EU Pharma Reform 2025: New Rules for Medicines

# EU Pharma Reform 2025: What Supplement Manufacturers Need to Know

On December 11, 2025, the EU adopted comprehensive pharmaceutical regulation reforms - the first in 20 years.

Reform Overview

Data Protection & Market Exclusivity - **8 years** baseline data protection for manufacturers - **+1 year** market exclusivity after EU marketing authorization - **+3 years** bonus when meeting certain criteria: - Development for unmet medical need - Significant clinical benefits - New active substance with multi-EU trials

Maximum: 11 years protection (under optimal conditions)

AMR Voucher System New incentive system for antibiotic development: - **+1 year** patent extension for antibiotics against antimicrobial resistance - Extension applicable to: - The antibiotic itself OR - Another authorized medicine from the same manufacturer - **Exception:** "Blockbuster" drugs excluded

Bolar Exemption Major relief for generic manufacturers: - Allows studies during patent protection - Regulatory dossiers may be prepared - **Important:** No sales before patent expiry - No patent lawsuits during preparation

Impact on Supplement Industry

Demarcation from Medicines - Clearer definitions between supplements & medicines - Stricter demarcation for health claims - More controls on "borderline products"

Compliance Requirements Supplement manufacturers should: 1. **Verify Claim Compliance** 2. **Adapt Labeling** to new regulations 3. **Validate Product Classification**

Use Supplement-Check.eu

With our tool: - Automatically validate health claims - Check demarcation from medicines - Verify 28 EU markets simultaneously

Source: [Euronews: EU Pharma Deal 2025](https://www.euronews.com/health/2025/12/11/eu-unveils-new-pharma-deal-that-overhauls-two-decades-of-medicine-rules)

*Created: December 11, 2025 • Last updated: December 11, 2025*