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Centralised
Centralised Procedure (CP)
The Centralised Procedure essentially allows applicants to obtain a single Marketing Authorisation that is valid throughout the EU. This involves submitting an application directly to the European Medicines Agency (EMA) where it is assessed by the Committee for Medicinal Products for Human Use (CHMP).
Who uses the Centralised Procedure?
Compulsory for:
- Products manufactured using biotechnological processes
- Orphan medicinal products
- New active substances which are intended for the treatment of AIDS, cancer, neurodegenerative disorders, diabetes, auto-immune diseases and other immune dysfunctions and viral diseases
- imilar biological (“biosimilar”) medicinal products
Optional for:
- Innovative new active substances which are not for the conditions listed above
- Generic applications of products previously authorised via the Centralised Procedure
Choose CambReg to manage your CP
Our experience with EMA /Centralised Procedures includes:
- Being the integral part of key teams for several full MAA applications
- Project managing the regulatory process for orphan drugs; from Orphan Drug Designation, through to CHM review and then MAA stage
- Preparing and managing CHM appeals
Our Services
The CambReg Team love the challenge of providing support for products submitted via the Centralised Procedure. Projects of this nature are both rewarding and exciting. Through our many successful Centralised Applications we have identified that the key to a successful application is having the correct team in place with the right skill mix, early planning, awareness of ‘what is possible’ as well as a thorough knowledge of dossier and procedural requirements
At CambReg we can provide the full range of support including:
- Providing strategic advice on the legal basis of your application
- Preparing and submitting your Eligibility Application for the Centralised Procedure
- Investigating the need for Scientific Advice
- Exploring avenues to expedite the route to market for your product
- Setting up expert teams to support your application
- Undertaking the necessary EMA liaison activities throughout the procedure
- Preparing your dossier in the correct format
- Reviewing your data package (‘gap analysis’)
- Supporting your application post approval (variations and renewals)