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Storing and Handling Drugs without a Pharmaceutical Licence

Task

Providing support to our client in an audit of its business and obtaining a lift of Roszdravnadzor’s requirements in drug logistics as part of clinical studies

Client
Clinical study agency
Industry
Clinical study agency

Background

Our client received and delivered to medical centres drugs for use in clinical studies.

An audit conducted by the Roszdravnadzor, the Russian health care watchdog, found the client had no pharmaceutical licence to store the drugs.

Our review of the situation showed that the drug storage business required no licence in isolation from the pharmaceutical business (which is purely commercial).

We filed a complaint against the actions taken by the inspector and the higher-level managers then cancelled the inspector’s order.

Outcome

Our complaint promptly filed against the inspector’s behaviour supported the patient drug supply schedule and made it possible for the clinical study protocol to be met.