When a patient in Germany picks up a generic version of a blood pressure pill, and another in Poland gets the same medicine at half the price, they’re both benefiting from a complex, multi-layered regulatory system that’s changing faster than ever. The European Union doesn’t have one single rulebook for generic drugs-it has four different approval paths, 27 national agencies, and a major overhaul that took effect in 2025. This isn’t just paperwork. It determines whether a life-saving generic reaches the market in six months or two years. And it’s reshaping who can compete, where, and at what cost.
How Generic Drugs Get Approved in the EU
There are four ways a generic drug can get approved across the EU. Each has different rules, costs, and timelines. The choice a company makes can mean the difference between a successful launch and a financial loss.
The Centralized Procedure is the fastest way to get access to all 27 EU countries, plus Iceland, Liechtenstein, and Norway. A company submits one application to the European Medicines Agency (EMA). If approved, the drug can be sold everywhere at once. But it’s expensive-application fees alone run around €425,000, and consulting help can push total costs to €1.2-1.8 million. That’s only worth it for high-value generics expected to sell over €250 million across the EU. Sandoz used this route to launch its version of Novartis’s Cosentyx in Q2 2025, hitting all markets 11 months faster than the old way.
The Mutual Recognition Procedure (MRP) is the most popular, used in 42% of cases. A company gets approval in one country first-the Reference Member State-then asks others to recognize it. Sounds simple, right? In practice, it’s messy. National agencies often add extra requirements. Teva’s generic rosuvastatin got approved in Germany in 2023, but pricing delays pushed its launch in the Netherlands and Belgium out by over eight months. The official clock says 90 days for consensus. The real average? 132.7 days.
The Decentralized Procedure (DCP) lets companies apply to multiple countries at the same time. No prior approval needed. But coordination is a nightmare. One country’s objection can reset the entire timeline. A 2024 case study from the GMDP Academy found 37% of DCP applications faced delays longer than six months, especially in Eastern Europe, where quality standards for generics are interpreted differently. The process is supposed to take 210 days. It usually takes 247.
The National Procedure is the simplest-apply to just one country. But that means you only sell there. It’s used for just 5% of applications, mostly when a company wants to target a high-reimbursement market like France. But even here, timing varies. Accord Healthcare found it took 197 days for a national approval in France, versus 142 days using MRP across five countries.
What the EU Requires: Bioequivalence and Composition
No matter which path you choose, the rules for proving a generic works the same as the original are strict. The EMA requires three things: identical active ingredients, the same dosage form (tablet, injection, etc.), and proof of bioequivalence.
Bioequivalence means the generic must release the drug into the bloodstream at the same rate and amount as the original. This is proven through clinical studies on healthy volunteers. The results must show that the concentration of the drug in the blood (measured as AUC and Cmax) falls within 80% to 125% of the original. That’s not a suggestion-it’s a hard cutoff. If the data doesn’t meet this, the application is rejected.
But here’s where it gets complicated. While the EMA sets the standard, national agencies sometimes add extra tests. Germany’s BfArM requires additional pharmacodynamic studies for complex generics like inhalers. France demands specific documentation for pediatric formulations. These aren’t EU-wide rules-they’re national add-ons. A 2025 ABPI survey of 47 generic companies found 68% listed inconsistent national requirements as their biggest regulatory headache.
The 2025 Pharma Package: What Changed
In June 2025, the EU finalized its biggest drug regulation update in 20 years. The Pharma Package is designed to speed up generic access, reduce shortages, and make the system more predictable. Three changes hit hardest.
First, Regulatory Data Protection was shortened. Before, innovator drugs got 10 years of protection (8 years of data exclusivity + 2 years of market exclusivity). Now it’s 8 years of data protection, plus 1 year of market protection. That year can be extended to 2 if the drug meets public health targets. This means generics can enter sooner. For 78 high-value biologics in development, this could cut launch delays by over a year.
Second, the Bolar Exemption was expanded. Before, generic companies could only start pricing and reimbursement talks 2 months before a patent expired. Now, they can start 6 months before. This might sound small, but it’s huge. REMAP Consulting’s 2025 model shows this alone can cut generic market entry time by 4.3 months on average. It also gives payers more leverage-hospitals and insurers can negotiate prices earlier, which may lower launch prices by 12-18%.
Third, the EU introduced an Obligation to Supply. Companies must now prove they can make enough of a generic to meet demand. If they don’t, national authorities can step in and authorize another manufacturer to produce it. This is meant to prevent shortages. But experts like Professor Panos Kanavos warn that if countries interpret “sufficient quantities” too loosely, they might block new entrants in smaller markets.
Who’s Winning and Who’s Struggling
The EU generic market was worth €42.7 billion in 2024, growing 6.2% from the year before. But the winners aren’t evenly spread.
Indian manufacturers now control 38% of all EU generic approvals, up from 29% in 2020. Their low-cost production and aggressive pricing let them target high-volume, low-margin products. Meanwhile, European giants like Sandoz and Viatris still hold 52% of the market-but they’re winning by playing the long game. They use the Centralized Procedure for high-value drugs, invest in complex formulations, and build relationships with national payers.
Smaller companies are squeezed. The new €490 million sales threshold for Transferable Exclusivity Vouchers-a bonus incentive for drugs that meet public health goals-favors big players. Mid-sized firms can’t afford the upfront costs of the Centralized Procedure or the compliance burden of multiple national rules. One generic company executive told a 2025 EGA conference that the 180-day assessment clock resets every time a country objects. “It’s impossible to plan supply chains when the timeline keeps changing,” they said.
What’s Next: Electronic Files, Stockpiles, and Global Pressure
By 2026, all generic applications must include electronic product information (ePI) in XML format. That means companies need new software systems. White & Case estimates this will cost €180,000-250,000 per firm. Many small players can’t afford it.
Also in 2025, the Critical Medicines Act kicked in. It requires EU countries to stockpile 200 essential generics. That’s good for patients-it prevents shortages. But it adds another layer of quality checks. Companies now need to prove their product can be stored for years without degrading. That’s harder than it sounds, especially for complex molecules.
And then there’s the US-EU Framework Agreement, effective September 2025. It adjusts tariffs on pharmaceutical ingredients. The impact on generic manufacturing costs isn’t clear yet. But if raw materials from India or China become more expensive, European producers might raise prices-or shift production.
Why This Matters
Generics make up 65% of all prescriptions in the EU by volume, but only 18% by value. That gap exists because brand-name drugs still charge high prices, and generics often enter late or in limited supply. The 2025 reforms are trying to fix that. Faster approvals, earlier negotiations, and supply guarantees should bring more generics to more people, faster.
But the system is still fragmented. A drug approved in the Netherlands might still be held up in Bulgaria because of a paperwork mismatch. A small company might never get past the first national review. The EU’s goal is harmony. The reality? A patchwork of rules, costs, and delays.
For patients, the result should be lower prices and fewer shortages. For manufacturers, it’s a minefield. Those who understand the pathways, plan for national quirks, and invest in compliance will thrive. Everyone else will struggle to keep up.
How long does it take to get a generic drug approved in the EU?
Approval times vary by pathway. The Centralized Procedure takes about 210-250 days total. The Mutual Recognition Procedure averages 132.7 days, but often takes longer due to national delays. The Decentralized Procedure runs about 247 days on average. National approvals alone can take 180-240 days. The 2025 reforms aim to cut these times, especially with the expanded Bolar exemption allowing earlier pricing talks.
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 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 in practice because each country can add its own requirements, causing delays.
Can a generic drug be approved faster than the brand version?
No. Generics can’t enter the market until the brand’s patent and data protection expire. But the 2025 reforms let generic companies start pricing and reimbursement negotiations 6 months before patent expiry-instead of 2 months. This speeds up market entry after the patent ends, not before.
Why do some EU countries delay generic launches even after approval?
Approval means the drug is safe and effective. But it doesn’t mean it’s reimbursed. Countries control pricing and reimbursement separately. A drug can be approved in Germany but stuck for months because the health authority hasn’t set a price or included it in the public formulary. This is especially common in the Mutual Recognition Procedure.
Are Indian generic manufacturers dominating the EU market?
Yes. In 2024, Indian companies received 38% of all EU generic approvals, up from 29% in 2020. They focus on high-volume, low-cost products and compete aggressively on price. But European firms like Sandoz and Viatris still hold 52% of the market share because they target high-value, complex generics using the Centralized Procedure.
What’s the biggest challenge for small generic companies in the EU?
The cost and complexity of navigating multiple national rules. Small firms can’t afford the €1.6 million for the Centralized Procedure. But the Mutual and Decentralized Procedures are unpredictable-delays from one country can reset timelines. They also lack resources to handle new requirements like electronic submissions (ePI) or extra testing for complex drugs.
