Frequently Asked Questions and Answers on FMD and DR for Pharmaceutical Manufacturers

The views expressed in this questions and answers document should not be considered a formal interpretation of Union law, nor are legally binding.

These FAQ’s should be read in conjunction with European Commission – Safety Features for Medicinal Products for Human Use ‘Questions and Answers’ and the MHRA Newsletters.

NB. Although these FAQs are primarily directed at pharmaceutical manufacturers it is recognised that almost all of them will also hold a WDA. Consequently, there are FAQs included that have a relevance to wholesalers including wholesaler software that may be of interest to pharmaceutical manufacturers.

What about FMD after the End of Transition Period?

The Falsified Medicines Directive (FMD) is EU legislation which aims to increase the security of the manufacturing and distribution of medicines across Europe and protect patients and prevent falsified medicines from entering the supply chain. 

FMD in GB

  • The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 Statutory Instrument outlines changes to regulations around the use of medicines in the UK.

  • The requirements placed on all actors in the GB supply chain from 9 February 2019, by virtue of the Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regarding the safety features aspects of the Falsified Medicines Directive are removed by this instrument, according to the Explanatory Memorandum (Article 7.32).

  • The EU legislation requires that the Unique Identifier on medicines coming from the EU be decommissioned (made inactive) on export from the EU to a third country (Article 22 – EU Delegated Regulation).

  • There will be no obligations on the GB supply chain to affix safety features or to scan packs of medicines however, packs that already have FMD safety features will continue to be accepted in the GB, provided that they are in line with other GB packaging requirements.

  • The MHRA is encouraging companies to retain the tamper evidence device on packs supplied to the UK.

  • In the interests of public safety, the Government will evaluate the options for a future UK falsified medicines framework, considering the investment already made by stakeholders.

FMD in NI

  • Under the Northern Ireland Protocol (NIP), medicines in NI will be governed by EU rules and regulations. However, these rules are to be enforced by the UK’s medicines regulator, the MHRA.

  • As a result of the NIP, the Falsified Medicines Directive will continue to apply and FMD ‘safety feature’ requirements will continue in NI from 1 January 2021. Packs with a marketing authorization (MA) valid in NI will require a unique identifier and a tamper evident device on each pack.

  • The unique identifiers on packs with MA valid in NI (including UK-wide MAs) supplied from the EEA will not require decommissioning when exported to the UK until the 31 December 2021, according to MHRA guidance. The active unique identifiers on these packs should be decommissioned in NI at the time of dispense.

How does a ‘Designated Wholesaler’ get allocated?

The status of ‘Designated Wholesaler’ is in the gift of the MAH (and or its affiliate) and should be captured within the EMVS Master Data upload by On Boarding Partners to the Hub. It may be specific to a country and product.

The MHRA interpretation of this part of the regulations is as follows:

Article 20 of the Delegated Regulation states:

Article 20 - Verification of the authenticity of the unique identifier by wholesalers

A wholesaler shall verify the authenticity of the unique identifier of at least the following medicinal products in his physical possession:

(a) medicinal products returned to him by persons authorised or entitled to supply medicinal products to the public or by another wholesaler;

(b) medicinal products he receives from a wholesaler who is neither the manufacturer nor the wholesaler holding the marketing authorisation nor a wholesaler who is designated by the marketing authorisation holder, by means of a written contract, to store and distribute the products covered by his marketing authorisation on his behalf.

Part (b) of this Article covers designation. MHRA interpretation of this is that the Marketing Authorisation Holder (MAH) will designate and have a written contract with wholesalers who are storing and distributing products for which he holds the MA on his behalf. In our view these wholesalers are the pre-wholesalers / 3PL companies who store and distribute the MAH’s products prior to it being sold by the MAH into the wholesale supply chain.

How does a ‘Designated Wholesaler’ confirm he has been allocated this status by an MAH?

Each ‘Designated Wholesaler’ will hold a contract with the allocating MAH, and Article 36 (g) of the Delegated Regulation captures the expectation of each NMVS to provide information/confirmation regarding ‘Designated Wholesalers’. In the UK wholesalers can download this list (per product) via a transaction on the NMVS – End User software interface, documented in the Arvato SDK.

How do I contact the European Medicines Verification Organisation (EMVO)?

EMVO can be contacted at https://emvo-medicines.eu

How do I contact the UK National Medicines Verification Organisation (UK NMVO) – SecurMed UK?

SecurMed UK can be contacted via email at info@securmed.org.uk and or via www.securmed.org.uk

Does the European Commission have a FAQ / Q&A document?

Does the UK Regulator, the MHRA produce guidance and advice on FMD?

The MHRA has a dedicated FMD portal for advice and guidance

It also publishes a regular FMD Safety Features Newsletter. To receive copies, or place questions about FMD please use the dedicated mailbox, FMD.safetyfeatures@mhra.gov.uk.

The MHRA published Supplying authorised medicines to Northern Ireland from 1 January 2021, including in relation to FMD

  • The serialisation requirements of EU Delegated Regulation 2016/161 will continue in Northern Ireland from 1 January 2021. Medicines with a marketing authorisation valid in Northern Ireland will require a unique identifier and a tamper evident device on each pack.

  • The unique identifiers on packs with a marketing authorisation valid in NI (including UK-wide MAs) supplied by a manufacturer or wholesaler in the EEA will not require decommissioning when exported to the UK until the 31st December 2021. Unique identifiers on these packs should be decommissioned in Northern Ireland as required by EU Delegated Regulation 2016/161.

Which medicines are in scope of FMD and require safety features?

FMD primarily covers Prescription Only Medicines (POMs).  The Delegated Regulation states that it encompasses all Prescription Medicines except those excluded in Annex 1.

All over-the-counter medicines in the UK Pharmacy Only (P), General Sales List (GSL) except in Annex 2 DR, Unlicensed Medicines, and those procured under article 5(1) of Council Directive 2001/83/EC are out of scope of the FMD implementation

Will anti-tamper devices be allowed on OTCs and other out-of-scope products after February 2019?

The MHRA has confirmed that following the outcome of a public consultation anti-tamper devices may continue to be placed on out-of-scope products after 9th February 2019 if the relevant manufacturer considers that it is necessary to do so in the interests of patient safety. Similarly, anti-tamper devices may be placed on new out-of-scope products introduced to the market after February 2019, based on a similar risk assessment and on a voluntary basis.

See the Government Response to - A Consultation on implementing ‘safety features’ under the Falsified Medicines Directive.

How will the FMD be enforced?

Enforcement of FMD in Member States is the responsibility of national competent authorities. Sanctions introduced in the UK can be found in the Government Response to - A Consultation on implementing ‘safety features’ under the Falsified Medicines Directive.

Will there be a consultation? Will there be an impact assessment?

The consultation and impact assessment have now been published and can be viewed here: https://www.gov.uk/government/consultations/implementing-safety-features-under-the-falsified-medicines-directive.

Who will pay for the FMD?

The EU Delegated Regulation 2016/161 makes it clear that the costs of establishing the repositories system (i.e. the European and national verification systems and their governing bodies) is to be borne by manufacturers (i.e. research-based companies, generic manufacturers and parallel traders).

Community and hospital pharmacies and wholesalers will be required to pay for any “physical scanning equipment” that is required for reading unique identifiers Article 32. They will also need the software required to connect with their national verification system.

What is the process of on-boarding for FMD and what master data needs to be prepared?

There are two processes Marketing Authorisation Holders (MAHs) need to perform to on-board for FMD:

  1. On boarding to EMVO - all MAHs must on-board to EMVO to be able to upload pack information into the EMVS/ NMVS repositories system. EMVO will perform a detailed set of assessments, contract with the MAH and require payment of a fee before granting access to EMVS. EMVO will also provide a Master Data Guide to assist in the preparation of master data. You can on-board to EMVO at https://emvo-medicines.eu/pharmaceutical-companies. EMVO has prepared a knowledge database at https://emvo-medicines.eu/knowledge-database/ for manufacturers and MA holders who need to connect to the EU Hub.

  2. Contracting with SecurMed UK and paying fees to fund the EMVS/NMVS repositories system. All MAHs are required, under Article 31 (5) of the Delegated Regulation to bear the costs of the EMVS/NMVS repositories system. For the UK, this will mean contracting with and paying fees for access to the SecurMed UK Medicines Verification System, in respect of Northern Ireland. SecurMed UK can be contacted via email at info@securmed.org.uk

Can the EMVS system be used by manufacturers and wholesalers to reconcile batches?

The EMVS system is not a track and trace system and does not have the functionality to reconcile batches of medicines

What is the difference between decommissioning and verification?

Verification is a process that can take place at any time during movement of the medicine through the supply chain. It checks the Unique Identifier of the product against data held in the national repository to verify that the product is authentic and is available for supply to the patient.

Decommissioning happens once only (unless a product’s status is reverted) and takes place at the end of the supply chain when the product is supplied to the patient or otherwise leaves control of the pharmacy (e.g. ward stock supply). Decommissioning changes the active status of the Unique Identifier (UI) in the repository.

If a product is decommissioned in error, then it can be recommissioned within 10 days provided this is undertaken at the same location.

Will manufacturers and wholesalers be able to see data on products dispensed? What about national competent authorities?

The Delegated Regulation makes clear that all stakeholders that are connected to the repositories system, including manufacturers, wholesalers and pharmacies, have sole responsibility, ownership and access to any data that they generate. This data is not available to any other stakeholders. The only exception is the ‘status of products’ UIs’, which is available to any party that has a relevant pack in their possession.

Each national medicines verification system will maintain an audit trail of when and where product information was uploaded and accessed, and where and when UIs are decommissioned. This data cannot be shared with other parties, other than with the express written permission of the data owner. The only exception is when an alert is investigated e.g. incident of potential falsification. National competent authorities shall supervise the functioning of the repository to ensure that it complies with the obligations in the Delegated Regulation.

Furthermore, national competent authorities have authority to access the repositories system to investigate matters relating to pharmacoepidemiology, pharmacovigilance and reimbursement, and an agreement is being discussed between EMVO and the EU Commission as to how such data is reported. Contact EMVO for further information on this.

Can pharmacy and wholesalers sell data to IMS?

Pharmacy contractors and wholesalers will be able to sell dispensing data generated by their PMR & wholesaler systems in the normal way, but it is likely that commercial restrictions will be placed on the use of individual pack data derived from the FMD system, in line with the data ownership rules outlined above. Reference: FAQs – The UK FMD Working Group for Community Pharmacy (www.fmdsource.co.uk)

Will pharmacies be able to return stock to their wholesaler or a DTP manufacturers’ distributor?

This will depend upon the wholesaler’s and manufacturer terms and conditions, but in general, as long as the stock has not be decommissioned and the anti-tamper device is still intact, it is expected the current returns process will remain valid. Wholesalers and distributors will have to verify the status of any products returned to them, to ensure it is authentic and to confirm its ‘active’ status.

See also Alert Management

  • Alert Management

Alert management will be a critical to the functionality and smooth running of each national verification system. Ultimately a simple summary guide of activities in response to reported issues would assist all stakeholders manage enquiries and avoid patient inconvenience, whilst reducing the risk of false signal overload. However, the challenges faced by each group of stakeholders in preventing unnecessary alerts and managing alerts once generated has led to the publication of several guidance documents – each considering the perspective from the stakeholder concerned. This includes the ABPI – who have generated a working paper which recognises that MAHs have widely publicised customer services, medical information or contingency (emergency) supply contact details and that these contact points may well be a frequently used route for EMVS alert enquiries, irrespective of whether the alert is within the span of control of the MAH. This is the experience with pack related enquires today and may expand due to FMD implementation, at least in the early days.

This Working Paper should be read alongside other similar guidance documents e.g. EMVO Guideline for EMVO and NMVO stakeholder - recommendations for alert handling and prevention processesUK FMD Working Group for Community Pharmacy guidance - FMD Scanning and Error Messages; Royal Pharmaceutical Society ‘Professional decision-making guidance for FMD alerts and dispensing’

How will Brexit affect the FMD and its' processes?

As the UK has left the EU and the Transition Period ends on 31st December 2020, some regulatory requirements will no longer apply. However, certain EU legislation will continue to have effect in Northern Ireland under the Northern Ireland Protocol.

Pharmacies in Great Britain

The ‘safety features’ elements of the EU Falsified Medicines Directive (FMD, 2011/62/EU) and Delegated Regulation (2016/161) cease to have effect in Great Britain from 31st December 2020. This means that pharmacies (and other end users such as wholesalers, hospitals and others handling or supplying medicines) will no longer be required by law to verify and decommission unique identifiers on prescription medicine packs.

  • End users in Great Britain will be disconnected automatically from the UK National Medicines Verification System (UKMVS) run by SecurMed UK. This means that it will no longer be possible to verify and authenticate packs from 1st January 2021. Pharmacy operators and system suppliers need to check that any integrated pharmacy systems with FMD functions are no longer actively connecting to or seeking a response from the UKMVS after the end of 2020. Stand-alone FMD systems can simply be turned off.

  • Integrated pharmacy systems can still use batch details, expiry dates or product details (GTINs) from packs’ 2D barcodes while these packs are still in circulation. However, pack serial numbers no longer have any function. These packs remain valid and can be dispensed for as long as they are still in date.

  • SecurMed UK will continue to provide end user registration and necessary support up to 31st December 2020 for end users in Great Britain.

Pharmacies in Northern Ireland

Under the terms of the Northern Ireland Protocol, part of the UK’s Withdrawal Agreement with the EU, FMD will still apply in Northern Ireland, for at least four years (until the NI Protocol is due to be reviewed).

  • End users in Northern Ireland will remain connected to the UKMVS. They need to continue to verify and decommission any packs with the FMD safety features (unique identifiers and anti-tamper devices) in line with the requirements of relevant EU and UK medicines legislation.

  • SecurMed UK will continue to provide end user registration and necessary support to enable Northern Ireland end users to decommission packs with FMD identifier features in to 2021 and beyond.

How will small/ medium sized pharmaceutical company with a small scale of business in the UK be affected? Are there any discounts or waivers regarding the MAH fee if the company turnover is below a certain amount?

Article 31(5) of the Delegated Regulation advises that the costs of the repositories system must be borne by the manufacturers of medicinal products bearing the safety features within Article 54a(2)(e) of Directive 2001/83/EC. It is expected that the same fee will apply to all Marketing Authorisation Holders per authorisation regardless of size, as the costs of the National system are more strongly influenced by the number of connections to pharmacy/wholesalers as opposed to the volume of product data flow. Further consideration will be given by SecurMed to MAH’s who claim exceptional circumstances e.g. micro MAHs. See https://www.securmed.org.uk/mah-onboarding/

Does FMD apply to clinical trials materials? If an existing licensed drug is used in a clinical trial, when would it need to be decommissioned?

No, the clinical trial supply chain sits outside the scope of the Delegated Regulation. However, if a pack of medicines within the scope of the Delegated Regulation is to enter the clinical trial supply chain and intended to be used as an investigational medicinal product, it must be decommissioned before it leaves the ‘commercial’ supply chain and becomes part of the trial medication stock

Who will have to decommission homecare supplied drugs?

Where medicines are dispensed for a named patient as a homecare supplied drug, the medicine will be decommissioned by the homecare service provider ‘at the time of supply’ to that patient.

What are the UK pack labelling requirements?

Will the UK require a reimbursement code as well?

Can additional information be included in the 2D matrix)

The serialisation requirements of EU Delegated Regulation 2016/161 will continue in Northern Ireland from 1 January 2021. Medicines with a marketing authorisation valid in Northern Ireland will require a unique identifier and a tamper evident device on each pack.

The unique identifiers on packs with a marketing authorisation valid in NI (including UK-wide MAs) supplied by a manufacturer or wholesaler in the EEA will not require decommissioning when exported to the UK until the 31st December 2021. Unique identifiers on these packs should be decommissioned in Northern Ireland as required by EU Delegated Regulation 2016/161.

Medicines with a marketing authorisation valid only in Great Britain (England, Wales and Scotland) will not require a Unique Identifier. However, the MHRA encourage companies to retain the tamper evidence device. Unique Identifiers may be placed voluntarily on GB packs; however, these do not require upload as there is no obligation and will be no capability to decommission in GB.

Can ‘soft-wrap (e.g. cellophane) bundle of packs be labelled with an individual label showing the UK pack labelling requirements (above)

The safety features legislation sits within point o of Article 54 of Council Directive 2001/83/EC. The expectation therefore is that the 2D data matrix code and associated information along with the anti-tampering device must be applied to packaging components which meet the full labelling provisions in Article 54 of the Directive.  This has been considered by the European Commission and the recent version of the FAQs addresses this in more detail.https://ec.europa.eu/health/human-use/falsified_medicines_en

How is a product modelled in the NHS dictionary of medicines and devices (dm+d)?

The dm+d consists of five distinct sub-sections each containing a set of entries. These sub-sections that can be visualised in the diagram below are:

  • Virtual Therapeutic Moiety (VTM)
  • Virtual Medicinal Product (VMP)
  • Actual Medicinal Product (AMP)
  • Virtual Medicinal Product Pack (VMPP)
  • Actual Medicinal Product Pack (AMPP)

What is an AMPP?

An AMPP is the packaged product which is supplied for direct patient use or from which AMPs are supplied for direct patient use.

For a medicine, the AMPP description consists of:

AMP name (SmPC/packaging name) + Supplier + Quantity + Quantity unit of measure

e.g. Triludan Forte 120mg tablets + (Hoechst Marion Roussell) + 30 tablet

What is an AMPP code?

An AMPP code is an identifier for each AMPP and is also known as the Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) code. This comprises a string of numbers (usually 16 or 17 digits) unique to that product and pack. The AMPP identifier will never be re-used and given to another product or concept. The identifier will not be deleted, although there will be circumstances in which it could be marked as discontinued or no longer valid.

When NHSBSA and NHS Digital authoring teams update dm+d, SNOMED codes are auto-allocated at the AMPP level.

Note SNOMED CT is an Anglo-American health information classification initiative.

Note A prefix ‘0’ should not be added to convert a 16 digit AMPP code to a 17 digit AMPP code. AMPP codes should be displayed as allocated.

How can I identify an AMPP code for my medicine?

The AMPP code is available to view on the dm+d browser which is available here
Alternatively, the codes can be accessed by downloading the dm+d files from the Technology Reference data Update Distribution (TRUD) website.

What are AMPP codes used for?

AMPP codes uniquely identify a product pack. They are used to identify a particular product pack in the supply chain, on electronic purchasing and record systems, from the initial point at which it is prescribed and reimbursed to when it appears on the patient record.

How do I apply for an AMPP code if my product does not have one?

For accurate, fast and reliable updating of licensed medicines on dm+d, many companies use the eMC In-Demand website hosted by the NHSBSA here to enable generation of AMPP codes.

If you need any help you can contact the team at the NHSBSA by Email:
nhsbsa.indemandppdsupport@nhs.net  or telephone: 0191 203 5289

Is there any order that the text has to appear in the 2D Matrix or as ‘human readable’ on the pack?

The UK will not require the text to appear in any particular order in the 2D matrix or on the pack. Changes to packs need to be submitted to the MHRA in the usual manner for approval.

Is it possible to convert EAN codes to GTIN by adding 0 at the beginning of GTIN or new GTIN will be issued?

Please refer to the European Pack Coding Guidelines from EFPIA

Is the Product Code (PC) taken obligatory from the Agency or it can be taken from MAH internal database assigned by GS1?

Please refer to the European Pack Coding Guidelines from EFPIA

Does SecurMed UK have a database of 14-digit GTIN codes?

No SecurMed - does not currently hold a database of these codes and recommend you contact the GS1 organisation if you need to find this information. However, as the EMVS is populated the NMVO will provide a useful look-up facility and link between GTIN and AMPP

How does a company affiliate to GS1

Contact the GS1 organisation in your respective country or at www.gs1.org/contact

How will the EMVS & UK MVS cater for manufacturers of medicines who have multi-market packs labelled and supplied to UK and Ireland be catered for?

The EMVS system will manage data transfer and synchronise information relating to multi-market packs. 

Brexit and the End of Transition calls into question the long term feasibility of GB – Ireland (or any other EU country) multi-market packs.

Will there be interaction between the UK national hub and each MAH for downloading pack data?

The OBP will upload the pack data to EMVS and the EMVS manage the transfer of data to the appropriate market NMVS as appropriate. OBP’s will not have the facility to upload data directly to the UK repository.

Will veterinary wholesalers need to comply with the FMD regulatory requirements?

Although veterinary medicines fall outside the scope of the Delegated Regulation, veterinary wholesalers who handle human medicines for supply to veterinary surgeons will need to connect up to National systems. Veterinarians and retailers of veterinary medicinal products are part of the MHRA consultation under Article 23. For further information, veterinary wholesalers are advised to contact the MHRA.

Do dental pharmaceuticals company need to comply with the FMD regulatory requirements?

Pharmaceutical companies manufacturing or supplying prescription only dental pharmaceuticals will need to comply with the FMD regulatory requirements. Dental practitioners are part of the MHRA consultation under Article 23.

What is the definition of a Healthcare Institution in scope of FMD for the UK?

Article 3(f) Delegated Regulation defines a Healthcare Institution as a Hospital, In- or Out-Patient Clinic or a Health Centre. The UK has classed General Practitioners (GPs) and Dispensing Doctors as health centres and therefore healthcare institutions.

For more information see MHRA Additional Guidance on Healthcare Institutions

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/767788/Additional_guidance_on_Article_23_HCI_s_and_Article_26.pdf

A manufacturer has a WDA as does its' 3rd party logistics provider (3PL). The 3PL was intending to decommission medicines on behalf of the manufacturer but the manufacturer wants to do all decommissioning itself in the EMVS using its WDA. Is this allowed?

Manufacturers point of upload of data should be as an OBP to the EMVS Hub. However, if the manufacturer holds a WDA at a National level, they will be expected to connect up to the national repository where they will have the facility available to a wholesaler, to verify and decommission medicines as described in Article 23.

Where the MAH/manufacturer has a separate WDA will the warehouse need to be linked in to the UK MVS for decommissioning of packs or will this be done via an MA holder/manufacturer link?

Each manufacturer who also holds a WDA will need to review their business operations and wholesaling processes and where applicable will need to create a connection to SecurMed for medicines verification and decommissioning as a wholesaler. It is up to each manufacturer/MAH to perform this assessment.

Will there be any requirement for the WDA holder to have an interaction with the EMVO?

Unless the WDA holder is also a manufacturer (MAH) or a parallel distributor (PI) there should be no need to connect to the European Hub via the EMVO?

Will a wholesaler performing QP batch release against the manufacturers MA and then wholesales these products under a WDA to hospitals, pharmacies and GPs, need to register with SecurMed UK?

A wholesaler is not allowed to perform QP batch release. All wholesalers located in NI will need to register and connect to SecurMed UK to verify and decommission medicines as required under the Delegated Regulation. Only manufacturers and specifically MAHs and holders of parallel import authorisations will be expected to pay fees to SecurMed UK. All wholesale dealers will need to create a connection to the UK Medicines Verification System

Is aggregation permitted, in particular for use of downstream wholesalers?

The Delegated Regulation allows for aggregation but does not stipulate the need for pack aggregation and the EMVS / NMVS system does not support aggregation. It is for manufacturers and MAHs to decide unilaterally whether their IT functionality extends to aggregation of pack data.

If stock is transferred from one nominated site to another, does the receiving nominated site have to do full checks of the stock received?

If stock is transferred within the same designated wholesaler or to another designated wholesaler, then there is no need for packs to be verified under FMD. Normal GDP rules apply

How do developers of pharmacy and wholesaler software register for the Arvato developers’ toolkit (SDK)?

Please go to SecurMed UK web-page at www.securmed.org.uk. Presentations explain the toolkit and provide a registration link.

The Arvato toolkit only allows one certificate per developer, is there a way to get a group or enterprise level certificate?

Arvato only provides per user certificates. Each company can apply for more than one developer user.

Will there be ‘approved’ list of software suppliers for pharmacy and wholesalers that will also be suitable for MAHs with WDAs?

It will be for organisations to identify appropriate software suppliers. SecurMed will publish the list of software suppliers who are content with being publicised and who have successfully registered and connected. Software suppliers will be asked to identify on whose behalf they are requesting to register for connectivity to SecurMed UK

Who is going to pay for software and hardware changes in healthcare institutions, pharmacy and wholesaler systems - and how much will it cost?

Each healthcare institution, pharmacy and wholesaler will need to purchase the equipment required to enable it to scan the unique identifier and undertake verification and decommissioning. This will require the development of software to link through to the repository system via software changes and/or stand-alone systems depending on how systems are configured, and the support provided by your software supplier

Is there a document that explains the configuration, format, and dependencies on the national code requirement for the UK?

The national code does not need to be embedded in the 2D data matrix, however, according to the EMVO coding requirements, it is still required to be sent to the UK Medicines Verification System.

The national code does not need to be embedded in the 2D data matrix, however, according to the EMVO coding requirements, it is still required to be sent to the UK Medicines Verification System.

The national code does not need to be embedded in the 2D data matrix, however, according to the EMVO coding requirements, it is still required to be sent to the UK Medicines Verification System.

The UK National number  the dm+d AMPP - http://dmd.medicines.org.uk/DesktopDefault.aspx?tabid=2 The UK regulator (MHRA) will publish further guidance.

There is no need to share this number with the UK verification organisation – but it should be uploaded into the Master Data via the EU Hub. Any data upload questions involving the European Hub should be sent to EMVO.

Are medical devices in the scope of serialisation?

Medical Devices are not part of the FMD. There is a separate serialisation project outside of the FMD dealing with medical devices and suggest enquiries are directed to the MHRA about this

There are some standalone devices without medicine and devices which contain medicinal product, do MAH have to apply serialisation on both?

If the medicine associated with a device has an MA and is included in the list or products within scope (virtually all POMs) then under the FMD, it should be labelled with safety features.

Who is responsible for implementing serialisation when an MAH is manufacturing and supplying ‘own label suppliers’?

The MAH of the medicine being placed on the market is the person legally responsible for compliance with the legislation. When a MAH is manufacturing for a certain national retail pharmacy but in their own label and the MA belongs to the MAH, then the MAH is responsible

How should serialisation be implemented for ‘titration’ packs, only to outer box or it should also be applied to the inner boxes too?

Serialisation should be applied to the pack which is the unit of sale and to which the labelling provisions in Article 54 of Council Directive 2001/83/EC apply.  In the case of titration packs where different strengths of a medicine are included in separate blister strips within a single outer carton, the single outer carton will be serialised.

If product is manufactured outside the EU and batch released in the UK, who will be responsible for releasing the serial number in the HUB and when?

The On-Boarding partner (OBP) has the responsibility to upload data to the European Hub on behalf of its MAH’s. Please see the EMVO website for further details of how to register OBPs https://emvo-medicines.eu/pharmaceutical-companies

What is scan4safety? Is there a relationship to FMD?

Adoption of GS1 and PEPPOL standards associated with common ways of working have been selected by the UK Government to help transform the NHS.

More information is available at https://www.scan4safety.nhs.uk/.

Scan4safety is not part of the FMD.

What is PEPPOL? Is there a relationship to FMD?

PEPPOL enables government organisations such as the NHS and private companies to exchange electronic trading documents over an interoperable, European-wide network. In simple terms it offers a standardised network connection for electronic ordering, invoicing and shipping.

Specifically, PEPPOL is not part of the FMD but a set of open and interoperable technical specifications across purchase-to-pay (P2P) business processes. It is not an eProcurement system – it only connects organisations together so that they can do business electronically

India Medicine Pack on EU market?

Regulations have been in place in India since 2011 to support a Track and Trace system for export of pharmaceuticals to address counterfeit and ineffective product recall challenges. This system falls under the jurisdiction of the Directorate General of Foreign Trade, Department of Commerce, Ministry of Commerce and Industry.

Core features include:

  • Product Item serialisation and aggregate level to pallet
  • Track & Trace reporting to Government Database: DAVA (Drugs Authentication and Verification Application)
  • All exported drugs are in scope (Rx and OTC)
  • Specific requirements for placement of 14 digit GTIN Pack Level indicator

However, the specifications for the Indian GTIN are different from the GTIN coding used under FMD regulations. Therefore, confusion is possible with both Indian complaint packs, and FMD compliant packs available on the EU market.

The GTINs applied to European packs will almost always present with a “0” as a first character in the 14-digit string. This is because GTINs in Europe are typically represented as prefix 0 + EAN-13 i.e. the linear barcode that carries the 13-digit GTIN.

However, the GTINs  issued in India, in conjunction with the DGFT India Export requirements, follow different rules: For India pack coding, values "1", "2" and "3” are reserved, where "1" is to be used on innermost and “3" on outermost secondary package.

This means that there will be Indian packs in EU markets that look as if they carry the  same four data elements that are specified by the EU-FMD, but when scanned the UI will not be found in the EMVS (as the GTIN may be in a different format) leading to a suspect pack alert.

How to differentiate between FMD compliant and India coded packs?

The practical - if not 100% fool-proof way of identifying India packs would be to check:

  1. Does the GTIN in the 2D Data matrix start with a digit other than “0”?
  2. If there is a linear EAN barcode on the pack, are the 13 numbers in the linear barcode different to the last 13 digits of the GTIN in the 2D data matrix?
  3. Is the pack serialized but does not carry tamper-evidence?

If the answer to any of these questions is “Yes” then this is likely to be the pack has been serialised under India DGFT requirements rather than EU-FMD and should be expected that the UI has not been uploaded to the EMVS. A scan of the India 2D data matrix will therefore not be recognised and an alert will be generated.

Is there a published standard for the tamper evidence device?

New ISO Standard for Tamper-Evident Packaging

On 30 November 2018, the International Organization for Standardization (ISO) published the new ISO standard 21976:2018 entitled "Packaging - Tamper verification features for medicinal product packaging". This standard deals with possible types of tamper-evident seals to ensure the integrity of pharmaceutical packaging. As a basis for the ISO 21976:2018 standard, the DIN working group "Characteristics for checking manipulations on pharmaceutical packaging" proposed the European standard 16679:2014 "Tamper verification features for medicinal product packaging".

Pharmaceutical companies that have prescription drugs in their portfolio must provide these with two security features as of 9 February 2019 in accordance with the Anti-Counterfeiting Directive 2011/62/EU. There are exceptions to this obligation, but for most prescription-only medicines it applies that, from this date at the latest, the (secondary) medicinal product packaging must not only have an individual identification feature but also tamper protection (tamper-evident closure), the so-called "Anti Tampering Device". The delegated EU Regulation 2016/161 provides details on the individual identifier, but not on the technical specifics regarding the device against tampering.

The Question and Answer paper of the EU Commission recommends (in its current version 14 under 1.14 - 1.14. Question: Are there any mandatory specifications for the anti-tampering device? Answer: In accordance with Article 54(o) of Directive 2001/83/EC and Article 3(2)(2) of Commission Delegated Regulation (EU) 2016/161, an anti-tampering device has to allow the verification of whether the packaging of the medicinal product has been tampered with. There are no other mandatory specifications. The CEN standard EN 16679:2014 "Tamper verification features for medicinal product packaging" is available for manufacturers to consider.) the CEN standard EN 16679:2014 "Tamper verification features for medicinal product packaging". This standard specifies requirements for tamper evidence for medicinal product packaging and provides guidance on the application, use and verification of the tamper-evident closure. There is a wide range of choices for manufacturers. The ISO standard largely follows the European standard. Manufacturers are therefore not required to make any changes to packaging materials that have already been converted to prepare for the anti-counterfeiting directive.

The ISO Standard 21976:2018 Packaging - Tamper verification features for medicinal product packaging is available for purchase from the International Organization for Standardization. 

How does FMD link to dm+d and GS1?

The information stored in the 2D data matrix bar code will include a product code. The product code will comprise of the GTIN (Global Trade Identification Number). This is a GS1 code and creates a useful link to the EMA proposed ISO IDMP coding system. The EMVS Master data which will be uploaded for packs intended for the UK market will require the inclusion of a National Number – the dm+d AMPP. This will create a useful look-up facility between the GTIN and the AMPP.

For information as to when the upload of the AMPP to the OBP Master Data upload will become mandatory please see https://securmed.org.uk/how-can-we-help/what-is-an-ampp-code-and-how-can-i-identify-it/

Is there a published standard for the tamper evidence device?

New ISO Standard for Tamper-Evident Packaging

On 30 November 2018, the International Organization for Standardization (ISO) published the new ISO standard 21976:2018 entitled "Packaging - Tamper verification features for medicinal product packaging". This standard deals with possible types of tamper-evident seals to ensure the integrity of pharmaceutical packaging. As a basis for the ISO 21976:2018 standard, the DIN working group "Characteristics for checking manipulations on pharmaceutical packaging" proposed the European standard 16679:2014 "Tamper verification features for medicinal product packaging".

Pharmaceutical companies that have prescription drugs in their portfolio must provide these with two security features as of 9 February 2019 in accordance with the Anti-Counterfeiting Directive 2011/62/EU. There are exceptions to this obligation, but for most prescription-only medicines it applies that, from this date at the latest, the (secondary) medicinal product packaging must not only have an individual identification feature but also tamper protection (tamper-evident closure), the so-called "Anti Tampering Device". The delegated EU Regulation 2016/161 provides details on the individual identifier, but not on the technical specifics regarding the device against tampering.

The Question and Answer paper of the EU Commission recommends (in its current version 14 under 1.14 - 1.14. Question: Are there any mandatory specifications for the anti-tampering device? Answer: In accordance with Article 54(o) of Directive 2001/83/EC and Article 3(2)(2) of Commission Delegated Regulation (EU) 2016/161, an anti-tampering device has to allow the verification of whether the packaging of the medicinal product has been tampered with. There are no other mandatory specifications. The CEN standard EN 16679:2014 "Tamper verification features for medicinal product packaging" is available for manufacturers to consider.) the CEN standard EN 16679:2014 "Tamper verification features for medicinal product packaging". This standard specifies requirements for tamper evidence for medicinal product packaging and provides guidance on the application, use and verification of the tamper-evident closure. There is a wide range of choices for manufacturers. The ISO standard largely follows the European standard. Manufacturers are therefore not required to make any changes to packaging materials that have already been converted to prepare for the anti-counterfeiting directive.

The ISO Standard 21976:2018 Packaging - Tamper verification features for medicinal product packaging is available for purchase from the International Organization for Standardization.