# The Medicines (Products for Human Use) (Fees) Regulations 2013 (revoked) S.I. 2013/532 · made 7 March 2013 · revised to 1 April 2016 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PDFs: Printed copy https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2013-revoked/pdf/uksi_20130532_en.pdf; Explanatory Memorandum https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2013-revoked/pdf/uksiem_20130532_en.pdf ## Introductory text Medicines Fees And Charges Made 7th March 2013 Laid before Parliament 11th March 2013 Coming into force in accordance with regulation 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 1: General ## 1 Citation and commencement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Interpretation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 2: Capital Fees for Pre-Application Meetings ## 3 Interpretation of Part 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 Fee for scientific advice: application for, or variation to, EU marketing authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 Fee for scientific advice: classification of a medicinal product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 Fee for advertising advice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 Fee for pharmacovigilance advice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 Fee for advice on labelling or leaflets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 9 Fee for regulatory advice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 10 Fee for advice for other purposes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 11 Time for payment of fees under regulations 4 to 10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 3: Capital Fees for Applications for Authorisations, Registrations, Licences or Certificates and for Associated Inspections ## 12 Fees for applications for authorisations, registrations, licences or certificates etc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 13 Fee for applications for additional copy certificates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 14 Fees for applications for certificates and copy certificates by exporters of medicinal products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 4: Capital Fees for Assistance in Obtaining Marketing Authorisations in Other EEA States ## 15 Meaning of “set of applications” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 16 Fees for applications for regulatory assistance under the mutual recognition procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 17 Time for payment of fees under regulation 16 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 5: Capital Fees for Applications for Variations of Authorisations, Registrations and Licences and for Associated Compliance Activities ## 18 Fees for variations of authorisations, registrations and licences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 19 Fees for amendments to clinical trial authorisations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 20 Fees for notification of changes and reports for broker's registrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 21 Fees for notification of changes and compliance Reports for active substance registrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 22 Applications for multiple variations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 6: Capital Fees for Assessment of Labels and Leaflets ## 23 Meaning of “set of proposed changes” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 24 Fees for assessment of a set of proposed changes to labels and leaflets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 25 Time for payment of fees under regulation 24 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 7: Capital Fees for Applications for Renewals of Certain Licences, Authorisations and Registrations and for Associated Inspections ## 26 Fees for renewals of certain manufacturer's licences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 27 Fees for renewals in terms which are not identical to the existing authorisation, licence or registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 8: Capital 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 Authorisations ## 28 Fees for regulatory assistance for certain marketing authorisations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 9: Capital Fees for Inspections ## 29 Fees for inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 30 Fees for inspections of pharmacovigilance service providers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 31 Payer of inspection fee (contract laboratories and API manufacturing sites) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 32 Inspections in connection with multiple applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 33 Fees for inspections relating to good clinical practice in clinical trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 34 Amount, and time for payment, of inspection fees in respect of an application for a wholesale dealer's licence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 35 Adjustment and refund of inspection fees in respect of a wholesale dealer's licence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 36 Amount, and time for payment, of inspection fees in respect of an application for a broker's registration or an active substance registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 10: Periodic Fees for Authorisations, Registrations and Licences ## 37 Periodic fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 11: Capital Fees for Application for Membership of Good Clinical Practice Accreditation Scheme and for Certificate of Membership ## 38 Meaning of “good clinical practice accreditation scheme” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 39 Fees for applications for membership and certificates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 12: Capital Fee for a Review Upon Oral Representations or a Person Appointed Hearing ## 40 Fee for a review upon oral representations or a person appointed hearing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 41 Time for payment under regulation 40 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 13: Fees in relation to the Part 6 of the Human Medicines Regulations (certification of homoeopathic medicinal products) ## 42 Interpretation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 43 Fees for applications made at the invitation of the licensing authority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 44 Fees for applications for certificates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 45 Fees for variations of certificates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 46 Time for payment of fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 14: Administration ## 47 Payment of fees to Ministers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 48 Time for payment of capital fees in connection with applications or inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 49 Time for payment of capital fees – applications made by small companies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 50 Payment of fees in respect of a traditional herbal registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 51 Time for payment of periodic fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 52 Penalty fees for late payment of periodic fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 53 Daily penalty fees for late payment of periodic fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 54 Refund or waiver of fees under regulation 52 or 53 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 55 Adjustment, waiver, reduction or refund of fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 56 Suspension of licences and authorisations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 57 Civil proceedings to recover unpaid fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 15: Consequential Amendments ## 58 Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 16: Revocations and Savings ## 59 The Medicines (Products for Human Use) (Fees) Regulations 2012 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 60 The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2012 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 61 Other Revocations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Schedule 1: General interpretation provisions ## 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 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 ## 1 Interpretation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 General: categories of applications and variations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Administrative variation application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 Extension application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 Complex application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 Complex registration application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 Complex variation application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 Decentralised procedure application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 9 Extended Type II Complex Variation Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 10 Major application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 11 Mutual recognition procedure incoming application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 12 New excipient variation application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 13 New indication variation application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 14 Parallel import licence application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 15 Reclassification variation application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 16 Reduced registration application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 17 Simple application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 18 Standard application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 19 Standard registration application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 20 Standard variation application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 21 Standard variation application for a homoeopathic medicinal product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 22 Type IB and Type II Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 23 Type II Complex Variation Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 2: Capital Fees for Applications for Authorisations, Licences, Registrations and Certificates ## 24 Marketing authorisations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 25 Fees where application includes reclassification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 26 Fees where person holds clinical trial certificate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 27 Joint development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 28 Application for multiple authorisations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 29 Authorisation for a national homoeopathic product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 30 Manufacturer's licences and authorisations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 31 Wholesale dealer's licences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 32 Broker's registrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 33 Active substance registrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 34 Clinical trial authorisations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 35 Traditional herbal registrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 3: Capital Fees for Assistance in Obtaining Marketing Authorisations in Other EEA States ## 36 Outgoing mutual recognition applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 4: Capital Fees for Applications for Variations of Authorisations, Licences and Registrations ## 37 Marketing authorisations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 38 Variation of marketing authorisations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 39 Reclassification of marketing authorisations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 40 Variation of marketing authorisation: national homoeopathic products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 41 Variation of parallel import licence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 42 Manufacturer's authorisations and licences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 43 Variation of manufacturer's authorisations and licences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 44 Wholesale dealer's licences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 45 Variation of wholesale dealer's licence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 46 Variation of a broker's registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 47 Variation of an active substance registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 48 Clinical trial authorisations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 49 Traditional herbal registrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 50 Identical variations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 51 Complex Variation Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 52 Multiple reclassification variation applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 5: Capital Fees for Assessment of Labels and Leaflets ## 53 A set of changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 54 More than one set of changes proposed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 6: Capital 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 Authorisations ## 55 Regulatory assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 56 Regulatory assistance – same manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 7: Relevant Substances ## 57 Substances listed for the purposes of paragraph 24(2)(b) and (4)(b) and 37(2)(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Schedule 3: Fees for inspections ## 1 General provisions relating to fees for inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Fees: general . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Traditional herbal medicinal products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 Sites concerned with starting materials for traditional herbal medicinal products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 Wholesale dealer's licence: general . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 Wholesale dealer's licence: traditional herbal medicinal products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 Wholesale dealer's licences: inspection of short duration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 Broker's registrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 9 Active substance registrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 10 Office-based inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Schedule 4: Periodic fees for licences ### Part 1: Interpretation ## 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 2: Value of the Product Sold or Supplied ## 2 Determining the total value of the product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Manufacturer's prices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 Information requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 3: Periodic Fees for Marketing Authorisations and Licences ## 5 Marketing authorisations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 Marketing authorisation: where Part 2 of the Act applies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 Marketing authorisation: derivatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 Number of fee periods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 9 Authorisation for two or more kinds of medicinal product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 10 Reduced fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 11 Manufacturer's licences or manufacturing authorisations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 12 Wholesale dealer's licences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 13 Wholesale dealer's licences: evidence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 14 Wholesale dealer's licences: special medicinal products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 15 Additional amount for manufacturer's licences and wholesale dealer's licences which relate to special medicinal products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 16 Traditional herbal registrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 4: Types of Marketing Authorisation for which only One Periodic Fee is Payable ## 17 Parallel import licences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Schedule 5 Fees for certificates of registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Schedule 6: Time for payment of capital fees: small companies ## 1 Interpretation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Major application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Complex application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 Multiple application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 Outgoing mutual recognition application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 Application for traditional herbal registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 Traditional herbal registration: complex variation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 Application for manufacturer's licence, manufacturing authorisation or wholesale dealer's licence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 9 Inspection fees in connection with applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Schedule 7: Waiver, reduction or refund of capital fees ## 1 Interruptions of manufacture, assembly, sale or supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Reclassification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Variation of a traditional herbal registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 Withdrawal of application in relation to marketing authorisation, traditional herbal registration or clinical trial authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 Withdrawal of application in relation to a certificate of registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 Withdrawal of application in relation to manufacturing authorisation, wholesale dealer's licence, manufacturer's licence, broker's registration or active substance registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 Refusal of application for grant of marketing authorisation, traditional herbal registration or clinical trial authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 Parallel import licence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 9 Surrender of marketing authorisation at same time as a variation application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 10 Clinical trial authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 11 Scientific advice: paediatric indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 12 Refunds: treated as having been paid on account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Schedule 8: Adjustment, reduction or refund of periodic fees ## 1 Refund on surrender or revocation of authorisation, registration or licence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Adjustment and refund: licences relating to imported special medicinal products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Refunds: treated as having been paid on account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Schedule 9 Further revocations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Explanatory note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . --- Source: https://www.legislation.gov.uk/uksi/2013/532 (the official version) Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2013-revoked Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.