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The company receives the approval of the information on the product intended for healthcare professionals and patients (the packaging insert) at the same time as the authorisation.

To obtain an authorisation for a medicinal product, the applicant must submit documentation proving its efficacy, safety and quality.

The life cycle of a medicinal product The process from the development of a medicinal product to its market authorisation is a lengthy one.

On average, it takes between ten to twelve years from the first laboratory studies until the first time a product is prescribed.

It then takes the necessary decisions in order to minimise possible risks for patients.