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THE PHARMA REVIEW (MAY JUNE 2018)

Certificate of Suitability as a Contributory Document for the Registration of Medicinal Product in European Union and in Australia, New Zealand, South Africa, Canada

Devnani Jaya1, Maji K Jayanta2, Chokshi Nirav3 & Mehta J Priti*

Introduction: Certification of Suitability to the monographs of the European Pharmacopoeia come into force by European Directorate for the Quality of Medicines & HealthCare with respected to controlling the chemical purity of pharmaceutical substances along with addition of a risk of transmissible spongiform encephalopathy (TSE) and an inspection programmed for manufacturing site was also incorporated. The most tentative new applicant has the option to file Certificate of suitability or active substance master file in Europe for the registration of drug substance. CEP ensures that all the possible impurities from the drug substance manufacturing route can be control by European pharmacopoeia. It is not mandatory but act as an importance document by reducing compilation and approval time. Transparency of the certificate procedure and the monographs make the European pharmacopoeia extremely important in the registration of the medicines in European countries as well as other countries like Australia, New Zealand, South Africa, Canada etc.

 

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