Supply Chain

Wholesalers in the whole world are obliged to adapt to different regulations and directives, for example EU FMD – Falsified medicines directive whose purpose is to prevent entering of a falsified medicine to a legal supply chain.

Wholesalers in the whole world are obliged to adapt to different regulations and directives, for example EU FMD – Falsified medicines directive whose purpose is to prevent entering of a falsified medicine to a legal supply chain.

Managing upstream and downstream as demanded in all regulations and/or acts (DSCSA, FMD, ANVISA…)  in any group, regardless of its size is always challenging. Since wholesalers usually have a wide range of partners that vary from small pharmacies to large pharmaceutical companies, managing end to end verification and authorization process becomes extremely demanding and overall challenging issue. 

Wholesalers have to keep records in the form of account purchases / sales, in computerized form or in any other form, having at least the minimum required information on each transaction through which the drug was received, shipped or supplied, depending on the country they work in or work for.

When the drug was received from other wholesaler, authorization carriers for wholesale of medicinal products have to check that the wholesalers who supplied the drug acted in accordance with the principles and good practices in the wholesale distribution of drugs. This includes checking if the wholesaler who supplied the drug is licensed for the wholesale distribution.

Are you able to:

  • Create aggregation schemas?
  • Perform all aggregation functions, from identifying the product, verifying packaging options, to the formation of the SSCC number to be printed on the packaging. 
  • Perform deaggregation action on the package, returning items in the package and change the status to deaggregated. 

Your solution has to be able to manage the aggregation and deaggregation of the products. Products at the item level, with its specific Product Identification number (GTIN, IFA PPN, Self-defined, etc.) are bundled into bigger packages. Bundling options may be several, e.g. packaging could be of 12 or 6 bottles of pills on first level, and then this can be further bundled. Each aggregation level should have separate Product number (e.g. GTIN), but if the manufacturer prefers not to define products with the standard GS1 principle, the system has to assign the product identification internally. However, some aggregation bundles can consist of different types of products, e.g. 6 pieces of one, and 6 pieces of different type of product, which is important when the system is used as distributor system. 

Can you...

  • ... create and share event data, both within and across enterprises, or enable shared view of physical or digital objects within a relevant business context?

    EPCIS is a GS1 standard that enables trading partners to share information about the physical movement and status of products as they travel throughout the supply chain – from business to business and ultimately to consumers. It helps to answer the “what, where, when and why” questions to meet consumer and regulatory demands for accurate and detailed product information.


  • ... enable and logistics company or your trading partners to use the system, or create a new order request which will move items from one location to another?

    The system allows the definition of specific types of data to assign to the partner attributes, so you can choose what kind of user and permission your partner will have and monitor what happens with the goods thru its whole life cycle, even thru transportation process.

Solutions

  • CMO's

    Can you continue your work without serialization solution? Since majority of MAH companies are outsourcing manufacturing to CMO’s you are...

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  • Generic and Originator Pharma

    Can I have 5 different solutions for 5 different markets? Most commonly manufacturers are operating on international market and their...

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  • Marketing Authorization Holder

    What are MAH obligation in regards to Serialization? MAHs are, from perspective of regulatory bodies, only legally recognized entities...

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  • Serialization

    Serialization is applying a traceable serial number to a smallest selling item. A serial number must be assigned to each selling item as...

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  • Supply Chain

    Wholesalers in the whole world are obliged to adapt to different regulations and directives, for example EU FMD – Falsified medicines...

    Read More ...

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