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Pharmaceutical labels with full regulatory compliance

UPM Raflatac – EMA, FDA and ISO compliant pharmaceutical labels 

All of our pharmaceutical packaging and labeling materials are developed to meet or exceed strict industry regulations and safety requirements, including:

  • EMA (European Medicines Agency) /CVMP/205/04 Guideline on Plastic Immediate Packaging Materials (2005)
  • FDA (Food and Drug Administration, USA) Guidance on Container Closure Systems for Packaging Human Drugs and Biologics (1999)
  • Regulation 1907/2006/EC (REACH)
  • European food-contact regulations; Food Framework Regulation 1935/2004, plastics regulated by EU 10/2011
  • FDA Food Contact Compliance: FDA 21 CFR 175.105 and 175.125 for adhesives; FDA 21 CFR 176.170 and 176.180 for papers
  • Falsified Medicines Directive (2011/62/EU) regarding packaging for prescription drugs and high-risk, over-the-counter medicines. Compliance is achieved by incorporating tamper-evident features as described in the new European Standard EN 16679, “Tamper verification features for medicinal product packaging”.
     

For more information, please contact your closest UPM Raflatac representative.

Safe and reliable pharmaceutical and healthcare labels
Safe and reliable pharmaceutical and healthcare labels

 Pharmaceutical & Health care labeling news

 

 

The EU Falsified Medicines Directive: New legislation for pharmaceutical manufacturers, and a simple label remedy to beat the 2019 deadlinehttp://www.upmraflatac.com/emea/en/news/details/the-eu-falsified-medicines-directive-new-legislation-for-pharmaceutical-manufacturersThe EU Falsified Medicines Directive: New legislation for pharmaceutical manufacturers, and a simple label remedy to beat the 2019 deadline11/07/2016 13:00:00
Tamper-verification with UPM Raflatac’s RP62 EU adhesive – UPM Raflatac at Pharmaceutical Packaging and Labelling Summithttp://www.upmraflatac.com/emea/en/news/details/tamper-verification-with-upm-raflatac’s-rp62-eu-adhesive-–-upm-raflatac-at-pharmaceutical-packaging-and-labelling-summitTamper-verification with UPM Raflatac’s RP62 EU adhesive – UPM Raflatac at Pharmaceutical Packaging and Labelling Summit20/06/2016 06:00:00
Pharmaclear PP Seal RP 62 EU introduces doubly effective counterfeit protection for pharmaceuticalshttp://www.upmraflatac.com/emea/en/news/details/pharmaclear-pp-seal-rp-62-eu-introduces-doubly-effective-counterfeit-protection-for-pharmaceuticalsPharmaclear PP Seal RP 62 EU introduces doubly effective counterfeit protection for pharmaceuticals22/02/2016 09:00:00

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