21 CFR Appendix E to Subpart A of Part 26 - Elements To Be Considered in Developing a Two-Way Alert System

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Appendix E to Subpart A of Part 26 - Elements To Be Considered in Developing a Two-Way Alert System
1. Documentation
- Definition of a crisis/emergency and under what circumstances an alert is required
- Standard Operating Procedures (SOP's)
- Mechanism of health hazards evaluation and classification
- Language of communication and transmission of information
2. Crisis Management System
- Crisis analysis and communication mechanisms
- Establishment of contact points
- Reporting mechanisms
3. Enforcement Procedures
- Followup mechanisms
- Corrective action procedures
4. Quality Assurance System
- Pharmacovigilance programme
- Surveillance/monitoring of implementation of corrective action
5. Contact Points
For the purpose of subpart A of this part, the contact points for the alert system will be:
A. For the European Community:
the Executive Director of the European Agency for the Evaluation of Medicinal Products, 7, Westferry Circus, Canary Wharf, UK - London E14 4HB, England. Telephone 44-171-418 8400, Fax 418-8416.
B. For the United States :
Biologics:Food and Drug Administration, Center for Biologics Evaluation and Research, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002, telephone: 240-402-9153, FAX: 301-595-1302.
Human Drugs: Director, Office of Compliance, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, phone: 301-796-3100, fax: 301-847-8747.
Veterinary Drugs: Director, Office of Surveillance and Compliance (HFV-200), MPN II, 7500 Standish Pl., Rockville, MD 20855-2773, phone: 301-827-6644, fax: 301-594-1807.
[63 FR 60141, Nov. 6, 1998, as amended at 69 FR 48775, Aug. 11, 2004; 74 FR 13112, Mar. 26, 2009; 80 FR 18090, Apr. 3, 2015]

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