21 CFR Part 26, Appendix E

—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

—Crisis analysis and communication mechanisms

—Establishment of contact points

—Reporting mechanisms

—Followup mechanisms

—Corrective action procedures

—Pharmacovigilance programme

—Surveillance/monitoring of implementation of corrective action

For the purpose of subpart A of this part, the contact points for the alert system will be:

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.

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]