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The safety features legislation sits within Article 54 of Council Directive 2001/83/EC.
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.
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.
'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.
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.
Yes. Duplicate credentials can be requested for the same location. SecurMed UK will validate the request.
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.
SecurMed UK has not implemented the T&Cs module.
Please refer to the European Pack Coding Guidelines from EFPIA.
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.
Yes. New interfaces will have different endpoints, URLs may be subject to change but will remain on the same domain.
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.
The use of multi-factor authentication is mandated by the Delegated Regulation.
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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