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MEB 48: a national informed consent marketing authorization application

MEB

The Medicines Evaluation Board (MEB) introduced MEB 48, a new policy concerning the application of marketing authorizations for medicines that are identical to medicines already authorized. For this, a national informed consent marketing authorization application has to be used including a copy of the full dossier of the reference medicine. However, when applying for a license to market such a medicine, the company needs to have permission of the marketing authorization holder of the reference medicine. If the reference medicine is authorized for less than 5 years, the application procedure will take 45 days at maximum. If the reference medicine is authorized for more than 5 years, the application procedure can last up to 210 days.
Summarized, MEB 48 thus promotes the authorization of generic medicines!

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