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Are medical devices in the scope of serialisation?

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 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 do I do when the NMVS returns an Alert?

Refer to your SOP and/or guidance on FMD Source or RPS. To progress the investigation of an Alert with SecurMed UK please click here.

Does the UK GTIN product code require 13 or 14 characters?

GTIN product codes require 14 characters. For more information, please refer to the EMVS Pack Coding Guidelines.

Does the EMVS and UK MVS cater for multi-market packs labelled and supplied to UK and Ireland?

Yes. Multi-market packs can be supplied to the UK, Ireland and Malta. The EMVS will know when multi-market packs are uploaded, which systems to send the pack data to, and will also manage the decommissioning activity between them.

Is a 3PL relationship required between a Wholesaler and MAH to register them as the Designated Wholesaler?

No, but a signed contract between the MAH and Wholesaler is required.

Where can Doctors and GPs get further information about the FMD?

For more information, please visit the NHS Digital GP FMD Toolkit. The BMA, DDA and MHRA websites also have useful resources for Doctors and GPs. If you can’t find what you’re looking for, please contact the BMA.

What is Peppol?

Pan-European Public Procurement OnLine (PEPPOL) enables government organisations such as the NHS, and private companies, to exchange electronic trading documents over an interoperable, European-wide network. It offers a standardised network connection for electronic ordering, invoicing and shipping. For more information, please visit NHS Scan4Safety.

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

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.

Do dental pharmaceuticals companies, dental wholesalers or dentists 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 pharmaceutical wholesalers will need to comply with the FMD regulation where they also supply human medicines as those medicines may be returned from dental practitioners.

Is supply-side aggregation only being considered for hospitals?

Aggregation for Hospitals has been considered by stakeholders but will not be implemented in the near term (3-5 years).

If baseline testing has already been completed in the existing interface, will it need to be redone for the new interface?

Yes, you will be required to submit a new baseline for each new interface version. Two interface versions will be available at all times for backwards compatibility.

Does resetting the password also require a new certificate?

No, the certificate remains valid for the user. Useful Resources:

Technical Bulletin: Certificate and Password Management Issues

 

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.

I am a biopharmaceutical manufacturer operating within the research sector; where can I find more information about FMD?

The Association of the British Pharmaceutical Industry (ABPI) is the trade association for the research-based pharmaceutical industry in the UK. Please visit their website.  www. abpi. org. uk. Alternatively you can contact the British Generic Manufacturers Association (BGMA): www. britishgenerics. co.

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