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National / MRP / DCP

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.

The National Route

A National Marketing Authorisation (MA) is a licence to market a product in an individual EU member state.  Due to the advent of procedures such as the Decentralised and Centralised Procedures, which allow registration across the community, the number of national submissions has declined over the years.

Mutual Recognition Procedure   

Once a national application has been approved in a Member State, further national submissions in subsequent Member States are not possible.  To gain approval in other member states the Mutual Recognition Procedure (MRP) must be used.  MRP is a 90 procedure (no ‘clock stops’ are allowed) during which the recipients of the applications are asked to ‘recognise’ the positive opinion of the member state that granted the first (National) MA.  This procedure results in a series of national MAs.

Why is the National Route still important?

Despite the advent of multi-member state procedures, the National route is still important in certain circumstances for companies wishing to:

  • Launch in one market only (smaller/local companies)
  • ‘Test the market’ in one country only before going for Mutual Recognition
  • Launch a niche product for a particular member state
  • Sort out contentious issues (pre MRP) that could arise during assessment
  • Prompt an overseas site inspection (e.g. GMP inspection of a manufacturing site)

Legislation

Although all EU Member states have to abide by EU Regulations and Directives, very often at the National level countries have their own individual dossier and submission requirements.  Such information is published by the Member States on their websites (1). However, in some cases information is incomplete, out of date and / or only available in the local language. Thus, advice from locally based regulatory professionals is a must to ensure that all National requirements are fully met.

Our Services

For National applications

We can advise you on the best route to market for your product and manage a National Procedure from start to end in any Member State through the support of our tried and tested  EU associate network.

For any country we can:

  • Undertake the necessary National Health Authority liaison activities (pre-submission, during assessment and post-approval)
  • Prepare dossiers to local requirements in the correct format (NeeS or eCTD)
  • Provide necessary translations
  • Provide local personnel to fulfil National requirements (e.g. Local Safety Officers, ‘Exploitant,’ Medical Information etc)
  • Support your supply chain (identify distributors, batch release sites, provide Pricing and Reimbursement information etc)
  • Support your application post approval (variations and renewals)

For MRP

As for DCP - see below. CambReg can assist with any aspect of the procedure from start to finish.

Our experience can help you

Numerous successful National Licences obtained for many returning clients over the years, makes CambReg the optimum service provider in this area

The combined MRP experience of the whole CambReg team, of over 30 procedures (all with successful outcome), allows you to put your trust in us

Decentralised Procedure

The CambReg team is highly experienced in this area, running several DCPs in tandem on a regular basis, and has become the service provider of choice for a whole host of Mumbai based companies

Work with us for:

  • Competitive Pricing
    Having 8 years of experience we know which corners are safe to cut and which areas are worthy of special attention resulting in the best value for money service.
  • EU wide Service 
    With associates in every EU member state we can provide you with a truly pan European service.  If you want to use your distributors to carry out local activities we can train and audit them.  If you prefer we can take care of the whole process 
  • Speedy granting of  MAs

What is DCP

The Decentralised Procedure is a means of obtaining Marketing Authorisations in two or more EU member states simultaneously.

In order to be eligible for the Decentralised Procedure, the applicant must not hold a licence for the product in question in any EU member state. If such a licence already exists, the Mutual Recognition Procedure can be used to achieve the desired market presence in further countries.

The Decentralised Procedure follows tight timelines and is characterised by close coordination between the Health Authorities of the participating Member States. It is the principle route to market for generic products

Legal Framework within the EU

Chapter 4 of EU Directive 2001/83/EC as amended describes the procedure

National laws with regard to labelling and reimbursement also need to be followed

Why would you choose the Decentralised Procedure?

  • If you want to apply for a Marketing Authorisations in several EU countries at the same time and do not have the product registered any where else in the EU
  • If your product is not eligible for - or required to use - the Centralised Procedure

Benefits of CambReg’s Service

Our experience

We have run numerous DCPs (5- 8 per year) , gaining registration in any number of EU Member States from 2 to 27.  The time frame from submission to grant of the Marketing Authorisations can vary from 10 – 20 months. Companies that enjoy a rapid grant of MAs using this route are those that take advantage of our Gap Analysis service – see below

What we offer

CambReg can manage your Decentralised Procedure from start to end. Besides providing legal and procedural advice at all stages of the procedure we can also review your submission documents to identify points where compliance with requirements can be improved. This will save valuable time during the procedure and increase your chances for a successful outcome.

Our good working relationship with Health Authorities around Europe and our network of associates in the EU member states will facilitate the speedy and efficient completion of the authorisation process, from DCP slot booking to the end of the national phase of the procedure.

We can also equip you with access to quality, clinical and pre-clinical experts and take care of your User Testing and Pharmacovigilance needs.

We can provide you with a tailored package that addresses all your DCP requirements.

Additional Services (please also see entry to EU page)

Company set up

Slot Booking

Interim MA holder

Pre Inspection Audit

Provision of address for Batch Release site

Distribution

 

References

Table 1: Regulatory requirements and considerations for international markets

  1. The Heads of Medicines Agencies website http://www.hma.eu/index.html