UPMRaflatac

Pharmaceutical labels with full regulatory compliance

Developed, formulated and manufactured for comprehensive regulatory compliance

 

Choosing a label that is made from pharmaceutical grade materials is crucial to protecting patients and ensuring that pharmaceutical products are safe. At UPM Raflatac, we assure the safety of our labels by using materials that have been rigorously pre-tested, meet global regulatory requirements and offer a secured long-term supply.

 

Food contact material regulations

Our label materials for pharmaceuticals and healthcare are designed to meet food contact material regulations. Our label materials meet or exceed one or both of the following regulatory and safety requirements for food contact:

  • 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

Migration safe pharmaceutical labels

Labels play a role in protecting patient safety by carrying crucial medical information. Labels can also cause concern in cases when certain pharmaceutical products require migration safe materials, such as liquid nasal sprays. Developed in accordance with industry guidelines, our selected materials and advanced adhesive technology meets the compliance requirements defined in the regulations listed below: 

  • 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)

Falsified Medicines Directive (2011/62/EU)

The Falsified Medicines Directive (2011/62/EU) regards packaging for prescription drugs and high-risk, over-the-counter medicines. Compliance is achieved by incorporating tamper-evident features as described in ISO 21976 standard ‘Packaging — Tamper verification features for medicinal product packaging’, supporting the harmonization and implementation of tamper verification features to the packaging of medicinal products worldwide.

 

Medical device regulations

Medical device guidelines require that the printing and labeling systems are compatible with the sterile barrier system processing, device and materials as well as remain intact and legible until the point of use.  Medical device labeling helps patients or end-users in understanding the device, its operation, care, and maintenance. Medical device regulations include: 

  • The new emerging global Medical Device regulation includes the adoption of a Unique Device Identification (UDI) serialization system to mark and identify medical devices in the healthcare supply chain. One of the latest UDI regulatory updates is the new EU Medical Device Regulation [MDR], with a May 2020 implementation deadline, which is a similar  system to the one adopted by the US FDA in 2013. 
  • The In Vitro Diagnostics Regulations (IVDR) is the regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market. The deadline for implementing  The In Vitro Diagnostics Regulations (IVDR) in EU is May 2022.
 

Why use dedicated pharmaceutical labeling solutions?

Labels carry crucial medical information throughout the life cycle of the product, while also playing a role in protecting and sealing the contents of the product. Patient-safe labeling solutions are everyone’s responsibility. High durability, print quality, performance, regulatory compliance and patient safety are just some of the features the label must possess. By choosing dedicated pharmaceutical labeling solutions, brands and businesses ensure that those label materials are:

  • designed and pre-tested for pharmaceutical applications
  • developed with patient safety and compliance in mind
  • assured through long term availability and stability, with change management notifications and secured availability
  • supported by a documentation service to assist end-user product regulatory validation
 
 

Extended documentation for drug product developers