If your company is holding a licence to sell pharmaceutical products in territories covered by Serialization regulation, you might be required to obtain proper serialization solution. Under term Marketing Authorization Holder (MAH) TradeTicity distinguish those companies that are selling products to certain market under own Brand, however they are not manufacturers of that specific pharmaceutical product. Thus, it means product is produced in full, or in significant share by externally contracted organization, called CMO or Contract manufacturing organization. If you are also Manufacturing by yourself, your sister or mother organizations products scheduled to be serialized, please refer to Pharmaceutical manufacturers.

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What are MAH obligation in regards to Serialization?

MAHs are, from perspective of regulatory bodies, only legally recognized entities that have submitted Market Authorization and have obtained licence to market the specific product on specific territory. From legal perspective MAH is responsible to satisfy all regulatory requirements, and thus, MAH is also responsible to generate and if needed provide to regulatory bodies, repositories or other reporting agencies randomized number and other accompanying information.

Thus, in brief, and based on specific regulations, MAH is responsible to:

  • Generate serial numbers in required form
  • Secure that desired information is printed in form defined by regulation to each box, bottle or even blister of the serialized drug
  • If drugs are manufactured by external party (CMO) provide serial numbers to CMO, in secure and reliable way, minimizing risk of possible human errors and fraud
  • Provide, based on regulation reports and data to repositories, or regulatory bodies
  • Provide information about serialized items to supply chain partners (distributors, wholesalers, pharmacies)

Are you are distributor or wholesaler and are looking for solution? Click here to learn how CureSync can satisfy requirements for you, within the same, enterprise level, integrated serialization solution
Click here to download national specific regulation (requires registration): EU | USA |Turkey | Brazil | Russia

What Serialization solution should contain in order to fulfill my requirements

In general, your solution has to support following hi-level functions?

  • Security and secure user management – Why and when do I need this module? – links to (To satisfy requirements of GAMP5 and to minimize the risk of counterfeiters accessing your system, you have to secure highest standards of user management. From defining users, assigning roles to users, tracking the access to the system and obtaining the information from the system, everything -from access, change over pieces of information, logins has to be monitored and logged. Learn how CureSync satisfies security and authentication challenges)
  • Serial number generation– Why and when do I need this module? (If your product is on list and has to be serialized, you have to be able to generate randomized numbers, prove that they are unique in your generation database, and that possibility of guess is aligned to standard set by regulation. Generating serial numbers may vary from country to country, regarding structure or length. For example, Russia may require MAH to generate using Cyrillic letters sequnces of 15 characters, while some other country will decide for numeric sequences of size 20. MAH has to be prepared to satisfy all possibilities. Verify for your regulation what is the requirement here EU | USA |Turkey | Brazil | Russia )
  • Product catalogue - Why and when do I need this module? (Certain information are likely not to be stored in your existing databases, like SAP. Such information may be those of Drug registration number or National reimbursement code. Also, in certain regulations, like EU, selection of the serialization necessity for the product is based on dynamic lists – so called black and white lists. If, your company can not easily support this, or any other attribute then having the internal product catalogue inside serialization solution is a must)
  • CMO partner’s management  – Why and when do I need this module? (While you may decide to export serial number and send them via email to your partner, as well as import results using manual means, MAHs are aware that responsibility for making human mistakes is solely on them. Easy integration using automated mean, which you can configure independently from any solution provider is a must to any serious, professional MAH. When considering automated mean of integration, take into account to buy extended setup package – thus our technical consultants will solve for you hard integration tasks)
  • Logistics – Why and when do I need this module? – (Once products are ready, they will be shippend from manufacturer to you, or distributor you have selected. No matter what will be the route, take care that in some regulations items will have to be registered in your system, and from your system delivered to report repositories of national regulators. Having EPCIS to serve this in automated way is convenient and standard way how properly to solve this problem. To learn exactly what is EPCIS and how it can support you, please click here. To see graphically what you have to do in order to keep to your serialization requirements please select geography of your interest EU | USA |Turkey | Brazil | Russia

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Learn about market specifics related to Market authorization holders

EU | USA |Turkey  | Brazil  | Russia 

How should I know if I am required to obtain serialization solution? 

 

 

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