Source: http://www.legislation.gov.uk/uksi/2010/551/contents/made
Timestamp: 2020-07-12 03:16:46
Document Index: 105641701

Matched Legal Cases: ['ART 4', 'ART 2', 'ART 3', 'ART 4', 'ART 6', 'ART 2', 'ART 3', 'art 2', 'ART 4']

The Medicines (Products for Human Use) (Fees) Regulations 2010The Medicines (Products for Human Use) (Fees) Regulations 2010
2010 No. 551
4.Fee for scientific advice: application for, or variation to, EU marketing authorization
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 EEA
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
18.Fees for variations of authorizations, registrations, licences and authorisations
19.Fees for amendments to clinical trial authorisations
20.Applications for multiple variations
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
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 registration
26.Fees for regulatory assistance for certain marketing authorizations
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
31.Amount, and time for payment, of inspection fees in respect of an application for a wholesale dealer’s licence
32.Adjustment and refund of inspection fees in respect of a wholesale dealer’s licence
33.Periodic fees
34.Periodic fees for clinical trial authorisations
35.Meaning of “good clinical practice accreditation scheme”
36.Fees for applications for membership and certificates
37.Fee for a person appointed hearing
38.Time for payment under regulation 37
39.Payment of fees to Ministers
40.Time for payment of capital fees in connection with applications or inspections
41.Time for payment of capital fees – applications made by small companies
42.Payment of fees in respect of a traditional herbal registration
43.Time for payment of periodic fees
44.Penalty fees for late payment of periodic fees
45.Daily penalty fees for late payment of periodic fees
46.Refund or waiver of fees under regulation 44 or 45
47.Adjustment, waiver, reduction or refund of fees
48.Suspension of licences and authorisations
49.Civil proceedings to recover unpaid fees
50.Amendment of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994
51.Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004
52.Revocations and savings
CAPITAL FEES FOR APPLICATIONS FOR, AND VARIATIONS TO, MARKETING AUTHORIZATIONS, LICENCES, AUTHORISATIONS, REGISTRATIONS AND CERTIFICATES
PART 2 Capital Fees for Applications for Authorizations, Licences, Registrations and Certificates
24.Marketing authorizations
28.Application for multiple authorizations
32.Clinical trial authorisations
33.Traditional herbal registrations
PART 3 Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States
34.Outgoing mutual recognition applications
PART 4 Capital Fees for Applications for Variations of Authorizations, Licences and Registrations
35.Marketing authorizations
36.Variation of marketing authorizations
37.Reclassification of marketing authorizations
38.Variation of marketing authorization: national homoeopathic products
39.Variation of parallel import licence
40.Manufacturer’s authorisations and licences
41.Variation of manufacturer’s authorisations and licences
42.Wholesale dealer’s licences
43.Variation of wholesale dealer’s licence
44.Clinical trial authorisations
45.Traditional herbal registrations
46.Identical variations
47.Complex Variation Applications
48.Multiple reclassification variation applications
49.A set of changes
50.More than one set of charges 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 Authorizations
51.Regulatory assistance
52.Regulatory assistance – same manufacturer
8.Office-based inspections
PART 2 Calculation of Turnover
2.Calculation of turnover
4.Evidence of turnover
PART 3 Periodic Fees for Marketing Authorizations and Licences
5.Marketing authorizations
6.Marketing authorization: where Part 2 of the Act applies
7.Marketing authorization: derivatives
14.Wholesale dealer’s 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
TIME FOR PAYMENT OF CAPITAL FEES
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 licence 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
1.Refund on surrender or revocation of authorization, registration or licence
2.Adjustment and refund: licences relating to exempt imported products