Falsified Medicines and the Introduction of Safety Features for Wholesale Distribution Authorisation Holders

by | Dec 19, 2014 | Falsified Medicines

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Welcome to the new unique identifier that will come into implementation during 2015. Giving a three year count-down to all companies involved with the distribution of medicines. The composition, format and carrier of the unique identifier will be harmonised across the European Union.

 

What information will it contain?

  1. Manufacturer code
  2. Serialisation number
  3. Batch number
  4. Expiry date
  5. National reimbursement number (if applicable)

 

What medicines will this effect?

 

As stipulated by the Falsified Medicines Directive 2011/62/EU

  • Any medication subject to a prescription shall bear the safety features.
  • Any medication not subject to prescription shall not bear the safety features

 

Simple then! Prescription only medicines = 2D barcodes P and GSL = no 2D barcode

 

The plot thickens…

 

Medication can be listed by the commission to include or not include the unique identifier!

 

POM’s that do not require a unique identifier will be listed on the ‘white’ list

P and GSL’s that do require a unique identifier will be listed on the ‘black’ list

The medicines to be placed on these list are yet to be decided upon. The UK have made comments which have been forwarded to the commission for review. The waiting game is upon us!

 

What will the process look like?

  • The manufacturer will load the product and its unique serialisation number to the data repository
  • Wholesalers will be expected to carry out risk based verification – such as products with a high risk of falsification, returns, medicines with a supply chain of more than one wholesaler.
  • Final verification prior to dispensing

 

Reason behind this:

  • Verify authenticity
  • Identification of individual packs
  • Harmonisation across the European Union
  • Reduce the number of falsified medicines circulating

Time to get ready Wholesalers the countdown is on! For more information regarding the Safety Features or the future of wholesaling and the regulations contact Pharmacy Consulting Limited on 01252 302342

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