Part 14 Amendment of Part 13 (packaging and leaflets)

United Kingdom

1. 198Amendment of regulation 257 (packaging requirements: general)
2. 199Amendment of regulation 257A (packaging requirements: medicinal products required to bear safety features)
3. 199AAmendment of regulation 257B (transitional arrangements)
4. 200Insertion of regulations 257C (packaging requirements: advanced therapy medicinal products) and 257D and 257E (guidance and regulations in relation to packing, leaflets and labelling)
5. 201Amendment of Schedule 24 (packaging information requirements)
6. 202Amendment of regulation 259 (packaging requirements: information for blind and partially sighted patients)
7. 203Amendment of regulation 260 (package leaflets)
8. 204Amendment of Schedule 27 (package leaflets)
9. 205Amendment of regulation 266 (language requirements etc)
10. 206Amendment of regulation 267 (submission of mock-ups of packaging and leaflets to licensing authority)
11. 207Amendment of regulation 268 (offence relating to packaging and package leaflets)
12. 207AInsertion of new regulation 268A (offence relating to packaging and package leaflets in Northern Ireland: holder of authorisation etc)
13. 208Amendment of regulation 269 (offences relating to packaging and package leaflets: other persons)
14. 208AInsertion of new regulation 269A (offences relating to packaging and package leaflets in Northern Ireland: other persons)
15. 209Amendment of regulation 270 (non-compliance with requirements of this Part)
16. 209AAmendment of regulation 271 (offences: penalties)
17. 210Amendment of regulation 273 (child resistant containers for regulated medicinal products)