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.
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.
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.
Despite the advent of multi-member state procedures, the National route is still important in certain circumstances for companies wishing to:
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 However, in some cases information is incomplete, out of date and / or only available in the local language.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.
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:
As for DCP - see below. CambReg can assist with any aspect of the procedure from start to finish.
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
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
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
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
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 provide you with a tailored package that addresses all your DCP requirements.
Company set up
Interim MA holder
Pre Inspection Audit
Provision of address for Batch Release site
Table 1: Regulatory requirements and considerations for international markets