Inspections and other control measures
Article 4
1. 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.