European Commission 8 April 2015, 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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European Union · · · Cited by 83 · 08-04-2015

CHAPTER I. GENERAL PROVISIONS
Article 1. Scope
Article 2. Definitions
CHAPTER II. OBLIGATIONS ON MEMBER STATES' AUTHORITIES
Article 3. Accreditation, designation, authorisation or licensing of importing tissue establishments
Article 4. Inspections and other control measures
CHAPTER III. OBLIGATIONS ON IMPORTING TISSUE ESTABLISHMENTS
Article 5. Applications for accreditation, designation, authorisation or licensing as an importing tissue establishment
Article 6. Updated information
Article 7. Written agreements
Article 8. Register of importing tissue establishments
CHAPTER IV. FINAL PROVISIONS
Article 9. Transposition
Article 10. Entry into force
Article 11. Addresses
ANNEX I. Minimum requirements concerning the information and documentation to be provided by importing tissue establishment applicants when applying to be accredited, designated, authorised or licensed for the purpose of import activities

9.4.2015

Official Journal of the European Union

L 93/56

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)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European

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