Procedural advice on the certification of quality and non-clinical data for small and medium sized enterprises developing advanced therapy medicinal products


Article 18 of Regulation (EC) No 1394/20071 provides that Small and Medium-sized Enterprises (SMEs) developing an Advanced Therapy Medicinal Product (ATMP) may submit to the European Medicines Agency (EMA) all relevant quality and, where available, non-clinical data required in accordance with modules 3 and 4 of Annex I to Directive 2001/83/EC2 (as amended) on the Community code relating to medicinal products for human use, for scientific evaluation and certification.