Applications for accreditation, designation, authorisation or licensing as an importing tissue establishment
1. 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.
Updated information
1. 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.
Written agreements
1. 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.
Register of importing tissue establishments
1. 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.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
