orangeglobal - your specialist for marketing authorisations of medicinal products
Before a medicinal product can be brought to market for the first time it must undergo a special regulatory submission and approval procedure, whether for national or international registration. Regulatory submission and approval management is a complex field and particularly inhomogeneous outside of the European Union. Regulatory requirements are also subject to constant change and are becoming increasingly extensive all the time.
Hardly any companies manage to keep their bearings in the choppy waters of laws, ordinances and directives without assistance when submitting their products for registration. At the same time, an optimal regulatory strategy for medicinal products is also becoming increasingly important. The reason for this is globalisation and the imperative it brings with it to position and market new medicinal products in Europe and around the world as quickly as humanly possible.
orangeglobal is able to guide your medicinal products cost-effectively along the path of registration in the target countries by virtue of its many years of expertise in the registration of medicinal products and the process-compliant fulfilment of statutory and official requirements.
Overview of the registration and approval procedures for medicinal products (CP, DCP, MRP, NP)
Marketing authorisation for medicinal products can be obtained in the EU either by the centralised procedure or by a non-centralised procedure:
The centralised procedure for medicinal products (CP)
enables the applicant to obtain marketing authorisation for a medicinal product in the European Economic Area (EU members, Iceland and Norway) with a single application. All marketing authorisation applications and their scientific evaluation are coordinated by the European Medicines Agency (EMA) in London.
The decentralised procedure (DCP) and
the mutual recognition procedure (MRP)
In these procedures, marketing authorisations for medicinal products are applied for in several EU Member States, with one country acting as the Reference Member State (RMS) for the marketing authorisation concerned. If the application is successful, the medicinal product is authorised for marketing in the RMS and the other countries involved, known as the Concerned Member States (CMS).
Separate national procedures (NP) are confined exclusively to medicinal products that are to be authorised by the national regulatory authorities for medicinal products, such as MHRA, BfArM, ANSM, DKMA, HALMED, AFMPS, AIFA, ZVA, ŠÚKL, etc., and marketed in one European Member State (MS) only.
