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MOU 225-11-0021

 

MEMORANDUM OF UNDERSTANDING
BETWEEN
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
AND
THE UPPSALA MONITORING CENTRE
 
1. Purpose
 
The U.S. Food and Drug Administration (FDA) and the Uppsala Monitoring Centre (UMC) share interests in promoting scientific progress through the mutual exchange of information on adverse events associated with the use of medical products. This Memorandum of Understanding (MOU) establishes a strategic framework for collaboration between FDA and UMC and outlines the process for collaborative sharing of public information between the FDA and the UMC for carrying out their common goal to improve the global safety and effective use of medicinal products.
 
2. Background
 
FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the FD&C Act). In fulfilling its responsibilities under the FD&C Act, FDA among other things, directs its activities toward promoting and protecting the public health by assuring the safety, effectiveness, and security of human drugs, vaccines and other biological products, veterinary products, medical devices and radiological products and the safety and security of the food supply, dietary supplements and cosmetics, as well as advancing the public health through regulation of tobacco products. To accomplish its mission, FDA must stay abreast of the latest developments in research and also communicate with stakeholders about complex scientific and public health issues.
 
UMC, also known as the World Health Organization (WHO) Collaborating Centre for International Drug Monitoring, maintains a global post-marketing pharmacovigilance system, Vigibase. To support its pharmacovigilance efforts, UMC maintains a comprehensive source of medicinal product information, the WHO-Drug Dictionary (WHO-DD); a terminology for coding clinical information, WHO-ART; and collaborates with the WHO Collaborating Centre for Drug Statistics Methodology to provide the Anatomical Therapeutic Chemical classification, WHO-ATC. Inaddition, UMC supports innovative research and development, and provides data, reference, consultative and training resources to regulatory agencies, health professionals, researchers and the pharmaceutical industry all over the world.
 
3. General Provisions
 
Access to non-public information shall be governed by separate Confidentiality Disclosure Agreements and/or supplemental agreements (such as "data disclosure clearance agreements" which will be required for any access to the WHO DDE)in which the UMC and FDA will agree and certify in writing that they shall not further release, publish or disclose such information and that they shall protect such information in accordance with the provisions of2l US.C. 3310),21 U.S.C 360j(c),18 US.C. 1905, and other pertinent laws and regulations governing the confidentiality of such information. Non-public information, such as proprietary data, tradesecrets or patient confidential information, shall be disclosed between the UMC and FDA unless agreed and permitted by applicable law.
 
4. Resource Obligations
 
This MOU represents the broad outline of the UMC's and FDA's intent to enter into specific agreements for collaborative efforts in intellectual areas of mutual interest to FDA and UMC. All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds. This MOU does not affect or supersede any existing or future agreements or arrangements among the UMC and FDA. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and the UMC operate. Nothing in this agreement is intended to create or should be interpreted to create any obligations under United States, international or other laws.
 
5. Liaison Officers
 
Initial Liaison Officers for purposes of communications under this MOU are as follows:
 
A. For the Food and Drug Administration:
Dr. Gerald Dal Pan, OSE Acting Director
FDA, CDER, Office of Surveillance and Epidemiology (OSE)
10903 New Hampshire Avenue
BLDG 22 Room 4304
Silver Spring, MD 20993
301-796-2380
Gerald.Dalpan@fda.hhs.gov
 
B. For the Uppsala Monitoring Centre Health:
Ola Strandberg
Vendor Liaison Officer
Box 1051
SE-751 40 Uppsala
Sweden
+46 18656060
Ola.Strandberg@umc-products.com
Ola.strandberg@umc-products.com
 
Each Participant may designate new Liaison Officers at any time by notifying the other Participant's Liaison Officer in writing. If, at any time, a Participant's individual designated as a Liaison Officer under this MOU becomes unavailable to fulfill those functions, that Participant will name a new Liaison Officer within two weeks and notify the other Participant through the designated Liaison Officer.
 
6. Term, Termination, and Modification
 
This MOU will be effective when signed by FDA and UMC. This MOU may be modified by mutual written consent by the Participants or may be terminated by FDA or the UMC upon 60-day advance written notice to the other.
 
 
Approved and Accepted
for the Uppsala Monitoring Centre
Signed by: Marie Lindquist, PhD, MSc Pharm, Dr Med SC
Chairman, Board of Directors
Director
Date: May 15, 2012
 
Approved and Accepted
for the Food and Drug Administration
Signed by: Janet Woodcock, M.D.
Director
Center for Drug Evaluation and Research
Date: April 1, 2012
 
Approved and Accepted
for the Food and Drug Administration
Signed by: Karen Midthun, M.D.
Director
Center for Biologics Evaluation and Research
Date: May 10, 2012