Guidance for industry to prevent and mitigate medicine shortages-2023/5/17

Regulatory and procedural guideline: Good practices for industry for the prevention of human medicinal product shortages-2023/5/17

Scientific guideline: Concept paper on revision of the Guideline on clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome-2023/5/4

Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes -2023/4/25

Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes-2023/4/25

Pre-authorisation guidance-2023/4/25

Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes-2023/4/25

Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure-2023/4/25

Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure-2023/4/25

Regulatory and procedural guideline: Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to