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]