CHAPTER IGENERAL PROVISIONS

Article 1Scope1.This Directive shall apply to the import into the Union of:(a)human tissues and cells intended for human application; and(b)manufactured products derived from human tissues and cells intended for human applications, where those products are not covered by other Union legislation.2.Where the human tissues and cells to be imported are intended to be used exclusively in manufactured products which are covered by other Union legislation, this Directive shall only apply to the donation, procurement and testing which takes place outside of the Union as well as to contributing to ensuring traceability from donor to recipient and vice versa.3.This Directive shall not apply to:(a)the import of tissues and cells referred to in Article 9(3)(a) of Directive 2004/23/EC which are directly authorised by the competent authority or authorities;(b)the import of tissues and cells referred to in Article 9(3)(b) of Directive 2004/23/EC which are directly authorised in case of emergencies;(c)blood and blood components as defined by Directive 2002/98/EC;(d)organs or parts of organs, as defined in Directive 2004/23/EC.

Article 2DefinitionsFor the purposes of this Directive, the following definitions apply:(a)"emergency" means any unforeseen situation in which there is no practical alternative other than to urgently import tissues and cells from a third country into the Union for immediate application to a known recipient or known recipients whose health would be seriously endangered without such an import;(b)"importing tissue establishment" means a tissue bank or a unit of a hospital or another body established within the Union which is a party to a contractual agreement with a third country supplier for the import into the Union of tissues and cells coming from a third country intended for human application;(c)"one-off import" means the import of any specific type of tissue or cell which is for the personal use of an intended recipient or recipients known to the importing tissue establishment and the third country supplier before the importation occurs. Such an import of any specific type of tissue or cell shall normally not occur more than once for any given recipient. Imports from the same third country supplier taking place on a regular or repeated basis shall not be considered to be "one-off imports";(d)"third country supplier" means a tissue establishment or another body, established in a third country, which is responsible for the export to the Union of tissues and cells it supplies to an importing tissue establishment. A third country supplier may also carry out one or more of the activities, which take place outside of the Union, of donation, procurement, testing, processing, preservation, storage or distribution of tissues and cells imported into the Union.

CHAPTER IIOBLIGATIONS ON MEMBER STATES' AUTHORITIES

Article 3Accreditation, designation, authorisation or licensing of importing tissue establishments1.Without prejudice to Article 1(3), Member States shall ensure that all imports of tissues and cells from third countries are undertaken by importing tissue establishments accredited, designated, authorised or licensed by a competent authority or authorities for the purposes of these activities.2.The competent authority or authorities, having obtained the information set out in Annex I to this Directive and, having verified that the importing tissue establishment complies with the requirements of this Directive, shall accredit, designate, authorise or license the importing tissue establishment to import tissues and cells and indicate any conditions which apply such as any restrictions of the types of tissues and cells to be imported or the third country suppliers to be used. The competent authority or authorities shall issue the accredited, designated, authorised or licensed importing tissue establishment with the certificate set out in Annex II to this Directive.3.The importing tissue establishment shall not undertake any substantial changes to its import activities without the prior written approval of the competent authority or authorities. In particular, any changes to the type of tissues and cells imported, the activities undertaken in third countries which may have an influence on the quality and safety of imported tissues and cells or the third country suppliers used shall be considered as substantial changes. Where an importing tissue establishment undertakes a one-off import of tissues or cells originating from a third country supplier not covered by its existing accreditation, designation, authorisation or licence, such an import shall not be considered as a substantial change if the importing tissue establishment is authorised to import the same type of tissues or cells from another third country supplier or suppliers.4.The competent authority or authorities may suspend or revoke the accreditation, designation, authorisation, or licence, in part or in full, of an importing tissue establishment if, in particular, inspections or other control measures demonstrate that such an establishment no longer meets the requirements of this Directive.

Article 4Inspections and other control measures1.Member States shall ensure that the competent authority or authorities organise inspections and other control measures of importing tissue establishments and, where appropriate, their third country suppliers and that importing tissue establishments carry out appropriate controls in order to ensure the equivalency of the quality and safety standards of the tissues and cells to be imported with the standards laid down in Directive 2004/23/EC. The interval between inspections of any given importing tissue establishment shall not exceed 2 years.2.Such inspections shall be carried out by officials representing the competent authority or authorities who shall:(a)be empowered to inspect importing tissue establishments and, where appropriate, the activities of any third country suppliers;(b)evaluate and verify the procedures and activities carried out in importing tissue establishments and the facilities of third country suppliers that are relevant to ensuring the equivalency of the quality and safety standards of the tissues and cells to be imported with the standards laid down in Directive 2004/23/EC;(c)examine any documents or other records that are relevant for this evaluation and verification.3.Member States shall, upon a duly justified request from another Member State or the Commission, provide information on the results of inspections and other control measures relating to importing tissue establishments and third country suppliers.4.Member States into which tissues and cells are imported shall, upon a duly justified request from another Member State into which imported tissues and cells are subsequently distributed, consider carrying out inspections or other control measures on importing tissue establishments and the activities of any third country suppliers. The Member State in which the importing tissue establishment is located shall decide on the appropriate measures to take following consultation with the Member State which made such a request.5.Where an on-site inspection takes place following such a request, the competent authority or authorities of the Member State in which the importing tissue establishment is located shall agree with the competent authority or authorities of the Member State which made such a request on whether and how the Member State which made such a request shall participate in the inspection. The final decision on any such participation shall rest with the Member State in which the importing tissue establishment is located. The reasons for any decision to refuse such participation shall be explained to the Member State which made such a request.

CHAPTER IIIOBLIGATIONS ON IMPORTING TISSUE ESTABLISHMENTS

Article 5Applications for accreditation, designation, authorisation or licensing as an importing tissue establishment1.Importing tissue establishments, having taken measures to ensure that any imports of tissues and cells meet standards of quality and safety equivalent to the ones laid down in Directive 2004/23/EC and that imported tissues and cells can be traced from the donor to the recipient and vice versa, shall apply for an accreditation, designation, authorisation or licence as an importing tissue establishment by:(a)providing to the competent authority or authorities the required information and documentation as set out in Annex I to this Directive;(b)making available and, when requested by the competent authority or authorities, providing the documentation listed in Annex III to this Directive.2.Member States may choose to not apply the documentation requirements of Annex I, part F and Annex III to this Directive to one-off imports as defined in Article 2 of this Directive, provided they have suitable national measures in place to regulate such imports. Those national measures shall ensure the following:(a)traceability from donor to recipient and vice versa; and(b)imported tissues and cells are not applied to anyone other than their intended recipients.

Article 6Updated information1.Importing tissue establishments shall seek the prior written approval of the competent authority or authorities for any planned substantial changes to their import activities, and in particular those substantial changes described in Article 3(3), and inform the competent authority or authorities of their decision to cease their import activities in part or in full.2.Importing tissue establishments shall notify, without delay, the competent authority or authorities of any suspected or actual serious adverse events or reactions, reported to them by third country suppliers and which may influence the quality and safety of the tissues and cells they import. The information laid out in Annexes III and IV to Directive 2006/86/EC shall be included in such notifications.3.The importing tissue establishment shall notify, without delay, the competent authority or authorities of:(a)any revocation or suspension, in part or full, of a third country supplier's authorisation to export tissues and cells; and(b)any other decision taken for reasons of non-compliance by the competent authority or authorities of the country in which the third country supplier is based and which may be relevant to the quality and safety of imported tissues and cells.

Article 7Written agreements1.Importing tissue establishments shall have in place written agreements with third country suppliers where any of the activities of donation, procurement, testing, processing, preservation, storage or export to the Union of tissues and cells to be imported into the Union are carried out outside of the Union.Member States may choose to not apply this requirement to one-off imports as defined in Article 2 of this Directive, provided they have suitable national measures in place to regulate such an imports. Those national measures shall ensure the following:(a)traceability from donor to recipient and vice versa; and(b)imported tissues and cells are not applied to anyone other than their intended recipients.2.The written agreement between the importing tissue establishment and the third country supplier shall specify the quality and safety requirements to be met to ensure the equivalency of the quality and safety standards of the tissues and cells to be imported with the standards laid down in Directive 2004/23/EC. In particular, the written agreement shall include, as a minimum, the contents listed in Annex IV to this Directive.3.The written agreement shall establish the right of the competent authority or authorities to inspect the activities, including the facilities, of any third country suppliers during the duration of the written agreement and for a period of 2 years following its termination.4.Importing tissue establishments shall provide copies of written agreements with third country suppliers to the competent authority or authorities as part of their application for accreditation, designation, authorisation or licensing.

Article 8Register of importing tissue establishments1.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.

CHAPTER IVFINAL PROVISIONS

Article 9Transposition1.Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive by 29 October 2016 at the latest. They shall forthwith communicate to the Commission the text of those provisions.They shall apply those provisions from 29 April 2017.When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.2.Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 10Entry into forceThis Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Article 11AddressesThis Directive is addressed to the Member States.

Done at Brussels, 8 April 2015.For the CommissionThe PresidentJean-Claude JunckerANNEX IMinimum 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 activitiesWhen applying for an accreditation, designation, authorisation or licence for the purpose of import activities, the importing tissue establishment applicant shall, unless already provided as part of previous applications for accreditation, designation, authorisation or licensing as a tissue establishment or importing tissue establishment, provide the most up-to-date information and, for part F, documentation on the following:A.General Information on the Importing Tissue Establishment (ITE)1.Name of the ITE (Company name).2.Visiting address of the ITE.3.Postal address of the ITE (if different).4.Status of the applicant ITE: It should be indicated if this is the first application for accreditation, designation, authorisation or licensing as an ITE or, where applicable, whether this is a renewal application. Where the applicant is already accredited, designated, authorised or licensed as a tissue establishment, the TE compendium code should be provided.5.Name of the applying unit (if different from the company name).6.Visiting address of the applying unit.7.Postal address of the applying unit (if different).8.Name of the site of reception of imports (if different from the company name and applying unit).9.Visiting address of the site of reception.10.Postal address of the site of reception (if different).B.Contact Details for the Application1.Name of contact person for the application.2.Telephone number.3.E-mail address.4.Name of Responsible Person (if different from contact person).5.Telephone number.6.E-mail address.7.URL of ITE website (if available).C.Details of Tissues and Cells to be Imported1.A list of the types of tissues and cells to be imported, including one-off imports of specific types of tissues or cells.2.The product name (where applicable, in accordance with the EU generic list) of all types of tissues and cells to be imported.3.The trade name (if different to the product name) of all types of tissues and cells to be imported.4.The name of the third country supplier for each type of tissue and cell to be imported.D.Location of Activities1.A list specifying which of the activities of donation, procurement, testing, processing, preservation or storage are carried out prior to import by the third country supplier per type of tissue or cell.2.A list specifying which of the activities of donation, procurement, testing, processing, preservation or storage are carried out prior to import by sub-contractors of the third country supplier per type of tissue or cell.3.A list of all activities carried out by the ITE subsequent to import per type of tissue or cell.4.The names of the third countries in which the activities prior to import take place per type of tissue or cell.E.Details of Third Country Suppliers1.Name of third country supplier(s) (company name).2.Name of contact person.3.Visiting address.4.Postal address (if different).5.Telephone number including international dialling code.6.Emergency contact number (if different)7.E-mail address.F.Documentation to Accompany the Application1.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.ANNEX IICertificate of Accreditation, Designation, Authorisation or Licence to be issued by the competent authority or authorities to importing tissue establishments 32015L0566_en_img_1

ANNEX IIIMinimum 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 countriesWith the exception of one-off imports as defined in Article 2 of this Directive which have been exempted from these documentation requirements, the applicant importing tissue establishment shall make available and, unless already provided as part of previous applications for accreditation, designation, authorisation or licensing as an importing tissue establishment or tissue establishment, shall provide when requested by the competent authority or authorities the most up-to-date version of the following documents regarding the applicant and its third country supplier(s).A.Documentation relating to the importing tissue establishment1.A job description of the Responsible Person and details of his/her relevant qualifications and training record as laid down in Directive 2004/23/EC;2.A copy of the primary label, repackage label, external package and transport container;3.A list of relevant and up-to-date versions of standard operating procedures (SOPs) relating to the establishment's import activities including SOPs on applying the Single European Code, reception and storage of imported tissues and cells at the importing tissue establishment, management of adverse events and reactions, management of recalls and traceability from donor to recipient.B.Documentation relating to the third country supplier or suppliers1.A detailed description of the criteria used for donor identification and evaluation, information provided to the donor or donor family, how consent is obtained from the donor or donor family and whether the donation was voluntary and unpaid or not;2.Detailed information on the testing centre(s) used by third country suppliers and the tests performed by such centres;3.Detailed information on the methods used during the processing of the tissues and cells including details of the validation for the critical processing procedure;4.A detailed description of the facilities, critical equipment and materials and criteria used for quality control and control of the environment for each activity carried out by the third country supplier;5.Detailed information on the conditions for release of tissues and cells by the third country supplier or suppliers;6.Details of any sub-contractors used by the third country suppliers including the name, location and activity undertaken;7.A summary of the most recent inspection of the third country supplier by the third country competent authority or authorities including the date of the inspection, type of inspection and main conclusions;8.A summary of the most recent audit of the third country supplier carried out by, or on behalf of, the importing tissue establishment;9.Any relevant national or international accreditation.ANNEX IVMinimum requirements concerning the contents of written agreements between importing tissue establishments and their third country suppliersWith the exception of one-off imports as defined in Article 2 of this Directive which have been exempted from these requirements, the written agreement between the importing tissue establishment and the third country supplier shall contain at least the following provisions.1.Detailed information on the specifications of the importing tissue establishment aimed at ensuring that the quality and safety standards laid down in Directive 2004/23/EC are met and the mutually agreed roles and responsibilities of both parties in ensuring that imported tissues and cells are of equivalent standards of quality and safety;2.A clause ensuring that the third country supplier provides the information set out in Annex III B to this Directive to the importing tissue establishment;3.A clause ensuring that the third country supplier informs the importing tissue establishment of any suspected or actual serious adverse events or reactions which may influence the quality and safety of tissues and cells imported or to be imported by the importing tissue establishment;4.A clause ensuring that the third country supplier informs the importing tissue establishment of any substantial changes to its activities, including any revocation or suspension, in part or in full, of its authorisation to export tissue and cells or other such decisions of non-compliance by the third country competent authority or authorities, which may influence the quality and safety of tissues and cells imported or to be imported by the importing tissue establishment;5.A clause guaranteeing the competent authority or authorities the right to inspect the activities of the third country supplier, including on-site inspections, should it wish to do so as part of its inspection of the importing tissue establishment. The clause should also guarantee the importing tissue establishment the right to regularly audit its third country supplier;6.The agreed conditions to be met for the transport of tissues and cells between the third country supplier and importing tissue establishment;7.A clause ensuring that donor records relating to imported tissues and cells are kept by the third country supplier or its sub-contractor, in line with EU data protection rules, for 30 years following procurement and that suitable provision is made for their retention should the third country supplier cease to operate;8.Provisions for the regular review and, where necessary, revision of the written agreement including in order to reflect any changes in the requirements of the EU quality and safety standards laid out in Directive 2004/23/EC;9.A list of all standard operating procedures of the third country supplier relating to the quality and safety of imported tissues and cells and a commitment to provide these on request.

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