21 CFR 26, Subpart A, Appendix E to Subpart A of Part 26 - Elements To Be Considered in Developing a Two-Way Alert System
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Pt. 26, Subpt. A, App. 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: Director, Office of Compliance and Biologics Quality (HFM-600), 1401 Rockville Pike, Rockville, MD 20852, phone: 301-827-6190, fax: 301-594-1944.
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]
Title 21 published on 2012-04-01
no entries appear in the Federal Register after this date.
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
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