SCHEDULE 2
Directions for securing compliance with the first, second and third Directives
Traceability and coding system
1.Directions shall require that licence holders adopt such systems as...
2.Directions given for the purposes of paragraph 1 shall include...
Reporting obligations
3.Directions under paragraph 2(4)(c) to (e) of Schedule 3 to...
Serious adverse events and serious adverse reactions
4.Directions shall require licence holders to adopt such—
Third party agreements and termination of licensed activities
5.For the purpose of securing compliance with the requirements of...
Procurement and use of tissue or cells
6.Directions shall specify the requirements to be met by all...
7.Directions shall be given— (a) for the purpose of securing...
8.In giving directions for the purposes of paragraph 7, the...
Selection criteria and laboratory tests required for donors of tissues and cells
9.In relation to donors of tissues or cells who are...
10.In relation to donors of tissues or cells who are...
11.Directions shall, in respect of all donors of tissues or...
Donation and procurement procedures and reception at the tissue establishment
12.In respect of— (a) donation and procurement procedures, and
Requirements for holding a licence under Schedule 1
13.Directions shall be given for the purpose of securing compliance...
Requirements for holding a licence under Schedule 1 for tissue and cell preparation processes
14.In respect of tissue and cell preparation processes, directions shall...