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.
Our services in the area of marketing authorisations for medicinal products
orangeglobal’s Centre of Competence (CoC) Regulatory Affairs supports you before, during and after the approval of your medicinal products.The interdisciplinary cooperation and expertise of the CoC in the individual processes ensure acceptance of your documents by the authorities.
1. Management of marketing authorisation applications
- Consultancy services and strategy planning for all types of regulatory submission procedures and applications all over the world
- Scientific advice
- Regulatory intelligence
- Regulatory information management
- Regulatory due diligence
- In-licensing and transfer of the marketing authorisation
- Data management in accordance with xEVMPD or the new IDMP
2. Regulatory documentation
- Compilation and revision of all necessary regulatory documents for modules 1 to 5, e.g. labelling such as SmPCs, PLs, ERAs, PIPs, summaries/overviews, EDMFs, study reports
- Creation of complete medicinal product dossiers (CTD/eCTD)
- Review of documents (4-eyes checks)
- Readability Compliance (Readability User Tests, Bridging Reports and Statements)
- Technical translations of all kinds of documents in the regulatory and clinical fields
3. Regulatory submission procedures
- Implementation of CP, DCP, MRP and NP for medicinal products
- Support in processing marketing authorisation applications
- Conformity check with regulations
- Preparation and implementation of dossier submissions to the authorities
- Communication with authorities
- Deficiency letters
4. Regulatory maintenance
- Revision and maintenance of dossiers and updates of regulatory documentation
- Variation management
- Line extensions
- Renewals
- Sunset clause
- Deregistration
- Lifecycle maintenance
- Pharmacovigilance reporting
Your benefits from obtaining marketing authorisations for medicinal products (CP, DCP, MRP, NP) with orangeglobal
This is how you benefit from the innovative solutions offered by orangeglobal:
- Increased quality and certainty
- Cost reductions through a process-oriented procedure
- Shorter time-to-market as a result of the interdisciplinary processes
- Reliable service through our DIN EN ISO 9001:2015- certified quality management system
- Inclusion of local country experts through our worldwide network
Process optimisation is one of the most effective options for minimising costs and time and achieving a very attractive ROI with customer-specific solutions.
YOUR CONTACT PERSON:
Frau Dipl. Biol. Jana Wolkow
Project Manager Regulatory Affairs
Tel. +49 (0) 731 954 95 - 511
jana.wolkow@orangeglobal.(.)de