Part 4 Transitional provision in respect of UK marketing authorisations, parallel import licences and parallel distribution noticesF1
- 26ZAStatus of certain UK marketing authorisations granted before IP completion day
- 26Place of establishment for UK marketing authorisation holder or parallel import licence holder established in an EEA State before IP completion day
- 27Temporary exemption as to packaging requirements: change of place of establishment
- 27AStatus of parallel import licences granted before IP completion day
- 28Conversion of parallel distribution notices in to parallel import licences
- 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)
- 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)
- 30Existing data and marketing exclusivity and global marketing authorisations
- 31Applications for EU marketing authorisations made before IP completion day
- 32Place of establishment for UK marketing authorisation holder established in EEA state before IP completion day (pre-exit EU marketing authorisation applications)
- 33Packaging in relation to UK marketing authorisations granted in response to application for EU marketing authorisation made before IP completion day
- 34Applications made for a UK marketing authorisation before IP completion day to which Chapter 4 of Title III of the 2001 Directive applied
- 35Transitional provision in respect of Plasma Master Files
- 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
- 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)