Spring Intro 2023

16/02/2023

MAINTAINING COMPLIANCE: - SUNSET CLAUSE MONITORING

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Why Important?

EU Legislation (2005): ● Cessation of the validity of the marketing authorisation if a medicinal product is not: – Placed on the market within three years of authorization OR – Marketed for three consecutive years.  Clock typically starts from approval date ● At least one presentation/pack size required in a single EU market (incl. Norway, Iceland, Lichtenstein) to maintain authorization ● Exceptional circumstances: MA holders may request an exemption. Example: Product not placed on market due to emergency medicinal preparedness If granted = a further 3 years

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