Updated information
Article 6
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.