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 in the event of a no-deal Brexit?

How does a ‘Designated Wholesaler’ get allocated?

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

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

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

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

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

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

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

How will the FMD be enforced?

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

Who will pay for the FMD?

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

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

What is the difference between decommissioning and verification?

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

Can pharmacy and wholesalers sell data to IMS?

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

How will Brexit affect the FMD and its' processes?

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?

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?

Who will have to decommission homecare supplied drugs?

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)

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

How does FMD link to dm+d and GS1?

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

What is an AMPP?

What is an AMPP code?

How can I identify an AMPP code for my medicine?

What are AMPP codes used for?

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

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

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

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

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

How does a company affiliate to GS1

Are EMA Marketing Authorisations the same as UK MHRA Marketing Authorisations?

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?

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

We are a Marketing Authorisation Holder who have active MAs for UK, but we do not market any medicines here at the moment?

Are we required to contract with SecurMed UK and pay fees for the UK system?

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

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

Will 6 months in advance of the 9th of February 2019 when the FMD go-live be enough time for MAHs to submit a notification pursuant to article 61(3) of Directive 2001/83/EC?

Providing an updated version of the QRD template confirming implementation of the safety features on the packaging?

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Is Gibraltar in scope of the FMD implementation and what about British Crown Dependencies and British Overseas Territories?

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

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?

Can you confirm what relationship a wholesale dealer needs to have with the MAH to allow them to be registered as a designated wholesaler for that MAH. Does it have to be a 3PL relationship?

How do manufacturers (MAHs) who also hold a WDA register with the SecurMed UK contracting process for connectivity of the wholesaling FMD/DR functionality required under?

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?

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

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

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

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

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

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

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

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.

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Are medical devices in the scope of serialisation?

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

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

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

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?

Pharmacists can still dispense the product to patients without serialisation after 9th of February 2019, until all the stocks get depleted which was batch released before 9th of February 2019, is that correct?

What is scan4safety? Is there a relationship to FMD?

What is PEPPOL? Is there a relationship to FMD?

India Medicine Pack on EU market?

How to differentiate between FMD compliant and India coded packs?

Is there a published standard for the tamper evidence device?