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Commission Directive (EU) 2015/565 of 8 April 2015 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells Text with EEA relevance ANNEX II

ANNEX II附則

ANNEX II ‘ANNEX VIII Data to be recorded in the EU Tissue Establishment Compendium A.   Tissue establishment information 1. Name of the tissue establishment 2. National or international code of tissue establishment 3. Name of the organisation in which the tissue establishment is located (if applicable) 4. Address of the tissue establishment 5. Publishable contact details: functional e-mail address, phone and fax B.   Details on the authorisation, accreditation, designation, or license of the tissue establishment 1. Name of the authorising, accrediting, designating or licensing competent authority or authorities 2. Name of the national competent authority or authorities responsible for maintenance of the EU Tissue Establishment Compendium 3. Name of the authorisation, accreditation, designation or licence holder (if applicable) 4. Tissues and cells for which the authorisation, accreditation, designation or license was granted 5. Activities actually carried out for which the authorisation, accreditation, designation or licence was granted 6. Status of the authorisation, accreditation, designation or license (authorised, suspended, revoked, in part or in full, voluntary cessation of activities) 7. Details of any conditions and exemptions added to the authorisation (if applicable).’

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