This aim of present work to understand the requirements for preparation and compilation of dossier for prescription drugs (Generics) in United Kingdom (UK) and also to facilitate a brief overview of Marketing Authorisation procedures in UK. Medicines and Health products Regulatory Agency (MHRA) is the Regulatory Agency in UK. A license, also referred to as a Marketing Authorisation, from the MHRA is required before any medicine can be used to treat people in the UK. Once the MHRA is satisfied that the medicine works as it should, and that it is acceptably safe, it is given a Marketing Authorisation or product license. There are four types of procedures that applicants can take to obtain a Marketing Authorisation. To get a Marketing Authorisation in UK the applicant may choose any one of the four procedures those are Centralised Procedure (CP), National Procedure (NP), Decentralised Procedure (DCP) and Mutual Recognition Procedure (MRP). In these procedures the Centralized Procedure is mandatory for certain types of medicines and optional for others. To get a Marketing Authorisation in UK the generic manufacturer should provide quality data, bioequivalence with EU reference product and applicable Clinical and Non- Clinical reports in CTD/eCTD format. Under the medicines legislation which was implemented on the 30 October 2005, Marketing Authorisations are be valid for five years and then may be renewed on the basis of a re-evaluation of the risk-benefit balance.
