Doc. Ref: US/MRA/EMEAv1.0
United States - EC Mutual Recognition Agreement
Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs)
FINAL
Joint Procedure for the Exchange of Serious or Life-Threatening Human / Animal Pharmaceutical Product Recalls
Status
Title: SOP US/MRA/EMEAv1.0 |
Final Date: 23 March 2000 |
Applies to: Parties of the United States - EC MRA |
Effective Date: 1 April 2000 |
Status: Public |
Posting Date: 30 March 2000 |
1 April 2000
Doc. Ref: US/MRA/EMEAv1.0
Joint Procedure for the Exchange of Serious or
Life-Threatening Human / Animal Pharmaceutical
Product Recalls
I. General
A. Introduction
Article 20 of the U.S.-EC MRA Pharmaceutical Good Manufacturing Practices Annex (hereinafter referred to as "the Annex") requires that an alert system be developed and maintained. The intention of the alert system is to promptly notify authorities of quality defects, recalls, counterfeiting and other problems concerning quality which could necessitate additional actions or suspension of the distribution of pharmaceutical/medicinal products.
Appendix 5 of the Annex indicates a number of elements to be considered in developing this alert system. The elements include documentation, a crisis management system, enforcement procedures, a quality assurance system, and contact points. The MRA Framework states that the U.S. and the EU "will maintain, to the extent required under its laws, the confidentiality of information exchanged under this Agreement."
It is the responsibility of the Competent Authority of each EU Member State and the FDA in the United States to assist the recalling firm in the recall process, as appropriate, and to monitor its effectiveness. It is also the responsibility of the Competent Authority/FDA to ensure that information concerning a recall of pharmaceutical products is notified to other Member States and MRA-Partners, if the nature of the defect presents a risk to public health.
By joint collaboration and agreement this document establishes the procedures for US-EU exchanges of certain product recall information in partial implementation of Article 20 of the U.S.-EC MRA, Pharmaceutical GMPs Annex. In the future, additional information exchanges or procedures will be established to fully implement Article 20.
B. Purpose and Goals
The purpose of this procedure is to share information in a timely and effective manner so as to minimize the risk to the affected public and maintain confidence in the system. It includes the transmission of information relating to the quality of pharmaceutical products under recall.
The goals expected to be achieved by this procedure are:
C. Scope
This recall notification standard operating procedure is intended to cover the same human/animal pharmaceutical products covered by the Annex, as stated below:
D. Definitions
Recall |
means a firm's removal or correction of a marketed product that is in violation of applicable laws and may pose a potential hazard to public health. |
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Recall classification |
means the numerical designation, i.e., Class I, Class II, or Class III, assigned to a particular product recall to indicate the relative degree of health hazard presented by the product being recalled. |
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Class I |
is a recall situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. (U.S.) |
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is a recall situation in which there is a reasonable probability that the use of, or exposure to, a defective product is life threatening or could cause serious risk to health or death. (EC) |
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Class II |
is a recall situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. (U.S.) |
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is a recall situation in which the use of, or exposure to, a defective product could cause illness or mistreatment but is not Class I. (EC) |
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Class III |
is a recall situation in which the use of, or exposure to, a violative product is not likely to cause adverse health consequences. (U.S.) |
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is a recall situation in which the use of, or exposure to, a defective product is not Class I or II and may not pose a significant hazard to health, but withdrawal may have been initiated for other reasons. (EC) |
II. Procedures for the Exchange of Recall Information
A. Information to be Exchanged
Parties agree to exchange product recall information with the designated contacts in a timely manner. Parties will exchange all Class I and Class II recalls of pharmaceutical products, as defined by the respective party, if the recalled product or a component in the product that causes the product to be in violation of the law or is considered to be defective was distributed to the jurisdiction of the other party (i.e., any EU Member State or the USA) or originated from the jurisdiction of the other party (i.e., any EU Member State or the USA). Whenever feasible, parties will make an effort to exchange information about emerging Class I recalls prior to their official classification.
Specifically, only the following information about each recall is to be exchanged:
Attachment A, Notice of Recall is the standard form to be used in this exchange. Shaded areas are not required in the information to be exchanged.
B. Responsibilities
For a batch manufactured in an EU Member State, or a batch manufactured in a third country and imported into the EU, which is the subject of a national or decentralized marketing authorization, it is the responsibility of the Competent Authority of that State to issue the Notice of Recall. Normally this is the State in which the defect was first identified.
In the case of a centralized authorization, it is the responsibility of EMEA to issue the Notice of Recall and to co-ordinate subsequent action.
For a batch manufactured in the United States, it is the responsibility of the FDA to issue the Notice of Recall.
C. Mode of Communication
Both parties will endeavor to exchange the Notice of Recall (described in II. A. above and Attachment A) in the English language and transmit by fax and/or electronic mail to the EU Member State/EMEA/FDA contacts identified in Attachment B. The EMEA will facilitate clarification of any document received by the FDA under this SOP.
III. References
U.S. FDA:
EU:
IV. Implementation
This SOP is for immediate implementation and will be reevaluated after being in effect for a time period of six (6) months.
Attachment A: Notice of Recall
IMPORTANT -- DELIVER IMMEDIATELY
RAPID ALERT NOTIFICATION OF A RECALL |
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1. To: (see list attached, if more than one) |
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2. Product Recall Classification: (circle one) |
I |
II |
III |
3. Counterfeit / Fraud (specify) |
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4. Product: |
5. MA Number: For use in humans/animals (delete as required) |
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6. Brand/Trade Name: |
7. INN/Generic Name: |
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8. Dosage Form: |
9. Strength: |
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10. Batch/Lot Number: |
11. Expiry Date: |
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12. Packaging Information: |
13. Date Manufactured: |
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14. MA Holder: |
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15. Manufacturer:
Contact Person: Telephone: |
16. Recalling Firm:
Contact Person: Telephone: |
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17. Recall Number Assigned: |
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18. Details of Defect/Reason for Recall:
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19. Information on distribution including exports (type of customer, e.g. hospitals): |
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20. Action taken by Issuing Authority:
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21. Date and Method of Recall:
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22. From (Issuing Authority):
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23. Contact Person: Telephone: |
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24. Signed: |
25. Date: |
26. Time: |
This is intended only for the use of the party to whom it is addressed and may contain information that is privileged, confidential, and protected from disclosure under applicable law. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized. If you have received this document in error, please notify us by telephone immediately and return it to us at the above address by mail. Thank you.
Attachment B: Designated Contacts
The U.S. FDA contact points are:
The EU Member State/EMEA contact points (at the request of the EU/EMEA, the designated contact list is not being posted at this time).
(Hypertext updated by mev 2000-OCT-03)