Sunday , 19 May 2024

Registration of Drug Products in European Market and their Marketing Authorization Application

Kandula Pavani*, Yarra Sai Phanindra, Pachigolla Naga Sravani, Doonaboyina Ragava, Kavala Nageswara Rao
Department of Pharmaceutical Drug Regulatory Affairs, K.G.R.L College of Pharmacy, Bhimavaram-534201, Andhra Pradesh, India

ABSTRACT
European Union has different types of registration procedures for different types ofdrugs following which the drug may be registered in the Entire EU i.e., Centralized Procedure.The drug may be registered in one of the EU member countries and needs registration in other country but is not eligible for Centralized Procedure then Decentralized procedure is used. Then there is Mutual Recognition Procedure in which the drug is registered in Concerned Member State (CMS) other than the Reference Member State (RMS) where the drug is previouslyapproved. In orderto get the drug approved in onlyone Member Country, there is Nationalized Procedure.EU has different types ofprocedure and different types ofapplications which will specifythe product and time framerequired for theapprovalofthedrug which helps intracking oflifeof the respective product. Inkeeping witheffortsto rationalize and harmonies the regulations of medicinal product, EU established standardize specifications for the medicinal product. The retaining of the current marketing authorization systems, DCP together with scope of CP provide a great flexibility of the choice between different marketing authorization and also allowed to go for the national application of medicinal product.

Keywords: EU, EMA, EMEA,EMU, WHO,MAH, MA

Scroll To Top