Navigating the European regulatory landscape can be complex, especially when seeking approval for medicinal products across multiple countries. Two key procedures streamline this process: Decentralized Procedure (DCP) and Mutual Recognition Procedure (MRP). While both facilitate multi-country approvals, understanding their differences is essential for strategic regulatory planning.
Decentralized Procedure (DCP)
DCP is the go-to pathway for products that have not been previously approved in any EU/EEA country. It enables simultaneous submission and evaluation in multiple Member States, with one country acting as the Reference Member State (RMS) and others as Concerned Member States (CMSs).
Key Advantages:
- Enables parallel assessment in multiple EU countries.
- Offers a structured 210-day timeline, ensuring predictability.
- Ensures harmonized approval, avoiding fragmented national decisions.
Challenges:
- Requires careful selection of RMS, as their assessment influences CMS decisions.
- Potential delays if CMSs raise objections, leading to further discussions or referrals.
- High administrative burden, as all agencies must align.
Mutual Recognition Procedure (MRP)
MRP is used when a product is already approved in at least one EEA country and the company wants to expand that approval to other markets. The existing approval serves as the basis for recognition by additional Member States.
Key Advantages:
- Faster than DCP, leveraging an existing national approval.
- Reduces regulatory effort, as the RMS has already reviewed the dossier.
- Ideal for line extensions or expanding to new markets.
Challenges:
- RMS dependency – If there are issues with the original approval, they impact MRP.
- CMS disagreements may lead to arbitration or referral to CMDh, causing delays.
- Not applicable for new products – It requires prior national approval.
Which One Should You Choose?
- DCP if your product has never been approved in the EU and you seek multi-country authorization.
- MRP if your product already has national approval in one EEA country and you want to extend its reach.
Both procedures require strategic planning, strong regulatory engagement, and clear communication with authorities to ensure success.
Read also:
- Legal Basis for Marketing Authorization in the EEA
- Key Insights on Post-Approval Regulatory Requirements | EU vs. US
Resource Person: Pratik Pawar