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Commission Directive (EU) 2015/566 of 8 April 2015 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells Text with EEA relevance Article 8

Register of importing tissue establishments

Article 8

1.   Importing tissue establishments shall keep a record of their activities, including 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 referred to in Article 10(1) of Directive 2004/23/EC shall include information about those activities. 2.   The competent authority or authorities shall include importing tissue establishments 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 licences of importing tissue establishments shall also be made available through the network of registers referred to in Article 10(3) of Directive 2004/23/EC.

查看整部法規全文 → · 開啟所屬章節:CHAPTER III — OBLIGATIONS ON IMPORTING TISSUE ESTABLISHMENTS

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