Entering the EU pharmaceutical market typically raises a set of practical questions: which authorisation procedure to choose, what needs to be in place before submission, and how long the process will take in reality.
This Q&A addresses the most common questions related to applying for a new marketing authorisation (MA) in the European Union and helps clarify what is required in practice before submission.
What is a marketing authorisation in the EU?
A marketing authorisation is a regulatory approval required before a medicinal product can be sold and distributed within the EU. Without it, a pharmaceutical product cannot legally be placed on the market. It is granted based on dossier (CTD format), where authorities assess quality (CMC), safety (non-clinical data) and efficacy (clinical data).
The application must demonstrate that the benefit–risk balance is positive for the intended indication. The approved dossier then forms the legal basis for the product, meaning all future changes must remain consistent with the authorised documentation.
See also: How to obtain a marketing authorisation in the EU
What makes the EU market challenging for new products?
While the regulatory framework is harmonised, practical implementation is fragmented. Companies must manage:
- multiple regulatory procedures (CP, DCP, MRP, national)
- different authority expectations between member states
- parallel national processes for pricing, reimbursement and market access
Even with a solid regulatory strategy, timelines and requirements can vary significantly between countries, especially after approval.
Do I need a legal entity in Europe?
Yes, the Marketing Authorisation Holder (MAH) must be established in the EU or EEA. However, this does not necessarily mean setting up your own legal entity. Companies may either:
- establish their own EU/EEA entity to act as MAH, or
- appoint an experienced local partner to act as MAH or representative on their behalf.
Regardless of the setup, the MAH carries full responsibility for regulatory compliance, quality, pharmacovigilance oversight, and lifecycle management of the medicinal product.
See also: What does it take to enter the EU pharmaceutical market?
What is the role of the MA applicant when applying for a marketing authorisation?
The Marketing Authorisation Holder (MAH) is the legal entity responsible for the application and for interacting with regulatory authorities during the procedure. The MAH is accountable for the accuracy and completeness of the submitted data.
In the application phase, this includes:
- submitting the marketing authorisation application and all required documentation
- ensuring the dossier is complete, consistent and compliant (e.g. CTD structure, CMC, non-clinical and clinical data)
- responding to authority questions during the assessment
- coordinating input from different functions, such as regulatory, quality and clinical teams
- ensuring that required roles and systems (e.g. QPPV, pharmacovigilance system) are in place by the time of approval
See also: What regulatory lifecycle activities must MAH manage after approval?
Which marketing authorisation procedure should we choose in the EU?
The choice between procedures depends on the product type, target markets and regulatory strategy.
- Centralised Procedure (CP): mandatory for certain products (e.g. biotech), results in a single EU-wide authorisation via the European Medicines Agency
- Decentralised Procedure (DCP): used when the product is not yet authorised in any EU country and multiple markets are targeted simultaneously
- Mutual Recognition Procedure (MRP): used to expand an existing national authorisation to additional countries
- National Procedure: used when targeting a single country
CP offers broad access but requires a high level of dossier readiness, while DCP allows more flexibility in market selection.
See also: How to obtain a marketing authorisation in the EU?
What supply chain requirements apply?
Before placing a product on the market, companies must ensure that the full supply chain is authorised and compliant. This includes:
- manufacturing authorisations
- import authorisation, where applicable
- batch release in the EU/EEA by a Qualified Person (QP)
- Wholesale Distribution Authorisation (WDA) for distribution activities
- compliance with GMP and GDP standards
Any gaps in supply chain readiness can delay product launch even after marketing authorisation is granted.
See also: What does it take to enter the EU pharmaceutical market?
How is reimbursement handled?
Pricing and reimbursement are managed entirely at national level, not centrally in the EU. After obtaining marketing authorisation, companies must:
- submit dossiers to national HTA bodies
- demonstrate clinical and economic value
- negotiate pricing and reimbursement conditions
These processes vary widely between countries and can take several months or in some cases, over a year, depending on the market and product – meaning regulatory approval does not automatically translate into market access.
See also: What does it take to enter the EU pharmaceutical market?
How long does it take to bring a pharmaceutical product to market in Europe?
Timelines vary by product type, regulatory route, and national reimbursement procedures. Companies often need several years from submission to full market uptake across Europe.
Official timelines vary by procedure, but real-world timelines are often extended due to authority questions, clock stops or dossier deficiencies, especially in CMC sections. Regulatory timelines depend on the procedure:
- Centralised procedure: 210 active assessment days (excluding clock stops)
- In practice: typically ~300 days or longer due to questions and data requests
However, the total timeline to market is longer due to dossier preparation, national implementation steps and pricing and reimbursement processes. Full commercialisation across multiple EU markets often takes several years.
When are national approvals received after the EoP of the DCP?
After the End of Procedure (EoP), member states grant national marketing authorisations typically within 30 days. However, this phase may include:
- finalisation of product information translations and mock-ups
- administrative steps at national level
- country-specific requirements
Delays can occur if documentation is not fully aligned at the end of the procedure.
Can SME status support a New MA application?
Yes. SMEs registered with the EMA may benefit from fee reductions, administrative support and access to certain regulatory incentives. However, SME status does not simplify scientific or regulatory requirements. The same level of dossier quality and compliance is expected.
See also: How pharma companies can benefit from SME status in the EU
How can I speed up market entry?
A common issue is treating regulatory approval, supply chain setup, and market access as separate workstreams. Lack of alignment often leads to delays, even when the regulatory procedure itself proceeds as planned. Delays are often caused by gaps in documentation or late alignment between functions.
The most effective way to accelerate timelines is early and structured planning:
- selecting the optimal regulatory pathway early
- aligning CMC, clinical and regulatory strategies
- engaging with authorities (e.g. scientific advice)
- preparing supply chain and MAH structures in parallel
Working with an experienced regulatory partner, such as Medfiles, can help ensure that these elements are aligned early and that the process is managed efficiently from the start.
Entering the EU/EEA pharmaceutical market is a long-term process rather than a single regulatory step. Bringing a medicinal product to the EU/EEA market depends on a series of regulatory and national decisions.
If internal resources or specific expertise are limited, Medfiles’ highly qualified team can support companies throughout the process. By working with Medfiles, companies gain access to customised services tailored to their specific needs. We can support the entire marketing authorisation application process (DCP/MRP/CP/NP) in any EU country, from registration strategy to marketing authorisation and it’s maintenance.
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