European Procedures

There are now four possible routes to authorisation of products within Europe, largely dependent upon the type of product to be authorised. The choice of procedure for your particular product should be one of the key factors that are considered when you are devising your Regulatory strategy, long before the actual submission date. There will be many drivers and options for considerations before that decision can be made. Even if your product is mandated to use the Centralised Procedure, you will need to understand the procedure, consider how best to liaise with the authorities, what options are available for dialogue, timelines and many more factors.

• Providing full assistance and advice on all European procedures national, Mutual Recognition, Decentralised, Centralised drawing from experience of these
• Assistance in seeking Scientific Advice as required
• Support from submission, throughout the chosen procedure to final Marketing Authorisation
• Liaison with Regulatory Authorities on your behalf
• Strategic input into the choice of procedure for your product
• Review of potential options such as orphan drug, accelerated review, exceptional circumstances, options for small and medium sized enterprises (SMEs)