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Submission of eligibility request to find out whether a product can be evaluated under the centralised procedure, applicants should always submit an eligibility request using the specific form and accompanied by a justification In january 2022 ema published its “reflection paper on good manufacturing practice and marketing authorisation holders” 18 to 7 months before submission of marketing authorisation application more information
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Steps prior to submitting the. Read a comprehensive blog about the steps, requirements and different options for obtaining marketing authorisation in the eu. Becoming a marketing authorisation holder in europe and the uk is a multifaceted journey that demands meticulous planning, adherence to regulations, and ongoing commitment to product quality and safety.
Obtaining marketing authorization (ma) in the eu can be a critical step in securing a commercial foothold for a new medicinal product or in providing vital momentum to a sponsoring company’s market expansion plans.
Learn about the role and responsibilities of marketing authorization holders in the eu Discover key regulatory requirements and compliance strategies for successful authorization. This resource provides a clear and comprehensive overview of the responsibilities of marketing authorisation holders (mahs) under eu legislation Designed as a practical compliance tool, it helps mahs ensure that all key obligations are met efficiently and with confidence.
For companies registered outside of the eu and us, we can act as the market authorization holder (mah) and/or applicant on behalf of the client for registration purposes We can do this because we have legal entities within the eu and a legal entity in the us.
