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The Medicines (Products for Human Use — Fees) Regulations 1991

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  1. Introductory Text

  2. PART I GENERAL

    1. 1.Citation, commencement and scope

    2. 2.Interpretation

    3. 3.Fees payable in connection with applications and inspections

  3. PART II CAPITAL FEES FOR APPLICATIONS FOR LICENCES OR CERTIFICATES AND FOR ASSOCIATED INSPECTIONS

    1. 4.Applications for licences and certificates

    2. 5.Inspections in connection with multiple applications for licences

    3. 6.Applications for certificates by exporters of medicinal products

  4. PART III CAPITAL FEES FOR APPLICATIONS FOR VARIATIONS OF LICENCES OR CERTIFICATES AND FOR ASSOCIATED INSPECTIONS

    1. 7.Variations of licences and certificates

    2. 8.Inspections in connection with multiple applications for variations of licences

    3. 9.Applications for multiple variations

  5. PART IV CAPITAL FEES FOR APPLICATIONS FOR RENEWALS OF CLINICAL TRIAL CERTIFICATES AND FOR CERTAIN MANUFACTURERS' LICENCES AND FOR ASSOCIATED INSPECTIONS

    1. 10.Renewals of clinical trial certificates

    2. 11.Renewals of certain manufacturers' licences

    3. 12.Renewals in terms which are not identical to the existing certificate or licence

  6. PART V FEES FOR INSPECTIONS MADE DURING THE CURRENCY OF A LICENCE

    1. 13.Fees payable

  7. PART VI PERIODIC FEES FOR LICENCES

    1. 14.Fees payable

  8. PART VII ADMINISTRATION

    1. 15.Payment of fees to Ministers

    2. 16.Time for payment of capital fees in connection with applications or inspections

    3. 17.Time for payment of capital fees — applications made by small companies

    4. 18.Time for payment of periodic fees

    5. 19.Adjustment, waiver, reduction or refund of fees

    6. 20.Suspension of licences or certificates

    7. 21.Civil proceedings to recover unpaid fees

  9. PART VIII REVOCATION, SAVINGS AND TRANSITIONAL PROVISIONS

    1. 22.Revocation and Savings

    2. 23.Transitional provisions

  10. Signature

    1. SCHEDULE 1

      CAPITAL FEES FOR APPLICATIONS FOR, AND VARIATIONS TO, LICENCES AND CERTIFICATES

      1. PART I INTERPRETATION

        1. 1.In this Schedule— “active ingredient” means an ingredient of a...

      2. PART II CAPITAL FEES FOR APPLICATIONS FOR LICENCES AND CERTIFICATES

        1. 1.Product licences

        2. 2.Notwithstanding the provisions of paragraph 1, in the case of...

        3. 3.Where a major application is made by a person who...

        4. 4.(1) In this paragraph— “joint development” means the development by...

        5. 5.(1) Subject to sub-paragraphs (2) and (3), where an application...

        6. 6.Manufacturers' licences

        7. 7.Wholesale dealers' licences

        8. 8.Clinical trial certificates

      3. PART III CAPITAL FEES FOR APPLICATIONS FOR VARIATIONS OF LICENCES AND CERTIFICATES

        1. 1.Product licences

        2. 2.Where a product licence has been granted in accordance with...

        3. 3.The fee payable under regulation 7(a) in connection with an...

        4. 4.The fee payable under regulation 7(a) in connection with an...

        5. 5.Manufacturers' licences

        6. 6.The fee payable under regulation 7(a) in connection with an...

        7. 7.Wholesale dealers' licences

        8. 8.The fee payable under regulation 7(a) in connection with an...

        9. 9.Clinical trial certificates

        10. 10.Where an application is made for a variation to a...

        11. 11.Identical variations

        12. 12.Where more than one complex application is made at the...

    2. SCHEDULE 2

      FEES FOR INSPECTIONS

      1. 1.Interpretation

      2. 2.Fees

      3. 3.(1) Subject to sub-paragraph (2), unless the applicant or, as...

      4. 4.In the case of an inspection in connection with the...

      5. 5.The fee payable in respect of an inspection at a...

    3. SCHEDULE 3

      PERIODIC FEES FOR LICENCES

      1. PART I INTERPRETATION

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

      2. PART II CALCULATION OF TURNOVER

        1. 1.(1) Subject to sub-paragraph (2) below, “turnover” means, for the...

        2. 2.For the purposes of paragraph 1, manufacturer’s prices are the...

        3. 3.(1) For the purpose of satisfying the licensing authority for...

      3. PART III PERIODIC FEES FOR LICENCES

        1. 1.Product licences

        2. 2.Notwithstanding the provisions of paragraph 1, in the case of...

        3. 3.Subject to paragraph 4 below, where a licence is held...

        4. 4.(1) The appropriate fee specified in the Table in paragraph...

        5. 5.Where a product licence relates to any two or more...

        6. 6.Where a reduced rate fee or a maintenance fee may...

        7. 7.Manufacturers' licences

        8. 8.Wholesale dealers' licences

        9. 9.Where in respect of any relevant licence fee period, the...

      4. PART IV TYPES OF PRODUCT LICENCE FOR WHICH ONLY ONE PERIODIC FEE IS PAYABLE

        1. 1.Product licences (parallel import) held by the same person each...

        2. 2.Licences held in respect of homoeopathic or anthroposophic products which...

    4. SCHEDULE 4

      TIME FOR PAYMENT OF CAPITAL FEES — APPLICATIONS MADE BY SMALL COMPANIES

      1. 1.In this Schedule a reference to an application is to...

      2. 2.In connection with a major application for a product licence...

      3. 3.In connection with an application to which paragraph 5 of...

      4. 4.In connection with an application for a manufacturer’s licence or...

      5. 5.In connection with an application for a product licence, manufacturer’s...

    5. SCHEDULE 5

      WAIVER, REDUCTION OR REFUND OF CAPITAL FEES

      1. 1.Where the manufacture, assembly, sale or supply of medicinal products...

      2. 2.(1) Subject to sub-paragraph (2), where an application for the...

      3. 3.Where an application for the grant of, or a variation...

      4. 4.Where the same site is inspected at the same time...

      5. 5.In relation to a product licence (parallel import), the fee...

    6. SCHEDULE 6

      ADJUSTMENT, REDUCTION OR REFUND OF PERIODIC FEES

      1. 1.(1) Subject to sub-paragraphs (2) and (3) below, where a...

      2. 2.Where, after payment of any periodic fee payable in accordance...

      3. 3.Any sums payable to the applicant by way of refund...

  11. Explanatory Note

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