The Most Head-Scratching Section Of The FMD
Can you put an anti-tamper device on OTC drugs in the EU after next February? Surprise! No.
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FMD, One Year Out
Will the FMD go into effect on-time in one year? Will there be problems? Will there be doom? Probably; Yes; Probably not.
A US Medicines Verification Organization (USMVO)? Again
Should the US pharma supply chain stakeholders create a National Medicines Verification Organization like the EMVO?
A US Medicines Verification Organization (USMVO)?
Should the pharma industry create a US Medicines Verification Organization (USMVO) to help expedite the development of the electronic, interoperable systems that will be necessary by 2023?
The FMD Product Code
Different Member States require different Product Codes under the FMD. Make sure you understand your options.
Sponsored: How Long Until You Are Fully Serialized?
And how soon will the EMA announce a delay in the start of the FMD/DR?
Is Your Drug Too Small For The Mandated 2D Barcode?
What if your drug package is too small to fit the new mandated 2D barcode and human readable information on the label? Let’s take a look at what the regulations say in the E.U., Brazil and the United States.
Pharma Serial Number Randomization Under The Falsified Medicines Directive
Drug companies who serve markets within the European Union (EU) have until February 9, 2019 to add serial numbers within a Data Matrix barcode to their drug packages, among many other specific requirements (see “The ‘Unique Identifier’ in the EU Delegated Act”). The specific requirements are outlined in the EU Delegated Regulation (EUDR). I’ve written … Continue reading Pharma Serial Number Randomization Under The Falsified Medicines Directive
