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Great Britain and Ireland

MHRA and HPRA: one standard, two regulators

Great Britain, Northern Ireland and Ireland all work from the same EU GDP Guidelines (2013/C 343/01). What differs is how each regulator elaborates and enforces them: the HPRA in formal numbered guides, the MHRA largely in Inspectorate blog posts and its guidance note. This page compares what each one has published, and nothing more.

See the comparisonTalk to us about Ireland

The legal position

Where each set of rules comes from

  • The common baseline is the European Commission Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01), made under Article 84 of Directive 2001/83/EC. Both regulators' wholesale guidance cites this text.

    Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01), European Commission, 23 November 2013

  • Great Britain: regulation 43(1)(a) of the Human Medicines Regulations 2012 requires a GB wholesale licence holder to comply with the GDP guidelines 'published under, or that apply by virtue of, regulation C17'.

    The Human Medicines Regulations 2012, regulation 43, legislation.gov.uk, 18 October 2026

  • Regulation C17 lets the MHRA publish its own GDP principles and guidelines, which may replace or modify the Commission's, after consultation and only to take account of technical or scientific progress. Until it does, the Commission guidelines 'as they applied immediately before IP completion day' (31 December 2020) continue to apply. The MHRA has not used this power: there has been no consultation on a GB GDP guideline, and GOV.UK still lists the 2013 EU text and the Green Guide (2022). So in GB the 2013 EU text applies as it stood on 31 December 2020. The provision was amended from 1 January 2025 to refer to the United Kingdom.

    The Human Medicines Regulations 2012, regulation C17, legislation.gov.uk, 15 October 2026

  • Northern Ireland: regulation 43(1)(b) requires an NI wholesale licence holder to comply with the GDP guidelines 'published by the European Commission in accordance with Article 84' of Directive 2001/83/EC, so NI follows the live EU guidelines, not the frozen GB version. The MHRA states it 'remains the national competent authority in Northern Ireland'. Under the Windsor Framework medicines arrangements, which began on 1 January 2025, the Falsified Medicines Directive safety-features rules were disapplied UK-wide.

    Wholesalers' and manufacturers' guidance following agreement of the Windsor Framework, MHRA, 11 March 2025

  • MHRA Guidance Note 6 says GB wholesale dealers must comply with regulations 43 to 45AB of the HMR 2012, which include GDP, and footnotes the 2013/C 343/01 guidelines. It is the main MHRA wholesale guidance note; MHRA's GMP/GDP page also lists the Green Guide (2022) as MHRA guidance for distributors.

    Notes for applicants and holders of a Wholesale Dealer's Licence (WDA(H)) or Broker Registration (MHRA Guidance Note 6), MHRA, 2023

  • Ireland: Title VII of Directive 2001/83/EC is transposed by the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 (S.I. No. 538 of 2007), amended in 2009, 2010, 2012, 2013, 2019 (S.I. 36 and S.I. 217), 2021 (S.I. 1) and 2022 (S.I. 415); S.I. 415/2022 gives the collective citation 'Regulations 2007 to 2022'. The 2013 amendment is S.I. No. 164 of 2013, the (Amendment) Regulations 2013. IA-G0008-8 lists amendments only to 2019. IA-G0046 names the 'Medicinal Products (Control of Wholesale Distribution) Regulations 2013'. No regulation of that exact title exists; IA-G0008 and IA-G0011 name S.I. No. 538 of 2007 as amended, and IA-G0046's description matches IA-G0008's description of the 2007 Regulations. Schedule 2 paragraph 13 requires wholesalers to comply with the EU GDP guidelines, and the HPRA is the authority that grants, suspends and revokes WDAs.

    Guide to Wholesaling and Brokering of Medicinal Products for Human Use in Ireland (IA-G0008-8), HPRA, 27 August 2025

  • The HPRA temperature guide restates the legal basis: Article 80(g) of Directive 2001/83/EC, S.I. 538/2007 Schedule 2 paragraph 5 (staff, premises, equipment and procedures to avoid deterioration of products) and paragraph 13 (comply with EU GDP). It says EU GDP compliance is the 'minimum requirement' for a wholesaler's licence.

    Guide to Control and Monitoring of Storage and Transportation Temperature Conditions for Medicinal Products and Active Substances (IA-G0011-3), HPRA, 2 October 2020

  • The base Irish statutory instrument is available on the Irish Statute Book.

    S.I. No. 538/2007 - Medicinal Products (Control of Wholesale Distribution) Regulations 2007, Irish Statute Book (Office of the Attorney General), 2007

  • S.I. No. 164 of 2013 is titled the Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2013 and is 'construed as one with' the 2007 Regulations as amended.

    S.I. No. 164/2013 - Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2013, Irish Statute Book (Office of the Attorney General), 22 May 2013

Reviewed by Jake Farrow, Managing DirectorLast reviewed 19 October 2026

The MHRA and the HPRA both apply the same 2013 EU Good Distribution Practice text, so a wholesaler working in Great Britain and Ireland is held to one underlying standard. What differs is how each regulator has written up its expectations: the HPRA in formal numbered guides with specific figures, the MHRA mainly in Guidance Note 6, GOV.UK guidance and Inspectorate blog posts. The one thing to remember: read each regulator's own material for each site, and where the published detail differs, meet the more specific written expectation and record why.

Why they differ

One text, two ways of explaining it

The common baseline is the European Commission's Guidelines of 5 November 2013 on Good Distribution Practice (2013/C 343/01). The text sets principles, such as mapping storage areas 'under representative conditions', and leaves each national authority to explain how it reads them. That is where the two regulators part company in style.

The HPRA publishes formal, numbered guides. IA-G0011 (2020) is a dedicated guide to temperature control in storage and transport. IA-G0046 (April 2025) works through the EU guidelines chapter by chapter and says wholesalers should comply in full with both. IA-G0008 (August 2025) covers wholesaling and brokering, including inspections.

The MHRA's material is spread across Guidance Note 6 (licensing, the Responsible Person, deficiency classes), its GMP and GDP guidance on GOV.UK, the Green Guide, and Inspectorate blog posts from 2016 to 2020 on mapping, refrigerated products, freezers and transport. The MHRA does not publish a document equivalent to IA-G0011, and it has not restated the blog positions as formal guidance on GOV.UK.

The legal position in brief

In Great Britain, regulation 43 of the Human Medicines Regulations 2012 requires a licence holder to comply with the guidelines that apply under regulation C17. Until the MHRA publishes its own, those are the Commission guidelines as they applied immediately before 31 December 2020, which in practice is the 2013 text held at that date. The MHRA has not used that power: it has not consulted on a GB guideline, and GOV.UK still lists the 2013 EU text and the Green Guide (2022).

Northern Ireland differs: regulation 43(1)(b) points to the guidelines the European Commission publishes, so the live EU text applies, while the MHRA states it 'remains the national competent authority in Northern Ireland' (Windsor Framework guidance). In Ireland, S.I. No. 538 of 2007, as amended (including by S.I. No. 164 of 2013, the (Amendment) Regulations 2013, and most recently by S.I. No. 415 of 2022, which gives the collective citation 'Regulations 2007 to 2022'; IA-G0046 names 'Regulations 2013', a title that does not exist, but its description matches IA-G0008's description of the 2007 Regulations), requires wholesalers to comply with EU GDP, and the HPRA grants, suspends and revokes wholesale authorisations. IA-G0011 describes EU GDP compliance as the 'minimum requirement' for a licence.

Operating in both

What this means if you trade in GB and Ireland

Each site needs its own authorisation, because the HPRA can only grant a WDA for activities in Ireland, and each storage area needs its own mapping, because EU GDP 3.2.1 requires mapping of 'the storage area before use'. Each inspector will read your system against the material their own regulator has published, so the same SOP may be questioned on different points in Dublin and in Great Britain.

The two inspectorates find problems in the same places. At its GDP Information Day on 3 May 2022, the HPRA listed Major deficiencies by 'percentage frequency': 'Management of temperature at the site was deficient' 87% and 'Mapping studies were not performed correctly or not at all' 79%. Its transport slides gave 51% for missing or insufficient transport validation or risk assessment (including unvalidated seasons or routes), and 23% for excursion investigation, reporting and passive-shipper deficiencies, among Major transport deficiencies. The MHRA's last full data set, for 2016, put transportation at 13% and temperature control at 9% of sampled inspections with a Major, and it has published no temperature breakdown since. The years and units differ, so the figures show where to look, not which regulator is stricter.

Escalation works in a similar way on both sides. The MHRA refers serious or unresolved findings to its Inspection Action Group, with a compliance escalation process below that. Newsletter 73 (February 2023) reports that the HPRA has implemented the EU compliance management process through a Compliance Regulatory Group, for wholesalers (and manufacturers) whose compliance is below standard (Newsletter 73). The MHRA does not publish GDP non-compliance statements for GB sites, while HPRA ones appear in EudraGMDP.

Some differences are about people. Guidance Note 6 asks for at least one year's practical experience for an RP; IA-G0046 treats six months' full-time direct GDP experience as the minimum (RP experience). The Responsible Person (import) is a GB-only role. Both regulators have published 'storage of products requiring refrigeration at ambient temperatures' as a possible Critical example (MHRA Guidance Note 6; HPRA GDP Information Day slides, 2022). The current HPRA web page names failure to meet storage and transport conditions as a Major example. Either regulator can escalate a finding on its seriousness, so the examples do not predict how a given case will be graded.

Where each regulator's published guidance spells it out
HPRA guidesMHRA published material
A dedicated temperature guidance document✓·
A time limit for storage in transit✓✓
Excursion defined as any duration✓·
Mapping empty and full✓✓
Mapping to cover seasonal variation✓✓
Listed equipment re-mapping triggers✓·
A minimum number of calibration points✓·
Monthly RP review of temperature records✓·
Cross-GxP data integrity guidance·✓

A tick means the point is written in that regulator's own published material (HPRA IA-G0011, IA-G0046; MHRA Guidance Note 6, data integrity guidance, Inspectorate blog). An empty cell means we did not find it written there, not that it is not expected.

Three worked differences

Storage in transit: 36 hours and 48 hours

MHRA policy, set out in the refrigerated products blog, part 1, is that a site need not be on a licence if ambient products are held there in transit for under 36 hours and ownership has not passed. Refrigerated products need a licensed site even for shorter periods, unless they stay overnight in continuously refrigerated vehicles. IA-G0046 says storage for more than 48 hours in transport, or any storage of refrigerated product regardless of time, is storage that needs a WDA; IA-G0008 words the refrigerated case more softly.

In an illustrative case, a courier holds refrigerated stock overnight in a depot cold room. In Great Britain the depot needs to be licensed because the stock has left the vehicle; in Ireland, any storage of refrigerated product points the same way. The ambient thresholds differ, so the same overnight hold can be treated differently either side of the Irish Sea (36 or 48 hours).

Excursions: any duration, or noted when very short?

IA-G0011 defines an excursion as a departure from labelled conditions 'for any duration of time'. The RP is told immediately, stock is quarantined, the manufacturer is consulted, the investigation and CAPA are documented, and the HPRA is told at once if a recall may be needed.

On the MHRA side, a 2018 reply on the Inspectorate blog says very short excursions, around five minutes or under, are not typically raised as individual formal deviations but should still be noted. It is a reply to a reader's comment, not formal guidance. The 20-minute figure used by SPS and UKHSA belongs to clinical settings, not wholesale (any duration, 5 or 20 minutes).

Mapping: listed triggers or a justified risk assessment

IA-G0011 says warehouses should be mapped empty and full, in summer and winter, and cold rooms on installation, empty and full, with an ambient probe outside. It lists re-mapping triggers: refrigeration repairs, layout or set-point changes, changes to duty and back-up condensers, moving a fridge, and heating changes.

The MHRA mapping blog recommends mapping empty, with dummy product if needed, then fully stocked, repeated for seasonal variation, and asks the operator's risk assessment to define and justify how often mapping is repeated. In substance the two largely agree, and neither sets a fixed interval (re-mapping frequency, seasonal mapping of cold rooms).

One quality system

Building one system that works for both inspectors

Neither regulator publishes a method for running one system across both countries, so what follows is a reasonable approach drawn from their texts, not legal advice. Write the core SOPs to the EU text both apply. Where one regulator's published guidance is more specific, meet that expectation across the business unless there is a reason not to, and record the rationale, so either inspector can see why you work the way you do.

Keep what is genuinely local in regional annexes: transit thresholds apply in the country where the depot sits, and Northern Ireland sites follow the live EU text.

  • Map each site separately, planned to cover empty and full, summer and winter, and the problem areas the MHRA blog lists.
  • Record every excursion, however short, and classify it using thresholds written in your SOP.
  • Calibrate probes across their range of use and document the points chosen.
  • Set and record the RP's review of temperature records, with its frequency justified.
  • Check each RP against each authority's own experience criteria.
  • Hold one change control list that also names your re-mapping triggers.

In summary

The short version

  • Both regulators apply the 2013 EU GDP text: GB as held at 31 December 2020, Ireland and Northern Ireland as the EU publishes it.
  • The HPRA writes detail into numbered guides; the MHRA into Guidance Note 6, GOV.UK guidance and blog posts.
  • Read each regulator's own material for each site you hold.
  • Transit storage, excursion duration and mapping triggers are worded differently: know both.
  • Where one is more specific, meet it and record why.
  • Keep country-specific thresholds in regional annexes to one core SOP.
  • Map each site, record every excursion and check RP criteria against both texts.

Side by side

What each regulator publishes and emphasises

Each row uses only the regulators' own guidance, deficiency data, reports and newsletters. Where little is published, the row says so instead of guessing.

AspectMHRA (Great Britain)HPRA (Ireland)How strong is the evidence
Guidance documents published

The MHRA relies on the retained 2013 EU GDP text, Guidance Note 6 (licensing, RP, inspection, deficiency classes) and the Green Guide. It does not publish a dedicated temperature guidance document: its detailed temperature interpretation is in Inspectorate blog posts (mapping 2016, refrigerated products parts 1 and 2 in 2016, freezers 2017, transport risk 2020), which it has not restated as GOV.UK guidance. The only formal temperature text on GOV.UK is the 2020 COVID flexibilities page.

Medicines: good manufacturing practice and good distribution practice (13 May 2024); MHRA Guidance Note 6 (2023); Temperature mapping - an introduction (14 July 2016)

The HPRA publishes formal numbered guides: a dedicated temperature guide (IA-G0011, 2020), a GDP guide that elaborates on the EU guidelines chapter by chapter (IA-G0046, April 2025), a wholesaling and brokering guide (IA-G0008, August 2025) and a model quality system for general sale wholesalers with a temperature mapping SOP (IA-G0038, October 2026). The GDP guide says wholesalers should comply in full with both the EU guidelines and the HPRA guide.

Wholesale distribution of medicines for human use; IA-G0011-3 (2 October 2020); IA-G0046-8 (8 April 2025)

Strong. The difference in format is clear from what each regulator publishes. The HPRA's temperature guidance is formal and numerical; the MHRA's is mostly blog-based and much of it is from 2016-2020. This is a difference in format, not evidence that one regulator expects more.
Temperature mapping expectations

The MHRA blog restates EU GDP 3.2.1 (map before use under representative conditions). It recommends mapping empty (with dummy product if needed) and again when fully stocked, repeating to cover seasonal variation, and covering high storage points, heaters, windows and doors, loading bays, CD rooms, returns and quarantine. Re-mapping frequency should be set and justified by a documented risk assessment. No probe density or study duration is given. Guidance Note 6 expects new applicants to show a mapping exercise with a clear method.

Temperature mapping - an introduction (14 July 2016); MHRA Guidance Note 6 (2023)

IA-G0011 expects warehouses to be mapped empty and full, in both summer and winter. Large fridges and cold rooms should be mapped on installation empty and full with an external ambient probe. It lists specific re-mapping triggers: repair or replacement of refrigeration units, layout changes, set-point changes, changes to how duty/back-up condensers run, moving fridges, and changes to heating. IA-G0046 makes initial mapping a 'must' for areas larger than a few square metres; smaller room-temperature areas can use a risk assessment instead.

IA-G0011-3 (2 October 2020); IA-G0046-8 (8 April 2025)

Strong on what is written; thin on how it is enforced. In substance the two largely agree (empty/full, seasonal, risk-based re-mapping). The HPRA puts more triggers in formal guidance, while the MHRA leans on the operator's documented risk assessment. Neither publishes a fixed re-mapping interval.
Excursion handling

The MHRA blog says deviations should be documented, investigated for root cause, assessed by temperature and duration, referred to the manufacturer for advice, and reported to the RP. Suspect deliveries are quarantined in a fridge while enquiries are made. A 2018 reply in the comments on the blog says very short excursions (around 5 minutes or under) are not typically raised as individual formal deviations, but should still be noted. The 2016 and 2020 blogs discourage using MKT without strong supporting data, and the 2020 post calls accepting loads after excursions for commercial reasons unacceptable.

Refrigerated medicinal products, part 1 (26 January 2016); Refrigerated medicinal products, part 2 (5 May 2016); A Practical example of applying Quality Risk Management in GDP - Transportation Risks (15 July 2020)

IA-G0011 defines an excursion as any departure from labelled conditions 'for any duration of time'. The steps are: notify the RP immediately, quarantine affected product, consult the manufacturer or MAH, document the investigation, take CAPA, and notify the HPRA immediately if a recall may be needed. MKT is allowed only for controlled-room-temperature products, never above 30°C and never for refrigerated products, with MAH consultation and excursions still reported to the MAH.

IA-G0011-3 (2 October 2020)

Moderate. The core steps match EU GDP. One published difference in emphasis: the HPRA's 'any duration' definition versus a 2018 MHRA blog reply that very brief excursions need not each be a formal deviation. The MHRA remark is a reply to a reader comment, not formal guidance. The HPRA spells out conditions for MKT; the MHRA discourages MKT without strong data. The two positions point the same way, with different levels of detail.
Monitoring systems and data integrity

The MHRA blog expects daily min/max monitoring with calibrated devices accurate to ±0.5°C and readable without opening the door. It says fridge display units should not be relied on, alarms should be tested at set points, records should be free of alterations and routinely signed off by the RP, and transport data kept for five years. The MHRA's GXP Data Integrity Guidance (March 2018) applies to GDP among other GxPs, covering ALCOA+ and data governance.

Refrigerated medicinal products, part 1 (26 January 2016); MHRA GXP Data Integrity Guidance and Definitions, Revision 1 (March 2018)

IA-G0011 requires continuous monitoring (at minimum calibrated max/min thermometers read, recorded and reset daily) and recording probes independent of control probes, placed at mapped extremes. Probes should be accurate to ±0.5°C (stated for large cold storage in section 3.3, and repeated generally in the 2022 mapping slides) and calibrated annually at three or more points across the whole system, with auxiliary probes during calibration. Alarm set points may include alert and action limits (alert limits set so preventive action can be taken before an excursion), and provision should be made for an out-of-hours response. The RP should review records monthly, though IA-G0011 allows the frequency to be extended where alarms notify in real time, including out of hours. IA-G0046 requires risk-based validation of GDP computerised systems and refers to EU GMP Annex 11.

IA-G0011-3 (2 October 2020); IA-G0046-8 (8 April 2025)

Moderate. The MHRA has a cross-GxP data integrity guide, whose section 6.20 covers cloud and hosted services in general terms (data ownership and location, inspector access, readability for the retention period, tested business continuity). The HPRA has no standalone GDP data integrity or computerised systems guide and refers to EU GMP Annex 11. The HPRA gives more explicit calibration detail (three points, the whole system, auxiliary probes). Neither regulator addresses wireless monitoring by name or sets a frequency for testing alarms: EU GDP says 'regularly tested', the MHRA blog 'routinely tested', and IA-G0011 'regularly checked for functionality at the designated set points'.
RP / RPi responsibilities

Guidance Note 6 says the RP must have at least 1 year's practical experience of the licensed activities, including knowledge of storage conditions and temperature control, and should have 1 year's experience running a quality system. A contract RP needs a contract with the individual. 'Deputy RP' is not a legally recognised term. The RPi (Responsible Person (import)) is a GB-only role for imports of QP-certified medicines from an 'approved country for import'. The RPi carries out the RP functions and also checks batch certification.

MHRA Guidance Note 6 (2023)

IA-G0046 treats six months' full-time direct GDP experience as the minimum, with suitability assessed case by case at application and on inspection. A contract RP needs a contract, and time on site must be set by a documented risk assessment, with a record of time spent in the role. IA-G0011 gives the RP specific temperature duties: independent monthly review of records and immediate notification of excursions. Ireland has no RPi role; imports from outside the EEA require a manufacturing/importation authorisation and QP certification.

IA-G0046-8 (8 April 2025); IA-G0011-3 (2 October 2020)

Strong for the written criteria: 1 year (MHRA) versus 6 months full-time (HPRA) minimum experience. How each regulator applies these in practice is not published. The RPi exists only in the GB framework.
Transport

MHRA blogs set out a risk-based approach: assess 'lanes' by season, route and mode, monitor throughout the load (optionally with vehicle mapping), and set alarm limits correctly. Shipments that are not monitored need very thorough validation, and a breach means the whole load is treated as compromised. Validated passive boxes suit short (under about three hours) low-risk journeys. Guidance Note 6 expects new applicants to provide evidence of transport validation. EX-WORKS terms do not remove the supplier's GDP responsibility. MHRA policy (2016 blog) lets ambient products sit in transit for under 36 hours without the site being licensed; refrigerated products need a licensed site unless they stay in continuously refrigerated vehicles.

A Practical example of applying Quality Risk Management in GDP - Transportation Risks (15 July 2020); Refrigerated medicinal products, part 2 (5 May 2016); Refrigerated medicinal products, part 1: receipt and storage (26 January 2016)

IA-G0011 requires insulated shippers to be qualified under actual transport conditions: chamber studies 'are not considered to be reflective of actual conditions'. Studies should cover the furthest delivery point, seasonal pack-outs, full and empty loads, and door openings, and the time of packing should be recorded. Refrigerated vehicles that provide the primary control should be mapped under worst-case conditions. IA-G0046 says storage in transit for more than 48 hours, or any storage of refrigerated product, requires a WDA.

IA-G0011-3 (2 October 2020); IA-G0046-8 (8 April 2025)

Moderate to strong. A clear published difference in emphasis: the HPRA's formal statement against chamber-only qualification of shippers, and a 48-hour transit threshold where the MHRA's policy uses 36 hours. The MHRA's material puts more emphasis on lane risk assessment and monitoring throughout the load. Both regulators' deficiency figures put transport high: chapter 9 was in the MHRA's top five for Majors in its 2016 and 2018 data, and the HPRA's 2022 transport slides give 51% for missing or insufficient transport validation or risk assessment (including unvalidated seasons or routes), and 23% for excursion investigation, reporting and passive-shipper deficiencies, among Major transport deficiencies.
How findings are graded

MHRA grades findings as Critical, Major or Other. Guidance Note 6 gives 'storage of products requiring refrigeration at ambient temperatures' as a possible Critical example. A Major includes a deficiency that 'has caused or may cause' non-compliance with the MA, 'in particular its storage and transport conditions'. Several Majors can amount to a Critical, indicating a serious systems failure. GOV.UK also allows 'Other' where there is not enough information to classify higher.

MHRA Guidance Note 6 (2023); Medicines: good manufacturing practice and good distribution practice (13 May 2024)

HPRA grades findings as Critical, Major or Other. Critical means a significant risk to patients (example: increased risk of falsified medicines). Major means a deviation resulting, or likely to result, in non-compliance with authorisations, with failure to meet required storage and transport conditions given as an example. Related lower findings can be escalated. The current HPRA inspections page gives no temperature example at Critical level. However, the HPRA's GDP Information Day slides (3 May 2022) listed 'storage of products requiring refrigeration at ambient temperatures' as an example of a possible Critical deficiency, the same example as MHRA Guidance Note 6.

GDP inspections; GDP Deficiency Trending, HPRA GDP Information Day (archived 27 June 2024) (3 May 2022)

Strong on wording, thin on practice. The three tiers and definitions are almost identical, following the EU format. The published examples are close too. Both regulators have published 'storage of products requiring refrigeration at ambient temperatures' as a possible Critical example (MHRA Guidance Note 6; HPRA GDP Information Day slides, 2022). The current HPRA web page names failure to meet storage and transport conditions as a Major example. This does not show that either regulator grades actual cases differently.
How often each kind of finding appears (deficiency statistics)

The MHRA's only full GDP deficiency data set is for 2016, published in November 2017. It sampled 148 of 1,428 inspections and counted Majors only. Share of sampled inspections with a Major: 1.2 Quality system 22%, 9.2 Transportation 13%, 2.2 RP 12%, 5.2 supplier qualification 10%, 3.3 Equipment 9%, 4.2 Documentation 9%, 3.2.1 Temperature control 9%. Since then it has published only top-five chapter shares in symposium blog posts (2018 post: Chapter 1 47%, Chapter 5 42%, Chapter 3 41%, Chapter 9 29%, Chapter 2 22%; 2019 post: Chapter 1 38%, Chapter 9 25%, Chapter 5 20%, Chapter 6 18%, Chapter 2 15%) and, for October 2021 to November 2022, a total of 1,189 deficiencies across 473 inspections with no category breakdown and no slides. A GOV.UK entry labelled 'GDP Inspection Deficiency Data 2018' is in fact GMP data. No MHRA GDP symposium has been held since 2023.

MHRA GDP Inspection Deficiency Data 2016 (November 2017); GDP Inspection Deficiency Data for 2016 (blog) (13 December 2017); GMDP Symposium 2017: GDP days (19 February 2018); The 2018 Good Distribution Practice (GDP) Symposium (11 June 2019); MHRA Good Distribution Practice Symposium 2023 (2 May 2023); Good manufacturing practice inspection deficiencies (statistics page) (15 October 2020)

At its GDP Information Day on 3 May 2022 the HPRA presented trends from 286 inspections (135 routine, 151 non-routine): 3 inspections contained a Critical, 221 a Major and 282 an Other. Its temperature mapping slides list Major deficiencies by 'percentage frequency': 'Management of temperature at the site was deficient' 87%, 'Mapping studies were not performed correctly or not at all' 79%, 'CC/CAPA/Deviations raised not handled correctly or not raised/not fit for purpose' 47%, storage at the site deficient 23%, transport validation and management deficient 20%. The slides are no longer on hpra.ie; archived copies are on the Wayback Machine. Newsletter 73 (February 2023) reviewed 102 GDP inspections in 2020 to 2021: 328 Major and 665 Other deficiencies, no Critical. Annual reports give 130 GDP inspections at wholesalers and distributors in 2024 and 128 in 2025.

GDP Deficiency Trending, HPRA GDP Information Day (archived 27 June 2024) (3 May 2022); Temperature Mapping, HPRA GDP Information Day (archived 27 June 2024) (3 May 2022); Transportation and Outsourced Activities, HPRA GDP Information Day (archived 27 June 2024) (3 May 2022); HPRA Medicinal Products Newsletter, Issue 73 (February 2023); HPRA Annual Report 2024 (2025); HPRA Annual Report 2025

Moderate, but not comparable. Both regulators have published deficiency figures, and both put temperature and transport among the frequent Major areas: the HPRA's 2022 slides most directly (87% and 79%), the MHRA's 2016 data at 9% for temperature control and 13% for transportation. The figures cover different years and use different units (share of sampled inspections, share of deficiencies, or a percentage frequency with no stated denominator), so they do not show which regulator finds temperature problems more often.
How inspection reports are published

After a satisfactory response to the post-inspection letter, the company gets a GDP certificate and the report. Reports are not published. Since 1 January 2021 MHRA authorisations and certificates have been on the MHRA-GMDP database, and UK records in EudraGMDP are no longer updated except for Northern Ireland sites. MHRA-GMDP publishes GDP certificates and GMP non-compliance statements, but no GDP non-compliance statements; the MHRA does publish a list of suspended and revoked licences. A 2025 blog says GDP certificates do not expire, and the MHRA stopped automatic validity extensions after December 2024.

Medicines: good manufacturing practice and good distribution practice (13 May 2024); Welcome to MHRA-GMDP; GMP & GDP Certificates (16 May 2025); Suspended and revoked licences for manufacturers and wholesalers of medicines (15 October 2026)

Reports are sent to the company within 15 days, and the company responds to each deficiency with CAPA and dates. We found no HPRA publication of inspection reports; the HPRA's inspection material describes reports being issued to the company only. Routine and application inspections result in a GDP certificate or a 'statement of non-compliance with GDP', published to EudraGMDP. Non-routine inspections can produce a non-compliance statement but not a certificate.

IA-G0008-8 (27 August 2025); GDP inspections

Moderate. Neither regulator publishes full reports. HPRA GDP non-compliance statements appear in the EU-wide EudraGMDP. The MHRA does not publish GDP non-compliance statements for GB sites: MHRA-GMDP's GDP section lists certificates only, and its non-compliance listing covers GMP.
Enforcement tools

The MHRA refers critical findings, or unresolved action plans, to the Inspection Action Group (IAG). IAG can refuse or suspend a licence, increase inspections or call meetings. Where compliance is poor but below the threshold for regulatory action, a compliance escalation process run by the Compliance Management Team (CMT) applies. Formal options include compulsory variation, suspension or revocation and criminal proceedings. Inspections are risk-rated, licence-wide inspections aim at roughly 3-4 year cycles (2023), and short-notice or unannounced inspections remain possible.

Medicines: good manufacturing practice and good distribution practice (13 May 2024); MHRA Guidance Note 6 (2023); MHRA Good Distribution Practice Symposium 2023 (2 May 2023)

The HPRA may refuse, suspend or revoke a WDA under S.I. 538/2007 (procedures in Schedule 3), and correspondence continues until CAPA responses are satisfactory. Its counterpart to the MHRA's escalation route is the Compliance Regulatory Group (CRG): Newsletter 73 (February 2023) reports that the HPRA has implemented the EU compliance management process, applying it to wholesalers (and manufacturers) whose compliance is below standard but under the threshold for regulatory action. Triggers include one or two Critical deficiencies, several Majors, broken commitments and repeat Majors; actions include meetings, cautionary letters and restricted or shorter GDP certificates marked 'compliance management', visible to other EU authorities. Routine inspections of wholesalers take place at least once every three years (IA-G0008); the HPRA inspections page says the first routine follow-up usually takes place 18 to 24 months after the initial (application) inspection; IA-G0008 says new wholesalers may be inspected about 12 to 18 months after the authorisation is granted. General sale wholesalers are on a risk-based cycle of six months to five years (IA-G0038).

IA-G0008-8 (27 August 2025); HPRA Medicinal Products Newsletter, Issue 73 (compliance management) (February 2023); GDP inspections; IA-G0038-12 Guide to Quality System for General Sale Wholesale Distributors (2 October 2026)

Moderate. Both regulators publish a named escalation route below formal regulatory action: the MHRA's IAG and CMT, and the HPRA's CRG under the EU compliance management procedure. Both also hold statutory powers to refuse, suspend or revoke. No source compares how often either regulator uses these powers.

What isn't published

  • The MHRA has published no GDP deficiency data set since the 2016 data (November 2017), and no temperature breakdown since. Later figures are top-five chapter shares in symposium blog posts (2018, 2019) and totals for October 2021 to November 2022 (1,189 deficiencies across 473 inspections), with no slides. The GOV.UK file labelled 'GDP Inspection Deficiency Data 2018' contains GMP data.
  • The HPRA's 2022 GDP Information Day slides, including the temperature deficiency frequencies, are no longer on hpra.ie; the copies cited here are Wayback Machine captures from 27 June 2024. The slides do not state the denominator for the percentage frequencies.
  • Neither regulator publishes deficiency figures on a common basis (years, method and units differ), so no published source shows which regulator finds temperature problems more often.
  • The MHRA does not publish a dedicated temperature guidance document equivalent to HPRA IA-G0011, and has not restated its 2016 to 2020 Inspectorate blog positions as formal GOV.UK guidance.
  • The MHRA has not used regulation C17 to publish a GB or UK GDP guideline, and has not consulted on one. GOV.UK lists the EU 2013/C 343/01 text and the Green Guide (2022).
  • The MHRA does not publish GDP non-compliance statements for GB sites. MHRA-GMDP lists GDP certificates and GMP non-compliance statements only, and EudraGMDP has carried UK documents only for Northern Ireland sites since 1 January 2021.
  • The HPRA's GDP inspections page does not describe its Compliance Regulatory Group; the process for wholesalers is set out in Newsletter 73 (February 2023).
  • HPRA material gives two follow-up periods that start from different points, both hedged: the inspections page says the first routine follow-up usually takes place 18 to 24 months after the initial (application) inspection, and IA-G0008 says new wholesalers may be inspected about 12 to 18 months after the authorisation is granted.
  • IA-G0046-8 names the transposing law as the 'Medicinal Products (Control of Wholesale Distribution) Regulations 2013'. No regulation of that exact title exists; IA-G0008 and IA-G0011 name S.I. No. 538 of 2007 as amended (most recently by S.I. No. 415 of 2022, collectively the Regulations 2007 to 2022), and IA-G0008-8 lists amendments only to 2019.
  • Neither regulator publishes a required alarm-test frequency or addresses wireless monitoring by name in GDP guidance. The HPRA has no cloud-specific guidance; the MHRA covers cloud and hosted services only in its cross-GxP data integrity guidance (2018, section 6.20).

Record retention

How long to keep records: GB and Ireland

The legal minimum for wholesale is the same on both sides: at least 5 years. Longer periods in Ireland usually come from customers' quality agreements, not from GDP.

SettingRecordHow longBasis
Wholesale (GDP), GB and Northern IrelandAll GDP documentation: procedures, records and data, including storage and transport temperature records. Backups of computerised system data are covered separately in chapter 3.3.1.At least 5 years, or longer if national legislation says soLaw (guidelines made binding by HMR reg 43(1))EU GDP Guidelines 2013/C 343/01, chapter 4.2 ('Documents should be retained for the period stated in national legislation but at least five years') and 3.3.1 (backups at least five years). Human Medicines Regulations 2012 reg 43(1) makes compliance a licence condition: in GB via reg C17, in NI via the Commission guidelines.Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01)Compliance is mandatory for wholesale dealer's licence holders under HMR 2012 reg 43(1).
Wholesale (GDP), IrelandTransaction records for each medicinal product received or dispatched; all GDP documentation, including temperature records, under the EU GDP GuidelinesAt least 5 yearsLawS.I. No. 538/2007, Schedule 2, para 8(1) (transaction records kept available for inspection 'for a period of not less than five years') and para 13 (must comply with the Commission GDP guidelines, which set at least 5 years in chapter 4.2)S.I. No. 538/2007, Medicinal Products (Control of Wholesale Distribution) Regulations 2007The HPRA GDP guide (IA-G0046 v8, chapter 4) adds that superseded master copies of procedures should be kept for at least 5 years. The HPRA temperature guide (IA-G0011 v3) sets no retention period of its own. Neither HPRA guide gives a 15-year figure for GDP.

These are differences between regimes, not contradictions: each period applies to its own records. Sources checked 19 October 2026.

In practice

In Ireland, many pharmaceutical companies require their distributors to keep temperature records for 15 years through quality agreements; GDP itself requires at least 5. If a customer asks for 15, that's a contractual requirement: build it into your retention settings. This is what we see in practice, not a regulatory figure, so it is a difference between contract and law rather than a contradiction. When a customer or auditor quotes 15 years, ask which clause they rely on: usually it is the quality or technical agreement, sometimes a group data integrity policy. Other laws can also set longer periods for other records; for example, the EU MDR keeps device technical documentation for at least 10 years after the last device is placed on the market (15 for implantable devices).

The full retention table, all settings · Download it as a PDF

From the HPRA

Irish guidance in the library

HPRA positions on temperature control, in the same format as the rest of the library.

Can our monitoring use the fridge or cold room's own control probe?Guidance

No. For manufacturers, wholesalers and transporters, the HPRA says recording probes should be independent of controlling probes, and placed where mapping found the greatest temperature variability. WHO TRS 961 Annex 9 (clause 4.5.1) says the same from the other side, and this is the part that applies to hospital, laboratory and blood settings: control sensors should be independent of the temperature monitoring system. If the controller's sensor drifts or fails, a monitor that shares it reads normally while the product warms.

What's agreed, and what isn't

IA-G0011's scope (section 1) is manufacturers, wholesalers, transporters and API manufacturers, so the HPRA point is not attributed to hospitals, labs or blood services. EU GDP 3.3 treats equipment that controls and equipment that monitors as two things to calibrate, but does not itself say they must be separate. EN 12830, the recorder standard, opens its requirements with the same principle: the recorder's measurement must be independent of the one used to control the refrigerating system. A built-in display usually shows the controller's sensor, which is why the Green Book also asks for a separate max/min thermometer.

Status
Formal guidance
Applies to
Wholesalers (WDA), Hospitals and wards, Laboratories, Blood
Last checked
19 October 2026
In Ireland, does the HPRA expect an ambient warehouse to be mapped in both summer and winter, and empty and full?Guidance

Yes. The HPRA temperature guide (IA-G0011) says warehouses should be mapped in the empty and full states and that mapping should be performed during both summer and winter to assess worst-case conditions. Mapping should be repeated after significant modification to the premises, changes in stock layout or changes to the heating system, and areas such as skylights and controlled drug cabinets should be included.

What's agreed, and what isn't

The guide does not set a fixed re-mapping interval (e.g. every X years); re-mapping is trigger-based. It also flags turning heating off overnight or at weekends as something to consider. The EU GDP Guidelines themselves only say mapping should be done 'under representative conditions'; the explicit summer/winter and empty/full wording is HPRA elaboration.

Status
Formal guidance
Applies to
Wholesalers (WDA), Manufacturers
Last checked
18 October 2026
When does the HPRA expect a walk-in cold room or large fridge to be re-mapped?Guidance

IA-G0011 says large refrigerators and walk-in cold rooms should be mapped on installation in the empty and full states, with an ambient probe outside the unit. Re-mapping is expected after significant changes such as repair or replacement of the refrigeration unit, changes to internal layout, changes to set points, and changes to how duty/back-up condensers are run, including swapping which is main and which is back-up; if units are routinely rotated, both should be in the mapping study. Moving a small fridge may also require re-mapping.

What's agreed, and what isn't

These are specific triggers that go further in detail than the EU GDP text. The guide's wording varies in strength: re-mapping after a change to how duty/back-up condensers are run 'is required', while moving a fridge 'may' require it, and most other triggers use 'should'. None of it is a legal requirement. No fixed periodic re-mapping frequency is given.

Status
Formal guidance
Applies to
Wholesalers (WDA), Manufacturers
Last checked
18 October 2026
Our Irish storage area is tiny. Do we need a full temperature mapping study?Guidance

The HPRA GDP guide says an initial mapping exercise must be performed and documented for areas greater than a few square metres; for room-temperature areas smaller than that, a risk assessment can be used instead. Continuous monitoring probes should then be placed according to the mapping or risk assessment in all storage areas, including pick-face, quarantine and returns, with at least a max/min thermometer read and reset daily.

What's agreed, and what isn't

This mirrors EU GDP 3.2.1, which has the same 'few square meters' concession; the HPRA wording makes mapping a 'must' above that size. 'A few square metres' is not defined numerically. The concession applies to room-temperature areas only; IA-G0011 still expects mapping to inform probe locations in small fridges. Products with no labelled storage condition may be stored at temperatures not exceeding 30°C according to the same guide.

Status
Formal guidance
Applies to
Wholesalers (WDA)
Last checked
18 October 2026
How often does the Responsible Person have to review temperature records under HPRA guidance?Guidance

IA-G0011 repeatedly states that temperature records should be checked daily and independently reviewed (and, for ambient storage, approved) on a monthly basis by the Responsible Person, with a record of the review kept. Deviations outside limits should be notified promptly to the RP and investigations documented.

What's agreed, and what isn't

Where alarms notify staff audibly in real time and out of hours, the guide allows the frequency of checking monitoring records to be extended if the rationale is documented and justified. The EU GDP Guidelines do not specify a monthly RP review; this is HPRA-specific detail.

Status
Formal guidance
Applies to
Wholesalers (WDA)
Last checked
18 October 2026
What calibration does the HPRA expect for temperature monitoring probes?Guidance

Probes should be calibrated at least annually against a traceable reference, at a minimum of three points across the range of use (examples given: 0, 15 and 30°C for ambient warehouse probes; -10, 0 and 10°C for fridge probes). Calibration should cover the entire monitoring system (probes, receiver, display), certificates should state the method and be reviewed and approved by the wholesaler, and a failed calibration should trigger a review of previous readings.

What's agreed, and what isn't

Auxiliary calibrated probes should be used so storage areas stay monitored during calibration; serial numbers and certificates of these should be kept. Recording probes should have an accuracy of at least +/-0.5°C and be independent of control probes. In IA-G0011 section 3.3 the ±0.5 °C figure applies to large-volume cold storage only; the HPRA's 2022 mapping slides (slide 9) repeat it generally.

Status
Formal guidance
Applies to
Wholesalers (WDA), Manufacturers
Last checked
18 October 2026
What does the HPRA say we must do after a temperature excursion?Guidance

The HPRA defines an excursion as a deviation from labelled storage conditions 'for any duration of time' in storage or transport. Excursions should be notified immediately to the RP, affected product quarantined until the investigation outcome is known, the manufacturer/MAH consulted on quality impact, the investigation and outcome documented, and corrective actions implemented. If a recall may be required, the HPRA should be notified immediately.

What's agreed, and what isn't

Excursions in fridges or freezers used only to condition ice packs should be investigated with equal thoroughness. The guide does not set a minimum duration below which an excursion can be ignored, which differs from informal commentary elsewhere about very short excursions.

Status
Formal guidance
Applies to
Wholesalers (WDA), Manufacturers, Transport
Last checked
18 October 2026
Can we use mean kinetic temperature (MKT) to justify an ambient excursion in Ireland?Guidance

Only under strict conditions. IA-G0011 says MKT applies only to controlled room temperature products (e.g. 'Do not store above 25°C'), never to refrigerated products, cannot compensate for poor premises control, and storage temperatures should not exceed 30°C at any point if MKT is used. The MA holder should be consulted on whether MKT is applicable, and excursions outside labelled conditions should still be documented, investigated and reported to the MA holder.

What's agreed, and what isn't

Use of MKT should be described in a written procedure and the number of excursions above label limits kept limited. Whether MKT is acceptable for a given product depends on the product's stability data, so the MAH's view is decisive.

Status
Formal guidance
Applies to
Wholesalers (WDA)
Last checked
18 October 2026
Can we qualify insulated cold-chain shippers in an environmental chamber for Irish distribution?Guidance

IA-G0011 states that qualification should use actual transport conditions and that chamber studies 'are not considered to be reflective of actual conditions'. Studies should send containers with loggers to the furthest delivery location, cover seasonal extremes (possibly separate summer and winter pack-outs), full and empty loads, and any door openings during delivery. The time of packing, not dispatch, should be recorded so receivers can confirm receipt within the validated time.

What's agreed, and what isn't

Ice-pack conditioning and re-freezing times should form part of validation, and freezers used for ice packs are subject to the same qualification as product freezers. The position on chamber studies is a notable HPRA-specific statement; it is not wording from the EU GDP Guidelines.

Status
Formal guidance
Applies to
Wholesalers (WDA), Transport
Last checked
18 October 2026
Does the HPRA require refrigerated vans to be temperature mapped?Guidance

Where refrigerated vehicles or containers are the primary means of environmental control, IA-G0011 says they should be validated and monitored, including mapping to find hot and cold spots under worst-case conditions (loaded to capacity, seasonal extremes) and considering door openings, power sources and breakdowns. Loads at risk of freezing should be monitored with calibrated data loggers, and single-use monitors should be qualified.

What's agreed, and what isn't

Vehicle validation is not necessary if a validated container/packaging configuration provides the primary environmental control. The guide gives no mapping frequency for vehicles.

Status
Formal guidance
Applies to
Wholesalers (WDA), Transport
Last checked
18 October 2026
Can a returned fridge line go back into saleable stock in Ireland?Guidance

HPRA policy is that cold-chain products may only be returned to saleable stock where there is no reasonable possibility the cold chain was compromised. Examples given are where the batch was recorded on distribution and the whole delivery-and-return process is validated, or where a unique monitoring device attached to the product shows whether it left refrigerated conditions.

What's agreed, and what isn't

This closely mirrors EU GDP section 6.3, which already requires documented evidence of authorised storage throughout and lists the same chain of steps (delivery, examination, re-packing, collection, return to the fridge); the HPRA adds the attached-monitor option. If any deviation occurred, EU GDP requires a risk assessment demonstrating product integrity. Returns criteria should be established in procedures.

Status
Formal guidance
Applies to
Wholesalers (WDA)
Last checked
18 October 2026
What does the HPRA expect from temperature alarms?Guidance

Where possible, monitoring systems should have alarms that immediately notify relevant personnel. Alarm set points may include alert and action limits (alert limits set so preventive action can be taken before an excursion), and provision should be made for an out-of-hours response. Alarms should be checked regularly at their set points without exposing product to out-of-specification temperatures, with records kept, and alarm nominees trained.

What's agreed, and what isn't

Probes may be placed in a load simulator to avoid nuisance alarms from door openings. For cold rooms, section 3.3 says 'Alarms should be fitted to the unit'. The freezer section (3.4) expects alarms on large and walk-in units and smaller units holding at-risk product; for small fridges an alarm is 'if fitted'. The guide gives no specific test frequency.

Status
Formal guidance
Applies to
Wholesalers (WDA), Manufacturers
Last checked
18 October 2026
Does a haulier or courier holding medicines in transit in Ireland need a wholesale authorisation?Guidance

The HPRA's position is that storage of medicinal products for more than 48 hours during transportation, or any storage of refrigerated product regardless of time, is storage requiring that premises to hold a WDA. A carrier that does not own the product and only transports it generally does not need a WDA under the same conditions.

What's agreed, and what isn't

The wholesaling guide words the refrigerated case more softly ('may be regarded as falling within' WDA requirements), so for any cold-chain cross-dock arrangement it is worth confirming with the HPRA. Contracted transport should be audited and covered by a service level agreement that includes sub-contracting.

Status
Formal guidance
Applies to
Wholesalers (WDA), Transport
Last checked
18 October 2026
What experience does the HPRA expect of a Responsible Person, and can the RP be contracted?Guidance

The HPRA GDP guide treats evidence of six months' full-time direct GDP experience as a minimum, plus knowledge of the WDA conditions, the products and their storage needs, and the relevant law. A contract RP is allowed but needs a contract, must fulfil all RP duties under EU GDP 2.2, and time on site should be based on a documented risk assessment, with a record of time spent in the role.

What's agreed, and what isn't

Suitability is assessed case by case at application and on inspection, and part-time RPs must show they are contactable and present enough. This six-month minimum is HPRA-specific; the MHRA's comparable guidance sets one year's practical experience, so multi-country RPs should check each authority's text.

Status
Formal guidance
Applies to
Wholesalers (WDA)
Last checked
18 October 2026
Does an electronic temperature monitoring system need validating under HPRA GDP guidance?Guidance

The HPRA GDP guide says a computerised system relating to GDP processes should be shown, through validation or verification, to achieve results accurately, consistently and reproducibly before use, with the level of validation set by risk (complexity, bespoke vs off-the-shelf, customisation). It points to EU GMP Annex 11 for further information, and equipment qualification protocols should be approved by the RP.

What's agreed, and what isn't

The guide does not single out temperature monitoring systems or give data integrity (ALCOA+) detail; no HPRA GDP-specific data integrity guide was found. IA-G0011 adds that records must be retrievable, allow excursions to be identified, and that reviews must be recorded.

Status
Formal guidance
Applies to
Wholesalers (WDA)
Last checked
18 October 2026
Does changing our insulated shipper or heating settings need formal change control in Ireland?Guidance

Yes, the HPRA GDP guide gives a change of insulated shipper for cold-chain products, a change to heating system settings and relocation of a storage area as examples of changes needing change control. Changes should be evaluated for impact on quality and traceability, including validation, and approved by relevant managers and the RP before implementation.

What's agreed, and what isn't

Such changes can also be mapping or qualification triggers under IA-G0011. The guide notes wholesalers working to other accredited standards should do a gap analysis against GDP.

Status
Formal guidance
Applies to
Wholesalers (WDA), Transport
Last checked
18 October 2026
How does the HPRA grade GDP inspection findings, and where do temperature failures fit?Guidance

The HPRA uses Critical, Major and Other. Critical means a significant risk to patients or public health (example: activity increasing the risk of falsified medicines reaching patients). Major means a deviation resulting, or likely to result, in a product not complying with its authorisations, and HPRA names failure to comply with required storage and transport conditions as an example; combinations of related lower findings can be escalated.

What's agreed, and what isn't

The current HPRA inspections page gives no temperature example at Critical level. However, the HPRA's GDP Information Day slides (3 May 2022) listed 'storage of products requiring refrigeration at ambient temperatures' as an example of a possible Critical deficiency, the same example as MHRA Guidance Note 6. In practice a severe temperature failure could be graded Critical by either regulator.

Source
GDP inspections HPRA, undated
Status
Formal guidance
Applies to
Wholesalers (WDA), Transport
Last checked
18 October 2026
How often does the HPRA inspect wholesalers and what is published afterwards?Guidance

The HPRA wholesaling guide says routine inspections take place at least once every three years, more often for large wholesalers or those with poor compliance, and new wholesalers may be inspected about 12 to 18 months after the authorisation is granted. Inspection reports are sent within 15 days; routine and application inspections result in a GDP certificate or a 'statement of non-compliance with GDP', both published to EudraGMDP. The HPRA may refuse, suspend or revoke a WDA under S.I. No. 538 of 2007.

What's agreed, and what isn't

Published frequencies vary between HPRA documents: the GDP inspections web page says the first routine follow-up usually takes place 18 to 24 months after the initial (application) inspection, a different starting point from IA-G0008, and later ones are risk-based, and the general sale guide cites a six-month to five-year cycle. HPRA annual reports record 130 GDP inspections at wholesalers and distributors in 2024 and 128 in 2025. We found no HPRA publication of inspection reports; the HPRA's inspection material describes reports being issued to the company only.

Status
Formal guidance
Applies to
Wholesalers (WDA)
Last checked
18 October 2026
For a general sale (GSL) wholesaler in Ireland, how should a temperature deviation be classified in our own deviation system?Guidance

The HPRA's model quality system for general sale wholesalers gives 'temperature deviations' as an example of a Major deviation (potential to compromise product quality) in the company's own classification scheme, alongside a Critical tier (e.g. failure to quarantine unsuitable product) and a Minor tier. Its temperature SOP template requires initial mapping or a documented RP-approved risk assessment, worst-case probe placement and daily max/min recording.

What's agreed, and what isn't

This is a company-level deviation classification example, not the HPRA's inspection grading. The guide says inspection frequency for these distributors is risk-based, between six months and five years.

Status
Formal guidance
Applies to
Wholesalers (WDA)
Last checked
18 October 2026
Does the HPRA temperature guide apply to manufacturers in Ireland, or only wholesalers?Guidance

Its scope covers human and veterinary medicinal product manufacturers, wholesalers and transporters in Ireland, and manufacturers of APIs. It says a continuous temperature monitoring system is required for the storage of medicinal products, recording probes should be independent of controlling probes and placed at the greatest variability found by mapping, warehouses mapped empty and full in summer and winter, and probes calibrated at least annually at a minimum of three points.

What's agreed, and what isn't

Its legal basis and much of its wording are written for wholesale (it cites the wholesale regulations and the RP), so present it as HPRA temperature guidance that includes manufacturers, not as a GMP guideline. Irish manufacturers' legal duty to follow GMP is in S.I. No. 539/2007, regulation 10.

Status
Formal guidance
Applies to
Manufacturers
Last checked
19 October 2026

Questions

Common questions

Is the HPRA standard different from the MHRA's?

The underlying standard is the same 2013 EU GDP Guidelines (2013/C 343/01). In Great Britain it applies as the version in force on 31 December 2020 unless the MHRA replaces it, and in Ireland it applies via S.I. 538/2007. What differs is the published elaboration. The HPRA has formal numbered guides with specific numbers (e.g. three-point annual calibration, monthly RP review of records, summer and winter mapping, 48-hour storage-in-transit threshold). The MHRA's temperature interpretation sits mainly in Inspectorate blog posts and Guidance Note 6. Neither regulator's published material says that either is stricter overall. Sources: The Human Medicines Regulations 2012, regulation C17; IA-G0046-8 Guide to Good Distribution Practice; IA-G0011-3 temperature guide.

Does Northern Ireland follow MHRA or EU rules for GDP?

Both, in different senses. The MHRA is the competent authority and inspects and licenses NI wholesalers. But regulation 43(1)(b) of the Human Medicines Regulations 2012 requires an NI licence holder to follow the GDP guidelines published by the European Commission under Article 84, so the current EU text applies, whereas GB follows the version frozen at the end of 2020 unless the MHRA replaces it. The Windsor Framework medicines arrangements began on 1 January 2025. Sources: The Human Medicines Regulations 2012, regulation 43; Wholesalers' and manufacturers' guidance following agreement of the Windsor Framework.

Is a Responsible Person the same as an RPi?

No. An RP is named on any wholesale licence in either country. The RPi (Responsible Person (import)) is a GB-only role, needed where a GB licence holder imports licensed medicines from an 'approved country for import'. The RPi does everything an RP does and also confirms each batch has been QP-certified (or equivalent) and, where relevant, batch-tested. Ireland has no RPi role; imports from outside the EEA require a manufacturing/importation authorisation and QP certification. Sources: MHRA Guidance Note 6.

Does the RP need the same experience in Ireland and the UK?

The published minimums differ. MHRA Guidance Note 6 says the RP must have at least one year's practical experience of the licensed activities, including temperature control, and should have one year's quality system experience. The HPRA GDP guide treats six months' full-time direct GDP experience as the minimum and assesses suitability case by case. Sources: MHRA Guidance Note 6; IA-G0046-8 Guide to Good Distribution Practice.

Do I need separate mapping for an Irish and a UK warehouse?

Each storage area needs its own mapping: EU GDP 3.2.1, which both regulators apply, requires an initial mapping exercise 'on the storage area before use'. Each site also needs its own authorisation, because the HPRA can only grant a WDA for wholesaling activities in Ireland. Neither regulator publishes guidance on using one methodology across both countries or on accepting the other's mapping reports. A study planned to meet the HPRA's more detailed written expectations (empty and full, summer and winter) would also cover the points in the MHRA's blog, but neither regulator says this. Sources: EU GDP Guidelines 2013/C 343/01; IA-G0011-3 temperature guide; Temperature mapping - an introduction.

Would storing a fridge line at room temperature be a Critical finding?

It could be. Both regulators have published 'storage of products requiring refrigeration at ambient temperatures' as a possible Critical example (MHRA Guidance Note 6; HPRA GDP Information Day slides, 2022). The current HPRA web page names failure to meet storage and transport conditions as a Major example. Critical is reserved for significant risk to patients. Either regulator can escalate a finding based on its seriousness, so the published examples do not predict how a given case will be graded. Sources: MHRA Guidance Note 6; HPRA GDP inspections; GDP Deficiency Trending, HPRA GDP Information Day (archived 27 June 2024).

Can a courier hold our medicines overnight without a wholesale licence?

Both regulators set a threshold, and they differ. For Ireland, the HPRA says storage of more than 48 hours in transit, or any storage of refrigerated product, needs that premises to hold a WDA, while a pure carrier generally does not. In Great Britain, MHRA policy (Inspectorate blog, 2016) is that a site need not be named on a licence if ambient products are held for less than 36 hours in transit and ownership has not passed; refrigerated products need a licensed site even for less than 36 hours, unless they stay overnight in continuously refrigerated vehicles. Sources: IA-G0046-8 Guide to Good Distribution Practice; IA-G0008-8 Guide to Wholesaling and Brokering; Refrigerated medicinal products, part 1: receipt and storage.

How often will the HPRA inspect a wholesaler?

IA-G0008 (August 2025) says routine inspections take place at least once every three years, more often for large wholesalers or poor compliance. The HPRA inspections page says the first routine follow-up usually takes place 18 to 24 months after the initial (application) inspection; IA-G0008 says new wholesalers may be inspected about 12 to 18 months after the authorisation is granted. Wholesalers of general sale medicines only are on a risk-based cycle of six months to five years (IA-G0038, October 2026). The MHRA risk-rates its inspections, and its 2023 symposium described licence-wide inspection cycles of roughly three to four years. Sources: IA-G0008-8 Guide to Wholesaling and Brokering; HPRA GDP inspections; IA-G0038-12 Guide to Quality System for General Sale Wholesale Distributors; MHRA Good Distribution Practice Symposium 2023.

What do inspectors most often find on temperature?

The HPRA's GDP Information Day slides (3 May 2022) list Major deficiencies by 'percentage frequency': 'Management of temperature at the site was deficient' 87% and 'Mapping studies were not performed correctly or not at all' 79%. Its transport slides give 51% for missing or insufficient transport validation or risk assessment (including unvalidated seasons or routes), and 23% for excursion investigation, reporting and passive-shipper deficiencies, among Major transport deficiencies. The MHRA's last full data set (2016) put temperature control at 9% and transportation at 13% of sampled inspections with a Major; it has published no temperature breakdown since. The figures use different years and units, so they cannot be compared directly. Sources: Temperature Mapping, HPRA GDP Information Day (archived); Transportation and Outsourced Activities, HPRA GDP Information Day (archived); MHRA GDP Inspection Deficiency Data 2016.

Ireland

JTF supports customers in Ireland through partners

If you run sites on both sides of the Irish Sea, talk to us about how monitoring, calibration and mapping can be arranged for each.

Talk to us about Ireland

Sources

  1. EU GDP Guidelines 2013/C 343/01
  2. The Human Medicines Regulations 2012, regulation 43
  3. The Human Medicines Regulations 2012, regulation C17
  4. Wholesalers' and manufacturers' guidance following agreement of the Windsor Framework
  5. MHRA Guidance Note 6
  6. IA-G0008-8 Guide to Wholesaling and Brokering
  7. IA-G0011-3 temperature guide
  8. S.I. No. 538/2007 - Medicinal Products (Control of Wholesale Distribution) Regulations 2007, 2007
  9. S.I. No. 164/2013 - Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2013, 22 May 2013
  10. Medicines: good manufacturing practice and good distribution practice, 13 May 2024
  11. Temperature mapping - an introduction
  12. Wholesale distribution of medicines for human use
  13. IA-G0046-8 Guide to Good Distribution Practice
  14. Refrigerated medicinal products, part 1: receipt and storage
  15. Refrigerated medicinal products, part 2, 5 May 2016
  16. A Practical example of applying Quality Risk Management in GDP - Transportation Risks, 15 July 2020
  17. MHRA GXP Data Integrity Guidance and Definitions, Revision 1, March 2018
  18. HPRA GDP inspections
  19. GDP Deficiency Trending, HPRA GDP Information Day (archived 27 June 2024)
  20. MHRA GDP Inspection Deficiency Data 2016
  21. GDP Inspection Deficiency Data for 2016 (blog), 13 December 2017
  22. GMDP Symposium 2017: GDP days, 19 February 2018
  23. The 2018 Good Distribution Practice (GDP) Symposium, 11 June 2019
  24. MHRA Good Distribution Practice Symposium 2023
  25. Good manufacturing practice inspection deficiencies (statistics page), 15 October 2020
  26. Temperature Mapping, HPRA GDP Information Day (archived)
  27. Transportation and Outsourced Activities, HPRA GDP Information Day (archived)
  28. HPRA Medicinal Products Newsletter, Issue 73 (compliance management), February 2023
  29. HPRA Annual Report 2024, 2025
  30. HPRA Annual Report 2025
  31. Welcome to MHRA-GMDP
  32. GMP & GDP Certificates, 16 May 2025
  33. Suspended and revoked licences for manufacturers and wholesalers of medicines, 15 October 2026
  34. IA-G0038-12 Guide to Quality System for General Sale Wholesale Distributors

Sources last checked 19 October 2026. This page compares published material only; it is not a view of either regulator or of any organisation they inspect.

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