| CRO01-2025/26 | Core Business Escalation Procedure | Communication to industry | 18/11/2025 | 1 | Biological Medicines, Clinical Evaluations Management, Clinical Trials, Complementary Medicines, Inspectorate, Licencing, Medical Devices, Pharmaceutical Evaluation Management, Radiation Control, Regulatory Compliance, Section 21, Veterinary medicines | Download | communication-to-industry | biological-medicines-evaluation-and-research clinical-evaluations-management clinical-trials complementary-medicines inspectorate licencing medical-devices pharmaceutical-evaluation-management radiation-control regulatory-compliance section-21 veterinary-medicines |
| Retention Fee Notification – 9 June 2022 | Communication to industry | 24/06/2022 | 1 | Biological Medicines, General ECTD & human medicines, Inspectorate and good manufacturing practices, Medical Devices | Download | communication-to-industry | biological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines inspectorate-and-good-manufacturing-practices medical-devices |
| Submission of Post-Importation Testing Exemption requests for Biological and Biosimilar Medicines | Communication to industry | 24/03/2022 | 1 | Biological Medicines, Inspectorate and good manufacturing practices | Download | communication-to-industry | biological-medicines-evaluation-and-research inspectorate-and-good-manufacturing-practices |
| 9.126 | Reflection document on regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2 | Communication to industry | 20/05/2021 | 1 | Biological Medicines | Download | communication-to-industry | biological-medicines-evaluation-and-research |
