but only if all the applications have the same 90 day assessment period for the purposes of Article 28(4) of the 2001 Directive.

Fees for applications for regulatory assistance under the mutual recognition procedure

16.  The fee payable by an applicant to the licensing authority for regulatory assistance in connection with obtaining recognition according to the procedure laid down in Title III, Chapter 4 of the 2001 Directive of a single United Kingdom marketing authorization in another EEA State or in other EEA States, is the fee prescribed in Part 3 of Schedule 2 in connection with the application or set of applications.

Time for payment of fees under regulation 16

17.  Unless regulation 46 (applications made by small companies) applies, all sums payable by way of fees under regulation 16 must have been paid at the time when, in connection with the application or set of applications for regulatory assistance, a request is made pursuant to the second sub-paragraph of Article 28(1) of the 2001 Directive for an assessment report to be prepared or updated.

PART 5Capital Fees for Applications for Variations of Authorizations, Registrations, Licences and Authorisations and for Associated Inspections

Fees for variations of authorizations, registrations, licences and authorisations

18.—(1) Unless Part 16 of these Regulations (revocations and savings) applies, the fee for an application—

(a)under regulation 4 (applications for the grant, renewal or variation of a United Kingdom marketing authorization) of the Marketing Authorisation Regulations(5) for the variation of a United Kingdom marketing authorization;

(b)under regulation 6 (consideration and grant or refusal, of an application for, or for renewal or variation of, a traditional herbal registration) of the Herbal Regulations for the variation of a traditional herbal registration;

(c)under section 30 (variation of licence on application of holder) of the Act(6) for the variation of a product licence, a manufacturer’s licence or a wholesale dealer’s licence; or

(d)under regulation 44 (variation of manufacturing authorisation) of the Clinical Trials Regulations(7) for the variation of a manufacturing authorisation,

is the fee mentioned in paragraph (2).

(2) The fee referred to in paragraph (1) is—

(a)the fee prescribed in Part 4 of Schedule 2 in connection with the application; and

(b)in respect of an inspection of a site made in connection with the application, the fee payable in accordance with regulations 27 to 29 and 31.

(3) Unless regulation 28 applies, the fee in paragraph (1) is payable by the applicant.

Fees for amendments to clinical trial authorisations

19.—(1) A person who sends a valid notice of amendment under regulation 24 (amendments by the sponsor) of the Clinical Trial Regulations(8) relating to amendment of the dossier accompanying a request for authorisation in accordance with paragraph 11 of Part 2 of Schedule 3 (request for authorisation) to those Regulations must pay the fees mentioned in paragraph (2).

(2) The fees referred to in paragraph (1) are—

(a)the fee prescribed in paragraph 44 of Schedule 2 in connection with that amendment; and

(b)in respect of an inspection of a site made in connection with the application, the fee payable in accordance with regulations 27 to 29 and 31.

Applications for multiple variations

20.—(1) Unless paragraph (3) or (5) applies, a separate fee is payable in respect of each application to vary each term of a marketing authorization.

(2) Unless paragraph (5) applies, a separate fee is payable in respect of each variation of each provision of a traditional herbal registration, manufacturing authorisation or licence applied for in any one application.

(3) A separate fee is not payable for each application to vary a term of a marketing authorization which—

(a)falls within the same type of group application; or

(b)the licensing authority—

(i)in consultation with other Member States concerned, have agreed, in accordance with Article 7(2)(b) of EC Regulation No. 1234/2008, should be subject to the procedure for grouping of variations within the meaning of that Article; and

(ii)have agreed fall, or should be treated as falling, within the same type of group application.

(4) For the purposes of paragraph (3) the reference to a group application means an application which is a—

(a)Minor Variation (Type IB) Group Application;

(b)Major Variation (Type II) Group Application;

(c)Major Variation (Type II) Complex Group Application; or

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

(5) A separate fee is not payable for a variation which is wholly consequential upon another variation of a provision of a marketing authorization, traditional herbal registration, manufacturing authorisation or licence which is applied for in the same application.

(6) In a case where a recommendation on the classification of a variation is made in accordance with Article 5 of EC Regulation No. 1234/2008, the fee payable for the application made in respect of that variation shall be the appropriate fee for the classification given to the variation or, as the case may be, the appropriate fee which arises as a consequence of the classification given to the variation.

(7) In this regulation and Part 4 of Schedule 2—

“Major Variation (Type II) Group Application” means an application for several variations to one marketing authorization and—

“Major Variation (Type II) Complex Group Application” means an application for several variations to one marketing authorization and—

“Major Variation (Type II) Extended Complex Group Application” means an application for several variations to one marketing authorization and—

“major variation of type II” has the meaning given in Article 2(3) of EC Regulation No. 1234/2008;

“Minor Variation (Type IB) Group Application” means an application for several variations to one marketing authorization and—

“minor variation of type 1A” has the meaning given in Article 2(2) of EC Regulation No. 1234/2008;

“minor variation of type 1B” has the meaning given in Article 2(5) of EC Regulation No. 1234/2008; and

“work sharing” means the work sharing procedure within the meaning of Article 20 of EC Regulation No. 1234/2008.

PART 6Capital Fees for Assessment of Labels and Leaflets

Meaning of “set of proposed changes”

21.  For the purposes of this Part and Part 5 of Schedule 2, a “set of proposed changes” means a number of proposed changes to the labelling or package leaflet of a medicinal product, where—

(a)if there is more than one version of the labelling or package leaflet for that product, those changes all relate to the same version; and

(b)those changes are submitted to the licensing authority at the same time.

Fees for assessment of a set of proposed changes to labels and leaflets

22.—(1) Unless paragraph (2) applies, where—

(a)a set of proposed changes to the labelling or the package leaflet of a medicinal product which is the subject of a United Kingdom marketing authorization (other than a parallel import licence) is submitted to the licensing authority in accordance with Article 61(3) of the 2001 Directive; or

(b)a set of proposed changes to the labelling or the package leaflet of a medicinal product which is the subject of a parallel import licence is submitted to the licensing authority,

the fee payable by the holder of that authorization or licence is the fee prescribed in Part 5 of Schedule 2 in connection with that change.

(2) Paragraph (1) does not apply where a change to the labelling or package leaflet of a medicinal product is proposed in connection with an application for the variation of the marketing authorization for that product.

Time for payment of fees under regulation 22

23.  All sums payable by way of fees under regulation 22(1) must be paid by the time that the proposed changes are submitted to the licensing authority.

PART 7Capital Fees for Applications for Renewals of Certain Licences, Authorizations and Registrations and for Associated Inspections

Fees for renewals of certain manufacturer’s licences

24.—(1) The fee payable by the applicant for an application to renew a manufacturer’s licence which falls within the description in paragraph (2) is £174.

(2) The licence referred to in paragraph (1) is one—

(a)which is solely for the manufacture of medicinal products the sale or supply of which does not require a marketing authorization or a product licence; and

(b)to which article 2(2)(i)(e) (exemptions for certain special manufactured products) of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971(9) applies.

(3) Where an inspection of a site is made in connection with the application referred to in paragraph (1) an inspection fee of £287 is also payable by the applicant.

Fees for renewals in terms which are not identical to the existing authorization, licence or registration

25.  Where an applicant applies for renewal of a—

(a)marketing authorization (other than a European Union marketing authorization);

(b)traditional herbal registration, or

(c)manufacturer’s licence,

so as to contain provisions which are not identical to those in the authorization, registration or licence as in force at the date of the application, the fee payable under this Part is increased by an amount equal to the fee which would have been payable under Part 5 of these Regulations had the applicant made a separate application for variation of that authorization, registration or licence in respect of each provision which is not identical.

PART 8Capital Fees for Regulatory Assistance Given by the United Kingdom Acting as Reference Member State Relating to the Assessment of Applications for the Renewal of Specified Marketing Authorizations

Fees for regulatory assistance for certain marketing authorizations

26.—(1) Where—

(a)an application is made to the licensing authority for the renewal of a United Kingdom marketing authorization for a medicinal product which has been subject to the procedures specified in paragraph (2); and

(b)the United Kingdom is to provide regulatory assistance acting as reference Member State in relation to that application,

the fee payable by the applicant is the fee prescribed in Part 6 of Schedule 2 in connection with that regulatory assistance.

(2) The procedures referred to in paragraph (1) are—

(a)the procedures laid down in Articles 7 and 7a of Council Directive 65/65/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products(10) and in Articles 17 and 18 of the 2001 Directive;

(b)the procedures laid down in Article 9(4) of Directive 75/319/EEC and in Article 28 of the 2001 Directive;

(c)the procedures laid down in Articles 10 to 14 of Directive 75/319/EEC and in Articles 29 to 34 of the 2001 Directive;

(d)referral to the Committee for Proprietary Medicinal Products in accordance with Council Directive 87/22/EEC on the approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology(11), if the opinion of the Committee in accordance with Article 4(1) of that Directive was given before 1st January 1995.

(3) For the purposes of this regulation and Part 6 of Schedule 2, the United Kingdom provides regulatory assistance acting as reference Member State if—

(a)the licensing authority prepares or updates an assessment report in respect of the medicinal product to which the renewal application relates in order to make it available to the competent authorities of another EEA State; and

(b)an application to renew the marketing authorization relating to that product has been made in that other EEA State.

PART 9Capital Fees for Inspections

Fees for inspections

27.—(1) Unless Part 16 of these Regulations applies, a fee is payable in accordance with—

(a)paragraphs 1 to 7 of Schedule 3 for any inspection of a site made in connection with an application for, or during the currency of, a marketing authorization, a traditional herbal registration, a clinical trial authorisation, a manufacturing authorisation, a manufacturer’s licence or a wholesale dealer’s licence, except for an inspection for which a fee is payable under regulation 24 or 30; and

(b)paragraphs 1 and 8 of Schedule 3 for any inspection comprising an office-based evaluation and risk assessment of documentation but not involving inspection of a site, in connection with the monitoring of—

(i)good manufacturing practice;

(ii)good clinical practice;

(iii)good pharmacovigilance practice; or

(iv)good distribution practice.

(2) Unless regulation 28 or 29 applies, the fee in paragraph (1) is payable by the holder of, or as the case may be, applicant for, the authorization, registration, authorisation or licence in relation to which the inspection is made.

Payer of inspection fee (contract laboratories and API manufacturing sites)

28.  Where an inspection is made of a contract laboratory or a site used by an API manufacturer the fee is payable by the operator of that laboratory, or as the case may be, that API manufacturer.

Inspections in connection with multiple applications

29.—(1) Unless paragraph (4) applies, where an inspection is made outside the United Kingdom at a site which is named as a possible site for the manufacture or assembly of a medicinal product, or for the preparation of a substance which is to be used in the manufacture of an immunological product or a blood product—

(a)in more than one marketing authorization, clinical trial authorisation, traditional herbal registration; or

(b)by more than one applicant for such an authorisation or licence,

the fee for the inspection referred to in regulation 27(1) is payable in equal proportions by the holders of, or as the case may be, applicants for, the authorization, registration, authorisation, or licence.

(2) In paragraph (1), the reference to an applicant for a clinical trial authorisation is a reference to a person who sends a valid notice of amendment as mentioned in regulation 19(1).

(3) Where an inspection is made in the United Kingdom at a site which is named as a possible site for the manufacture or assembly of a medicinal product, or the preparation of a substance which is to be used in the manufacture of an immunological product or a blood product—

(a)in more than one manufacturer’s licence or manufacturing authorisation; or

(b)by more than one applicant for such a licence or authorisation,

the fee for the inspection referred to in regulation 27(1) is payable in equal proportions by each applicant.

(4) This regulation does not apply if the inspection is made of a contract laboratory or a site used by an API manufacturer.

Fees for inspections relating to good clinical practice in clinical trials

30.  A fee in accordance with paragraph 2 of Schedule 3 is payable by a person in respect of an inspection of one or more sites for the purpose of ascertaining whether that person—

(a)is—

(i)conducting, or has conducted, a clinical trial, or

(ii)performing, or has performed, the functions of a sponsor of a clinical trial (whether that person is the sponsor or is acting under arrangements made with that sponsor),

in accordance with good clinical practice, pursuant to regulation 28(1) (good clinical practice and protection of clinical trial subjects) of the Clinical Trials Regulations; or

(b)has put and kept in place arrangements for the purpose of ensuring that with regard to a clinical trial the requirements of good clinical practice are satisfied or adhered to, pursuant to regulation 28(2) of those Regulations.

Amount, and time for payment, of inspection fees in respect of an application for a wholesale dealer’s licence

31.—(1) All sums payable by way of fees in respect of any inspection of a site in connection with an application for a wholesale dealer’s licence under regulation 27(1) must be paid—

(a)in advance of an application; or

(b)at the time that application is made.

(2) Except where paragraph (3) applies, the inspection fee payable as a consequence of paragraph (1) shall be the amount specified in paragraph 5(a) of Schedule 3.

(3) In a case where—

(a)the site to be inspected falls within the description specified in paragraph 7(1)(a) or (b) of Schedule 3; or

(b)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 (within the meaning given in paragraph 7(2) of that Schedule),

the inspection fee payable as a consequence of paragraph (1) shall be the amount specified in paragraph 5(b) of Schedule 3.

Adjustment and refund of inspection fees in respect of a wholesale dealer’s licence

32.—(1) If the inspection in respect of an application for a wholesale dealer’s licence takes—

(a)in the case where regulation 31(2) applies, more than 7 hours; or

(b)in the case where regulation 31(3) applies, more than 3 hours and 30 minutes,

a further fee of the amount specified in paragraph 5(b) of Schedule 3 for each subsequent period of 3 hours and 30 minutes or less is payable by the applicant.

(2) The fee payable under paragraph (1) must be paid within a period of 14 days commencing on the date of the written notice issued by the licensing authority requiring payment of those fees.

(3) The licensing authority shall refund the whole of the inspection fee paid where, after an inspection fee is paid as a consequence of regulation 31, the application for a wholesale dealer’s licence is withdrawn—

(a)before a date on which the inspection is due to take place is arranged with or notified to the applicant; or

(b)in the case where a date on which the inspection is due to take place is fixed, 15 or more days before the date on which that inspection is due to take place.

PART 10Periodic Fees for Authorizations, Registrations, Licences and Authorisations

Periodic fees

33.—(1) Unless paragraph (4), (5) or (6) or Part 16 of these Regulations (revocations and savings) applies, the periodic fee must be paid for each fee period during which the marketing authorization, registration, authorisation or licence is in force, even if it is in force for only part of that fee period.

(2) For the purposes of paragraph (1), marketing authorizations of a type referred to in Part 3 of Schedule 4 shall be treated as if they were one marketing authorization and only one periodic fee in respect of each relevant fee period is payable in connection with the holding of such authorizations.

(3) The periodic fee is the appropriate fee prescribed in Part 3 of Schedule 4 and, for the purposes of that Part, Parts 1 and 2 of that Schedule have effect.

(4) No periodic fee is payable in respect of the fee period during which a marketing authorization or a traditional herbal registration is first granted unless the authorization or registration is granted pursuant to—

(a)a change of ownership application; or

(b)an application for a marketing authorization or traditional herbal registration which—

(i)is for a product for which an authorization or registration has expired;

(ii)will contain identical provisions to those contained in the expired authorization or registration;

(iii)is made by the person who held the expired authorization or registration; and

(iv)is made no later than three months after the expiry of the authorization or registration referred to in paragraph (i),

and, in each case, a periodic fee has not been paid in respect of that fee period in connection with the expired marketing authorization or a traditional herbal registration.

(5) An authorization, registration, authorisation or licence which is in force is treated for the purposes of this regulation as not being in force during any part of a fee period if—

(a)at least three months before the commencement of that fee period, the holder of that authorization, registration, authorisation or licence has given written notice to the licensing authority indicating that he wishes it to cease to have effect before the commencement of that period; and

(b)no products are sold, supplied or manufactured pursuant to that authorization, registration authorisation or licence within that fee period.

(6) No periodic fee is payable in respect of the fee period during which a manufacturing authorisation, a manufacturer’s licence or wholesale dealer’s licence is first granted unless—

(a)that authorisation or licence is granted pursuant to a change of ownership application; and

(b)a periodic fee has not been paid in respect of that fee period in connection with the manufacturing authorisation or manufacturer’s licence or wholesale dealer’s licence which is mentioned in that application in the statement of intention to cease activities.

Periodic fees for clinical trial authorisations

34.—(1) Unless paragraph (3) applies, the holder of a clinical trial authorisation must pay the periodic fee for each fee period during which the authorisation is in force, even if the authorisation is in force for only part of that fee period.

(2) The periodic fee is the fee prescribed in paragraph 16 of Part 3 of Schedule 4.

(3) No periodic fee is payable in respect of the fee period during which the clinical trial to which the authorisation relates was authorised by the licensing authority in accordance with regulation 18 (authorisation procedure for clinical trials involving general medicinal products), 19 (authorisation procedure for clinical trials involving medicinal products for gene therapy etc.) or 20 (authorisation procedure for clinical trials involving medicinal products with special characteristics) of the Clinical Trials Regulations(12).

PART 11Capital Fees For Application For Membership of Good Clinical Practice Accreditation Scheme and for Certificate of Membership

Meaning of “good clinical practice accreditation scheme”

35.  In this Part—

“good clinical practice accreditation scheme” means the non-statutory voluntary scheme of accreditation operated by the licensing authority in relation to Phase 1 trials which participants may join following satisfactory completion of a good clinical practice inspection; and

“Phase 1 trials” are clinical trials 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.

Fees for applications for membership and certificates

36.—(1) The fee payable by an applicant for membership of the good clinical practice accreditation scheme is £126.

(2) The fee payable by an applicant for a certificate of membership of the good clinical practice accreditation scheme is £67.

PART 12Capital Fee for a Person Appointed Hearing

Fee for a person appointed hearing

37.—(1) The fee payable by an applicant or holder of an authorization, licence, authorisation or certificate of registration or sponsor or investigator who gives notice, under any of the provisions specified in paragraph (2), of their wish to make further representations to the licensing authority or appear before or be heard by a person appointed by the licensing authority, is £10,000.

(2) The specified provisions are—

(a)section 21(11) (licence under Part I of the Act where the appropriate committee are consulted), 22(3) (licence under Part I of the Act where the appropriate committee are not consulted or have been consulted but have not given a provisional opinion) or 27(3) (licence of right) of the Act, and paragraph 5 (product licence) or paragraph 6 (licence under Part 2 of the Act other than a product licence) of Schedule 2 to the Act(13);

(b)paragraph 3 of Schedule 5 (procedural provisions relating to the refusal or amendment of, or imposition of conditions relating to, clinical trial authorisations and the suspension or termination of clinical trails)(14) and paragraph 4 of Schedule 8 (procedural provisions relating proposals to grant, refuse to grant, vary, suspend or revoke manufacturing authorisations) to the Clinical Trials Regulations(15);

(c)paragraph 12 (traditional herbal registration), paragraph 17 (variation of registration) or paragraph 20 (decision to refer application to the Committee) of Schedule 2 to the Herbal Regulations;

(d)paragraph 11 (marketing authorizations) or paragraph 16 (Type II variation applications) of Schedule 2 to the Marketing Authorisation Regulations(16); or

(e)paragraph 12 of Schedule 5 (procedural provisions relating to the grant, renewal, variation, revocation and suspension of certificates of registration) to the Homoeopathic Regulations(17).

(3) The licensing authority will refund to that person—

(a)60% of that fee if the person withdraws the notice two weeks before the commencement of the hearing before the person appointed;

(b)100% of that fee if, in respect of the hearing before a person appointed, the decision notified by the licensing authority is—

(i)not to revoke, vary, suspend or terminate, as the case may be, the authorization, licence, authorisation or certificate of registration; or

(ii)to grant or renew, as the case may be, the authorization, licence, authorisation or certificate of registration.

Time for payment under regulation 37

38.  The fee prescribed in regulation 37 is payable at the time the notice is given.

PART 13Fees in relation to the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994

Interpretation

39.—(1) In this Part—

“administrative variation” means a variation of the provisions of a certificate of registration which does not require, in the opinion of the licensing authority, medical, scientific or pharmaceutical assessment;

“application” means an application for the grant of a certificate of registration;

“application to the licensing authority for regulatory assistance” in relation to a single certificate of registration means—

“application for an EC registration in a concerned Member State” in relation to a single certificate of registration means—

“decentralised procedure application” means an application relating to a homoeopathic medicinal product in respect of which at the time of the application—

“EC registration” means a registration granted by a competent authority of an EEA State in accordance with the procedure set out in Article 14 of the 2001 Directive;

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

“identical” means—

“mutual recognition procedure incoming application” means an application relating to a homoeopathic medicinal product in respect of which—

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

“set of applications” means—

“standard variation” means a variation of the provisions of a certificate of registration which, in the opinion of the licensing authority, requires medical, scientific or pharmaceutical assessment and which requires in respect of any homoeopathic medicinal products to which that certificate relates—

(2) In this Part—

(a)any expression which is defined in the Act shall have the same meaning which it has in the Act;

(b)any expressions which are also used in the 2001 Directive shall have the same meaning as they have in the 2001 Directive and related expressions shall be interpreted accordingly;

(c)any reference to doing anything in accordance with a certificate of registration shall be interpreted in accordance with section 132(3) of the Act (general interpretation provisions); and

(d)any reference to the holder of a certificate of registration shall be interpreted as a reference to the holder of such a certificate which is for the time being in force.

Fees for applications made at the invitation of the licensing authority

40.  No fee shall be payable under this Part in connection with an application for the grant or variation of a certificate of registration under the Homoeopathic Regulations where the application is made at the specific request of the licensing authority.

Fees for applications for certificates

41.—(1) The fee payable by a person who makes an application for the grant of a certificate of registration under regulation 4 of the Homoeopathic Regulations shall be the fee specified in the Table in Schedule 5 to these Regulations according to the type of application.

(2) The fee payable by a person who makes an application or set of applications to the licensing authority for regulatory assistance in connection with obtaining recognition in accordance with the procedure laid down in Articles 28 and 29(1) to (3) of the 2001 Directive of a single certificate of registration in another EEA State, shall be the fee specified in item 4 of the Table in Schedule 5 to these Regulations.

Fees for variations of certificates

42.—(1) The fee payable by an applicant in connection with an application for an administrative variation of a certificate of registration shall be—

(a)where more than one application for an administrative variation is made at the same time by the same applicant and the applications are for identical variations—

(i)in respect of the first application considered by the licensing authority, a fee of £133, and

(ii)in respect of each other application so considered, a fee of £67;

(b)in any other case, a fee of £133.

(2) The fee payable by an applicant in connection with an application for a standard variation of a certificate of registration shall be—

(a)where more than one application for a standard variation is made at the same time by the same applicant and the applications are for identical variations—

(i)in respect of the first application considered by the licensing authority, a fee of £263;

(ii)in respect of each other application so considered, where further medical, technical or scientific assessment is required, a fee of £263;

(iii)in respect of the second to thirtieth applications so considered, where no further medical, technical or scientific assessment is required, a fee of £133;

(iv)in respect of each other application so considered, where no further medical, technical or scientific assessment is required, a fee of £67;

(b)in any other case, a fee of £263.

Time for payment of fees

43.—(1) Any fee payable under regulation 41(1) or 42 shall be payable to the licensing authority—

(a)in advance of the application; or

(b)at the time the application for grant or variation of the certificate of registration is made.

(2) Any fee payable under regulation 41(2) shall be payable to the licensing authority—

(a)in advance of any request; or

(b)at the time when, in connection with the application or set of applications for regulatory assistance, a request is made under Article 28(2) of the 2001 Directive for an assessment report to be prepared or updated.

PART 14Administration

Payment of fees to Ministers

44.  Any sum payable under these Regulations must be paid to one of the Ministers.

Time for payment of capital fees in connection with applications or inspections

45.—(1) All capitals fees under these Regulations shall be payable in accordance with—

(a)the specified provisions in paragraph (2) where appropriate, and

(b)paragraph (3).

(2) The specified provisions are—

(a)regulation 10 (pre-application meetings);

(b)regulation 16 (regulatory assistance);

(c)regulation 22 (change to labels and leaflets);

(d)regulation 31 (inspections in respect of wholesale dealer’s licence);

(e)regulation 37 (person appointed hearings); and

(f)regulation 46 (small companies).

(3) All fees payable under this regulation—

(a)in respect of inspections made either in connection with an application for, or during the currency of, an authorization, licence or certificate must be paid within a period of 14 days commencing on the date of the written notice issued by the licensing authority requiring payment of those fees; and

(b)in connection with any application, must have been paid at the time of the application or before.

Time for payment of capital fees – applications made by small companies

46.—(1) Schedule 6 shall have effect with respect to the capital fee payable in connection with an application made by or on behalf of a small company.

(2) For the purpose of these Regulations, a company is a small company if, for the financial year before that in which the application is made, the total value of products it has sold or supplied for the financial year is not more than the amount for the time being specified under the heading “Small company” in item 1 in section 382(3) (qualification of company as small) of the Companies Act 2006(18) and the conditions in paragraph (3) are met.

(3) The conditions for the purposes of paragraph (2) are—

(a)the company’s balance sheet total as defined in section 382(5) of the Companies Act 2006 is not more than the amount for the time being specified under the heading “Small company” in section 382(3) of that Act; or

(b)the average number of persons employed by the company in the financial year before that in which the application is made (determined on a weekly basis) does not exceed the number for the time being specified under the heading “Small company” in section 382(3) of that Act.

Payment of fees in respect of a traditional herbal registration

47.—(1) Where an application is made for the grant of a traditional herbal registration—

(a)in accordance with regulation 5 (applications for the grant or renewal of a traditional herbal registration) of the Herbal Regulations;

(b)on the grounds specified in paragraph (2); and

(c)in respect of a medicinal product which falls within the description in paragraph (3),

the fee payable under regulation 12 shall be refunded or, if it has not been paid, shall be waived.

(2) For the purposes of paragraph (1), the specified grounds are—

(a)that the marketing authorization in respect of the medicinal product in question; or

(b)in the case of a corresponding product the marketing authorization relating to product Y (as defined in paragraph (4)),

is to be revoked.

(3) A medicinal product falls within this paragraph if—

(a)a marketing authorization held by the applicant was granted under the Marketing Authorisation Regulations in respect of that medicinal product; or

(b)that medicinal product is a corresponding product.

(4) For the purposes of paragraph (3), a corresponding product is a product which is characterised by having—

(a)the same active ingredients, irrespective of the excipients used or reduction in the number or quantity of active ingredients;

(b)the same or similar intended purpose, equivalent strength and posology; and

(c)the same or similar route of administration,

as a medicinal product (“product Y”) in respect of which a marketing authorization held by the applicant was granted under the Marketing Authorisation Regulations.

(5) Where the licensing authority determines that the marketing authorizations in respect of the medicinal product in question or the marketing authorization in respect of product Y should not be revoked, the fee payable under regulation 12 which has been refunded or waived shall become payable within a period of 14 days commencing on the date of the written notice issued by the licensing authority requiring payment of those fees.

Time for payment of periodic fees

48.  All periodic fees must be paid by the first day of the fee period to which they relate.

Penalty fees for late payment of periodic fees

49.—(1) Subject to paragraph (2), if a person has failed to pay a periodic fee by the time it has become payable under regulation 48, a penalty fee is payable by that person.

(2) A penalty fee is payable only if, after a period of 60 days commencing on the date of the written notice (“the notice”) issued by the licensing authority requiring payment of that fee, the fee remains unpaid.

(3) Unless regulation 50 applies, where a periodic fee remains unpaid after 60 days commencing on the date of the notice, the penalty fee is—

(a)£100 where the total unpaid fee exceeds £200; or

(b)£50 where the total unpaid fee does not exceed £200.

(4) In paragraph (3), the “total periodic fee” means the total of all the periodic fees payable by a person in connection with all the authorizations, registrations, authorisations or licences held by that person.

Daily penalty fees for late payment of periodic fees

50.  If the periodic fee and penalty fee under regulation 49 (“the outstanding amount”) have not been paid within a period of 90 days commencing on the date of the written notice issued by the licensing authority, the amount of penalty fee payable shall be the amount specified in regulation 49(3) plus £5 for each day of the period which—

(a)begins with the day 90 days from the date of the written notice; and

(b)ends with the day before that on which payment of the outstanding amount is actually made.

Refund or waiver of fees under regulation 49 or 50

51.  The licensing authority may refund or waive payment of the penalty fee, or reduce the amount payable, where it is satisfied that the holder of the authorization, registration, authorisation or licence was not responsible for the failure to pay the periodic fee within the period specified in regulation 49(2) or 50.

Adjustment, waiver, reduction or refund of fees

52.—(1) If after a capital or periodic fee is paid it becomes apparent that—

(a)a lesser fee should have been paid, the excess shall be refunded to the applicant or, as the case may be, the holder of the authorization, registration, authorisation or licence concerned; or

(b)a higher fee should have been paid, the balance due shall be payable within a period of 14 days commencing on the date of the written notice issued by the licensing authority to the applicant or, as the case may be, the holder of the authorization, registration, authorisation or licence concerned requiring payment of that balance.

(2) The licensing authority shall, to the extent provided in Schedule 7 in relation to capital fees or in Schedule 8 in relation to periodic fees—

(a)adjust, waive payment of or reduce any fee or part of a fee otherwise payable under these Regulations; or

(b)refund the whole or part of any fee already paid.

Suspension of licences and authorisations

53.—(1) Where any sum due by way of, or on account of, any fee or any part of a fee payable under these Regulations remains unpaid by the holder of a—

(a)product licence or a product licence of right;

(b)manufacturer’s licence;

(c)manufacturer’s authorisation; or

(d)wholesale dealer’s licence,

the licensing authority may serve a written notice on the holder requiring payment of the sum unpaid.

(2) If after a period of one month commencing on the date of service of the notice referred to in paragraph (1), or such longer period as the licensing authority may allow, the said sum remains unpaid, the licensing authority may forthwith suspend the licence or, as the case may be, the authorisation until such sum has been paid.

Civil proceedings to recover unpaid fees

54.  All unpaid sums due by way of, or on account of, any fees payable under these Regulations shall be recoverable as debts due to the Crown.

PART 15Consequential Amendments

Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004

55.—(1) The Medicines for Human Use (Clinical Trials) Regulations 2004(19) are amended as follows.

(2) In regulation—

(a)17(2)(b)(ii) (request for authorisation to conduct a clinical trial),

(b)24(10) (amendments by the sponsor),

(c)38(3)(b) (application for manufacturing authorisation),

(d)44(8) (variation of manufacturing authorisation),

for “Medicines (Products for Human Use) (Fees) Regulations 2010” substitute “Medicines (Products for Human Use) (Fees) Regulations 2012”.

Amendment of the Homoeopathic Regulations

56.  The Homoeopathic Regulations are amended by omitting the following definitions in regulation 1(2)(20) (citation, commencement and interpretation)—

(a)“administrative variation”,

(b)“the Board”,

(c)“concerned member State”,

(d)“set of applications”, and

(e)“standard variation”.

PART 16Revocations and Savings

The Medicines (Products for Human Use) (Fees) Regulations 2010

57.—(1) Subject to paragraphs (2) to (4), the Medicines (Products for Human Use) (Fees) Regulations 2010(21) (“the 2010 Regulations”) are revoked.

(2) The savings introduced by regulation 52(2), (3) and (4) of the 2010 Regulations shall continue to apply as if those paragraphs of that regulation had not been revoked.

(3) The 2010 Regulations shall continue to apply as if they had not been revoked—

(a)in relation to capital fees payable under the 2010 Regulations in respect of any application or inspection made before the date on which these Regulations come into force; and

(b)to any periodic fee payable under the 2010 Regulations in relation to a fee period ending before the date on which these Regulations come into force.

(4) The revocation of the 2010 Regulations shall not affect any proceedings under those Regulations for the recovery of any fees due as debts to the Crown and for the purposes of those proceedings, the 2010 Regulations shall continue to apply as if they had not been revoked.

The Homoeopathic Regulations

58.—(1) The Homoeopathic Regulations are revoked to the following extent.

(2) In regulation 1 (citation, commencement and interpretation) paragraph (4)(22) is revoked.

(3) Regulations 12 to 18, Schedule 2, 2A and 3(23) are revoked.

(4) The Homoeopathic Regulations shall continue to apply as if they had not been revoked to the extent specified under paragraphs (2) and (3)—

(a)in relation to any application or inspection made before the date on which these Regulations come into force; and

(b)to any fee period ending before the date on which these Regulations come into force.

(5) Any revocation under paragraphs (2) or (3) shall not affect any proceedings under the Homoeopathic Regulations for the recovery of any fees due as debts to the Crown and for the purposes of those proceedings, the Homoeopathic Regulations shall continue to apply as if they had not been revoked.