| Pharmacovigilance |
Pharmacovigilance is defined as the gathering of clinical data related to the drug reliability in the daily clinical applications, the tracking of problems which are experienced during the application of drugs, determining the responsible reasons,...
Pharmacovigilance is defined as the gathering of clinical data related to the drug reliability in the daily clinical applications, the tracking of problems which are experienced during the application of drugs, determining the responsible reasons, identification, research, recording, announcing, and taking the necessary precautions.
It also comprises the scientific studies related to the determining of the adverse effects and the other possible problems based on medicinal products for human use, analysis, identification and prevention.
Source: http://farmakovijilansdernegi.org/ |
| Phase 1 |
The Pharmaceutical Track and Trace System consists of two phases based on its structuring. As it was believed that applying all the rules of the supply chain at one will raise difficulties for the stakeholders, the decision was made to apply the s...
The Pharmaceutical Track and Trace System consists of two phases based on its structuring. As it was believed that applying all the rules of the supply chain at one will raise difficulties for the stakeholders, the decision was made to apply the system with a two level transition. These transitions are called Phase 1 and Phase 2.
Phase 1 is identified as the former application that the Pharmaceutical Track and Trace System is using and applying right now. In the Phase 1 of the Pharmaceutical Track and Trace System it was manufacturers were obliged to make production notifications and pharmacies were obliged to make consumption notifications. Notifications like purchase, return, consumption, deactivation, dispatch etc. were optional. However with the transition to Phase 2 (The phase applied by ITS right now) to as of January 1, 2012 making the production, importation, dispatch, consumption, dispatch return, deactivation, purchase approval, exportation and dispatch cancellation notifications has been made obligatory for all stakeholders.
The starting date of Phase 2 is January 1, 2012. As of this date all the products whose production notification is made are considered as Phase 2 products. The important point here is that, the date that created the distinction between Phase 1 and Phase 2 is not the date of the product’s physical production, it rather is the date of the production notification. All the products whose production notifications have been done after this date will be treated as Phase 2 products in its transactions. For more information you may examine the “Phase 1 – Phase 2” article. |
| Phase 2 |
The Pharmaceutical Track and Trace System consists of two phases based on its structuring. As it was believed that applying all the rules of the supply chain at one will raise difficulties for the stakeholders, the decision was made to apply the s...
The Pharmaceutical Track and Trace System consists of two phases based on its structuring. As it was believed that applying all the rules of the supply chain at one will raise difficulties for the stakeholders, the decision was made to apply the system with a two level transition. These transitions are called Phase 1 and Phase 2.
Phase 2 is the phase of the Pharmaceutical Track and Trace System which is in operation right now. Making the production, importation, dispatch, consumption, dispatch return, deactivation, purchase approval, exportation and dispatch cancellation notifications has been made obligatory with Phase 2.
The starting date of Phase 2 is January 1, 2012. As of this date all the products whose production notification is made are considered as Phase 2 products. The important point here is that, the date that created the distinction between Phase 1 and Phase 2 is not the date of the product’s physical production, it rather is the date of the production notification. All the products whose production notifications have been done after this date will be treated as Phase 2 products in its transactions. For more information you may examine the “Phase 1 – Phase 2” article. |
| Product |
Are all the individual units of a drug. Defines every single drug unit which has been serialized and is traced by ITS.
Are all the individual units of a drug. Defines every single drug unit which has been serialized and is traced by ITS. |
| PTS |
ITS operates on the basis of single drug units. However, commercial transfers are not done by single units; instead they are done using transport units such as bundles, cases and pallets. Thus, the need to share information of the transport units ...
ITS operates on the basis of single drug units. However, commercial transfers are not done by single units; instead they are done using transport units such as bundles, cases and pallets. Thus, the need to share information of the transport units among the stakeholders arose. Therefore, an XML file standard that includes the hierarchical relation between the transportation unit and the drug units has been developed with the contribution of the stakeholders. Furthermore a secondary system, ITS-PTS, operating as web services has been developed to allow stakeholders to share created XML files among each other.
ITS-PTS uses the ITS authentication system in order to share transfer files among the stakeholders. In addition it also contributes to the stock regulation and tracking since it also contains the hierarchical structure of the transfer units.
For more information, visit the Package Transfer Service page. |
