ANNEX II附則
ANNEX II Certificate of Accreditation, Designation, Authorisation or Licence to be issued by the competent authority or authorities to importing tissue establishments Text of image Certificate of Accreditation, Designation, Authorisation or Licence of an Importing Tissue Establishment 1. Importing Tissue Establishment (ITE) Details 1.1 Name of ITE 1.2 EU Tissue Establishment Compendium Code 1.3 ITE Address and postal address (if different) 1.4 Site of reception of imports (if different from the above address) 1.5 Name of accreditation, designation, authorisation or licence holder 1.6 Address of accreditation, designation, authorisation or licence holder 1.7 Telephone number of accreditation, designation, authorisation or licence holder (optional) 1.8 E-mail address of accreditation, designation, authorisation or licence holder (optional) 1.9 URL of ITE website 2. Scope of Activities 2.1 Type of Tissues and Cells (list below using categories of tissues and cells listed in the EU Tissue Establishment Compendium adding rows as necessary) Activities in third countries Import Accreditation, Designation, Authorisation or Licence Status Donation Procurement Testing Preservation Processing Storage 3CS — Third country supplier SC — Sub-contractor of third country supplier G — Granted S — Suspended R — Revoked C — Cessation 2.2 One-off imports 2.3 Product name(s) of imported tissues and cells 2.4 Any conditions placed on the import or clarifying remarks Text of image 2.5 Third country or countries of procurement (per tissue and cell import) 2.6 Third country or countries in which other activities take place (if different) 2.7 Name and country of third country supplier(s) (per tissue and cell import) 2.8 EU Member States in which imported tissues and cells will be distributed (if known) 3. Competent Authority (CA) Accreditation, Designation, Authorisation or Licence 3.1 National accreditation, designation, authorisation or licence number 3.2 Legal basis of accreditation, designation, authorisation or licence 3.3 Date of expiry of accreditation, designation, authorisation or licence (if any) 3.4 First accreditation, designation, authorisation or licence as ITE or renewal First time Renewal 3.5 Additional remarks 3.6 Name of CA 3.7 Name of CA Officer 3.8 Signature of CA Officer (electronic or otherwise) 3.9 Date of accreditation, designation, authorisation or licence 3.10 CA Stamp