The Medicines (Products for Human Use) (Fees) Regulations 2012 (revoked)

1Citation and commencement

2Interpretation

PART 2Capital Fees for Pre-Application Meetings

3Interpretation of Part 2

4Fee for scientific advice: application for, or variation to, EU marketing authorization

5Fee for scientific advice: classification of a medicinal product

6Fee for advertising advice

7Fee for pharmacovigilance advice

8Fee for advice on labelling or leaflets

9Fee for regulatory advice

10Fee for advice for other purposes

11Time for payment of fees under regulations 4 to 10

PART 3Capital Fees for Applications for Authorizations, Registrations, Licences, Certificates or Authorisations and for Associated Inspections

12Fees for applications for authorizations, licences or certificates etc.

13Fee for applications for copy certificates of good manufacturing practice

14Fees for applications for certificates and copy certificates by exporters of medicinal products

PART 4Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States

15Meaning of “set of applications”

16Fees for applications for regulatory assistance under the mutual recognition procedure

17Time for payment of fees under regulation 16

PART 5Capital Fees for Applications for Variations of Authorizations, Registrations, Licences and Authorisations and for Associated Inspections

18Fees for variations of authorizations, registrations, licences and authorisations

19Fees for amendments to clinical trial authorisations

20Applications for multiple variations

PART 6Capital Fees for Assessment of Labels and Leaflets

21Meaning of “set of proposed changes”

22Fees for assessment of a set of proposed changes to labels and leaflets

23Time for payment of fees under regulation 22

PART 7Capital Fees for Applications for Renewals of Certain Licences, Authorizations and Registrations and for Associated Inspections

24Fees for renewals of certain manufacturer's licences

25Fees for renewals in terms which are not identical to the existing authorization, licence or registration

PART 8Capital 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

26Fees for regulatory assistance for certain marketing authorizations

PART 9Capital Fees for Inspections

27Fees for inspections

28Payer of inspection fee (contract laboratories and API manufacturing sites)

29Inspections in connection with multiple applications

30Fees for inspections relating to good clinical practice in clinical trials

31Amount, and time for payment, of inspection fees in respect of an application for a wholesale dealer's licence

32Adjustment and refund of inspection fees in respect of a wholesale dealer's licence

PART 10Periodic Fees for Authorizations, Registrations, Licences and Authorisations

33Periodic fees

34Periodic fees for clinical trial authorisations

PART 11Capital Fees For Application For Membership of Good Clinical Practice Accreditation Scheme and for Certificate of Membership

35Meaning of “good clinical practice accreditation scheme”

36Fees for applications for membership and certificates

PART 12Capital Fee for a Person Appointed Hearing

37Fee for a person appointed hearing

38Time for payment under regulation 37

PART 13Fees in relation to the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994

39Interpretation

40Fees for applications made at the invitation of the licensing authority

41Fees for applications for certificates

42Fees for variations of certificates

43Time for payment of fees

PART 14Administration

44Payment of fees to Ministers

45Time for payment of capital fees in connection with applications or inspections

46Time for payment of capital fees – applications made by small companies

47Payment of fees in respect of a traditional herbal registration

48Time for payment of periodic fees

49Penalty fees for late payment of periodic fees

50Daily penalty fees for late payment of periodic fees

51Refund or waiver of fees under regulation 49 or 50

52Adjustment, waiver, reduction or refund of fees

53Suspension of licences and authorisations

54Civil proceedings to recover unpaid fees

PART 15Consequential Amendments

55Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004

56Amendment of the Homoeopathic Regulations

PART 16Revocations and Savings

57The Medicines (Products for Human Use) (Fees) Regulations 2010

58The Homoeopathic Regulations

SCHEDULE 1INTERPRETATION

1Interpretation

2For the purposes of these Regulations, a clinical trial authorisation...

3In these Regulations any reference to an application for the...

SCHEDULE 2CAPITAL FEES FOR APPLICATIONS FOR, AND VARIATIONS TO, MARKETING AUTHORIZATIONS, LICENCES, AUTHORISATIONS, REGISTRATIONS AND CERTIFICATES

PART 1General: interpretation and categories of applications and variations

1Interpretation

2General: categories of Applications and Variations

3Administrative variation application

4Extension application

5Complex application

6Complex registration application

7Complex variation application

8Decentralised procedure application

9Extended Type II Complex Variation Application

10Major application

11Mutual recognition procedure incoming application

12New excipient variation application

13New indication variation application

14Parallel Import Licence application

15Reclassification variation application

16Reduced registration application

17Simple application

18Standard application

19Standard registration application

20Standard variation application

21Standard variation application for a homoeopathic medicinal product

22Type IB and Type II Applications

23Type II Complex Variation Application

PART 2Capital Fees for Applications for Authorizations, Licences, Registrations and Certificates

24Marketing authorizations

25Fees where application includes reclassification

26Fees where person holds clinical trial certificate

27Joint development

28Application for multiple authorizations

29Authorisation for a national homoeopathic product

30Manufacturer's licences and authorisations

31Wholesale dealer's licences

32Clinical trial authorisations

33Traditional herbal registrations

PART 3Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States

34Outgoing mutual recognition applications

PART 4Capital Fees for Applications for Variations of Authorizations, Licences and Registrations

35Marketing authorizations

36Variation of marketing authorizations

37Reclassification of marketing authorizations

38Variation of marketing authorization: national homoeopathic products

39Variation of parallel import licence

40Manufacturer's authorisations and licences

41Variation of manufacturer's authorisations and licences

42Wholesale dealer's licences

43Variation of wholesale dealer's licence

44Clinical trial authorisations

45Traditional herbal registrations

46Identical variations

47Complex Variation Applications

48Multiple reclassification variation applications

PART 5Capital Fees for Assessment of Labels and Leaflets

49A set of changes

50More than one set of changes proposed

PART 6Capital 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

51Regulatory assistance

52Regulatory assistance – same manufacturer

SCHEDULE 3FEES FOR INSPECTIONS

1General provisions relating to fees for inspections

3Traditional herbal medicinal products

4Sites concerned with starting materials for traditional herbal medicinal products

5Wholesale dealer's licence: general

6Wholesale dealer's licence: traditional herbal medicinal products

7Wholesale dealer's licences: inspection of short duration

8Office-based inspections

SCHEDULE 4PERIODIC FEES FOR LICENCES

PART 1Interpretation

1In this Schedule— “anthroposophic product” means a medicinal product prepared...

PART 2Value of the Product Sold or Supplied

2Determining the total value of the product

3Manufacturer's prices

4Information requirements

PART 3Periodic Fees for Marketing Authorizations and Licences

5Marketing authorizations

6Marketing authorization: where Part 2 of the Act applies

7Marketing authorization: derivatives

8Number of fee periods

9Authorisation for two or more kinds of medicinal product

11Manufacturer's licences or manufacturing authorisations

12Wholesale dealer's licences

13Wholesale dealer's licences: evidence

14Wholesale dealer's licences: exempt imported products

15Additional amount for manufacturer's licences and wholesale dealer's licences which relate to exempt imported products

16Clinical trial authorisations

17Traditional herbal registrations

PART 4Types of Marketing Authorization for which only One Periodic Fee is Payable

18Parallel import licences

SCHEDULE 5FEES FOR CERTIFICATES OF REGISTRATION

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

SCHEDULE 6TIME FOR PAYMENT OF CAPITAL FEES: SMALL COMPANIES

1Interpretation

2Major application

3Complex application

4Multiple application

5Outgoing mutual recognition application

6Application for traditional herbal registration

7Traditional herbal registration: complex variation

8Application for manufacturer's licence, manufacturing authorisation or wholesale dealer's licence

9Inspection fees in connection with applications

SCHEDULE 7WAIVER, REDUCTION OR REFUND OF CAPITAL FEES

1Interruptions of manufacture, assembly, sale or supply

2Reclassification

3Variation of a traditional herbal registration

4Withdrawal of application in relation to marketing authorization, traditional herbal registration or clinical trial authorisation

5Withdrawal of application in relation to a certificate of registration

6Withdrawal of application in relation to manufacturing authorisation, wholesale dealer's licence or manufacturer's licence

7Refusal of application for grant of marketing authorization, traditional herbal registration or clinical trial authorisation

8Parallel import licence

9Surrender of marketing authorization at same time as a variation application

10Clinical trial authorisation

11Scientific advice: paediatric indications

12Refunds: treated as having been paid on account

SCHEDULE 8ADJUSTMENT, REDUCTION OR REFUND OF PERIODIC FEES

1Refund on surrender or revocation of authorization, registration or licence

2Adjustment and refund: licences relating to exempt imported products

3Refunds: treated as having been paid on account

2012 No. 504

Medicines

Fees And Charges

The Medicines (Products for Human Use) (Fees) Regulations 2012 (revoked)F1

Made23rd February 2012

Laid before Parliament29th February 2012

Coming into force1st April 2012

F1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .