The EU is replacing the rulebook that has governed medicines for more than twenty years. The new EU pharmaceutical legislation, known as the Pharma Package, replaces the Community Code (Directive 2001/83/EC), the EMA Regulation (Regulation (EC) 726/2004), and the Orphan Medicinal Products Regulation.
Most coverage so far has focused on data protection periods, market exclusivity, and supply obligations. This article looks at what the reform means for the people who produce labels, leaflets, and promotional materials.
Where Things Stand
Last updated: October 2026
The compromise texts were published on March 6, 2026, and law firms tracking the process expect the final texts to closely reflect them. They aren't final law yet. Formal adoption by Parliament and Council is expected this fall, followed by publication in the Official Journal. The new rules then enter into force 20 days later, and most apply 24 months after that, with full application expected in late 2028. Some provisions, particularly on supply security, apply earlier.
We'll update this article when the final texts are published.
What Changes for Labels and Leaflets
Electronic leaflets become possible. Under current law, a printed package leaflet has to be included in every pack. The reform allows each Member State to decide whether package leaflets can be provided electronically instead, with patients able to get a printed copy on request, free of charge.
This doesn't mean paper disappears. Because it's a Member State choice, some countries will likely allow electronic-only leaflets and others won't, at least at first. For companies selling across several markets, that means managing printed and electronic leaflets side by side, and keeping them in sync. EMA's electronic product information (ePI) program is building the infrastructure for this, which we cover in our ePI and dual-channel PIL guide.
The references in your documents will change. The labeling requirements currently sit in Title V of Directive 2001/83/EC: the particulars for outer and immediate packaging, Braille, and the package leaflet. Because a new Directive replaces the old one, those requirements move to new article numbers. Templates, SOPs, labeling specifications, and regulatory submissions that cite "Article 54" or "Article 56a" will need updating once the new texts are final. It's a small change individually, but it touches a lot of documents.
The core principles carry forward. Particulars still need to be legible and in the official language of each market, and outer packaging and leaflets still can't carry promotional content. The practical work lies in transition rather than in rewriting every label from scratch. (For what each packaging level must carry today, see our guide to primary vs secondary pharmaceutical packaging.)
What Changes for Promotion
The advertising rules aren't being overhauled, but the changes are meaningful. Legal commentators expect companies will need to review existing promotional materials and compliance practices once the text is adopted. The main changes in the compromise text:
A broader definition of advertising. It now covers promotion that doesn't mention a specific medicine. Disease awareness campaigns, therapeutic class messaging, and corporate communications can all fall within scope.
A broader definition of healthcare professionals. It now includes people qualified to administer medicines, such as nursing staff, not just physicians and pharmacists.
Stricter comparative claims. Superiority claims must be objectively supported by the summaries of product characteristics (SmPCs) of both products being compared. Advertising that disparages another medicine is explicitly banned, and suggesting a biosimilar isn't interchangeable with its reference product counts as misleading unless the SmPCs support it.
New Member State powers. Member States gain several new powers, including the right to ban all advertising of unspecified medicinal products on their territory, so national rules may diverge further.
For medical marketing teams and agencies, the claims rule is the one to act on first. Every comparative claim will need to trace back to wording in the SmPC, which puts even more weight on getting promotional content to match its approved source exactly. We've written about why that breaks down in practice in Promotional Review Has a Version Problem Nobody Is Fixing.
What Labeling and Marketing Teams Can Do Now
The final texts aren't published yet, but the content is effectively settled, so companies can start their impact analyses and compliance planning now using the compromise texts. In practice:
For regulatory and labeling teams
- Inventory where Directive 2001/83/EC is referenced in templates, SOPs, labeling specifications, and artwork briefs, so updates can be made quickly once final article numbers are known.
- Map which markets are likely to allow electronic leaflets, and plan for printed and electronic versions to coexist.
- Strengthen version control between printed leaflets, electronic product information, and the SmPC they're based on. Our Document Version Control guide covers how.
For medical marketing teams and agencies
- Audit comparative claims against the SmPCs of both products.
- Review disease awareness and unbranded campaigns against the broader definition of advertising.
- Check materials aimed at nurses and other administering professionals, who now fall within the healthcare professional definition.
Frequently Asked Questions
What is the EU Pharma Package?It's the reform of EU pharmaceutical legislation that replaces Directive 2001/83/EC, Regulation (EC) 726/2004, and the Orphan Medicinal Products Regulation with a new Directive and a new Regulation. The Commission proposed it in April 2023, and a political agreement was reached on December 11, 2025.
When does the new EU pharmaceutical legislation apply?Formal adoption is expected in fall 2026. Most provisions will apply 24 months after entry into force, which puts full application around late 2028.
Will printed package leaflets be abolished?No. Each Member State will decide whether electronic leaflets can replace printed ones, and patients will still be able to get a printed copy on request.
What's the EU equivalent of the FDA?The European Medicines Agency (EMA) evaluates medicines for the centralized EU procedure, and the European Commission grants the marketing authorization. National competent authorities handle national procedures in each Member State.
When a regulation replaces the document your labels, leaflets, and claims are built on, the risk isn't one big change. It's hundreds of small ones that have to land consistently.
Content Compare verifies labels, leaflets, and promotional materials against their approved source, including the SmPC, across every language and market. See how it works on your own content.
