Marketing Authorization Applications
There are a number of possibilities, and also bindings on how a Marketing Authorization can be granted in one or more Member States of the European Economic Area.
National procedures can be suitable for companies with one-country market presence or as a first step of penetration into the European Market, as well as for well established use herbal medicines.
Mutual Recognition Procedures (MRPs) are used to widen the market for a product already authorized by one Member State (i.e. in a previous national procedure); and are also triggered by Competent Authorities when such a product is submitted for a second national procedure in another Member State (typically in relation to license-in or -out activities not prepared carefully).
The Decentralized Procedure (DCP) is the suitable registration alternative for products intended for concomitant marketing in multiple Member States.
The Centralized Procedure provides a possibility to obtain an EU-wide authorization to market a medicinal product, and is obligatorily to be followed for several categories of pharmaceutical products.
AccepTher can advise its clients on the most suitable registration strategy for their products. Upon experience in National, Mutual Recognition and Decentralized Procedures we support companies in preparing and/or reviewing the documentation needed, submission of their Marketing Authorization Applications, as well as in answering regulatory questions during these procedures, either by representing them towards Competent Authorities, or in liaison with their Regulatory staff.