Schedule 1 Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019
- 1Interpretation
- 2Amendment of regulation 15 (amendment of regulation 18 of the 2012 Regulations – wholesale dealing in medicinal products)
- 3Amendment of regulation 17 (amendment of regulation 19 of the 2012 Regulations – exemptions from requirement for wholesale dealer’s licence)
- 4Amendment of regulation 47 (amendment of regulation 48 of the 2012 Regulations – application of Part 5)
- 5Amendment of regulation 56 (substitution of regulation 51 of the 2012 Regulations - applications relating to generic medicinal products)
- 6Amendment of regulation 58 (amendment of regulation 53 of the 2012 Regulations - applications relating to similar biological medicinal products)
- 7Amendment of regulation 63 (amendment of Schedule 11 to the 2012 Regulations – advice and representations)
- 8Amendment of regulation 139 (amendment of regulation 177 of the 2012 Regulations – application of Part 11 (pharmacovigilance) and interpretation)
- 9Amendment of Schedule 6 (insertion of Schedule 12A into the 2012 Regulations)
- 10Amendment of Schedule 7 (insertion of Schedule 33A into the 2012 Regulations)