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.