What EU Pharmaceutical Regulation (2022/0134) - Article 5: Marketing Authorisation Requirements requires
EU Pharmaceutical Regulation (proposed, replacing Directive 2001/83/EC) Article 5 maintains the core requirement that no medicinal product may be placed on the EU market without a marketing authorisation (MA) granted by the European Medicines Agency (EMA) under the centralised procedure or by a national competent authority under national procedures. The MA application must include full pharmaceutical, non-clinical, and clinical data demonstrating quality, safety, and efficacy. The revised Regulation introduces environmental risk assessment as a mandatory MA application component and strengthens post-authorisation monitoring obligations. EMA and national competent authorities jointly enforce MA compliance.
Pillar: Pharmaceuticals & Life Sciences · Authority: European Medicines Agency (EMA) · Version: 2.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52022PC0134
SHA-256 integrity: af30fa610001b691bc8f3932d006c34cb5b9c540a38efa98c0419edb69525b41
Primary Citations — 8 traced to source
- {"source":"EU Pharmaceutical Regulation Proposal COM(2022) 134 - Article 5: Marketing Authorisation Requirement","url":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52022PC0134","type":"primary_legislation"}
- {"source":"EU Directive 2001/83/EC - Article 6: Prohibition on placing medicinal products on the market without MA (predecessor to 2022/0134)","url":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32001L0083","type":"primary_legislation"}
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