The Medicines (Products for Human Use) (Fees) Regulations 2012 (revoked)
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 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 Authorisations 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 Licences, Authorizations and Registrations 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 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 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
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
PART 10
Periodic Fees for Authorizations, Registrations, Licences and Authorisations
33
Periodic fees
34
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
35
Meaning of “good clinical practice accreditation scheme”
36
Fees for applications for membership and certificates
PART 12
Capital Fee for a Person Appointed Hearing
37
Fee for a person appointed hearing
38
Time for payment under regulation 37
PART 13
Fees in relation to the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994
39
Interpretation
40
Fees for applications made at the invitation of the licensing authority
41
Fees for applications for certificates
42
Fees for variations of certificates
43
Time for payment of fees
PART 14
Administration
44
Payment of fees to Ministers
45
Time for payment of capital fees in connection with applications or inspections
46
Time for payment of capital fees – applications made by small companies
47
Payment of fees in respect of a traditional herbal registration
48
Time for payment of periodic fees
49
Penalty fees for late payment of periodic fees
50
Daily penalty fees for late payment of periodic fees
51
Refund or waiver of fees under regulation 49 or 50
52
Adjustment, waiver, reduction or refund of fees
53
Suspension of licences and authorisations
54
Civil proceedings to recover unpaid fees
PART 15
Consequential Amendments
55
Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004
56
Amendment of the Homoeopathic Regulations
PART 16
Revocations and Savings
57
The Medicines (Products for Human Use) (Fees) Regulations 2010
58
The Homoeopathic Regulations
SCHEDULE 1
INTERPRETATION
1
Interpretation
2
For the purposes of these Regulations, a clinical trial authorisation...
3
In these Regulations any reference to an application for the...
SCHEDULE 2
CAPITAL FEES FOR APPLICATIONS FOR, AND VARIATIONS TO, MARKETING AUTHORIZATIONS, LICENCES, AUTHORISATIONS, 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 Authorizations, Licences, Registrations and Certificates
24
Marketing authorizations
25
Fees where application includes reclassification
26
Fees where person holds clinical trial certificate
27
Joint development
28
Application for multiple authorizations
29
Authorisation for a national homoeopathic product
30
Manufacturer's licences and authorisations
31
Wholesale dealer's licences
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
PART 5
Capital Fees for Assessment of Labels and Leaflets
49
A set of changes
50
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 Authorizations
51
Regulatory assistance
52
Regulatory assistance – same manufacturer
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
Office-based inspections
SCHEDULE 4
PERIODIC FEES FOR LICENCES
PART 1
Interpretation
1
In this Schedule— “anthroposophic product” means a medicinal product prepared...
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 Authorizations and Licences
5
Marketing authorizations
6
Marketing authorization: where Part 2 of the 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'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
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 authorization, 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 or manufacturer's licence
7
Refusal of application for grant of marketing authorization, traditional herbal registration or clinical trial authorisation
8
Parallel import licence
9
Surrender of marketing authorization 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 authorization, registration or licence
2
Adjustment and refund: licences relating to exempt imported products
3
Refunds: treated as having been paid on account
2012 No. 504

Medicines

Fees And Charges

The Medicines (Products for Human Use) (Fees) Regulations 2012 (revoked)
Made
23rd February 2012
Laid before Parliament
29th February 2012
Coming into force
1st April 2012
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Regulations revoked (1.4.2013) by The Medicines (Products for Human Use) (Fees) Regulations 2013 (S.I. 2013/532), reg. 59(1) (with reg. 59(2)-(4))