A simplified approach for the registration of medicines in small European countries

Abstract

Introduction: A medicine requires a marketing authorisation (MA) before being made available on the European market as specified in Directive 2001/83/EC to ensure its safety, quality and efficacy. The requirements to obtain a MA are complex and may adversely influence accessibility to medicines. The aim was to compile a guide intended to simplify the process for registration of medicines in Malta and other small EU countries. Methods: Functions of regulatory bodies, committees and organisations and legislation related to the registration of medicines were reviewed. Semi-structured interviews with two qualified persons and eight responsible persons from ten pharmaceutical companies with the largest number of medicines-licensed on the Maltese market were conducted to identify challenges encountered regarding the registration of medicines. A guide on the registration procedure of medicines was designed in booklet format and as an online version, validated and disseminated. Results: The main challenges encountered to register a product in Malta identified in the interviews were the availability of medicine packs in the English language (10 interviewees), obtaining regulatory support from the MA holder (7 interviewees) and delays in the evaluation process due to missing or incorrect information (6 interviewees). The compiled guide describes National and European MA procedures and post-authorisation requirements, and provides information on the MA application procedures. Conclusion: The compiled guide is intended to simplify the process for the registration of medicines. By preparing a simplified approach and clearly indicating national procedures required to apply for a MA, the opportunity to support access to medicines within small markets is presented.