Procedural guidance on inclusion of declared interests in the 2025

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The provision of information on all potential conflicts of interests by an individual, including recent work activities, investments and family connections with the pharmaceutical industry. More information can be found under Handling competing interests.
If a medicinal product is not placed on the market within three years or if the product is not present on the market for three consecutive years, the authorisation is terminated ing to Sunset Clause.
EMAs policy on handling competing interests of scientific committee members and experts (Policy 0044) allows it to restrict or exclude the potential involvement of an expert in any EMA activity, due to interests in the pharmaceutical industry or in the medical-device industry.
Sunset clauses (sometimes also referred to as survival or grandfathering clauses) guarantee that all investments made prior to the termination of a treaty continue to be protected during a certain period of time, typically ranging from 5, 10, 15 and up to 20 years.
In public policy, a sunset provision or sunset clause is a measure within a statute, regulation, or other law that provides for the law to cease to be effective after a specified date, unless further legislative action is taken to extend it.
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Sunset clauses provide that a treaty lapses automatically erga omnes (or for certain subjects) on (i) a fixed and precise date or (ii) after the passage of a specified, determined period of time.
A legal provision stating that the marketing authorisation of a medicine will cease to be valid if the medicine is not placed on the market within three years of the authorisation being granted or if the medicine is removed from the market for three consecutive years.
Eligibility request and letter of intent to submit an MAA You must use the EMA Pre-submission request form, which also provides an overview of the type of MAA the EMA should expect to receive from you. You can submit your eligibility request up to 18 months and at least 7 months before you plan to submit your MAA.

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