It is not recommended. It is necessary for the person registering to accept the terms and conditions of the EULA, which could not be justified without an agreement in place.
Please refer to the European Pack Coding Guidelines from EFPIA.
Aggregation data is not available in the NMVS/EMVS. Off-system solutions may be available dependent on the particular supply chain system. Further guidance is expected from the UK NCAs (DHSC/MHRA) who can be contacted at fmd. safetyfeatures@mhra. gov. uk.
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.
No. Unless the WDA holder is also an MAH or a Parallel Distributor, there is no need to connect to the EMVS Hub.
No, the clinical trial supply chain sits outside the scope of the Delegated Regulation.
No. The Delegated Regulation asserts that all parties that are connected to the repositories system, including manufacturers, wholesalers and pharmacies, have sole responsibility, ownership and access to any data that they generate.
The Delegated Regulation allows for aggregation but does not stipulate the need for pack aggregation. The EMVS / NMVS system does not support aggregation.
No.
The Master Data Download (G101) transaction allows positive confirmation that the product is in the system, but does not confirm that it is in scope of FMD, as some non-FMD products have been uploaded in error.
The EU Commission Q&A on FMD can be found on the European Commission site.
The European Medicines Verfication Organsiation (EMVO) is a Belgian non-profit organisation representing stakeholders united in securing the legal supply chain from falsified medicines. For more details go to their website.
Verification is a process that can take place at any time during movement of the medicine through the supply chain.
FMD Case Studies
NHS Digital have collected case studies to demonstrate how Community and Hospital Pharmacies have implemented the FMD.
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.
Although veterinary medicines fall outside the scope of the Delegated Regulation, veterinary Wholesalers who handle human medicines to supply to veterinary surgeons need to register with SecurMed. Veterinarians and retailers of veterinary medicines were part of the MHRA consultation under Article 23.
