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'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.
All Pharmacies will be registered with the relevant professional or sectoral body, such as the CQC in England, HIS in Scotland, GPhC, CIW or HIW in Wales, and PSNI or similar in Northern Ireland.
All Pharmacy staff involved in the dispensing process must be trained to follow FMD protocols on verification and/or decommissioning of products.
No. The MAH should upload the pack data to the EMVS, which will determine which packs need to be sent to the UK national hub. The EMVS is the master system of record for MAH pack data.
Yes the existing endpoints will be available for a period, but you should develop your software at the earliest opportunity to the new version. Two versions of endpoints will be available at all times for backwards compatibility
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.
“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.
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 MHRA does not allow direct decommissioning by manufacturers in the NMVS or EMVS for Article 23 customers.
No, whether a pack is IMT or local does not affect the transaction that is submitted to the UK MVS nor the response, therefore IMT is not relevant for baseline testing.
The Master Data Download (G101) transaction allows positive confirmation that the product is in the system and is in scope of FMD.
Pharmacies and Wholesalers will be able to sell dispensing data generated by their PMR and Wholesaler systems in the normal way.
Please refer to the European Pack Coding Guidelines from EFPIA.
NHS Digital have published a Toolkit for Secondary care functions. The NHS publish information, including frequently asked questions about FMD on their Specialist Pharmacy website: www. sps. nhs. uk
The safety features legislation sits within Article 54 of Council Directive 2001/83/EC.
To inform SecurMed UK of a change in account details (e. g. location, end-user contact, Software Supplier etc) :
please use our Contact Us form (link below).