A Guide to Secondary Packaging Requirements for Pharmaceuticals

Secondary packaging is vital for pharmaceutical safety, compliance, and supply chain integrity. As the outer layer that contains products such as blister packs and bottles, it must protect, inform, and prevent tampering.

Read on as we explore the different types and functions of secondary packaging, with a look ahead to the solutions that will be presented at this year’s PPMA Show.

What Is Secondary Packaging in Pharmaceuticals?

Secondary packaging (or grouped packaging) is the outer packaging used to protect, store, and present pharmaceutical products.

Common forms of secondary packaging include:

• Cartons and boxes for blister packs, vials, or tubes

• Wallet packs or folding cartons for tablets and capsules

• Multi-product kits for combination treatments

Featuring visual on-brand elements, secondary packaging should also keep pharmaceuticals from damage during storage and transit.

It must be clearly labelled, with patient information such as the recommended dosage.

Key Pharmaceutical Regulations

Pharmaceutical packaging should comply with regulations covering everything from material use to serialisation and environmental protection.

MHRA

UK requirements are set by the Medicines and Healthcare products Regulatory Agency (MHRA), with all medicines having to be properly packaged and labelled for use. Following such regulations should ensure that pharmaceutical packaging supports patient safety, product integrity, and traceability.

The MHRA requires secondary packaging to include:

• Clear labelling, featuring the product name, dosage, expiry date, and batch number

• Tamper-evident features to prevent unauthorised access

• Serialisation codes to support track-and-trace

Under the Windsor Framework, all medicines for the UK market must also carry a clearly legible “UK-only” label. This must be at least 7-point font and visible on the outer packaging.

EMA

Pharmaceutical packaging requirements for EU member states are set by the European Medicines Agency (EMA) under the Falsified Medicines Directive (FMD) 2011/62/EU. 

These regulations have been introduced to prevent the distribution of counterfeit medicines across Europe.

Core EMA packaging requirements include:

• Mandatory serialisation (with the addition of unique barcodes for authentication)

• Environmental sustainability (with the recommendation of biodegradable and recyclable packaging materials)

• Braille labelling (for the accessibility of people with visual impairments).

Best Practices for Compliance

A proactive approach is advised for compliance with the regularly updated pharmaceutical regulations.

This will mean:

• Monitoring regulatory updates from the MHRA, EMA, and industry bodies such as the PPMA and Pharmaceutical Quality Group

• Investing in packaging technology, such as vision inspection systems and label scanners, for improved accuracy and fewer manual errors

• Prioritising sustainability and the use of eco-friendly materials, reducing waste, and improving energy efficiency in production

Discover Secondary Packaging Solutions at the PPMA Show® 2026

Being held at the NEC, Birmingham, from 22 to 24 September, this year’s PPMA Show will present the greatest range of packaging solutions for pharmaceutical professionals. 

Visitors will have the chance to get ahead through insights into the latest materials, containers, and packaging designs.

With more than 350 exhibitors, this major event will put the spotlight on technologies to enhance safety and make products stand out in a crowded market. 

The latest pharmaceutical developments will take centre stage, with solutions for accurate dosing, preservation, and shelf-life extension.

Attending the PPMA Show will also present the opportunity to network with peers, suppliers, and other pharmaceutical sector experts. 

So, go ahead and register for your free PPMA Show tickets today!