Falsified Medicines Directive The DDA 2018 Annual Conference

Delegated Regulation – ‘Safety Features’ Introduced to enable manufacturers, wholesale distributors and those who supply to patients: to verify the authenticity of the medicinal product, to identify individual packs, to verify, by means of a device, whether the outer packaging has been tampered with 2D bar code with a unique identifier Tamper evident packaging Affects all prescription medicines (unless exempted) Products which are not subject a prescription are not impacted (unless listed within the Regulation) Medicinal Product Manufacturer Wholesale Distributor Pharmacy Patient VERIFICATION

Delegated Regulation – ‘Safety Features’ Comes into force 9 February 2019: UK wants to retain a close working relationship with the EU on medicines regulation FMD is a critical part of the EU regulatory framework Work to implement FMD in the UK continues There are 3 scenarios around Brexit

MHRA EU Exit no-deal contingency legislation for the regulation of medicines and medical devices FMD TEXT: “In a no-deal, we expect the UK would not have access to the EU central data hub, and therefore stakeholders would be unable to upload, verify and decommission the unique identifier on packs of medicines in the UK. Therefore, the legal obligation related to this would be removed for actors in the UK supply chain. Packs containing the FMD safety features would still be accepted in the UK, provided that they are in line with other UK packaging requirements. In the interests of public safety, we will evaluate the options around a future national falsified medicines framework, which would inform the detail of any short or longer-term modifications.” https://consultations.dh.gov.uk/mhra/mhra-no-deal-contingency-legislation-for-the-regul/

Unique Identifier Technical specifications of the UI Serial number Product Code Batch number Expiry date 2D data matrix carrier Human readable format in addition How do we identify packs?

Tamper Evidence Medicines required to include the safety features need to include anti-tampering devices CEN standard already approved “Tamper verification features for medicinal product packaging – EN 16679:2014” Choice will be for the MAH/manufacturer to determine

Delegated Regulation – Safety Features

Chapter 4 - Impact on manufacturers Must verify the Unique Identifier (UI), i.e. the 2D barcode complies with the requirements of the delegated regulation, such that it is the correct information and is readable Keep records If repacking must verify and replace UI and safety features Must take action if concerns are raised and inform the National Competent Authority If also a wholesaler dealer the obligations from Chapter 5 also apply

Challenges Order of the text Location on cartons Use of labels to apply coding Existence of linear barcodes Order of data within the 2D data-matrix code Inclusion of a national number Additional information (article 8 of DR) Format of 2D data matrix code

Chapter 5 – Wholesaler Dealers Impact on Wholesalers Risk based verification Decommission the UI in specific circumstances Take action if issues arise and inform the NCA Can decommission the UI on behalf of others if flexibilities have been used by MS

What is the impact on dispensers? General provisions on the verification of the safety features Check the UI against the numbers held in the repository Ensure the tamper-evident feature is intact When decommissioned the product will be “checked-out” of the repository UI can be checked back into the repository in certain circumstances Split packs: Shall be verified and decommissioned when the pack is opened for the first time.

What is the impact on GPs? Healthcare institution defined in the Regulation as a – ‘hospital, in- or outpatient clinic or health centre’ The UK has classed GPs and Dispensing Doctors as health centres and therefore healthcare institutions. However, to remain equitable to what pharmacies have to do, we would expect Dispensing Doctors to decommission as pharmacies. Healthcare institutions can verify and decommissioning at any point that the medicines is in their possession.

NHS Digital and NHS England support NHS Digital supporting FMD implementation in England FMD will be included in GPIT Futures (the replacement to GPSoC) from April 2019 but this will not be ready by February 2019. NHS Digital are evaluating the options for interim solutions Details of the specific plans will be confirmed by NHS England in the near future. .

Meeting our obligations as national competent authorities: Putting in place the additional regulatory changes allowed by the flexibilities within the Delegated Regulation Sanctions and enforcement as required under the FMD Supervision of SecurMed Supporting Implementation

Consultation Consultation closed on 23 September – so far, broad agreement on positions below. Reviewing responses – with an aim of published a formal consultation response by mid-November Issue Article We are minded to Extend the scope of the UI and anti-tampering device 2(1) (c) Continue to allow anti-tampering devices to be added. Do not extend the scope of the UI. National Reimbursement Number Article 4, b, iii and Article 7, 1, c Not to require a reimbursement or national number Additional information in 2D barcode Article 8 Allow other information to be included Wholesaler verification Article 23 Require wholesalers to decommission Exemption of obligations for healthcare institutions Article 26, 3 no practical benefit to exempting persons operating within a healthcare institution in the UK from the obligations of verification and decommissioning under the conditions set out – not to include

Sanctions and enforcement Background Sanctions are required to make the provisions enforceable in the UK. Part of our recent consultation. Proposal To be pragmatic in our approach – seeking compliance Government is minded to move to an approach that would use a mixture of both criminal and civil sanctions. Civil sanctions might include written warnings, stop notices and civil fines Criminal sanctions for the most serious breaches where public health is at risk Consistent with the other sanctions for medicines supply in the Human Medicines Regulations

Supervision of SecurMed UK SecurMed UK is the UK National Medicines Verification Organisation (NMVO), a not for profit organisation set up to establish the UK medicines verification system for the UK. The Department and MHRA has a supervisory role to ensure SecurMed is meeting its obligations under the Delegated Regulation. On 9 July SecurMed announced that it had signed a contract with Arvato Systems as the IT Blueprint Service Provider for the UK. Marketing Authorisation Holders (MAHs) are required to register with SecurMed UK and to pay the applicable fees. There is a fee waiver for micro MAHs. Registration required from by wholesalers and dispensers – process to open at the end of October For further information, please visit SecurMed’s website: https://www.securmed.org.uk/ or contact them at info@securmed.org.uk

Inspection & Supervision

Supporting Implementation: Implementation Advisory Board (IAB) - to ensure the views of all stakeholders in the supply chain are heard. UK Wide – continuing to work with closely colleagues in the DAs Working with the NHS and other UK Regulators - including GPhC and CQC NHS Digital is working with providers to support their readiness Single portal for FMD on GOV.UK to be launched by the end of this week FMD newsletter Dedicated mailbox: FMD.safetyfeatures@mhra.gov.uk Inputting into sector specific guidance (manufacturers, community pharmacy way forward, secondary care FAQs, homecare + more) Speaking engagements, like today

Supporting implementation Continued engagement with the European Commission through our attendance and input at expert group meetings. Four areas of focus: (1) supervision, (2) access to information/data in the repository, (3) data traceability and (4) best practice. The EU commission has also produced a Q&A document – which can be found on their FMD webpage: https://ec.europa.eu/health/sites/health/files/files/falsified_medicines/qa_safetyfeature_en.pdf Resolving the UK’s position on other issues such as: Further clarity on who is covered under HCI and Article 23 Designation Aggregation

The UK is making good progress despite Brexit Issues are that currently being raised demonstrate awareness and an understanding of FMD We will continue to work collaboratively with stakeholders to help resolve implementation challenges and to implement FMD Clear communication over Brexit