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Centralised Procedure

Europe’s Regulatory Procedures:

To be able to market a medicinal product in the European Union a Marketing Authorisation (MA) must be obtained for each product. There are four ways to achieve registration for your products:

Cambridge Regulatory Services has been guiding companies through these procedures since their inception, advising which procedure is the right one on a product by product basis and unlocking the doors to Europe

Centralised Procedure (CP)

The Centralised Procedure essentially allows applicants to obtain a 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).

Choose CambReg to manage your CP

Our experience with EMA /Centralised Procedures is extensive and 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

Legislation

The Centralised Procedure came into operation in 1995 and is legislated for by Regulation (EC) No 726/2004) (1).

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

  • Similar biological (“biosimilar”) medicinal products

Optional for:

  • Innovotive New active substances

  • Generic applications of products previously authorised via the Centralised Procedure

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 rage of support including:

  • Providing strategic advice on the route 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
  • Exploring avenues to reduce fees
  • Undertaking the necessary EMA liaison activities throughout the procedure
  • Preparing your dossier in the correct format (eCTD)
  • Reviewing your dossier (‘gap analysis’)
  • Supporting your application post approval (variations and renewals)

Our experience can help you

One of the main advantages that CambReg has over other consultants is that its key staff have had numerous years’ experience in the regulatory arena working, some within the EU Health Authorities. In addition, as a result of CambReg’s work with other clients, it has a good working relationship with the EMA, UK, Irish, Swedish and Danish CHM members. Through CambReg’s network of EU associates it can also obtain informal advice and meetings with CHM members from all other Member States.

We have a unique insight into not only what our client needs in terms of how a project is managed but excellent working relationships with major health bodies within the EU.

With plenty of success in this area, CambReg truly is the service provider of choice for your Centralised Application.

References 1: Regulatory requirements and considerations for international markets