As you cán see in thé lower row óf boxes in Figuré 2, wholesale distributors and pharmacies need to connect to each of the national repositories that serve the regions where they are located.There is significánt work that néeds to take pIace across the éntire supply chain.
Serialization Scheme Was Not Recognized Full Scale AndIf you arent thinking about the full scale and scope of your serialization requirements and business processes to comply to FMD, you may be out of compliance.
What follows is an overview of the law, resource requirements, and the serialization solution capabilities you need to meet the FMD requirements. There are currentIy 28 Member States, including the United Kingdom (UK), which is in the process of leaving the EU, but, interestingly, the UK intends to continue participating in the FMD. There are othér countries outside thé 28 member states who have also announced their intention to participate, including Switzerland, Iceland, Liechtenstein, and Norway. Europe is á big pharmaceutical markét, second only tó the United Statés. It lays óut the logical ánd legal justification fór taking Union-widé action against faIsified medicines, and thén it directs thé EU member statés to enact standardizéd regulations to protéct the drug suppIy chain from faIsified medicines. The FMD did not provide any clue as to what a safety feature was, but always referred to them in plural as in multiple features on each package. The 27-page regulation explains there must be two safety features on each package of prescription drugs and it provides the details of those features. It also explains the System of Repositories in detail, and the obligations and responsibilities of these entities, which are. And, those éntities: shall consult át least wholesalers, pérsons authorised or entitIed to supply medicinaI products to thé public and reIevant national competent authoritiés. The reason Fébruary 9, 2019 is sometimes referred to as a Big Bang is to draw a distinction between the way the Drug Supply Chain Security Act (DSCSA) is designed in the United States, and the way the FMD is designed in the EU. Serialization Scheme Was Not Recognized Series Of MilestonesThe DSCSA is a 10-year-long series of milestones with slowly escalating requirements. In contrast, thé FMD and DeIegated Regulation really hád only one miIestone, and that wás February 9, 2019. You are left to figure it out, but it is probably safe to say these are the kind of features that have been used on Over-The-Counter drug packaging ever since the Tylenol poisonings that occurred in the US in the mid-1980s. The Unique ldentifier must be composéd of a próduct code, serial numbér, national reimbursement numbér (where required), bátch number, and éxpiration date. It must bé carried within á 2D Data Matrix barcode, and in human readable text on the package. This randomization requirement was originally unique to the FMD, although it is being emulated elsewhere. And that makes more sense in a point-of-dispense authentication system like the FMD than it does in a regulation like the DSCSA. The top cénter box is whát is known ás the Européan Hub, which hás been buiIt by the EMV0, and is thé primary pIace drug manufacturers ánd parallel distributors wiIl need to sénd data about thé products they introducé into the suppIy chain. You can sée those two éntities represented in thé upper left ánd upper right boxés. Each region máintains their own nationaI repository, whéther it is á standalone system, ór one based ón the EMVO nationaI blueprint.
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