When you pick up a generic pill in Germany, France, or Poland, you might think it’s just a cheaper version of the brand-name drug. But behind that simple label is one of the most complex regulatory systems in the world. In the European Union, getting a generic medicine to market isn’t just about proving it works-it’s about navigating four different approval paths, 27 national bureaucracies, and a major regulatory overhaul that just changed the game in 2025.

The Four Ways Generics Get Approved in the EU

There’s no single route for generic drugs in Europe. Instead, manufacturers choose from four distinct pathways, each with its own timeline, cost, and challenges. The choice isn’t random-it’s a strategic decision that can make or break a product’s launch.

The Centralized Procedure is the fastest way to get a generic drug approved across all 27 EU countries, plus Iceland, Liechtenstein, and Norway. You submit one application to the European Medicines Agency (EMA), and if approved, you get a single marketing authorization valid everywhere. Sounds simple, right? But it’s expensive. Application fees alone run around €425,000, and you’ll need another €1.2 to €1.8 million in consulting and study costs. Only companies targeting high-value generics-those expected to sell over €250 million across the EU-usually go this route. Sandoz used it to launch its version of Novartis’s Cosentyx in Q2 2025, hitting all markets at once-11 months faster than other methods allowed.

The Mutual Recognition Procedure (MRP) is the most popular, used in 42% of cases. Here, a company gets approval in one country first-the Reference Member State-and then asks others to recognize it. It’s cheaper, costing between €180,000 and €220,000. But it’s slow and messy. Even after EMA approves the science, each country can drag its feet on pricing or reimbursement. Teva’s generic rosuvastatin got technical approval in Germany in 2023, but Dutch and Belgian markets didn’t see it for over eight months because of local negotiations.

The Decentralized Procedure (DCP) lets companies apply to multiple countries at the same time, without needing prior approval anywhere. It’s meant to be faster than MRP, but it’s often the most frustrating. A 2024 study found that 37% of DCP applications hit delays longer than six months. Why? Because countries like Poland, Romania, or Bulgaria sometimes demand extra tests or paperwork that don’t exist in EMA guidelines. The clock resets every time one country raises an objection. For manufacturers, this means unpredictable timelines and supply chain nightmares.

Then there’s the National Procedure, used in just 5% of cases. You apply to one country only. It’s useful if you’re targeting a single high-reimbursement market like France, where certain generics get better pricing. But it defeats the whole point of EU harmonization. Accord Healthcare found it took 197 days to get a national approval in France-yet with MRP, they got the same drug approved in five other countries in just 142 days.

What the EU Pharma Package 2025 Changed

In June 2025, the EU rolled out its biggest overhaul of generic drug rules in 20 years. The changes weren’t subtle. They touched everything from how long brand-name drugs are protected to when generics can start negotiating prices.

One of the biggest shifts was shortening Regulatory Data Protection. Before, brand-name companies had 10 years of protection-eight years of data exclusivity plus two years of market exclusivity. Now, it’s 8 years plus 1 year of market protection. That’s it. You can extend it to 10 years total if the drug meets public health goals, like treating rare diseases. This change alone could bring generics to market months earlier for dozens of high-cost drugs.

The Bolar exemption got a major boost too. Before, generic makers could only start negotiating prices with health systems two months before the patent expired. Now, they can start six months early. That might not sound like much, but it’s huge. REMAP Consulting estimates this alone will cut generic launch delays by 4.3 months on average. It also gives payers more power. Hospitals and insurers can now compare prices and demand discounts before the drug even hits shelves. That’s why analysts predict generic launch prices could drop 12-18% in the next few years.

There’s also a new obligation to supply rule. If a generic manufacturer gets approval, they can’t just sit on it. They must produce enough to meet demand. National authorities can now force them to ramp up production if shortages occur. That’s meant to fix the chronic problem of drug shortages in smaller countries. But experts like Professor Panos Kanavos warn that if countries interpret “sufficient quantities” too loosely, they might still block supply in low-volume markets.

Why National Differences Still Matter

Even with EU-wide rules, every country has its own quirks. The EMA sets the science. But each national authority decides how to apply it.

Germany’s BfArM, for example, requires extra pharmacodynamic studies for complex generics like inhalers-tests that aren’t required by EMA. France’s ANSM demands special documentation for pediatric formulations. Italy has stricter limits on impurities in older drugs. These aren’t just paperwork hurdles-they add months to timelines and tens of thousands to costs.

A 2025 survey of 47 generic manufacturers found that 68% listed inconsistent national bioequivalence requirements as their biggest headache. One company spent six months redoing studies because Spain and Austria disagreed on how to measure absorption rates for a generic asthma inhaler. The EMA’s guidance says one thing. The national regulator says another. And the generic company pays the price.

Who’s Winning in the EU Generic Market?

The EU generic market was worth €42.7 billion in 2024, growing 6.2% from the year before. But who’s getting the biggest slice?

Indian companies now control 38% of all EU generic approvals-up from 29% in 2020. Their low-cost manufacturing and aggressive pricing make them tough to beat on volume. But European firms like Sandoz and Viatris still hold 52% of the market share-not because they’re cheaper, but because they’re smarter about pathways. They use the Centralized Procedure for high-value drugs and stick to MRP for others, minimizing delays and maximizing reach.

The 2025 reforms are helping them too. With the Bolar exemption extended, companies can now run parallel health technology assessments (HTA) across multiple countries before launch. That means they can lock in pricing agreements faster. It’s not just about getting approved-it’s about getting paid.

What’s Next? The 2026 Deadline and Beyond

The biggest change is still coming. On July 1, 2026, the new Regulatory Data Protection rules fully kick in. That’s when the 8+1 system becomes standard for all new drugs. Around 78 biologics currently in development could see generic versions arrive years earlier than expected.

There’s also a new requirement: all product information must be submitted electronically in XML format by 2026. That means every generic company needs to upgrade its IT systems. White & Case estimates this will cost between €180,000 and €250,000 per company. Smaller firms might struggle. Bigger ones? They’ll absorb it.

The Critical Medicines Act of March 2025 adds another layer. It forces countries to stockpile 200 essential generics. That sounds good for patients-but it also means stricter quality checks. More inspections. More delays. More cost.

What This Means for Patients

You might not care about MRP vs. DCP. But you care if your prescription is cheaper, available, and reliable.

The 2025 reforms are designed to fix exactly that. By speeding up approvals and forcing manufacturers to keep supply flowing, the EU hopes to reduce medicine shortages by 35% by 2028. That’s 1 in 3 fewer times you’ll be told your drug is out of stock.

And prices? They’re likely to drop further. With generics entering earlier and payers negotiating harder, the gap between brand and generic prices-already 80% in many cases-could widen even more.

But there’s a risk. If the 1-year market protection is too short for complex drugs like biosimilars, companies might stop investing in them. That could leave patients with fewer options for advanced treatments.

Right now, generics make up 65% of all prescriptions in the EU by volume. By 2028, that number could hit 69.2%. More access. Lower costs. But only if the system keeps working as intended.

What Generic Manufacturers Need to Know

If you’re a company trying to launch a generic in Europe, here’s what you need to do:

• Choose your pathway wisely. Centralized for big drugs. MRP for mid-range. National only if you’re targeting one market.
• Start preparing 15-18 months before submission. Bioequivalence studies alone take 6-8 months under the 2025 guidelines.
• Don’t assume EMA rules = national rules. Check each country’s specific requirements-especially Germany, France, and Italy.
• Use the EMA’s free Q&A portal, but verify everything with national authorities. Their responses often contradict EMA guidance.
• Invest in XML-based ePI systems now. The 2026 deadline is real, and penalties are steep.
• Start pricing negotiations 6 months before patent expiry. Don’t wait. The window is open.

Final Thoughts

The EU’s generic drug system isn’t broken. It’s just incredibly complicated. The 2025 reforms are the most meaningful update in decades-aimed at making generics faster, cheaper, and more reliable. But complexity doesn’t vanish overnight. National differences, inconsistent interpretations, and bureaucratic inertia still slow things down.

The winners will be the companies that treat this like a chess game-not a checklist. They’ll know when to use the Centralized Procedure, when to push back on national demands, and when to start the pricing talks. For everyone else? The wait will be longer, the costs higher, and the risks greater.

For patients, the goal is clear: more generics, sooner. And if the EU can make that happen, it won’t just save money-it could save lives.