Schedule 2 Directions for securing compliance with the first, second and third Directives

1. Traceability and coding system
2. Reporting obligations
3. Serious adverse events and serious adverse reactions
4. Third party agreements and termination of licensed activities
5. Procurement and use of tissue or cells
6. Selection criteria and laboratory tests required for donors of tissues and cells
7. Donation and procurement procedures and reception at the tissue establishment
8. Requirements for holding a licence under Schedule 1
9. Requirements for holding a licence under Schedule 1 for tissue and cell preparation processes