The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010

  1. Introductory Text

  2. 1.Citation, commencement and interpretation

  3. 2.Disapplication of section 7 of the Medicines Act 1968 to exempt advanced therapy medicinal products

  4. 3.Licence conditions for exempt advanced therapy medicinal products

  5. 4.Traceability

  6. 5.Traceability in the event of bankruptcy or liquidation of holder of manufacturer’s licence for exempt ATMP

  7. 6.Amendment of the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971

  8. 7.Amendment of the Medicines (Applications for Manufacturer’s and Wholesale Dealer’s Licences) Regulations 1971

  9. 8.Amendment of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

  10. 9.Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004

  11. 10.Amendment of the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005

  12. Signature

    1. SCHEDULE 1

      Requirement that holders of manufacturer’s licences comply with certain obligations in relation to the manufacture and assembly of exempt advanced therapy medicinal products

    2. SCHEDULE 2

      Standard provisions for manufacturer’s licences insofar as those licences relate to exempt advanced therapy medicinal products

      1. 1.The holder of a manufacturer’s licence must—

      2. 2.The manufacturer’s licence holder may use a contract laboratory pursuant...

    3. SCHEDULE 3

      Requirement that holders of wholesale dealer’s licences comply with certain obligations in relation to exempt advanced therapy medicinal products

    4. SCHEDULE 4

      Standard provisions for wholesale dealer’s licences insofar as those licences relate to exempt advanced therapy medicinal products

    5. SCHEDULE 5

      Amendments to the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

      1. 1.Amendment of regulation 1

      2. 2.Amendment of Schedule 1

      3. 3.Amendment of Schedule 3

      4. 4.Amendment of Schedule 6

  14. Explanatory Note