31 January 2018
New guidance sets out the way forward for FMD
New guidance for community pharmacy owners has been issued by the UK FMD Working Group for Community Pharmacy. The detailed guidance is intended to build understanding of the options open to pharmacy contractors as the 12-month milestone for implementation approaches.
The Way Forward for FMD in community pharmacy covers key assumptions about FMD, high level processes for incorporating authentication in to existing dispensing workflows, handling stock transition, what IT systems will need to deliver and implications for patient safety.
9 November 2017
European conference highlights varying progress with FMD
Varying progress with implementing the EU Falsified Medicines Directive (FMD) across different Member States and different sectors of the medicines supply chain has been highlighted at a conference in Estonia.
The meeting, hosted by the Estonian Presidency of the Council of Europe, brought together representatives from National Medicines Verification Organisations (NMVOs), the European Medicines Verification Organisation (EMVO), Member States and trade bodies. Raj Patel, Chair of the UK FMD Working Group for Community Pharmacy and President of the Pharmaceutical Group of the European Union (which represents community pharmacy organisations), was among the UK’s representatives.
With exactly 15 months to go before the deadline imposed by EU Delegated Regulation 2016/161, the conference heard that while most Member States now have a functioning NMVO, a few have still to appoint their IT Blueprint Service Provider. Progress with connecting manufacturers to the central “hub” (the EMVS) through which they upload the unique identifiers used to determine the authenticity of medicines, is also behind schedule with fewer than 300 of the expected 2,500 connected so far, well behind the planned target of 1,900 by the end of 2017.
Some countries, including Ireland, Germany and Sweden, are making good progress. They have set up their NMVSs and are planning to start pilot testing with selected pharmacies, wholesalers and hospitals in early 2018.
The spectre of Brexit still hangs over the UK’s progress with implementing FMD. Although the UK Government maintains that it is committed to implementing FMD by February 2019, before the UK leaves the European Union at the end of March 2019, uncertainty over what will happen afterwards has delayed progress and the UK has fallen back compared with other countries.
25 September 2017
Arvato holds FMD workshop for pharmacy IT suppliers
Arvato Systems, which will be implementing the UK’s National Medicines Verification System (NMVS) on behalf of SecurMed UK, has held a workshop session for the main suppliers of IT systems for community pharmacies.
The workshop was held at the National Pharmacy Association in St Albans and hosted by the UK FMD Working Group for Community Pharmacy. During the event, Arvato and SecurMed UK outlined their plans for developing the NMVS and invited the IT suppliers to register for the software development kit and access to Arvato’s test-bed systems.
Connecting IT suppliers to the early-stage NMVS is the first step in a process which should lead to all pharmacies, wholesalers and others handling medicines being connected. This will enable them to undertake the authentication of medicines required under the Falsified Medicines Directive.
Arvato is also holding workshops for IT suppliers to wholesalers, hospitals and dispensing doctors.
18 July 2017
SecurMed UK appoints Arvato to develop verification system
SecurMed UK has signed a letter of intent with Arvato Systems GmbH as the Blueprint Service Provider (BSP) for the UK. The two organisations have started work to plan the implementation of the UK’s Medicines Verification System.
Arvato’s role will be to develop, implement and maintain the National Medicines Verification System (NMVS) that is required as part of the EU Falsified Medicines Directive. Pharmacies, wholesalers and others handling medicines will connect to the NMVS in order to authenticate medicines. This will be done by comparing the unique identifiers on packs of prescription medicines with data uploaded by manufacturers through the central “hub”, the European Medicines Verification System (EMVS).
One of Arvato’s first tasks will be to engage with the IT providers who supply the patient medication record systems used by community pharmacies. FMD authentication could be handled by add-ons to existing PMR systems or by developing stand-alone systems to go alongside PMRs. It is likely to be up to pharmacy owners to decide which type of system they will install.
26 April 2017
FMD consultation delayed by general election
A long-awaited consultation on how some elements of the EU Falsified Medicines Directive (FMD) will be implemented in the UK has been further delayed by the unexpected decision by the Prime Minister to hold a general election in June.
The Department of Health and MHRA had initially planned to start the consultation period at the beginning of 2017 but this was delayed by the need to seek further internal approvals. The consultation had been widely expected to be launched by the end of April. The pre-election “purdah” period means that this is no longer possible. The consultation is unlikely to be held until after the election, and after any Ministerial changes that might occur at the Department of Health as a result.
The consultation is expected to be accompanied by an impact assessment that sets out the potential costs and benefits of implementing FMD. The UK FMD Working Group for Community Pharmacy has facilitated visits by DH and MHRA officials to pharmacies so that they can understand the changes that are likely to be needed and the potential costs.
Whenever the consultation is published, the UK Working Group will be encouraging pharmacy contractors to respond to it.
The consultation will only cover selected elements of FMD. The majority of the EU Delegated Regulation (2016/161) that implements FMD is binding on all Member States, but there are a few areas where national governments can make changes to accommodate particular elements of their health systems.
These include the use of national reimbursement numbers, where applicable, in unique identifiers printed on packs of medicines, and Article 23, which allows wholesalers to undertake the decommissioning of medicines for certain groups or organisations that only handle small volumes of medicines as part of their activities. This does not include pharmacies or hospitals.
30 January 2017
MHRA launches Safety Features newsletter for FMD
The MHRA has launched a Safety Features e-mail newsletter dedicated to developments in implementing the EU Falsified Medicines Directive (FMD) in the UK.
The first issue covers work that has been undertaken since the publication of the EU Delegated Regulation (2016/161) which sets 9th February 2019 as the starting date for FMD authentication.
Those wanting to receive the newsletter can register with the MHRA by sending their name, organisation and job title (if applicable) to FMD.firstname.lastname@example.org. General enquiries about the implementation of safety features (unique identifiers and anti-tamper devices on medicine packs) can be directed to the same mailbox. A response is promised within five working days.
3 January 2017
SecurMed UK appoints general manager
SecurMed UK has appointed Jerome Bertin as its general manager. His role will be to formally set up the UK’s National Medicine Verification Organisation and to oversee the appointment of its IT Blueprint Service Provider on behalf of the NMVO Directors and member organisations.
Mr Bertin has a background in major project management in both the pharmaceutical industry, with GSK, and in the oil and gas sector, with Shell.
SecurMed UK can be contacted at email@example.com.
14 July 2016
SecurMed UK established as Medicines Verification Organisation
The UK’s National Medicines Verification Organisation (NMVO) has been formally established under the name SecurMed UK. The organisation brings together all the main trade bodies from across the medicines supply chain. The five sectors represented are:
- Research-based manufacturers – Association of the British Pharmaceutical Industry (ABPI)
- Generic manufacturers – British Generic Manufacturers Association (BGMA)
- Parallel distributors – British Association of European Parallel Distributors (BAEPD)
- Pharmaceutical wholesalers – Healthcare Distribution Association (HDA)
- Dispensing entities (pharmacies) – Company Chemists Association/National Pharmacy Association (CCA/NPA)
Each sector has one voting director on the board of SecurMed UK, with the pharmacy directorship being held for alternating six month periods by CCA and NPA.
SecurMed’s main purpose will be to establish and maintain a National Medicines Verification System for the UK, as required under the EU Delegated Regulation (2016/161), implementing what is commonly known as the Falsified Medicines Directive (FMD). SecurMed will do this by appointing one of three Blueprint Service Provider (BSP) companies: Aegate, Arvato or Solidsoft Reply. The BSP will develop the UK NMVS and connect all of the UK’s community and hospital pharmacies, dispensing doctors, wholesalers and others who commonly handle and dispense medicines, as well as connecting to the central European Medicines Verification System (EMVS).
The BSP appointment will be handled through a competitive tendering process and is expected to be concluded by the end of 2016, allowing the NMVS to be set up during 2017.
17 March 2016
Government holds first FMD roundtable
The UK Government has brought together organisations from across the medicines supply chain to discuss how the EU Falsified Medicines Directive (FMD) will be implemented in the UK. The meeting follows the publication of the Delegated Regulation (2016/161) that sets 9th February 2019 as the starting date for verification and authentication under FMD.
The meeting of the FMD Ministerial Implementation Advisory Board was organised by the Department of Health (DH) and the Medicines and Healthcare products Regulatory Agency (MHRA) which together form the “National Competent Authority” for medicines in the UK. The meeting was hosted by the Royal Pharmaceutical Society at its new headquarters in London.
Pharmacy representatives at the meeting included the RPS, CCA, NPA, PV, PSNC and Pharmacy Voice, as well as bodies representing pharmacists working in the hospital and prison sectors.
The board is expected to meet quarterly and a series of working groups will be established to examine particular areas around FMD implementation, including communications and the limited number of flexibilities available to Member States under the Delegated Regulation. The board will make recommendations to Health Ministers, via DH and MHRA, as to how FMD can best be implemented in the UK.