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“Article 3 of the Delegated Regulation lists a number of definitions including a ‘healthcare institution’ as meaning ‘a hospital, in-or outpatient clinic or health centre’. The UK has classed General Practitioners (GPs) and Dispensing Doctors as health centres and therefore healthcare institutions.
Wholesalers are not allowed to perform QP batch release. All Wholesalers need to register with SecurMed to verify and decommission medicines as required under the Delegated Regulation. Only MAHs and holders of parallel import authorisations will be expected to pay fees to SecurMed.
Intended Audience: Software Suppliers
Date: 01 July 2020
User certificate sare valid for 2 years and will start to expire from Autumn 2020, with large numbers expiring in Q1 2021.
Following consultation with UK national competent authorities we can provide some clarification on connection methodologies:
Software solutions for the wholesaler and dispensing communities must provide for transparency of end-user locations (i. e.
The ‘mixed bulk transaction’ is a bulk of individual transactions, as opposed to a single transaction applied to a bulk of packs. It should only be used to enable cached individual transactions when connectivity has been interrupted.
The use of multi-factor authentication is mandated by the Delegated Regulation.
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.
The safety features legislation sits within Article 54 of Council Directive 2001/83/EC.
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.
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.
Each GP Practice (with one or more GP partners) is a separate legal entity. SecurMed registers Locations, not people.
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.
Yes. New interfaces will have different endpoints, URLs may be subject to change but will remain on the same domain.