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The Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994

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  1. Introductory Text

  2. PART I GENERAL

    1. 1.Citation, commencement and interpretation

    2. 2.Application

    3. 3.Placing on the market

  3. PART II CERTIFICATES OF REGISTRATION

    1. 4.Application for certificate

    2. 5.Determination of application for certificate

    3. 6.Grant of a certificate

    4. 7.Requirements in respect of controls

    5. 8.Duration and renewal of certificates

    6. 9.Suspension and revocation

    7. 10.Withdrawal from the market

    8. 11.Variation of certificates

  4. PART III FEES

    1. 12.Application

    2. 13.Fees for applications for certificates

    3. 14.Fees for variations of certificates

    4. 15.Fees payable by holders of certificates

    5. 16.Time for payment of fees

    6. 17.Refund or waiver of fees

    7. 18.Civil proceedings to recover unpaid fees

  5. PART IV APPLICATION OF PROVISIONS OF THE ACT

    1. 19.Application of the Act to certificates of registration

  6. Signature

    1. SCHEDULE 1

      ACCOMPANYING MATERIAL AND INFORMATION FOR APPLICATIONS FOR CERTIFICATES OF REGISTRATION

      1. 1.The name or corporate name of and the permanent address...

      2. 2.Details of the scientific name or other name given in...

      3. 3.A statement of the various routes of administration, pharmaceutical forms...

      4. 4.A dossier describing how the homoeopathic stock or stocks is...

      5. 5.A manufacturing and control file for each pharmaceutical form and...

      6. 6.A copy of the manufacturer’s licence or corresponding authorisation granted...

      7. 7.Copies of any registrations or authorisations obtained for the same...

      8. 8.One or more specimens of mock-ups of the sales presentation...

      9. 9.Data concerning the stability of the product.

    2. SCHEDULE 2

      FEES FOR APPLICATIONS FOR THE GRANT OF CERTIFICATES OF REGISTRATION

      1. 1.Subject to paragraph 2, where an application for the grant...

      2. 2.Where an application for the grant of a certificate of...

    3. SCHEDULE 3

      REFUND OR WAIVER OF FEES

      1. 1.Subject to paragraph 2, where an application for the grant...

      2. 2.If an application for the grant of a certificate is...

    4. SCHEDULE 4

      APPLICATION OF PROVISIONS OF THE ACT

  8. Explanatory Note

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