The Medicines and Healthcare Products Regulatory Agency (MHRA) has been the United Kingdom’s (UK) standalone medicines and medical devices regulator since the time the UK started the separation process from the European Union (EU). Inspite of MHRA’s rigorous effort to streamline the process since the past 2 years, there is still a lot of confusion among pharmaceutical companies related to the serialization standard for products supplied in the UK & Northern Ireland (NI).
UK consists of Great Britain (England, Scotland, Wales, Channel Islands, and the Isle of Man) and Northern Ireland. The UK government has withdrawn the FMD legislation for the GB countries, but the regulation is still in place for Northern Ireland. As per the Northern Ireland Protocol for serialization, the packs arriving in Northern Ireland from other parts of the globe (including UK) need to be checked to ensure they comply with EU standards, which has further added to the confusion and uncertainty among the suppliers.
Requirements for GB & NI Markets
As per the Northern Ireland serialization requirements, medicines for the Northern Ireland market must follow the EU FMD norms on importation and unique identifier requirements and the information should be uploaded to the EMVS & the UKNI MVS. This is as set out in the draft EU Unilateral Declaration in the Withdrawal Agreement Joint Committee.
However, for the product to be placed in the GB market, Batch testing and QP certification will continue as per the requirements detailed in regulation 41(2) of the Human Medicines Regulations 2012. This Batch testing and QP certification done in Great Britain (England, Wales, and Scotland) will enable supply of medicines with a valid marketing authorization to Northern Ireland. Batch testing and QP certification done in the EU/EEA will also enable supply to Northern Ireland via Great Britain.
There are also a few alternative supply chain options for Northern Ireland. These include:
- Using Common Transit Convention when transporting goods via Great Britain
- Routing Northern Ireland logistics directly from the EEA
As the serialization requirements of EU Delegated Regulation 2016/161 will continue in Northern Ireland, medicines with a marketing authorization valid in Northern Ireland (PL and PLNI) will require a unique identifier and a tamper evident device on each pack. The unique identifiers on packs with a marketing authorization valid in Northern Ireland (PL and PLNI) supplied by a manufacturer or wholesaler in the EEA will not require decommissioning when exported to the UK until the 31st of December 2024.
However, medicines with a marketing authorization valid only in Great Britain (England, Wales, and Scotland) labelled as PLGB will not require a Unique Identifier, also the PLGB medicines must not be supplied to Northern Ireland unless specifically approved by MHRA.
How can CosmoTrace help?
We provide serialization consulting, implementation & integration services to help our clients with managing the end-to-end serialization projects and preparing them for the existing and upcoming regulations across the globe.
We are well versed with the compliance regulations for GB & NI markets and can help you with implementing the serialization project to meet the deadlines.
As Serialization Consulting & Implementation Experts, our focus is on delivering the absolute best serialization support by offering long-term serialization and sustainability strategies and providing forward-thinking industry solutions.
Disclaimer
This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just one possible interpretation of information available in the public domain or through membership organizations, partners and that interpretation is subject to change. This information does not constitute legal advice. Users must refer to the source material for the complete requirements and form their own interpretation before making business decisions.
