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Following the UK’s exit from the European Union, the pharmaceutical regulatory landscape has undergone significant transformation. One major area of change is in packaging and labeling artwork requirements, now governed separately by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).
For companies intending to commercialize pharmaceutical products in the UK, staying updated with evolving artwork regulations is critical to avoid market delays and ensure patient safety.
As a global regulatory partner, Freyr Solutions supports clients with end-to-end artwork compliance tailored to the UK market.
Who Regulates Packaging and Labeling in the UK?
The MHRA is the governing authority responsible for overseeing the safety, efficacy, and quality of medicinal products in the UK. All primary and secondary artwork components—labels, leaflets, and cartons—must comply with Human Medicines Regulations 2012 (as amended) and MHRA guidance documents.
Core Artwork Requirements in the UK
The following information must be present on pharmaceutical packaging and labeling in the UK:
- Name of the medicine and its active substances
- Strength and dosage form
- Route of administration
- UK-specific identifiers, such as a UK Marketing Authorisation (MA) number
- Name and address of the Marketing Authorisation Holder (MAH).
- Name and address of the actual manufacturer (if different from MAH).
- Batch number and expiry date
- Storage instructions (if applicable)
- Warnings and Special Precautions
- Patient leaflet with full directions for use
- Braille on outer packaging
UK-Specific Artwork Requirements (Post-Brexit)
| Requirement Type | UK-Specific Details |
| UK MA Number | A UK Marketing Authorization number must be displayed on the packaging. |
| UK Responsible Person (UKRP) | For Northern Ireland and imported goods, the UKRP details must be shown on the label. |
| Braille | Braille is mandatory on outer packaging (product name and strength). |
| Language | Labels and leaflets must be in English only. |
| Tamper-evident packaging | Required for certain product types (e.g., controlled drugs). |
| Unique Device Identifiers (UDI) | Applies to some medical devices, especially under UK MDR. |
| Northern Ireland Protocol | Products in NI must align with EU rules and may carry both EU and UK MA info. |
| Labelling Flexibility (until 2025) | EU-approved packs may still be used with UK stickers under MHRA guidance. |
Transition Period Considerations
MHRA has allowed some flexibility for EU packaging usage in Great Britain until December 31, 2025, including:
- Applying a UK compliance sticker to EU packaging
- Using a combined leaflet for UK and EU markets (if applicable)
Post-2025, dedicated UK packaging will be mandatory unless further extensions are granted.
Freyr’s Expertise in UK Artwork Compliance
At Freyr Solutions, we help clients navigate the complexities of UK pharmaceutical artwork through:
- Primary and secondary packaging artwork development aligned with MHRA templates
- Submission as well as commercial requirements with lifecycle management through a proper change control process
- Braille and accessibility integration
- UKRP and MA information placement validation
- Proofreading and quality review services
- Ongoing regulatory updates and compliance checks
Whether you're updating existing EU artworks or launching a new product in the UK, Freyr ensures accuracy, compliance, and seamless regulatory submission support.
