EMA-Compliant Pharmaceutical Promotional Materials
Ensure your pharmaceutical promotional content meets EMA Directive 2001/83/EC, EFPIA Code of Practice, and country-specific requirements across all 27 EU member states. Automated compliance checking with PubMed + EMBASE integration for comprehensive European literature coverage.
The Challenge of EU Multi-Market Compliance
Key EMA Regulatory Requirements
- • Directive 2001/83/EC Article 86-100 (advertising of medicinal products)
- • EFPIA Code of Practice on promotion of prescription medicines
- • Member state specific regulations (ANSM France, BfArM Germany, AIFA Italy, etc.)
- • SmPC (Summary of Product Characteristics) alignment
- • EPAR (European Public Assessment Report) requirements
- • QRD template compliance for patient information
How PromoPack Ensures EMA Compliance
Automated EMA Directive 2001/83/EC Checking
Every promotional material is automatically validated against EMA Directive 2001/83/EC requirements, ensuring compliance with EU-wide advertising regulations before member state review.
SmPC Alignment
Validates that all promotional claims align with approved Summary of Product Characteristics.
EFPIA Code Compliance
Ensures adherence to European pharmaceutical industry self-regulatory standards.
Member State Requirements
Country-specific rule checking for key markets (Germany, France, Italy, Spain).
Clinical Trial Data
Integration with EU Clinical Trials Register for up-to-date trial references.
European Literature Coverage: PubMed + EMBASE
Access the most comprehensive European pharmaceutical literature. Our platform searches PubMed's 36M+ global citations, with premium tiers offering EMBASE integration for 30% more European journal coverage—critical for EMA submissions.
Standard Tier: PubMed
- 36M+ citations including major EU journals
- The Lancet, BMJ, NEJM coverage
- ~80% of EMA submission references
Premium Tier: EMBASE
Coming Q2 2025- 8,500+ journals from 90+ countries
- 30% unique European content vs PubMed
- Preferred by EMA for comprehensive reviews
EMBASE includes more European regional journals, conference abstracts, and pharmaceutical literature than PubMed. For multi-country EU launches, EMBASE ensures you're not missing critical European studies that may be required by member state regulators.
Multi-Country Compliance Management
Manage promotional materials across multiple EU member states with country-specific compliance rules and workflow templates.
EMA Compliance Features
Ready for EU Multi-Market Launches?
Try PromoPack's EMA-compliant promotional content platform with PubMed coverage today, upgrade to EMBASE when you need comprehensive European literature
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