Introductory Text
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 EC marketing authorization
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 Authorizations, Registrations, Licences, Certificates or Authorisations and for Associated Inspections
12.Fees for applications for authorizations, licences or certificates, etc
13.Fee for applications for copy certificates of good manufacturing practice
14.Fees for applications for certificates and copy certificates by exporters of medicinal products
PART 4 Capital Fees for Assistance in Obtaining Marketing Authorizations 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 Authorizations, Registrations, Licences and Certificates and for Associated Inspections
18.Fees for variations of authorizations, registrations, licences and authorisations
19.Fees for amendments to clinical trial authorisations
20.Applications for multiple variations
PART 6 Capital Fees for Assessment of Labels and Leaflets
21.Meaning of “set of proposed changes”
22.Fees for assessment of a set of proposed changes to labels and leaflets
23.Time for payment of fees under regulation 22
PART 7 Capital Fees for Applications for Renewals of Certain Manufacturer’s Licences and for Associated Inspections
24.Fees for renewals of certain manufacturer’s licences
25.Fees for renewals in terms which are not identical to the existing authorization, licence or certificate
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 Authorizations
26.Fees for regulatory assistance for certain marketing authorizations
PART 9 Capital Fees for Inspections
27.Fees for inspections
28.Payer of inspection fee (contract laboratories and API manufacturing sites)
29.Inspections in connection with multiple applications.
30.Fees for inspections relating to good clinical practice in clinical trials
PART 10 Periodic Fees for Marketing Authorizations and Licences
31.Periodic fees
32.Periodic fees for clinical trial authorisations
PART 11 Capital Fees For Application For Membership of Good Clinical Practice Accreditation Scheme and for Certificate of Membership
33.Meaning of “good clinical practice accreditation” scheme
34.Fees for applications for membership and certificate
PART 12 Capital Fees for Persons Appointed Hearing
35.Fees for persons appointed hearing
36.Time for payment under regulation 35
PART 13 Administration
37.Payment of fees to Ministers
38.Time for payment of capital fees in connection with applications or inspections
39.Time for payment of capital fees – applications made by small companies
40.Time for payment of periodic fees
41.Penalty fees for late payment of periodic fees
42.Daily penalty fees for late payment of periodic fees
43.Refund or waiver of fees under regulation 41 or 42
44.Adjustment, waiver, reduction or refund of fees
45.Suspension of licences and certificates
46.Civil proceedings to recover unpaid fees
PART 14
47.Amendment of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994
PART 15 Revocationand Savings
48.Revocation and savings
Signature
SCHEDULE 1
CAPITAL FEES FOR APPLICATIONS FOR, AND VARIATIONS TO, MARKETING AUTHORIZATIONS, LICENCES AND CERTIFICATES
PART 1 Interpretation
1.In this Schedule— “active ingredient” means an ingredient of a...
PART 2 Capital Fees for Applications for Authorizations, Licences and Certificates
2.Marketing authorizations
3.Fees where application includes reclassification
4.Fees where person holds clinical trial certificate
5.Joint development
6.Applications for multiple authorisations
7.Authorisation for a national homoeopathic product
8.Manufacturer’s licences and authorisations
9.Wholesale dealer’s licences
10.Clinical trial authorisations
11.Traditional herbal registrations
PART 3 Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States
12.Interpretation
13.Outgoing mutual recognition applications
PART 4 Capital Fees for Applications for Variations of Authorizations, Licences and Registrations
14.Interpretation
15.Marketing authorizations
16.Variation of marketing authorizations
17.Reclassification of marketing authorizations
18.Variation of marketing authorization: natural homoeopathic products
19.Variation of parallel import licence
20.Manufacturer’s authorisations and licences
21.Variation of manufacturer’s authorisations and licences
22.Wholesale dealer’s licences
23.Variation of wholesale dealer’s licence
24.Clinical trial authorisations
25.Traditional herbal registrations
26.Identical variations
27.Complex Variation Applications
28.Multiple reclassification variation applications
PART 5 Capital Fees for Assessment of Labels and Leaflets
29.Interpretation
30.Single set of changes
31.More than one set of charges purposed
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 Authorizations
32.Regulatory assistance
33.Regulatory assistance – same manufacturer
SCHEDULE 2
FEES FOR INSPECTIONS
1.In this Schedule— (a) if an inspection is made at...
2.Fees: general
3.Third country 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: third country traditional herbal medicinal products
7.Wholesale dealer’s licences: inspection of short duration
SCHEDULE 3
PERIODIC FEES FOR LICENCES
PART 1 Interpretation
1.In this Schedule— “anthroposophic product” means a medicinal product prepared...
PART 2 Calculation of Turnover
2.Calculation of turnover
3.Manufacturer’s prices
4.Evidence of turnover
PART 3 Periodic Fees for Marketing Authorizations and Licences
5.Marketing authorizations
6.Marketing authorization: where Part 2 of Act applies
7.Marketing authorization: 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 licences: exempt imported products
15.Additional amount for manufacturer’s licences and wholesale dealer’s licences which relate to exempt imported products
16.Clinical trial authorisations
17.Traditional herbal registrations
PART 4 Types of Marketing Authorization for which only One Periodic Fee is Payable
18.Specified parallel import licences
SCHEDULE 4
Time for Payment of Capital Fees
1.Application by or on behalf of a small company
2.Major application
3.Complex application
4.Multiple applications
5.Outgoing mutual recognition applications
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 5
WAIVER, REDUCTION OR REFUND OF CAPITAL FEES
1.Interruptions of manufacture, assembly, sale or supply
2.Reclassification
3.Traditional herbal registration
4.Withdrawal of application in relation to marketing authorization, traditional herbal registration or clinical trial authorisation
5.Withdrawal of application in relation to manufacturing authorisation, wholesale dealer’s or manufacturer’s licence
6.Refusal of application for grant of marketing authorization, traditional herbal registration or clinical trial authorisation
7.Parallel import licence
8.Surrender of marketing authorization at same time as a variation application
9.Clinical trial authorisation
10.Scientific advice: paediatric indications
SCHEDULE 6
ADJUSTMENT, REDUCTION OR REFUND OF PERIODIC FEES
1.Refund on surrender or revocation of authorization, registration or licence
2.Adjustment and refund: licences relating to exempt imported products
3.Refunds: treated as having been paid on account
SCHEDULE 7
REVOCATION SCHEDULE
Explanatory Note