CRPT developed an instruction for connecting to the labeling system
The Center for Research in Perspective Technologies (CRPT) developed the instructions for pharmacies and medical institutions to register in the track & trace system.
The steps of the registration in IS MDLP (information system to monitor pharmaceutical products circulation) are described at Честный знак.рф. This website provides information on how to become an MDLP participant (for pharmaceutical products manufacturers, pharmacies, wholesalers, medical organizations). The description of main actions for MDLP participants, regulatory documents, preparation for marking, technical documents for software developers, etc. are also available here.
The instructional video on how to get registered in the track & trace system for pharmacies and medical institutions is available here.
CV Protek participates in the pilot project on track & trace system implementation for pharmaceutical products.
Prior to delivery of marked goods, the representatives of pharmacies and medical institutions should do as follows:
- to report their registration code, received in GIS Markirovka (this code is required for message exchange in GIS Markirovka format) to the manager of CV Protek CJSC;
- to request the registration code of CV Protek CJSC received in GIS Markirovka, and to confirm they are in the authorized counterparties list of CV Protek CJSC (request message to firstname.lastname@example.org);
- shipment of marked goods from the warehouse of CV Protek CJSC is generally performed with the confirmation of arrival issued by customer;
- the procedure when the confirmation of arrival is issued by the customer demands that the customer sends to MDLP system the confirmation of CV Protek CJSC marked goods delivery no later than 5 business days upon the delivery and in any case before the ownership on the medications is transferred to the customer.
Prior to shipment of marked goods, the manufacturers - suppliers should perform the following:
- to report the start date of production/delivery of the marked goods to the manager of CV Protek CJSC;
- to submit a tag list and a list of series, that have passed serialization and have been included into Marking (MDLP)
- to report to CV Protek CJSC (to a procurement department manager) the registration code, received in GIS Markirovka (this code is required for message exchange in GIS Markirovka format);
- to request the registration code of CV Protek CJSC received in GIS Markirovka (request message to email@example.com);
- delivery of marked goods to the warehouses of CV Protek CJSC is generally performed with the confirmation of arrival issued by supplier;
- the procedure when the confirmation of arrival is issued by supplier demands that the supplier sends to MDLP system the confirmation of marked goods shipment prior to actual delivery of pharmaceutical products to the warehouses of CV Protek CJSC.
General requirements to delivery of marked goods to CV Protek CJSC warehouse as part of the experiment include the following:
1. to issue a separate delivery slip for the marked products
2. to support the delivery of marked goods with messages in GIS Markirovka (MDLP). In this case, the data should be transmitted to GIS Markirovka prior to actual delivery of marked goods to the warehouses of CV Protek CJSC;
3. to put the marked goods on a separate pallet (when marked goods are delivered in large quantities, sufficient to form a full pallet), distinguished from the rest of the products delivered with a visible mark (for example, with colored Duct tape or by other means);
4. to make the box on a box pallet visually distinguished (when marked goods are delivered in small quantities, not sufficient to form a full pallet) with colored Duct tape or by other means. In this case, the box pallet containing boxes with marked goods should be made visually distinguished among other pallets delivered as well.
July 1, 2019 is a start date for the registration of pharmacies and medical institutions in the Chestny ZNAK track & trace digital system to handle medications listed as high-cost nosologies. On October 1, 2019, marking for medications from the list of high-cost nosologies will become mandatory. The launch of mandatory marking for all medications is January 1, 2020.
 Serialization is performed during production cycle stage “packaging/ pharmaceutical products secondary packaging”. It is generation of individual serial numbers for secondary (consumer) packages of pharmaceutical products and their encoding by pharmaceutical products circulation body along with other data required for CIM (Control Identification Mark) subsequently marked to provide for secondary (consumer) packages identification.
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