O diploma adequa as regras nacionais de rotulagem e sobre os dispositivos de segurança que devem figurar nas embalagens de certos medicamentos para uso humano, permitindo a sua identificação e autenticação, com vista a impedir a introdução de medicamentos falsificados na cadeia de abastecimento legal.
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- AI Regulation in Pharmacovigilance. REGULATORY BRIEFING 2026
- ICH Quality Risk Management as part of Integrated Quality Management
- FDA Examples of Real-World Evidence Used in Medical Device Regulatory Decisions
- FDA eMDR – Electronic Medical Device Reporting
- ACT EU Draft Guidance on Clinical Trials During Public Health Emergencies
- EMA’s ePI Roadmap
- Sponsor Frequently Asked Questions Clinical Trial Information System (CTIS) Frequently Asked Questions (FAQs) on the Sponsor’s workspace
- The new CTIS Sponsor Handbook (v6.2, March 2026)