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Are you looking for some specific information? Please use the search options below. Either type key words into the 'How can we help you?' box, then choose a category and your user type, or simply use the Category / User type selections. Then press the search icon and a series of articles will be generated for you.

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.

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

The MHRA has confirmed that subject to 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.

Can the 'Sub User ID' be used if each location has a separate User ID?

'Sub-user ID' is an optional field in the interface and, in the case of a cumulator model, is only useful to identify terminals in a location. Sub-user ID will not routinely be monitored by SecurMed UK.

Error 403 forbidden - what does it mean?

This error code occurs because the UK MVS cannot find the TAN Certificate. Problem

Solution

UK MVS Certificate has expired (two years)

Contact the SecurMed Service Desk to request a new Software (TAN) Code.

Can a single location have multiple sets of credentials for different software solutions?

Yes. Duplicate credentials can be requested for the same location. SecurMed UK will validate the request.

Is multi-factor authentication required?

Yes. The use of multi-factor authentication is mandated by the Delegated Regulation and has been implemented in the UK MVS using an X509 Certificate.

Is there further guidance on False Negatives – out of date, recalled pack, status error, data error, etc?

Several groups, including FMD Source, SecurMed UK and others, are working on establishing guidance for the various stakeholders. This guidance will be communicated in due course.

Will the endpoints be different for new versions of the interfaces?

Yes. New interfaces will have different endpoints, URLs may be subject to change but will remain on the same domain.

Where the MAH or Manufacturer has a separate WDA, how will packs be decommissioned?

Each Manufacturer who also holds a WDA needs to review their business operations and wholesaling processes and, where applicable, connect to SecurMed for medicines verification and decommissioning as a Wholesaler.  

It is up to each MAH or Manufacturer to perform this assessment.

Why is it essential to present a unique certificate as well as a unique username and password?

The use of multi-factor authentication is mandated by the Delegated Regulation.

Are out-of-hours GP services within the scope of FMD?

Yes. The Department of Health and Social Care agreed in July 2016 that all GP Surgeries, Practices and Health Centres, including out-of-hours GP services, are considered healthcare institutions, and are therefore within the scope of FMD.

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