HMA: Variation Procedure

HMA: Variation Procedure:

• BPG CMD(h) recommendations on unforeseen variations;
• Flow Chart for Recommendations on unforeseen variations - Request to CMD(h);
• Timetables for resquest to CMD(h) for a recommendation on the classification of an unforeseen variation - Article 5 of Commission Regulation (EC) No. 1234/2008;
• Template: Request form to CMD(h)/CMD(v)/EMEA for a recommendation on the classification on unforeseen variation under Article 5.