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OMPD Annual report- 14 months from day of COMP positive opinion or from EC decision
OMPD Annual report- 14 months from day of COMP positive opinion or from EC decision
Posted
Tue, 06 Dec 2022 11:28:06 GMT
by
Liron Gibbs-Bar
Senior Regulatory and Scientific Consultant
As the title suggests, I am wondering from which day to start counting the 14 months until OMPD annual report submission. Is it 14 months from day of COMP positive opinion or from receiving EC decision/ day noted on EC letter.
Answer
Posted
Tue, 06 Dec 2022 14:19:57 GMT
by
Monica Gomar Mengod
x
Annual reports for orphan medicinal products designated by the EU should be submitted within 2 months following the anniversary of the grant of the designation, meaning the EC decision.
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