OpenLegislation

Part 4 Transitional provision in respect of UK marketing authorisations, parallel import licences and parallel distribution noticesF1

  1. 26ZAStatus of certain UK marketing authorisations granted before IP completion day
  2. 26Place of establishment for UK marketing authorisation holder or parallel import licence holder established in an EEA State before IP completion day
  3. 27Temporary exemption as to packaging requirements: change of place of establishment
  4. 27AStatus of parallel import licences granted before IP completion day
  5. 28Conversion of parallel distribution notices in to parallel import licences
  6. 29Inclusion of the batch testing condition in relevant UK marketing authorisations, and batch testing of biological medicinal products in the EEA before IP completion day (regulation 60A)
  7. 29AApplication of the batch testing requirement to relevant EU marketing authorisations, and batch testing of biological medicinal products in the EEA before IP completion day (regulation 60B)
  8. 30Existing data and marketing exclusivity and global marketing authorisations
  9. 31Applications for EU marketing authorisations made before IP completion day
  10. 32Place of establishment for UK marketing authorisation holder established in EEA state before IP completion day (pre-exit EU marketing authorisation applications)
  11. 33Packaging in relation to UK marketing authorisations granted in response to application for EU marketing authorisation made before IP completion day
  12. 34Applications made for a UK marketing authorisation before IP completion day to which Chapter 4 of Title III of the 2001 Directive applied
  13. 35Transitional provision in respect of Plasma Master Files
  14. 36Suspensions of UK marketing authorisations that have effect immediately before IP completion day that were imposed under Chapter 4 of Title III of the 2001 Directive or Regulation (EC) No 726/2004
  15. 37Referrals made under Article 31 of the 2001 Directive concerning the suspension, variation or revocation of an EU marketing authorisation or a UK marketing authorisation that have not concluded before IP completion day

Annotations

Textual amendments

F1

Sch. 33A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 7 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 193); 2020 c. 1, Sch. 5 para. 1(1)