
2013 No. 532
Medicines
Fees And Charges
The Medicines (Products for Human Use) (Fees) Regulations 2013  (revoked)
Made 7th March 2013
Laid before Parliament 11th March 2013
Coming into force in accordance with regulation 1
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PART 1 General
Citation and commencement
1 
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Interpretation
2 
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PART 2 Capital Fees for Pre-Application Meetings
Interpretation of Part 2
3 
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Fee for scientific advice: application for, or variation to, EU marketing authorisation
4 
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Fee for scientific advice: classification of a medicinal product
5 
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Fee for advertising advice
6 
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Fee for pharmacovigilance advice
7 
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Fee for advice on labelling or leaflets
8 
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Fee for regulatory advice
9 
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Fee for advice for other purposes
10 
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Time for payment of fees under regulations 4 to 10
11 
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PART 3 Capital Fees for Applications for Authorisations, Registrations, Licences or Certificates and for Associated Inspections
Fees for applications for authorisations, registrations, licences or certificates etc.
12 
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Fee for applications for additional copy certificates
13 
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Fees for applications for certificates and copy certificates by exporters of medicinal products
14 
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PART 4 Capital Fees for Assistance in Obtaining Marketing Authorisations in Other EEA States
Meaning of  “set of applications”
15 
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Fees for applications for regulatory assistance under the mutual recognition procedure
16 
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Time for payment of fees under regulation 16
17 
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PART 5 Capital Fees for Applications for Variations of Authorisations, Registrations and Licences and for Associated Compliance Activities
Fees for variations of authorisations, registrations and licences
18 
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Fees for amendments to clinical trial authorisations
19 
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Fees for notification of changes and reports for broker's registrations
20 
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Fees for notification of changes and compliance Reports for active substance registrations
21 
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Applications for multiple variations
22 
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PART 6 Capital Fees for Assessment of Labels and Leaflets
Meaning of  “set of proposed changes”
23 
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Fees for assessment of a set of proposed changes to labels and leaflets
24 
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Time for payment of fees under regulation 24
25 
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PART 7 Capital Fees for Applications for Renewals of Certain Licences, Authorisations and Registrations and for Associated Inspections
Fees for renewals of certain manufacturer's licences
26 
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Fees for renewals in terms which are not identical to the existing authorisation, licence or registration
27 
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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
Fees for regulatory assistance for certain marketing authorisations
28 
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PART 9 Capital Fees for Inspections
Fees for inspections
29 
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Fees for inspections of pharmacovigilance service providers
30 
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Payer of inspection fee (contract laboratories and API manufacturing sites)
31 
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Inspections in connection with multiple applications
32 
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Fees for inspections relating to good clinical practice in clinical trials
33 
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Amount, and time for payment, of inspection fees in respect of an application for a wholesale dealer's licence
34 
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Adjustment and refund of inspection fees in respect of a wholesale dealer's licence
35 
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Amount, and time for payment, of inspection fees in respect of an application for a broker's registration or an active substance registration
36 
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PART 10 Periodic Fees for Authorisations, Registrations and Licences
Periodic fees
37 
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PART 11 Capital Fees for Application for Membership of Good Clinical Practice Accreditation Scheme and for Certificate of Membership
Meaning of  “good clinical practice accreditation scheme”
38 
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Fees for applications for membership and certificates
39 
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PART 12 Capital Fee for a Review Upon Oral Representations or a Person Appointed Hearing
Fee for a review upon oral representations or a person appointed hearing
40 
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Time for payment under regulation 40
41 
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PART 13 Fees in relation to the Part 6 of the Human Medicines Regulations (certification of homoeopathic medicinal products)
Interpretation
42 
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Fees for applications made at the invitation of the licensing authority
43 
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Fees for applications for certificates
44 
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Fees for variations of certificates
45 
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Time for payment of fees
46 
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PART 14 Administration
Payment of fees to Ministers
47 
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Time for payment of capital fees in connection with applications or inspections
48 
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Time for payment of capital fees – applications made by small companies
49 
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Payment of fees in respect of a traditional herbal registration
50 
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Time for payment of periodic fees
51 
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Penalty fees for late payment of periodic fees
52 
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Daily penalty fees for late payment of periodic fees
53 
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Refund or waiver of fees under regulation 52 or 53
54 
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Adjustment, waiver, reduction or refund of fees
55 
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Suspension of licences and authorisations
56 
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Civil proceedings to recover unpaid fees
57 
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PART 15 Consequential Amendments
Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004
58 
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PART 16 Revocations and Savings
The Medicines (Products for Human Use) (Fees) Regulations 2012
59 
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The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2012
60 
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Other Revocations
61 
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SCHEDULES
SCHEDULE 1
General interpretation provisions

Regulation 2
1 
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2 
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3 
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SCHEDULE 2
Capital fees for applications for, and variations to, marketing authorisations, licences, registrations and certificates

Regulations 12(1)(a); 16;18(2)(a); 19(2)(a); 22(7); 23; 24(1);28(1) and (3)
PART 1 General: interpretation and categories of applications and variations
Interpretation
1 
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General: categories of applications and variations
2 
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Administrative variation application
3 
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Extension application
4 
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Complex application
5 
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Complex registration application
6 
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Complex variation application
7 
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Decentralised procedure application
8 
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Extended Type II Complex Variation Application
9 
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Major application
10 
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Mutual recognition procedure incoming application
11 
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New excipient variation application
12 
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New indication variation application
13 
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Parallel import licence application
14 
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Reclassification variation application
15 
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Reduced registration application
16 
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Simple application
17 
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Standard application
18 
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Standard registration application
19 
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Standard variation application
20 
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Standard variation application for a homoeopathic medicinal product
21 
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Type IB and Type II Applications
22 
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Type II Complex Variation Application
23 
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PART 2 Capital Fees for Applications for Authorisations, Licences, Registrations and Certificates
Marketing authorisations
24 
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Fees where application includes reclassification
25 
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Fees where person holds clinical trial certificate
26 
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Joint development
27 
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Application for multiple authorisations
28 
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Authorisation for a national homoeopathic product
29 
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Manufacturer's licences and authorisations
30 
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Wholesale dealer's licences
31 
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Broker's registrations
32 
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Active substance registrations
33 
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Clinical trial authorisations
34 
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Traditional herbal registrations
35 
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PART 3 Capital Fees for Assistance in Obtaining Marketing Authorisations in Other EEA States
Outgoing mutual recognition applications
36 
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PART 4 Capital Fees for Applications for Variations of Authorisations, Licences and Registrations
Marketing authorisations
37 
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Variation of marketing authorisations
38 
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Reclassification of marketing authorisations
39 
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Variation of marketing authorisation: national homoeopathic products
40 
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Variation of parallel import licence
41 
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Manufacturer's authorisations and licences
42 
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Variation of manufacturer's authorisations and licences
43 
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Wholesale dealer's licences
44 
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Variation of wholesale dealer's licence
45 
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Variation of a broker's registration
46 
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Variation of an active substance registration
47 
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Clinical trial authorisations
48 
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Traditional herbal registrations
49 
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Identical variations
50 
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Complex Variation Applications
51 
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Multiple reclassification variation applications
52 
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PART 5 Capital Fees for Assessment of Labels and Leaflets
A set of changes
53 
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More than one set of changes proposed
54 
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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
Regulatory assistance
55 
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Regulatory assistance – same manufacturer
56 
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PART 7 Relevant Substances
Substances listed for the purposes of paragraph 24(2)(b) and (4)(b) and 37(2)(b)
57 
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SCHEDULE 3
Fees for inspections

Regulations 29(1); 33;34(2) and (3); and 35(1)
General provisions relating to fees for inspections
1 
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Fees: general
2 
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Traditional herbal medicinal products
3 
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Sites concerned with starting materials for traditional herbal medicinal products
4 
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Wholesale dealer's licence: general
5 
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Wholesale dealer's licence: traditional herbal medicinal products
6 
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Wholesale dealer's licences: inspection of short duration
7 
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Broker's registrations
8 
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Active substance registrations
9 
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Office-based inspections
10 
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SCHEDULE 4
Periodic fees for licences

Regulation 37(1) to (3)
PART 1 Interpretation
1 
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PART 2 Value of the Product Sold or Supplied
Determining the total value of the product
2 
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Manufacturer's prices
3 
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Information requirements
4 
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PART 3 Periodic Fees for Marketing Authorisations and Licences
Marketing authorisations
5 
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Marketing authorisation: where Part 2 of the Act applies
6 
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Marketing authorisation: derivatives
7 
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Number of fee periods
8 
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Authorisation for two or more kinds of medicinal product
9 
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Reduced fees
10 
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Manufacturer's licences or manufacturing authorisations
11 
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Wholesale dealer's licences
12 
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Wholesale dealer's licences: evidence
13 
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Wholesale dealer's licences: special medicinal products
14 
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Additional amount for manufacturer's licences and wholesale dealer's licences which relate to special medicinal products
15 
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Traditional herbal registrations
16 
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PART 4 Types of Marketing Authorisation for which only One Periodic Fee is Payable
Parallel import licences
17 
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SCHEDULE 5
Fees for certificates of registration

Regulation 44(1) and (2)

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SCHEDULE 6
Time for payment of capital fees: small companies

Regulation 49 (1)
Interpretation
1 
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Major application
2 
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Complex application
3 
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Multiple application
4 
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Outgoing mutual recognition application
5 
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Application for traditional herbal registration
6 
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Traditional herbal registration: complex variation
7 
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Application for manufacturer's licence, manufacturing authorisation or wholesale dealer's licence
8 
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Inspection fees in connection with applications
9 
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SCHEDULE 7
Waiver, reduction or refund of capital fees

Regulation 55(2)
Interruptions of manufacture, assembly, sale or supply
1 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Reclassification
2 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Variation of a traditional herbal registration
3 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Withdrawal of application in relation to marketing authorisation, traditional herbal registration or clinical trial authorisation
4 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Withdrawal of application in relation to a certificate of registration
5 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Withdrawal of application in relation to manufacturing authorisation, wholesale dealer's licence, manufacturer's licence, broker's registration or active substance registration
6 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Refusal of application for grant of marketing authorisation, traditional herbal registration or clinical trial authorisation
7 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Parallel import licence
8 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Surrender of marketing authorisation at same time as a variation application
9 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Clinical trial authorisation
10 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Scientific advice: paediatric indications
11 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Refunds: treated as having been paid on account
12 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SCHEDULE 8
Adjustment, reduction or refund of periodic fees

Regulation 55(2)
Refund on surrender or revocation of authorisation, registration or licence
1 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Adjustment and refund: licences relating to imported special medicinal products
2 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Refunds: treated as having been paid on account
3 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SCHEDULE 9
Further revocations

Regulation 61

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
