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S.L. 483.7 · Information Procedures For The (S.L. 483.7)

S.L. 483.7 Art. 10Interconnection between Member States.

In KraftAmtlicher Text

(1) The Licensing Authority shall communicate to the

Commission its contact details or those of the delegated bodies to which the relevant information shall be transmitted for the purpose of, on the one hand, regulation 6, and, on the other hand, regulations 7 and 8. These contact details shall include at least the following data: the organisation’s name, telephone number, e-mail address, fax number and postal address.

(2) The Licensing Authority or the delegated bodies shall ensure that the information received by one of them pursuant to regulations 6, 7 or 8 is forwarded to the Licensing Authority or delegated body at national level, in accordance with the repartition of competences.

(3) The Licensing Authority shall be responsible for updating the information related to the competent authorities and delegated bodies designated by it in the list made available by the Commission or any third party entrusted by it to establish and maintain the list updated. INTENDED FOR TRANSPLANTATION [

SCHEDULE I Initial Report for suspected serious adverse events or reactions