When a patient in Germany picks up a generic version of a blood pressure pill, it’s not the same as the one bought in Poland-even if the name and dosage are identical. Why? Because the European Union’s system for approving generic drugs isn’t one system at all. It’s five different paths, each with its own rules, delays, and hidden costs. And in 2025, everything is changing.
The Four Ways to Get a Generic Drug Approved in the EU
There are four main routes a company can take to get a generic medicine approved across the EU. Each one affects how fast the drug reaches pharmacies, how much it costs to file, and whether it’s available everywhere-or just in a few countries.
The Centralized Procedure is the fastest way to get EU-wide access. You submit one application to the European Medicines Agency (EMA), and if approved, the drug can be sold in all 27 EU countries plus Iceland, Liechtenstein, and Norway. This route takes about 180 days under the new 2025 rules, down from 210. But it’s expensive: application fees start at €425,000, and you’ll need another €1.2-1.8 million in consulting and study costs. That’s why only about 15% of generics use this path-usually big companies targeting high-sales drugs worth over €250 million annually. Sandoz used it to launch its version of Cosentyx across the entire EU in Q2 2025-11 months faster than traditional methods.
The Mutual Recognition Procedure (MRP) is the most popular, used in 42% of cases. Here, a company gets approval first in one country (the Reference Member State), then asks others to accept it. Sounds simple, right? Not really. While the official timeline is 90 days, the average takes 132.7 days because countries keep adding their own demands. Teva’s experience with generic rosuvastatin in 2023 showed how this can drag out: German pricing talks delayed rollout in the Netherlands and Belgium by over eight months-even after the drug was technically approved.
The Decentralized Procedure (DCP) lets companies apply to multiple countries at once. No prior approval needed. But coordination is messy. The lead country (RMS) has 210 days to review, but delays pile up. In 2024, 37% of DCP applications took more than six months longer than expected, especially in Eastern Europe, where quality standards were interpreted differently. One case study from the GMDP Academy found a single country’s objection reset the entire 180-day clock, making timelines unpredictable.
The National Procedure is the least used-just 5% of filings. You apply to one country only. It takes 180-240 days, and the approval only works there. But some companies still use it to target high-reimbursement markets like France, where local pricing can be more favorable. Accord Healthcare found that even though it took longer than MRP, the French market’s reimbursement rate made it worth the wait.
What Makes a Generic ‘Generic’? The Science Behind Approval
It’s not enough for a generic pill to look like the brand-name version. It has to work the same way. That means proving bioequivalence-showing that your version delivers the same amount of active ingredient into the bloodstream at the same speed.
The EMA requires strict standards: the 90% confidence interval for two key measures-Cmax (peak concentration) and AUC (total exposure)-must fall between 80.00% and 125.00%. This isn’t just a guideline; it’s the law. And it applies whether you’re filing under the Centralized Procedure or the National one.
But here’s where things get complicated. Some countries demand more. Germany’s BfArM, for example, requires extra pharmacodynamic studies for complex generics like inhalers. France requires detailed documentation on pediatric formulations. These aren’t EU-wide rules-they’re national add-ons. A 2025 survey of 47 generic manufacturers found that 68% listed inconsistent national bioequivalence requirements as their biggest regulatory headache.
Even the reference product matters. If the original drug was approved years ago, its impurity profile might be outdated. But generics must match it exactly. That forces companies to dig through decades-old data, sometimes with incomplete records. The EMA’s free Q&A portal helps, but 58% of companies say national regulators still give conflicting answers.
The 2025 Pharma Package: Big Changes Coming
In June 2025, the EU finalized its biggest overhaul of generic drug rules in 20 years. The changes are meant to fix fragmentation, speed up access, and ensure supply. But they’re also creating new challenges.
The biggest shift? The expanded Bolar exemption. Before, companies could start pricing and reimbursement talks only two months before a patent expired. Now, they can start six months earlier. That’s a game-changer. REMAP Consulting estimates this alone will cut generic launch delays by 4.3 months on average. It also gives payers more leverage-early negotiations mean more competition before launch, which could push prices down 12-18%.
Another key change: Regulatory Data Protection is being shortened. Previously, originator companies had 10 years of protection (8 years data + 2 years market). Now, it’s 8 years data + 1 year market, with a possible one-year extension if the drug meets public health targets. That means generics can enter sooner-78 high-value biologics currently in development will now face competition earlier than expected.
But not everyone’s happy. The new Transferable Exclusivity Voucher rewards companies that develop generics for rare diseases-but only if they hit a €490 million sales threshold. That’s a huge barrier for mid-sized firms. Dr. Sabine Rödl of EGA called it a “double-edged sword”: it helps rare disease patients, but could push smaller players out of the market.
Then there’s the obligation to supply. Companies must now guarantee enough stock of critical generics to prevent shortages. Sounds good-until you realize each country defines “sufficient quantities” differently. Professor Panos Kanavos of LSE Health warns this could lead to artificial shortages in smaller markets if companies choose to supply only where reimbursement is highest.
Who’s Winning? Who’s Struggling?
The EU generics market was worth €42.7 billion in 2024, growing 6.2% from the year before. But the winners aren’t evenly distributed.
Indian manufacturers now hold 38% of all EU generic approvals-up from 29% in 2020. They’re fast, cheap, and skilled at navigating the MRP and DCP. European firms like Sandoz and Viatris still lead with 52% of the market, but they’re doing it differently: they’re using the Centralized Procedure to launch big-volume drugs all at once, avoiding the delays of national negotiations.
Smaller companies are stuck in the middle. A 2024 report from Mylan (now Viatris) showed that MRP coordination delays added €3.2 million in carrying costs per high-value generic launch. Accord Healthcare’s regulatory head said the clock restarting with every national objection makes supply chain planning nearly impossible.
And now, the 2025 reforms add new costs. By 2026, all product information must be submitted electronically in XML format. That’s not a simple update-it’s a full IT overhaul. White & Case estimates it will cost €180,000-250,000 per company to upgrade systems. For a small generic firm, that’s a major investment.
What’s Next? The Real-World Impact
The EU wants generics to cover 69.2% of prescriptions by 2028, up from 65% today. That’s ambitious. The 2025 reforms are designed to make that happen.
The Critical Medicines Act, passed in March 2025, now requires stockpiling of 200 essential generics. That should reduce shortages. But it also means stricter quality checks-another hurdle for new entrants.
The US-EU Framework Agreement, effective September 2025, could change ingredient costs. Tariff adjustments on pharmaceutical raw materials are still unclear, but if they raise input prices, European manufacturers may have to raise prices-or cut margins.
One thing’s certain: the era of slow, patchwork approvals is ending. The system is becoming more standardized-but also more complex. Companies that succeed will be those who understand not just the EMA rules, but the hidden national quirks. They’ll need teams that can handle bioequivalence studies, electronic submissions, and reimbursement negotiations-all at once.
The patient wins when generics arrive faster and cheaper. But getting there means navigating a maze that’s still under construction.
Practical Tips for Generic Manufacturers in 2025
- If your drug has high EU-wide sales potential, go for the Centralized Procedure-even with the upfront cost. Speed and scale pay off.
- Avoid the Decentralized Procedure unless you’re targeting countries with aligned regulatory cultures. Eastern Europe remains a high-risk zone for delays.
- Start your Bolar exemption activities six months before patent expiry. Don’t wait. Payers are already planning.
- Invest in electronic submission systems now. The 2026 XML requirement isn’t optional.
- Build relationships with national authorities early. A call to the French ANSM or German BfArM before filing can save months.
- Track your reference product’s impurity profile. If it’s outdated, be ready to justify your testing strategy to regulators.
How long does it take to get a generic drug approved in the EU?
Approval times vary by pathway. The Centralized Procedure takes about 180 days under 2025 rules. The Mutual Recognition Procedure averages 132.7 days, but often takes longer due to national delays. The Decentralized Procedure averages 247 days, and the National Procedure takes 180-240 days. The 2025 reforms aim to reduce these timelines, especially with the expanded Bolar exemption allowing pre-patent expiry negotiations.
What’s the difference between the Centralized and Mutual Recognition Procedures?
The Centralized Procedure gives you approval across all EU countries with one application to the EMA. It’s faster for EU-wide launches but costs over €1.6 million. The Mutual Recognition Procedure starts with approval in one country, then asks others to accept it. It’s cheaper (€180K-220K) but slower because each country can delay or demand extra data, often adding months to the timeline.
Why are generic drug prices lower in some EU countries than others?
Price differences come from national reimbursement systems, not regulatory approval. Countries like Germany and France have strict price controls and negotiation processes. Others, like Poland or Romania, have lower reimbursement rates but faster market access. The 2025 expanded Bolar exemption lets companies start pricing talks earlier, which increases competition and can push prices down across the board.
Do all EU countries accept the same bioequivalence data?
No. While the EMA sets the baseline (80-125% confidence interval for Cmax and AUC), countries like Germany and France add extra requirements. Germany demands pharmacodynamic studies for inhalers. France requires pediatric formulation details. This inconsistency is the top regulatory challenge for generic manufacturers, according to a 2025 ABPI survey.
How will the 2025 Pharma Package affect small generic companies?
It’s mixed. The shortened data protection period helps them enter markets faster. But the new €490 million sales threshold for transferable exclusivity vouchers favors large firms. Plus, mandatory electronic submissions and supply obligations raise compliance costs. Small companies may struggle to afford the IT upgrades or absorb the risk of national delays. Those that survive will need to specialize-either in niche markets or by partnering with larger distributors.
Are Indian generic manufacturers dominating the EU market?
Yes. In 2024, Indian companies secured 38% of all EU generic approvals, up from 29% in 2020. They’re especially strong in the Mutual Recognition and Decentralized Procedures, where speed and low cost matter. European firms still lead in high-value, complex generics using the Centralized Procedure, but Indian manufacturers are gaining ground fast, particularly in high-volume, low-margin drugs.