Module 18 2021

07/02/2021

The requirement

 Directive 2001/83/EC requires that applications for authorisation to place a medicinal product on the market have to be accompanied by a dossier containing particulars and documents relating in particular to the results of physico-chemical, biological or microbiological tests as well as pharmacological and toxicological tests and clinical trials carried out on the product and thus proving its quality, safety and efficacy.

The Organisation for Professionals in Regulatory Affairs

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GMP and Quality…

 Directive 2003/94/EC “ The manufacturer shall ensure that all manufacturing operations subject to an authorisation for marketing are carried out in accordance with the information given in the application”

The Organisation for Professionals in Regulatory Affairs

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