Commission Directive (EU) 2015/566 of 8 April 2015 implementing Directive 2004/23... (32015L0566)
INHALT
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
- 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)
- 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
- A.
- General Information on the Importing Tissue Establishment (ITE)
- B.
- Contact Details for the Application
- C.
- Details of Tissues and Cells to be Imported
- D.
- Location of Activities
- E.
- Details of Third Country Suppliers
- F.
- Documentation to Accompany the Application
- ANNEX II
- Certificate of Accreditation, Designation, Authorisation or Licence to be issued by the competent authority or authorities to importing tissue establishments
- ANNEX III
- Minimum requirements concerning the documentation to be made available to the competent authority or authorities by tissue establishments intending to import tissues and cells from third countries
- A.
- Documentation relating to the importing tissue establishment
- B.
- Documentation relating to the third country supplier or suppliers
- ANNEX IV
- Minimum requirements concerning the contents of written agreements between importing tissue establishments and their third country suppliers
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