HDA RP Committee Minutes - 10 July 2018


HDA RP Committee


90 Long Acre, London

10th July 2018










Dale Williams – Cohens Chemist

Colin Rees – Marine Medical

David Livermore – Waymade

Ian Mulley  - Day Lewis

Taybi Mohamedbhai – Day Lewis

Nia Evans – Celesio

Vasanth Samson – Sigma

Steve Burns – Sangers

Louise Harrison – Well

Phil Stubbs – Well

James Gray – John Bell & Croyden

Amrit Kallar – Walgreens Boots Alliance

Victoria Barrell – Phoenix


Geoff Mellor, HDA

Martin Sawer, HDA (part of meeting)

Isabel Bruce, HDA



Kim Williams – AstraZeneca

Michelle Biggs – Mawdsleys




Previous minutes and matters arising


The previous minutes were approved.  





Company updates from members

  • Concerns were raised by members about the increasing number of instances of the batch number on the outside of packs being different from the batch number inside medicines packs imported from the EU. When reported, members noted that the MHRA had said to continue as normal, having checked with the EMA regarding the assembly license for this. Steve Burns will seek out more information on this and share with Geoff.
  • It was noted that manufacturers have been inquiring whether there are instances of medicine packs with no batch number; this issue has been referred to pharmacy level by members.
  • Members noted that government updates from the MHRA and Government blog were very helpful and gratefully received as a ‘belt and braces’ approach, particularly as there have been inconsistencies in the updates sent out to members previously.
  • Concerns were highlighted about the effect the current heatwave has had on ensuring good distribution practices are maintained. This has been hard to manage in some areas despite temperature control areas being in place. Members noted that in other parts of Europe certain temperature excursions are allowed and regional wholesalers have this in writing from their competent authorities.
  • Members noted that there is a need to ensure that the correct infrastructure is in place and regular scheduled maintenance is undertaken to ensure that there is the necessary infrastructure ready for potential heatwaves. Some members have temperature monitoring systems which make adjustments automatically before an excursion occurs – it was agreed that this represented best practice where possible.
  • It was reported that in some instances members have heard of RPs having been suspended in some companies because they are deemed not to have to competencies to carry out their work during inspections. It was also noted that many companies run RP competency training before they can start work.
  • The Technical Director reminded the Committee that the HDA runs relevant RP training that could be useful for both refreshers but also for junior members of teams. The next relevant training session will be running in November.
  • Concerns were noted from members about the regular thefts or attempted thefts from warehouses. Police have been involved in some cases but getting them involved before a shipment goes out can be a lengthy process.
  • FMD - Article 23 from a maritime perspective is still an issue – medical facilities onboard ships won’t be able to decommission and therefore the product will need to be decommissioned before being handed over. This needs to be clarified following the FMD consultation due to open soon.
  • Members posed questions on the usability of the SecurMed platform. It is not clear how the process will work or how MAH holders will be able to log-in to the system to designate members as a nominated wholesaler. It was noted that this has to be done through the European hub – so it is best for members to go to them to ask questions on this. The Executive Director will check with SecurMed and ask who would be best to address the question.
  • A member noted that temperature excursions during transit for airports have been increasingly problematic – this is the highest risk part of the supply chain but makes batch releasing difficult as it affects the stability data.  For example, when the shipment is left for 4 hours on the runway.
  • Other members notes issues with stability data more broadly - GIRP and EFPIA are working on standardising stability data to make this uniform across the industry and will make the streamlining of the supply chain operation easier.
  • Across the board members have seen an increase in suppliers asking for stock checks. Members unanimously agreed that this should be a service that is charged for.
































































HDA Technical Director’s Report

  1. Review HDA FMD Best Practice Workshop Document – Members proposed small edits to this document to clarify specific terms and conditions. The Association may come back to some areas to examine them in more detail later on. The document will be re-circulated when finalised.
  2. RP Training November
  • Feedback from previous training noted that the timing of the session was valuable since the competencies of RPs has been coming up in inspections. It would also be useful to look at new risk assessment systems and how best to make the most of these.
  • In terms of format for the next meeting – it may be beneficial to have a member of MHRA there but since they were there for the duration this meant that people were more reserved. The Technical Director will discuss with Tabriz Consulting for guidance.
  • The next meeting is scheduled for 7/8th November 2018 at Celesio in Stoke. The Technical Director noted that this session will need the support of members and it would also be helpful to send more junior members of teams. Technical Director asked for an attendance of at least 20 people. Additional details of this training will be sent out in the next 2/3 weeks.
  1. Supply Chain Security Concerns/ Fraudulent Calls
  • HDA is aware that this is an issue for members. It was noted that there is a need to brief customer sales teams on this issue and how best to deal with it.
  • Members could send in flagged emails to the HDA centrally regarding specific fraudulent requests and Geoff will share with other members of the committee for awareness
  • The Technical Director relayed updates to the committee on the Falsified Medicines stakeholder group and its latest work, Operation Pangea. This operation is a Europe-wide investigation designed to monitor activity and intelligence on supply chain with the aim of taking down fraudulent sites.  The watch-list and monitoring list was shared with members by the Technical Director. This watch list is distributed at the FMSC stakeholder group – latest document is from November 2017.
  • The HDA Security Group was started as part of this wider effort to tackle diversions from the legitimate supply chain. It is important for all members to be aligned and the Technical Director asked for members to send along representatives from their companies who oversee security to these committee meetings. The next meeting is scheduled for 28th November 2018 at 90 Long Acre.
  1. GIRP Update/Meetings
  • At the last GIRP meeting, the main topic was temperature excursions and the Association’s aim to bring together different groups of products to streamline stability data
  • Each country provides an update on FMD – in the UK, the software IT contract with Arvato was signed on 9 July 2018, thereby allowing the UK to be a member of the main group of countries building their respective data repositories this year
  • In terms of how to tackle the shortages of medicines, the European Commission is putting forward various proposals aiming to ensure the continuous supply of products.







































































MHRA Update / inspectorate update

  • 2150 licenses covering 4238 sites
  • 19 licenses revoked in June alone. Of those, 4 were suspended by the MHRA and 3 were voluntarily surrendered and 3 were surrendered after the MHRA announced an inspection
  • The MHRA are hoping to announce another update at the symposium later this year – agenda currently a moving target but will address FMD and Brexit. Three new inspectors will also be introduced.



  1. Falsified Medicines Directive
  • The MHRA reiterated that they are still being advised that the UK implementation date for FMD is 9th February 2019 and slots for the new regulations on UK ‘flexibilities’ have been scheduled for December 2018, in UK Parliament.
  • It was noted that the announcement of the FMD consultation is imminent – Article 23 will be part of this. The expectation is that wholesalers will be decommissioning prior to supply to the majority of Article 23 customers.
  • Members sought clarity on the list of those from whom it will be required to decommission prior to supply as the current list is not defined. For example, a hospice is on the list but it doesn’t define what constitutes a hospice.
  • Symposium could cover what the MHRA will be expecting to see from 9th February in inspections – members suggested that this would be hugely beneficial to include in the agenda for the symposium.
  • Members asked for a progress update on the MHRA economist’s Impact Assesment report as they have submitted cost evaluations for FMD but have not yet heard back from the MHRA team responsible for this.
  • Notifications coming out from MHRA are not always accessible for members. For example, when members have followed up regarding a class 1 recall notification – sometimes emails and attachments have not matched up. If an update is subsequently revised – these details should be highlighted by referencing version 1 of the document and version 2 etc.





































HDA Update

  1. HDA Business Day – topic ideas and issue areas to discuss for the Business Day on 15th November 2018 were requested from members by the Technical Director
  2. RP meeting dates for rest of 2018 – Next meeting is scheduled for 30th October. Another meeting could be scheduled before this date once the FMD consultation is opened to coordinate the HDA response.
  3. RP training – Next session will be 7/8th November 2018 in Stoke. Details will be circulated shortly.