CRED Managing Variations Effectively

Article 5 Recommendations

Aim of Article 5: To provide advice on classification of unforeseen variations in a harmonised way across EU ● If not already listed, MAH/MS can request a recommendation on unforeseen category from CMDh or EMA: – Official Article 5 request, via specific procedure: Agency can take up to 45 days to assess category – TIP: Template for request available from CMDh and EMA – No appeal process and publically published – Can be used to apply to products with same change – Go to CMDh or EMA website for published recommendations: CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008 (March 2017) http://www.hma.eu/