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”.
- The new Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR) published in May 2017 in the EU introduce specific requirements for medical device labeling.
For more information, please contact your closest UPM Raflatac representative.