Northern Ireland Field Safety Corrective Actions (FSCA)

D

debbie gallagher

Starting to get Involved
#1
#1
Can anyone answer. If Northern Ireland is affected by a FSCA from a non UK non EU manufacturer, who approves the FSN is it the MHRA or the other NCA or both?
 
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Jim Wynne

Jim Wynne

Leader
Admin
#2
#2
You would do well to unbundle the abbreviations FSCA, FSN, MHRA and NCA. You might also want to edit the post to provide a more descriptive thread title.
 
D

debbie gallagher

Starting to get Involved
#4
#4
Can anyone answer. If Northern Ireland is affected by a Field Safety Corrective Action from a non UK non EU manufacturer, who approves the Field Safety Notice? Is it the medicines-and-healthcare-products-regulatory-agency or the other National Competent Authority, where the EU Authorised Rep is based or both?
 
A

Awadine

Involved In Discussions
#5
#5
The NCA for Northern Ireland is MHRA so I would say MHRA would want to be consulted on and approving your FSN. But this is unchanged from before Brexit. MHRA would always have expected to receive a copy of an FSN for review even if the NCA where the Authorised rep is based had approved the letter. And the bottom line is that MHRA can issue their own advice if they disagree with your letter content so always best to involve them at the draft stage to ensure communication to users is clear.
 
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