Abstract – EMA has a 25-year track record of ensuring efficacy and safety of human and veterinary medicines across Europe, and promoting research and innovation in the development of medicines. The article states requirement of Marketing Authorization Application to get registration of drug product to EEA region. The procedures for application of marketing authorization are – Centralized Procedure, National Procedure, Mutual Recognition Procedure and Decentralized Procedure. EDQM the European Medicines Agency (EMA) works with the European Directorate for the Quality of Medicines and HealthCare (EDQM), a directorate of the Council of Europe. The EDQM traces its origins and statutes to a European treaty promoting the elaboration of a common pharmacopoeia in Europe. The EMA and the EDQM cooperate on matters aimed at ensuring the quality of medicines and protection of public health.¹The Certification of Suitability (CEP) is a certificate that certifies compliance of the active pharmaceutical ingredients (API) or pharmaceutical ingredients with that of the rules laid down in the monograph of the European Pharmacopoeia (EP). CEP should consist of an explicit description of the chemical composition of the substances. The manufacturer should provide evidence that the quality of the substance is controlled by the monographs of the EP and is granted by Certification Secretariat of the European Directorate for the Quality of Medicines (EDQM). The CEP also helps to bridge the gap between health authorities and industries, providing an added advantage for API manufacturers to enter the EU market. This article focuses on different registration procedures in Europe along with variations and renewal of drugs. It also gives an outline of CEP (Reading, Types, Suspension and Renewal)