CHAPTER II

OBLIGATIONS ON MEMBER STATES' AUTHORITIES

Import/export of human tissues and cells
Article 9
1
Member States shall take all necessary measures to ensure that all imports of tissues and cells from third countries are undertaken by tissue establishments accredited, designated, authorised or licensed for the purpose of those activities, and that imported tissues and cells can be traced from the donor to the recipient and vice versa in accordance with the procedures referred to in Article 8. Member States and tissue establishments that receive such imports from third countries shall ensure that they meet standards of quality and safety equivalent to the ones laid down in this Directive.
2
Member States shall take all necessary measures to ensure that all exports of tissues and cells to third countries are undertaken by tissue establishments accredited, designated, authorised or licensed for the purpose of those activities. Those Member States that send such exports to third countries shall ensure that the exports comply with the requirements of this Directive.
3
a
The import or export of tissues and cells referred to in Article 6(5) may be authorised directly by the competent authority or authorities.
b
In case of emergency, the import or export of certain tissues and cells may be authorised directly by the competent authority or authorities.
c
The competent authority or authorities shall take all necessary measures to ensure that imports and exports of tissues and cells referred to in subparagraphs (a) and (b) meet quality and safety standards equivalent to those laid down in this Directive.
4
The procedures for verifying the equivalent standards of quality and safety in accordance with paragraph 1 shall be established by the Commission Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 29(3).
Substituted by Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny Adaptation to the regulatory procedure with scrutiny — Part Four.