CHAPTER IINATIONAL REFERENCE LABORATORIES

Article 8Duties and tasks of rapporteur laboratories

The rapporteur laboratories shall be responsible for:

  1. (a)

    drafting an initial evaluation report concerning the data submitted in each application and submitting it for comments to the other laboratories;

  2. (b)

    compiling the comments received from the other laboratories and preparing a revised evaluation report;

  3. (c)

    submitting the revised evaluation report to the CRL in sufficient time to allow the CRL to submit its full evaluation report to the Authority within the deadline referred to in Article 5(1).