Part 2 Amendment of the Human Medicines Regulations 2012

1. 5Amendment of regulation 8 (general interpretation)
2. 6Amendment of regulation 43 (obligations of licence holder)
3. 7Amendment of regulation 45A (brokering in medicinal products)
4. 8Amendment of regulation 49 (application for grant of UK marketing authorisation or parallel import licence)
5. 9Amendment of regulation 58 (consideration of application)
6. 10Amendment of regulation 60A (condition as to the submitting of samples and other information to the appropriate authority)
7. 11Amendment of regulation 60B (submitting of samples and other information: EU marketing authorisations)
8. 12Amendment of regulation 167 (supply to fulfil special patient needs)
9. 13Amendment of regulation 182 (obligation on holder to operate pharmacovigilance system)
10. 14Amendment of regulation 188 (reporting obligations on holders)
11. 15Amendment of regulation 193 (harmonisation of PSUR frequency or date of submission)
12. 16Amendment of regulation 199 (submission of draft study protocols for required studies)
13. 17Amendment of regulation 200 (amendment to study protocols for required studies)
14. 18Amendment of regulation 201 (submission and evaluation of final study reports for required studies)
15. 19Amendment of regulation 202A (licensing authority power in relation to medicinal products subject to additional monitoring)
16. 20Amendment of Schedule 8 (material to accompany an application for a UK marketing authorisation)
17. 21Amendment of Schedule 11 (advice and representations)
18. 22Amendment of Schedule 27 (package leaflets)
19. 23Amendment of Schedule 33A (transitional provisions)