In the first three articles, we introduced the Centralized Procedure (CP), Decentralized Procedure (DCP), and Mutual Recognition Procedure (MRP) one after another. Today, we will elaborate on the fourth pathway in the EU drug registration system - the National Procedure (NP).
What is the National Procedure (NP)?
NP is a procedure independently approved by the National Competent Authority (NCA) of a single EU Member State, applicable only to medicines marketed solely within that Member State. Unlike CP, which covers the entire EU, and DCP/MRP, which involves multi-country collaboration, the approval result of NP is only valid in the approving country. It is a flexible choice for pharmaceutical companies targeting a single market.
Its core advantages lie in simplified procedures and strong pertinence, making it particularly suitable for:
- Medicines with market demand only in specific Member States (such as drugs for regional characteristic indications)
- Products that do not yet meet the mandatory requirements of CP (e.g., non-innovative drugs, non-major disease treatment drugs) and do not need to be marketed in multiple countries simultaneously
- Regional products such as traditional herbal medicines and niche specialty drugs
Core Process of NP
1. Application Submission: Submit a marketing authorization application to the NCA of the target Member State, which only needs to comply with the regulatory requirements of that country (while adhering to basic EU standards).
2. Independent Evaluation: The NCA of the country independently conducts a scientific evaluation (including safety, efficacy, quality control, etc.), and the evaluation standards and processes vary from country to country.
3. Decision and Marketing: The NCA makes an approval or rejection decision within the specified time limit (usually varying by country). Once approved, the drug can only be sold in that country.
4. Subsequent Expansion: If there are plans to enter other EU markets in the future, drugs approved through NP can be converted to MRP (Mutual Recognition Procedure) or DCP (Decentralized Procedure) to achieve marketing across Member States.
Core Requirements for eCTD Submission
The electronic submission of NP must strictly comply with unified EU norms while taking into account the characteristic requirements of each country. The core points are as follows:
1. Format Mandatory:
All new marketing authorization applications (including ASMF submissions) must use the eCTD format, which needs to comply with the EU eCTD v3.2 standard and supplementary requirements of NCAs of various countries.
2. Submission Channels:
-Priority is given to submission through CESP (Common European Submission Portal)
- Some Member States still accept CD/DVD, but only one submission method can be chosen (CESP and CD/DVD cannot be used simultaneously)
3. Product Information Specifications:
- The Word format files of product information must be placed in a separate folder "xxxx-workingdocuments" (in the same path as eCTD).
4. Signature and Identity Verification:
Different Member States have significantly different requirements for signatures:
- Some countries (such as the Czech Republic and Denmark) only require CESP login credentials
- Some countries (such as Belgium and Greece) require additional simple electronic signatures (scanned copies), advanced electronic signatures (such as Adobe PDF signatures) or qualified electronic signatures (certified advanced signatures). For details, please refer to the guidelines of the target country's NCA.
Connection with Other Procedures
Drugs approved through NP can seamlessly transition to MRP (Mutual Recognition Procedure) or DCP (Decentralized Procedure) if there are plans to expand into other EU Member States in the future. There is no need for repeated full evaluations, and only cross-member coordination based on the original NP data is required.
As a professional institution specializing in global drug registration, Beijing BrilliantMed Pharma Tech Co.,Ltd. can provide full-process support for NP: from interpreting the regulations of the target country, preparing eCTD documents (in line with Word & PDF format and signature requirements), electronic submission (CESP/EMA Gateway/CD/DVD) to communication and coordination with NCAs, helping enterprises efficiently layout in a single EU market.
So far, all four procedures for EU drug registration have been explained. From full EU coverage to single markets, from innovative drugs to regional characteristic products, enterprises can flexibly choose according to product characteristics and market strategies. If you need a customized registration plan, please feel free to contact us!
