The regulatory authorities' perception of the routine duties of the Qualified Person is to be found in Section 8 of Annex 16 for marketed products and in Section 40 of Annex 13 for investigational medicinal products.
Verification of Compliance of Investigational Medicinal Products with Good Clinical and Manufacturing Practice
Consistency with the arrangements on great clinical and assembling practice, Member States will delegate monitors to assess the destinations worried by any clinical preliminary led, especially the preliminary site or locales, the assembling site of the investigational therapeutic item, any research facility utilized for examinations in the clinical preliminary or potentially the support's premises.
Where a Member State has objective justification for thinking about that the conditions in the solicitation for approval are not generally met or has data raising questions about the security or logical legitimacy of the clinical preliminary, it might suspend or preclude the clinical preliminary and will advise the support thereof.
For the purposes of implementation of clinical trials, Member States shall take the measures necessary for the establishment and operation of Ethics Committees. The Ethics Committee shall give its opinion before a clinical trial commences, on any issue requested.