| Submission strategies in the EU call for careful navigation in order to ascertain the appropriate legal authorisation, argues Dr Jan van der Weide at Pharmalink Consulting
CURRENT EXISTING RULINGS
Four procedures are in force that can be used for the submission of a registration dossier in order to obtain a Marketing Authorisation in the EU: 1. National Procedure (NP) 2. Mutual Recognition Procedure (MRP) 3. Decentralised Procedure (DCP) 4. Centralised Procedure (CP)
The main legislation relevant to these European procedures are:
- Council Directive 2001/83/EC
- Council Directive 2004/27/EC
- The Notice to Applicants Volume 2A Procedures for Marketing Authorisation
National Procedure
The NP can be used if the product is not registered in any member state and if the application is restricted to one member state. The official time for granting a licence is 210 days (without the clock-stop), but in reality the average is about one year. The Marketing Authorisation is then issued by the national agency.
Mutual Recognition Procedure (MRP)
The MRP has to be used if the product is already registered in a member state. The MRP can also be used for new products. The MRP starts with an NP with the chosen reference member state (RMS).
The criteria for selecting an RMS is as follows:
- Importance/size of the market within the EU
- Integrity and standing (credibility) of the RMS to enable defence of the product against other concerned member states (CMS)
- Long-term partnership
- Open to dialogue
- Respecting timelines
- Consideration of future variations
- Expertise in respective medical field
- Potential for specific up-front agreements
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