New ECHAMP position: Suppliers of raw materials
24 Apr 2015
ECHAMP’s new position paper justifies the practice of manufacturers of homeopathic medicinal products not to fix suppliers of certain raw materials in registration dossiers for these products.
A national medicines agency recently requested manufacturers to indicate each supplier of raw materials in a registration dossier for a homeopathic medicinal product. ECHAMP’s paper outlines from a scientific and regulatory perspective why this is not practical, feasible or desirable for manufacturers of homeopathic medicinal products, explaining why flexibility of supplier is essential to guarantee quality and availability of these products.
Manufacturers who are members of ECHAMP are Good Manufacturing Practice (GMP) certified companies. Quality of raw materials, stocks, intermediates and the final products is ensured through internal quality control procedures and by qualifying all suppliers, main or alternative. Periodic audits by the respective authority of each Member State ensure compliance with the requirements.