Italian Medicines Agency Agenzia Italiana del Farmaco

Qualified person

Qualified person

The manufacturing authorisation holder shall appoint at least one qualified person. The qualified person is an employee of the company and carries out the tasks described in article 52, para. 8, of Leg. Decree 219/2006.

AIFA acknowledges the suitability of the qualified person at pharmaceutical sites producing/importing medicinal products according to the requirements described in article 52, para. 3.

A qualified person for medicinal products production sites can also be appointed as qualified person for the production of active substances and medicinal gases. The legislation provides for a second type of qualified person relating to the production of advanced therapy medicinal products.

AIFA also issues authorisations for the appointment and replacement of the qualified person at medicinal products production/importation sites, when an appropriate request is submitted by the production/importation site concerned. The appointment and replacement of the qualified person is an essential change for which companies are required to wait for a decision by AIFA.

If a qualified person needs to be replaced for reasons of necessity, the new qualified person may carry out its activities pending AIFA formal authorisation of such replacement. In any case, the above reasons of necessity shall be promptly communicated and duly documented in order for article 50, para. 6, to apply.

Where article 50, para. 6, is not applicable, the new qualified person is authorised to carry out its activities only after formal authorisation by AIFA, specifically by the GMP MED Office.

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Reference offices

Ufficio Ispezioni e autorizzazioni GMP medicinali

Domenico Di Giorgio (ad interim)

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