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Turkish Medicines and Medical Devices AgencyTurkish Medicines and Medical Devices Agency

Turkish Medicines and Medical Devices Agency
 

Accountability

Accountability Depot Meridian; allows clients to demonstrate effective compliance with regulatory requirements by providing a full chain of custody for every medication unit, from dispatch to dispensing to destruction.
Records of accountability documentation include:

  • Drug Receipt
  • Drug dispense
  • Drug Disposition (returned, destroyed, used, unused)

Import & Export Customs Clearance

  • Clearance dossier preparation, submission to customs,and makingnecessary payments for clearance.
  • Follow-up of all process and finalizing the clearance and shipment to Depot Meridian
  • Ensuring the appropriate documentation is filled out according to Turkish custom regulations and the correct importing and exporting procedures followed to minimize clearance delays.

Distribution

Our distribution network and project management experience ensures your products are handled by a highly skilled and trained team. Distribution services offered at Depot Meridian are:

  • Drug deliveries to the sites
  • Drug collection from sites
  • Reconciliation services
  • Exportation and Destruction of drugs

Import License Application

Depot Meridian offers the service of required data and documents collection and submission to receive the official approval to import the medicine used in clinical drug studies according to Turkish regulations.

Archiving

Secure archiving of hard copy completed study documents up to 12 years is also possible at Depot Meridian facility.

Storage Facilities

Depot Meridianhas the capability of storing IMPs in specialized 0.5 cubic meter cells in the following facilities and conditions:

  • Ambient Room (+15°C to +25°C)
  • Cold Room (+2°C to +8°C)
  • Biological Material Cold Room (+2°C to +8°C)
  • Controlled Substances (+2°C to +8°C and +15°C to +25°C)
  • Segregated area for returned goods, damaged products, and quarantined items

Temperature monitoring systems

Depot Meridian offers the service to monitor the temperature and humidity conditions of IMPs stored at Investigator sites in order to provide more accurate reporting to sponsor and ensure the safety of the patients.

The automated system covers all 24/7 instant and past temperature and humidity information of the IMPs stored at the investigator site. Abnormal temperature and humidity values are sent to assigned people as warnings via GSM, E-mail, and can also be viewed through the Web based system. This feature ensures that relevant people are instantly informed of alarm situations and make the necessary actions to ensure the well-being of the stored items.

Providing shippers (temperature controlled)

Depot Meridian also offers the solution to provide transfer boxes capable of maintaining temperature at +2°C to +8°C, and +15°C to +25°C, up to 120 hours.

  • Drug Receipt
  • Drug dispense
  • Drug Disposition (returned, destroyed, used, unused)

 

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