.app-navigation__wrapper--for-seo { display: block !important; }

Pharmaceutical label materials regulatory compliance

Regulatory compliance is not a box to check at the end of a project, it shapes every material decision from the start. UPM Raflatac™ pharmaceutical label materials are developed and formulated to meet applicable EU and US regulatory requirements across packaging, food contact, medical devices and pharmaceutical labeling. This page covers the key regulatory frameworks our materials address, the documentation we provide to support your qualification process and how to access what you need.

Talk to our compliance experts

Why pharmaceutical label materials require dedicated regulatory design

Pharmaceutical labels do two jobs simultaneously. They protect patient safety by carrying accurate dosage and identification information throughout the product lifecycle. They also form part of the packaging system, meaning the label's adhesive, face material, inks and coatings are all potential contact or migration points for the drug product within.

Using label materials not specifically designed for pharmaceutical applications creates risks that standard performance testing does not capture: inadequate migration testing, missing documentation for regulatory submissions, incompatible adhesive chemistry for the container type, no change management protocol to protect supply continuity and regulatory compliance over time, and label constructions that may not survive the sterilization or cold chain conditions required.

UPM Raflatac pharmaceutical label materials, powered by UPM PharmaSure™ adhesives, are designed to address these risks from the ground up.

Change management

Our change management process is designed to protect supply continuity and support your regulatory approval and lifecycle management requirements.

Aligned with best practices outlined by the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS), we provide up to 36 months’ secure rolling availability of unchanged materials, combining:

a two-year shelf life for label stock
with up to 12 months’ advance notice of any material change

This approach gives you time to test and validate new materials, complete qualification according to regulatory requirements, and maintain compliance across approved packaging systems.

By ensuring predictability and transparency, we help reduce the risk of disruption and support long pharmaceutical product lifecycles. This ensures that any material changes can be managed in a controlled and traceable way, without compromising ongoing regulatory approvals or product availability.

We also offer a last-call notification, allowing bulk purchases before production is discontinued to maintain continuity of supply.

Regulatory frameworks our materials address

Low migration and product safety

Labels in contact with pharmaceutical packaging are subject to strict migration controls, particularly where the container is plastic and the drug is in liquid or non-solid form. Glass acts as a natural barrier and is generally less sensitive to migration concerns. However, the increasing use of plastics in novel injectable packaging, including polyethylene (PE), polypropylene (PP), cyclic olefin polymer (COP), and cyclic olefin copolymer (COC) containers, makes migration safety a critical focus area.
EMA and FDA both require migration-safe packaging, printing inks, and labeling systems for liquid prescription drugs. UPM Raflatac pharmaceutical materials and UPM PharmaSure adhesives are developed in accordance with:

EMA CVMP/205/04 (European Medicines Agency Guideline on Plastic Immediate Packaging Materials, 2005), which sets requirements for pharmaceutical-grade materials in direct contact or proximity with medicinal products
FDA Guidance on Container Closure Systems for Packaging Human Drugs and Biologics (1999), which governs the suitability of packaging components including label adhesives for liquid prescription drugs

Low-migration labels designed for pharmaceutical packaging safety

Product safety for injectable packaging

Injectable packaging presents the most stringent product safety requirements of any pharmaceutical labeling application. Two distinct considerations apply.

Migration safety refers to the risk of chemical substances leaching from the label system into the drug product. For non-solid forms, including liquids, gels, and aerosols packed in plastic containers, extractable and leachable (E&L) risks are particularly high. The likelihood of packaging component interaction increases with plastic primary containers. UPM PharmaSure low-leachable adhesives RP31 Purus and RPMD are formulated to minimize this risk for injectable applications.

Biocompatibility applies to drug-device combination products, such as autoinjectors, pre-filled pens, and pre-filled syringes. These combination products combine a medical device with a medicinal product and may require review by device agencies, drug agencies, or both. Per regulatory requirement, any packaging material within a device that could come into contact with the patient must demonstrate biocompatibility. This ensures label system components do not leach chemicals that could affect patient health or cause irritation.

Thorough testing and evaluation of the label materials together with the primary packaging is always required before starting qualification activities. The chemistry of the entire packaging solution must be assessed.

Packaging and food contact regulations

Our label materials comply with applicable regulatory and safety requirements for packaging and food contact:

EU Directive 94/62/EC and the Toxics in Packaging Clearinghouse (TPCH, formerly CONEG): covering heavy metals in packaging
EU Food Framework Regulation (EC) No 1935/2004: materials and articles intended to come into contact with food
Regulation (EC) No 2023/2006: good manufacturing practice for materials and articles intended to come into contact with food
FDA 21 CFR 175.105: food contact compliance for adhesives
FDA 21 CFR Section 110: Good Manufacturing Practices (GMP)

Falsified medicines and tamper evidence

The EU Falsified Medicines Directive (2011/62/EU) requires tamper-evident features on packaging for prescription drugs and high-risk OTC medicines. Compliance requires incorporating tamper-evident features as described in ISO 21976 standard "Packaging – Tamper verification features for medicinal product packaging."

UPM PharmaSure adhesives like RP62 EU have been developed specifically for tamper evidence and are designed to meet these requirements. Tamper-evident seal label options include cardboard tear, void effect and fragile splitting or breaking, with Red Luminescence technology available for automated presence verification.

Medical device regulations

Medical device labeling must remain intact and legible through sterile barrier system processing, device assembly and point-of-use handling. Applicable regulations include:

EU Medical Device Regulation (MDR): including the Unique Device Identification (UDI) serialization system for marking and identifying medical devices in the healthcare supply chain, with a May 2020 implementation date
In Vitro Diagnostics Regulation (IVDR): the regulatory basis for placing in vitro diagnostic medical devices on the EU market, with an implementation deadline of May 2022
US FDA UDI regulations: the equivalent UDI system adopted in the US from 2013

UPM Raflatac labeling materials for medical devices are designed to maintain print legibility and label integrity throughout the sterile barrier system and end-use lifecycle, supporting the identification and traceability requirements of MDR and IVDR.

Documentation to support your regulatory submissions

Compliance documentation reduces your internal validation burden and helps you navigate regulatory submissions with confidence. UPM Raflatac and UPM PharmaSure provide two levels of support.

Standard compliance documentation

Certificates, regulatory declarations and product safety documentation for UPM Raflatac pharmaceutical label materials are available through our documentation service. These cover the regulatory frameworks listed above and are designed to support end-user product regulatory validation. Contact our experts to request the documentation relevant to your application.

Extended documentation for drug product developers

For drug product developers conducting extractables and leachables studies or biocompatibility evaluations, we provide comprehensive documentation packages for our UPM PharmaSure low-leachable adhesives RP31 Purus and RPMD. These packages contain:

Technical information and formulation details
Extraction profiles of our adhesives
Data to support extractables and leachables (E&L) shelf-life stability studies
Biocompatibility assessments and toxicology evaluations for medical devices

Extended documentation packages are provided upon request under NDA directly to pharmaceutical and medical device companies.

Talk to our experts to discuss your documentation needs

From compliance to qualification

Alignment with pharmaceutical labeling regulations is the starting point. The next step is selecting a pre-tested label construction and beginning your own qualification process. UPM Raflatac's pharmaceutical label specification guide maps container types, storage conditions and regulatory requirements to validated label material options, giving you a shortlist before you begin.

Request the pharmaceutical label specification guide

Frequently asked questions

You might be interested in

Pharmaceutical label materials built for performance, compliance and long-term reliability

Collection | 04/20/2026 07:55:34