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Commission Directive (EU) 2015/566Show full title
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)
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Changes over time for: Division F.
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F. Documentation to Accompany the Application U.K.
1.
A copy of the written agreement with the third country supplier(s).
2.
A detailed description of the flow of imported tissues and cells from their procurement to their reception at the importing tissue establishment.
3.
A copy of the third country supplier's export authorisation certificate or, where a specific export authorisation certificate is not issued, certification from the relevant third country competent authority or authorities authorising the third country supplier's activities in the tissue and cells sector including exports. This documentation shall also include the contact details of the third country competent authority or authorities. In third countries where such documentation is not available, alternative forms of documentation shall be provided such as reports of audits of the third country supplier.
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