2010 No. 551
Medicines
Fees And Charges
Consumer Protection
The Medicines (Products for Human Use) (Fees) Regulations 2010 (revoked)
Regulations revoked (1.4.2012) by The Medicines (Products for Human Use) (Fees) Regulations 2012 (S.I. 2012/504), regs. 1, 57(1) (with reg. 57(2)-(4)) and Regulations expressed to be revoked (N.I.) (1.4.2012) by The Medicines (Products for Human Use) (Fees) Regulations 2012 (S.R. 2012/134), regs. 1, 57 (with reg. 57(2)-(4))
Made 26th February 2010
Laid before Parliament 4th March 2010
Coming into force 1stApril 2010

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PART 1 General

1 Citation and commencement
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2 Interpretation
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PART 2 Capital Fees for Pre-Application Meetings

3 Interpretation of Part 2
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4 Fee for scientific advice: application for, or variation to, EU marketing authorization
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5 Fee for scientific advice: classification of a medicinal product
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6 Fee for advertising advice
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7 Fee for pharmacovigilance advice
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8 Fee for advice on labelling or leaflets
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9 Fee for regulatory advice
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10 Fee for advice for other purposes
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11 Time for payment of fees under regulations 4 to 10
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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.
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13 Fee for applications for copy certificates of good manufacturing practice
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14 Fees for applications for certificates and copy certificates by exporters of medicinal products
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PART 4 Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States

15 Meaning of “set of applications”
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16 Fees for applications for regulatory assistance under the mutual recognition procedure
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17 Time for payment of fees under regulation 16
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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
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19 Fees for amendments to clinical trial authorisations
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20 Applications for multiple variations
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PART 6 Capital Fees for Assessment of Labels and Leaflets

21 Meaning of “set of proposed changes”
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22 Fees for assessment of a set of proposed changes to labels and leaflets
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23 Time for payment of fees under regulation 22
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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
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25 Fees for renewals in terms which are not identical to the existing authorization, licence or registration
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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 Authorizations

26 Fees for regulatory assistance for certain marketing authorizations
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PART 9 Capital Fees for Inspections

27 Fees for inspections
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28 Payer of inspection fee (contract laboratories and API manufacturing sites)
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29 Inspections in connection with multiple applications
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30 Fees for inspections relating to good clinical practice in clinical trials
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31 Amount, and time for payment, of inspection fees in respect of an application for a wholesale dealer's licence
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32 Adjustment and refund of inspection fees in respect of a wholesale dealer's licence
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PART 10 Periodic Fees for Authorizations, Registrations, Licences and Authorisations

33 Periodic fees
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34 Periodic fees for clinical trial authorisations
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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”
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36 Fees for applications for membership and certificates
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PART 12 Capital Fee for a Person Appointed Hearing

37 Fee for a person appointed hearing
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38 Time for payment under regulation 37
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PART 13 Administration

39 Payment of fees to Ministers
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40 Time for payment of capital fees in connection with applications or inspections
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41 Time for payment of capital fees – applications made by small companies
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42 Payment of fees in respect of a traditional herbal registration
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43 Time for payment of periodic fees
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44 Penalty fees for late payment of periodic fees
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45 Daily penalty fees for late payment of periodic fees
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46 Refund or waiver of fees under regulation 44 or 45
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47 Adjustment, waiver, reduction or refund of fees
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48 Suspension of licences and authorisations
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49 Civil proceedings to recover unpaid fees
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PART 14

50 Amendment of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994
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PART 15 Consequential Amendments

51 Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004
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PART 16 Revocations and Savings

52 Revocations and savings
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SCHEDULE 1 CAPITAL FEES FOR APPLICATIONS FOR, AND VARIATIONS TO, MARKETING AUTHORIZATIONS, LICENCES, AUTHORISATIONS, REGISTRATIONS AND CERTIFICATES
Regulations 12(1)(a), 16,18(1), 19(1), 22(1), 26(1)

PART 1 General: interpretation and categories of applications and variations

1 Interpretation
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2 General: categories of Applications and Variations
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3 Administrative variation application
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4 Extension application
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5 Complex application
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6 Complex registration application
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7 Complex variation application
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8 Decentralised procedure application
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9 Extended Type II Complex Variation Application
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10 Major application
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11 Mutual recognition procedure incoming application
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12 New excipient variation application
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13 New indication variation application
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14 Parallel Import Licence application
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15 Reclassification variation application
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16 Reduced registration application
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17 Simple application
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18 Standard application
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19 Standard registration application
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20 Standard variation application
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21 Standard variation application for a homoeopathic medicinal product
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22 Type IB and Type II Applications
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23 Type II Complex Variation Application
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PART 2 Capital Fees for Applications for Authorizations, Licences, Registrations and Certificates

24 Marketing authorizations
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25 Fees where application includes reclassification
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26 Fees where person holds clinical trial certificate
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27 Joint development
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28 Application for multiple authorizations
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29 Authorisation for a national homoeopathic product
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30 Manufacturer's licences and authorisations
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31 Wholesale dealer's licences
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32 Clinical trial authorisations
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33 Traditional herbal registrations
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PART 3 Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States

34 Outgoing mutual recognition applications
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PART 4 Capital Fees for Applications for Variations of Authorizations, Licences and Registrations

35 Marketing authorizations
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36 Variation of marketing authorizations
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37 Reclassification of marketing authorizations
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38 Variation of marketing authorization: national homoeopathic products
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39 Variation of parallel import licence
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40 Manufacturer's authorisations and licences
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41 Variation of manufacturer's authorisations and licences
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42 Wholesale dealer's licences
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43 Variation of wholesale dealer's licence
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44 Clinical trial authorisations
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45 Traditional herbal registrations
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46 Identical variations
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47 Complex Variation Applications
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48 Multiple reclassification variation applications
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PART 5 Capital Fees for Assessment of Labels and Leaflets

49 A set of changes
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50 More than one set of charges proposed
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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 Authorizations

51 Regulatory assistance
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52 Regulatory assistance – same manufacturer
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SCHEDULE 2 FEES FOR INSPECTIONS
Regulations 27(1), 30,31(2), 32(1)

1 General provisions relating to fees for inspections
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2 Fees: general
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3 Traditional herbal medicinal products
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4 Sites concerned with starting materials for traditional herbal medicinal products
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5 Wholesale dealer's licence: general
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6 Wholesale dealer's licence: traditional herbal medicinal products
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7 Wholesale dealer's licences: inspection of short duration
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8 Office-based inspections
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SCHEDULE 3 PERIODIC FEES FOR LICENCES
Regulation 33(2) and (3), 34(2)

PART 1 Interpretation
1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 2 Calculation of Turnover

2 Calculation of turnover
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3 Manufacturer's prices
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4 Evidence of turnover
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PART 3 Periodic Fees for Marketing Authorizations and Licences

5 Marketing authorizations
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6 Marketing authorization: where Part 2 of the Act applies
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7 Marketing authorization: derivatives
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8 Number of fee periods
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9 Authorisation for two or more kinds of medicinal product
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10 Reduced fees
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11 Manufacturer's licences or manufacturing authorisations
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12 Wholesale dealer's licences
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13 Wholesale dealer's licences: evidence
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14 Wholesale dealer's licences: exempt imported products
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15 Additional amount for manufacturer's licences and wholesale dealer's licences which relate to exempt imported products
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16 Clinical trial authorisations
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17 Traditional herbal registrations
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PART 4 Types of Marketing Authorization for which only One Periodic Fee is Payable

18 Specified parallel import licences
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SCHEDULE 4 TIME FOR PAYMENT OF CAPITAL FEES
Regulation 41(1)

1 Interpretation
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2 Major application
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3 Complex application
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4 Multiple application
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5 Outgoing mutual recognition application
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6 Application for traditional herbal registration
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7 Traditional herbal registration: complex variation
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8 Application for manufacturer's licence, manufacturing authorisation or wholesale dealer's licence
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9 Inspection fees in connection with applications
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SCHEDULE 5 WAIVER, REDUCTION OR REFUND OF CAPITAL FEES
Regulation 47(2)

1 Interruptions of manufacture, assembly, sale or supply
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2 Reclassification
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3 Variation of a traditional herbal registration
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4 Withdrawal of application in relation to marketing authorization, traditional herbal registration or clinical trial authorisation
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5 Withdrawal of application in relation to manufacturing authorisation, wholesale dealer's licence or manufacturer's licence
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6 Refusal of application for grant of marketing authorization, traditional herbal registration or clinical trial authorisation
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7 Parallel import licence
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8 Surrender of marketing authorization at same time as a variation application
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9 Clinical trial authorisation
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10 Scientific advice: paediatric indications
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SCHEDULE 6 ADJUSTMENT, REDUCTION OR REFUND OF PERIODIC FEES
Regulation 47(2)

1 Refund on surrender or revocation of authorization, registration or licence
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2 Adjustment and refund: licences relating to exempt imported products
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3 Refunds: treated as having been paid on account
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SCHEDULE 7 INTERPRETATION
Regulation 2

1 Interpretation
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2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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