Division 1 The primary tissue/cell container must provide:

1. (a)

   type of tissues and cells, identification number or code of the tissue/cells, and lot or batch number where applicable;

2. (b)

   identification of the tissue establishment;

3. (c)

   expiry date;

4. (d)

   in the case of autologous donation, this has to be specified (for autologous use only) and the donor/recipient has to be identified;

5. (e)

   in the case of directed donations - the label must identify the intended recipient;

6. (f)

   when tissues and cells are known to be positive for a relevant infectious disease marker, it must be marked as: BIOLOGICAL HAZARDF1;

7. (g)

   F2Single European Code as applicable to the tissues and cells being distributed for human application or the donation identification sequence as applicable to the tissues and cells released for circulation, other than distributed for human application.

If any of the information under points (d), (e) and (g) above cannot be included on the primary container label, it must be provided on a separate sheet accompanying the primary container. This sheet must be packaged with the primary container in a manner that ensures that they remain together.