All medicinal products need to obtain a Marketing Authorisation (MA) before they can be placed on the market. The Marketing Authorisation certifies that the product meets the required standards of safety, quality and efficacy.
There are four routes to gaining a Marketing Authorisation in the EU - the route you take will be dependent upon your products' active ingredient, your intended market and regulatory strategy.
- Centralised Procedure (CP)
- Mutual Recognition Procedure (MRP)
- National Procedure (NP)
- Decentralised Procedure (DCP).
Considerable time and costs are associated with Marketing Authorisation Applications so it is important that you choose the optimal application route and your dossiers are accurate and compliant before submission to the Regulatory Agencies. TRAC can compile and submit Marketing Authorisation dossiers in either eCTD or NeeS format.
TRAC has a wealth of experience across all four procedures and can provide regulatory support and guidance throughout the application's lifespan, ensuring that your product will reach the market as quickly as possible and stay there.
We also have extensive experience in Post Marketing maintenance, maintaining your product by conducting license transfers, variations, renewal applications, reclassification of medicines and Periodic Safety Update Reports (PSURs) to ensure that your product continues to meet the necessary standards of safety, efficacy and quality.
Download our free guide to obtaining Marketing Authorisations for your products. This document will help you understand the various routes to market that are available and decide what the best option for your product is. If you have any further questions regarding Marketing Authorisation Applications please Contact Us.
Graham Donaldson
Senior Regulatory Affairs Executive
Guide: Obtaining Marketing Authorisations
This guide, as well as other information can be downloaded from our download centre.