To the Attention of Manufacturer Companies and Pharmaceutical Wholesalers

As you already know the PTS notifications during Phase 1 were not obligatory, and it was up to the bilateral agreements between the stakeholders whether or not to make the PTS notifications.

As the making notifications in all levels of the supply chain have become obligatory with Phase 2, PTS has become an obligation. However, not making a PTS notification when manufacturer companies and pharmaceutical wholesalers send products to each other will cause the recipient to have a hard time.

Manufacturer companies and pharmaceutical wholesalers have the right to request PTS packages when purchasing products from the manufacturers as of March 1. In this case the manufacturer companies and pharmaceutical wholesalers are responsible of making a PTS notification otherwise the recipient stakeholder has the right not to accept the incoming products.

In addition the below stated matters must be taken into consideration when creating a PTS XML file:

• Only a single XML file should be sent within a single PTS package and this XML file must belong to a single dispatch note.
• The PTS notifications must definitely be made along with the dispatch notification of the products whose aggregation has been done.
• Although the shipTo field is not an obligatory field, it has an importance within the workflow of some pharmacies. Therefore, companies should fill out this field in possible cases and make sure that the information within this field is correct.
• The incoherence of products in packages and the physical products sent by stakeholders will interrupt trade. It is necessary that stakeholders only add products which are physically sent and include all the products in the package which they are sending while creating the packages. Stakeholders have the right not to accept the products in case there are differences between the product list and the physically received products.
• It is of great importance that the SSCC barcode is printed on the carriers which are sent and that this information is consistent with the ones in the PTS XML document. Not entering the carriers in the documents of SSCC in the “carrierLabel” variable causes that the aggregation cannot be comprehended by the recipient.  In addition the barcode standards must be abided by while the SSCC is generated. (See Guideline on Implementation of Identification and Barcoding of Medicinal Products for Human Use)
• The expiration date information in the sent PTS packages must be consistent with the real expiration dates of the products.
• While preparing XML files for PTS, it must be prepared according to the XSD standards published for PTS and the hierarchical structure of the file must be appropriate to this standard. Stakeholders which prepare PTS packages must check that the XML files within the package according to these standards before the transfer.

It is kindly requested that our manufacturer companies and pharmaceutical wholesalers pay attention to these matters.