By the PharmaTradz BD Team. Published October 2026.
Europe's medicines law is about to change for the first time in more than twenty years. On 28 September 2026 the Council adopted its position on the new pharmaceutical directive and regulation, which together replace Directive 2001/83/EC and Regulation 726/2004. A final vote in the European Parliament is expected this autumn, followed by publication in the Official Journal.
Much of the coverage has focused on innovators and their incentives. But the reform also changes the calendar that generic and biosimilar companies plan around: how long originator data is protected, when a competitor can file and launch, what you can do before patents expire, and what is expected of you on supply. This piece walks through those changes in plain terms.
It is written for business development and regulatory teams planning EU launches. It is based on the agreed texts and lawyers' summaries published so far, and it is not legal advice. Check the final published text for any specific product.
The new protection periods
Today a reference product in the EU normally gets 8 years of data protection, then 2 years of market protection, with a possible extra year for a significant new indication: the familiar "8+2+1".
Under the new rules the baseline becomes 8 years of data protection plus 1 year of market protection. Originators can earn extensions of 12 months at a time, for example by addressing an unmet medical need, by running comparative trials and filing in the EU promptly after a first filing elsewhere, or by adding a new indication with significant clinical benefit. Total protection is capped at 11 years, or 12 where a transferable exclusivity voucher for a priority antimicrobial is used.
| Current rules | New rules | |
|---|---|---|
| Data protection | 8 years | 8 years |
| Market protection (baseline) | 2 years | 1 year |
| Possible extensions | +1 year for a new indication | +12 months each for set conditions |
| Maximum | 11 years | 11 years (12 with a voucher) |
| Orphan market exclusivity | 10 years | 9 years (11 for breakthrough orphans) |
What this means in practice: the earliest possible generic launch can come one year sooner than today for products that do not earn extensions. For products that earn the full set, the end date may not move at all. So the new rules shorten the minimum, not necessarily the typical period. You will need to check each reference product's own history.
Preparing before expiry: the wider Bolar exemption
The Bolar exemption lets generic companies run the studies and trials needed for approval without infringing patents. The current wording is narrow and has been read differently from one country to another.
The reform widens it to cover the activities needed to bring a generic or biosimilar to market. These include the marketing authorisation application, health technology assessment, pricing and reimbursement submissions, and taking part in public tenders, including when these are done by third parties on the generic company's behalf. Selling, supplying or marketing the product before protection ends is still not allowed.
This is a real practical gain. Tender preparation and price negotiations can take a year or more in some countries. Being able to do this work before expiry means a generic can reach patients much closer to day one.
Filing earlier
Summaries of the final texts indicate that applications for generic and similar products can be filed and assessed during the final two years of the reference product's protection, so that approval is ready when it ends. Combined with the wider Bolar exemption, this should mean fewer gaps between expiry and real availability.
When the new periods apply
This is the point that matters most for portfolio planning.
- The directive and regulation enter into force 20 days after publication in the Official Journal.
- Most of the regulation applies 24 months later, and member states have 24 months to transpose the directive.
- Reference products whose applications are submitted before that 24-month point keep the current protection periods, even if they are approved later.
So the new, shorter baseline mainly affects medicines filed from around 2028 onwards, and generics of those products will launch in the late 2030s. For the next decade, most EU generic launches will still follow the current "8+2+1" calendar. Our list of medicines going generic in 2026 and 2027 and the generic entry tracker are based on today's rules.
Supply obligations
The reform also strengthens supply rules for all marketing authorisation holders, generic companies included:
- Six months' advance notice of an expected supply disruption, under the agreed texts.
- More transparency on supply chains and on where products and active substances are made.
- Shortage prevention planning, with the detail set by the final text and by EMA guidance.
For generic companies with lean supply chains, these are not trivial. Expect buyers and tender authorities to ask more about second sources, API origin and stock levels. A dual-sourced API and a clear view of your contract manufacturers will become selling points. Our guide on choosing a CDMO in Europe covers the supply-side questions.
The separate Critical Medicines Act, provisionally agreed in May 2026, adds another layer. It allows public buyers to reward supply chains with more EU-made content for critical medicines that depend heavily on non-EU sources.
What to do now
- Map your pipeline by reference filing date. Products whose reference medicine was filed before the transition point stay on the current calendar.
- Plan pricing and tender work earlier. The wider Bolar exemption should allow this before expiry, but check how each member state applies it.
- Review supply resilience. Second API sources, contract manufacturing back-ups and stock policies will carry more weight with regulators and buyers.
- Watch the Official Journal. Publication starts the clock on every transition date.
How PharmaTradz can help
We connect generic and biosimilar companies with dossier holders, API manufacturers and contract manufacturers across Europe and other regions. If you are planning an EU launch and need a dossier, an API source or a manufacturing partner, send us your requirement, or browse dossiers offered for licensing.
Frequently Asked Questions(FAQs)
How long will originator data be protected under the new EU pharma rules?
The baseline becomes 8 years of data protection plus 1 year of market protection. Originators can earn 12-month extensions for meeting set conditions, up to a maximum of 11 years, or 12 years with a transferable exclusivity voucher.
When do the new protection periods start to apply?
The rules enter into force 20 days after publication in the Official Journal and mostly apply 24 months later. Reference products filed before that point keep the current protection periods, so the change mainly affects products filed from around 2028.
What does the wider Bolar exemption allow?
It covers the activities needed to bring a generic or biosimilar to market before protection ends, including the marketing authorisation application, health technology assessment, pricing and reimbursement, and tender participation. Selling or supplying the product early is still not allowed.
Can generic companies file before protection expires?
Summaries of the final texts indicate that applications can be filed and assessed during the final two years of protection, so approval can be ready when protection ends. Check the published text for the exact rule.
What changes for orphan medicines?
Orphan market exclusivity falls from 10 to 9 years as a baseline, with 11 years for breakthrough orphan medicines that treat conditions with no existing treatment.
Do the new supply obligations apply to generic companies?
Yes. They apply to all marketing authorisation holders, including six months' advance notice of expected supply disruptions and more transparency on supply chains.
