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Electronic notification for Inspection and GMP decrees

Electronic notification for Inspection and GMP decrees

The Inspection and GMP Authorisation Unit of the Italian Medicine Agency
informed that, in the frame of the extraordinary measures adopted to contain the COVID-19 pandemic, it will be possible to request the shipment of the decrees under notification via registered letter with return receipt.

All interested companies shall send a request on unstamped paper signed by the legal representative, enclosing copy of the ID of the latter and a revenue stamp of 16.00 € every 4 pages of the decree.

On this regard, the Unit reminded that, generally, the revenue stamps
required to obtain the documents are the following: 1 for QP appointments, resignations and replacements at a pharmaceutical manufacturing sites, and for deeds on the competence to take on the role of QP of pharmaceutical manufacturing sites; 1 or 2 for GMP certificates, CPPs and CPOs, and 2 or 3 for Manufacturing Import Authorisations (MIAs) (including change of trade name, ownership, legal office or address). It is also essential to indicate the exact shipment address.

Foto di Arek Socha da Pixabay