[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26A App E]

[Page 254]

                        TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
                                SERVICES

   PART 26_MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE
PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY--Table of Contents

      Subpart A_Specific Sector Provisions for Pharmaceutical Good
                         Manufacturing Practices

Sec. 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 (HFD-300), 5600 Fishers
Lane, Rockville, MD 20857, phone: 301-827-8910, fax: 301-827-8901.
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]