S.L. 483.8 Art. 9Register of importing tissue establishments. S.L. 483.01 Minimum provided accredited, When purpose of unless designation, establishme documentation A. 1. Name 2. 3. Postal 4. Status application for where already TE 5. Name 6. 7. Postal 8. Name and applying 9. 10. Postal 1. Name 2. 3. E-mail 4. Name

(1) The importing tissue establishments shall keep a record of their activities, including, but not limited to, the types and quantities of tissues and cells imported, and on their origin and destination. This record shall also include the same information for any one-off imports carried out. The annual report shall include the information provided for under regulation 7 of the Tissues and Cells (Quality and Safety) Regulations.

(2) The Authority shall include the importing tissue establishment in the publicly accessible register of tissue establishments laid down in Article 10(2) of Directive 2004/23/EC.

(3) Information on the accreditations, designations, authorisations or licence of importing tissue establishment shall also be made available through the network of the registers referred to in Article 10(3) of Directive 2004/23/EC. SCHEDULE I

requirements concerning the information and documentation to be by importing tissue establishment applicants when applying to be designated, authorised or licensed for the purpose of import activities applying for an accreditation, designation, authorisation or licence for the import activities, the importing tissue establishment applicant shall, already provided as part of previous applications for accreditation, authorisation or licensing as a tissue establishment or importing tissue nt, provide the most up-to-date information and, for Part F, on the following: General Information on the Importing Tissue Establishment (ITE) of the ITE (Company name).

Visiting address of the ITE. address of the ITE (if different). of the applicant ITE: It should be indicated if this is the first accreditation, designation, authorisation or licensing as an ITE or, applicable, whether this is a renewal application. Where the applicant is accredited, designated, authorised or licensed as a tissue establishment, the compendium code should be provided. of the applying unit (if different from the company name). Visiting address of the applying unit. address of the applying unit (if different). of the site of reception of imports (if different from the company name unit). Visiting address of the site of reception.

address of the site of reception (if different). B. Contact Details for the Application of contact person for the application.

Telephone number. address. of Responsible Person (if different from contact person). Telephone number. address. of ITE website (if available). C. Details of Tissues and Cells to be Imported of the types of tissues and cells to be imported, including one-off specific types of tissues or cells. product name (where applicable, in accordance with the EU generic types of tissues and cells to be imported. trade name (if of all types of tissues and different to the product name) imported. name of the third country supplier for each type of tissue and cell to be imported.

D. Location of Activities