Irish Regulatory Landscape
In Ireland, the HPRA requires every holder of a wholesale distribution authorisation (WDA) to have a Responsible Person (RP) named on the licence. The RP is legally accountable for ensuring that all medicinal products are stored, handled, and distributed in accordance with Good Distribution Practice (GDP). This includes oversight of quality systems, SOPs, personnel training, storage and transport conditions, deviations, and complaints.
The RP requirement is established under the EU guidelines on Good Distribution Practice (2013/C 343/01). The RP must have appropriate knowledge and experience to supervise GDP compliance and is personally responsible for ensuring legal and regulatory obligations are met.
UK Regulatory Landscape
Under UK law, every wholesale distribution licence WDA must have a Responsible Person (RP) who ensures that all medicinal products are stored, handled, and distributed in compliance with Good Distribution Practice (GDP). The RP carries personal legal responsibility for the wholesaler’s operations, including maintaining quality systems, approving documentation, and overseeing deviations, complaints, and temperature-controlled storage.
RP requirements are set out under Regulation 45 of the Human Medicines Regulations 2012 (SI 2012/1916). RPs must be named on the WDA before assuming responsibility for any operations. Post-Brexit, the RP also plays a critical role in verifying EU-certified imports under the listed-country route and ensuring compliance with the Windsor Framework and other UK-specific import regulations acting as a Responsible Person for import (RPi).
What We Handle Locally
Our UK or Irish-based RPs and RPis are named on clients’ WDAs or provide RP oversight where the company does not employ their own RP. This is not advisory work: our RPs take full legal responsibility for compliance in all aspects of the distribution operation.
RP oversight and GDP management
Oversight and qualification of transport providers, and storage and distribution sites, maintenance of SOPs, quality system documentation, and training records, ensuring compliance with storage conditions, and distribution processes.
Import verification and compliance
UK - verification of EU QP-certified imports from listed countries and management of non-listed country imports under UK GDP standards.
Ireland - oversight of imported medicinal products, ensuring GDP compliance and verification of certification from EU or third-country suppliers.
Deviation, complaint, and incident management
review, approval, and oversight of temperature excursions, supply chain deviations, and product complaints.
Internal GDP audits
routine proactive assessment of compliance gaps and mitigation of findings.
Regulatory correspondence
liaison with the MHRA / HPRA, submission of WDA variation applications, and guidance on any regulatory updates affecting the RP role.
UK & Ireland Operations
Our RPs operate across Great Britain, Northern Ireland, and Ireland, ensuring compliance under UK- and IE-specific GDP regulations:
| Jurisdiction | RP Arrangements |
|---|---|
| Great Britain | RPs and RPis named on WDA licences; full oversight of GDP operations; MHRA as competent authority |
| Northern Ireland | Operates under Windsor Framework; RPs and RPis ensure compliance with EU GDP recognition for listed-country imports; specific labelling and supply chain requirements apply |
| Ireland | RPs named on HPRA WDA licences; full oversight of GDP operations; HPRA as competent authority |
Need a Responsible Person?
Tell us about your products, distribution arrangements, and requirements, and we will outline how our RP services can ensure compliance and provide legal oversight.
Contact usKey UK Regulations
The regulatory framework for RP services in the UK.
Key Irish Regulations
UK-Specific FAQs
For general questions about RP responsibilities, batch certification processes, and GDP compliance, see the FAQs on Quality & Compliance.
Do I need a UK RP if I import EU products?
Yes. Even for listed-country imports, an RPi is legally required to oversee verification and compliance with GDP.
Can you provide an RP for my WDA quickly?
Timelines depend on portfolio size and complexity. Simple arrangements can often be onboarded within weeks. Contact us with the specifics and we will give you a realistic timeline.
Do you cover temperature-sensitive and high-risk products?
Yes. Our RP oversight includes cold chain management, controlled storage, and specialised product handling.
Can your RP oversee clinical trial or investigational products?
The requirements under UK legislation is that an MIA and oversight of the named QP are needed for importation of IMPs. It is not permissible to import IMPs under a WDA in the UK,
Ireland-Specific FAQs
For general questions about RP responsibilities, batch certification processes, and GDP compliance, see the FAQs on Quality & Compliance.
Do I need an RP to operate a WDA in Ireland?
Yes. Every wholesale distribution authorisation must have a named RP to ensure legal and GDP compliance.
Can your RP support imported products?
Yes. We provide RP oversight for both EU-certified and third-country imports, including verification of supplier documentation, transport, and storage conditions.
Can you provide an RP for my WDA quickly?
Timelines depend on portfolio size and complexity. Simple arrangements can often be onboarded within weeks. Contact us with the specifics and we will give you a realistic timeline.
Do you cover temperature-sensitive and high-risk products?
Yes. Our RP oversight includes cold chain management, controlled storage, and specialised product handling.