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

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 [phone], Fax [phone].

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: [phone], FAX: [phone].

Human Drugs: Director, Office of Compliance, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, phone: [phone], fax: [phone].

Veterinary Drugs: Director, Office of Surveillance and Compliance (HFV-200), MPN II, 7500 Standish Pl., Rockville, MD 20855-2773, phone: [phone], fax: [phone].

[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]