EMEA – SME Scheme Reminder
This guide has been prepared for micro, small and medium-sized enterprises (SMEs) operating in the pharmaceutical sector. Its aim is to facilitate understanding of the main aspects of medicinal product legislation. The guide is structured to follow the chronological stages of developing a medicinal product. An overview of the scientific data requirements for obtaining a marketing authorisation in the European Union (EU) is provided. The regulatory procedures in place to optimise development and obtain an EU marketing authorisation are also summarised.
The guide focuses primarily on the requirements for authorising innovative medicinal products for human or veterinary use. The guide is not intended to be an exhaustive document but rather to raise SMEs’ awareness of the various more detailed sources of information available, with links throughout the text to additional information.
In December 2005, Commission Regulation (EC) No 2049/20051 introduced provisions aimed at promoting innovation and the development of new medicinal products for human and veterinary use by SMEs. This guide is intended to fulfil the obligation laid down in Article 12 of that Regulation, which calls for a ‘User Guide’ on the administrative and procedural aspects of medicines legislation that are of particular relevance to smaller companies to be published by the European Medicines Agency (EMEA).
Pursuant to the SME regulation, companies can access financial assistance (in the form of fee reductions and fee deferrals) and administrative assistance from the agency, details of which are outlined in Section 2 of this guide. To facilitate contact with the agency, an ‘SME Office’ was launched in December 2005 and is dedicated to addressing the particular needs of smaller companies.
If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
