Title 21

PART 26 APPENDIX E



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

21:1.0.1.1.20.1.63.22.5 : Appendix E

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]