Commission Directive (EU) 2015/566Dangos y teitl llawn

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)

  1. Introductory Text

  2. CHAPTER I GENERAL PROVISIONS

    1. Article 1.Scope

    2. Article 2.Definitions

  3. CHAPTER II OBLIGATIONS ON MEMBER STATES' AUTHORITIES

    1. Article 3.Accreditation, designation, authorisation or licensing of importing tissue establishments

    2. Article 4.Inspections and other control measures

  4. CHAPTER III OBLIGATIONS ON IMPORTING TISSUE ESTABLISHMENTS

    1. Article 5.Applications for accreditation, designation, authorisation or licensing as an importing tissue establishment

    2. Article 6.Updated information

    3. Article 7.Written agreements

    4. Article 8.Register of importing tissue establishments

  5. CHAPTER IV FINAL PROVISIONS

    1. Article 9.Transposition

    2. Article 10.Entry into force

    3. Article 11.Addresses

  6. Signature

    1. 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

      1. When applying for an accreditation, designation, authorisation or licence for...

      2. A. General Information on the Importing Tissue Establishment (ITE)

      3. B. Contact Details for the Application

      4. C. Details of Tissues and Cells to be Imported

      5. D. Location of Activities

      6. E. Details of Third Country Suppliers

      7. F. Documentation to Accompany the Application

    2. ANNEX II

      Certificate of Accreditation, Designation, Authorisation or Licence to be issued by the competent authority or authorities to importing tissue establishments

    3. 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

      1. With the exception of one-off imports as defined in Article...

      2. A. Documentation relating to the importing tissue establishment

      3. B. Documentation relating to the third country supplier or suppliers

    4. ANNEX IV

      Minimum requirements concerning the contents of written agreements between importing tissue establishments and their third country suppliers

      1. With the exception of one-off imports as defined in Article...

      2. Detailed information on the specifications of the importing tissue establishment...