The European Falsified Medicine Directive
"Learn about the Falsified Medicine Directive and its purpose to protect patients by preventing counterfeit medicines in Europe. Discover how the system works with tamper-proof seals and 2D barcodes."
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Presentation Transcript
Falsified Medicine Directive Nicholas Falzon PRIMA President
Definition of a Falsified Medicine According to the WHO, a Falsified Medicine is a Medical product that deliberately/fraudulently composition or source . misrepresent their identity,
Falsified Medicine Directive For several years, the European Union (EU) has been concerned about the increasing threat of counterfeit or falsified medicines to public health and safety. In 2011, the European Commission (EC) started work to amend Directive 2001/83/EC to address these concerns under the Falsified Medicines Directive (FMD). The final phase of theFMD is dueto be rolledout from 9 February2019.
What is the purpose of the FMD? The FMD is designed to protect patients by minimising the chances of counterfeit medicines entering into the established medicines supply chain across Europe. wholesalers, distributors and everyone who supplies to patients to verify the authenticity of a medicinal product, identify individual packs, and check whether the outer packaging of medicines has beentampered with. It will enable manufacturers,
How will it work? The FMD will introduce a system to track legitimate medicines from manufacturers to patients. Manufacturers will be obliged to apply safety featuresto each pack: a tamper-proof security seal a 2Dbarcode.
2D barcode Enables each pack to be serialised with a unique randomised number This will beauthenticated before dispensing. This identification data will be stored in a database managed by the European Medicines Verification Organisation (EMVO), and supported at a National level in Malta by the Malta Medicine VerificationOrganisation (MaMVO), a non-profit organization.
2D barcode Manufacturers will check packs into the database and they will be authenticated, decommissioned or checked out in the pharmacy/ hospital or clinic by scanning the barcode. This sends a message to the database, which then considers the authenticity of that pack, sending confirmation back to the person scanning the pack.
Composition of Malta NMVO (MaMVO) 3 organizations have so far signed up to be full members of the Maltese NMVO (MaMVO) PRIMA Association GRTU Malta Chamber of Small and Medium Enterprises Malta Chamber of Pharmacists Pharmaceutical Research Based Industry Malta
Composition of MaMVO 2 Associate members of MaMVO CPSU Central Procurement and Supplies Unit as part of the Health Department Malta Qualified Persons Association
Status Update - MaMVO The members of MaMVO have signed all the necessary paperwork and lawyers are registering the organization locally. Once we get the confirmation that MaMVO is legally setup, MaMVO will be issuing a call for applications for the position of Project Manager. MaMVO will also be responsible to choose a blueprint provider for the Maltese system.
Blueprint Provider MaMVO has had several meetings with both Blueprint providers: Solidsoft Arvato We have explored a number of options due to the complexity of the Maltese system.
Malta Options 2 main options Joining a SupraNational Setting up own repository Contacted all blueprint providers UK Ireland
Difficulties with Malta About 50% of products byvolumeare registered with article 126(A) All packs that are meant for a particular market would have its information uploaded into the national repository. On verification or check out, the system would retrieve the information for the particular pack fromthe repository. Products registered with article 126A are usually products that weren`t meant specifically for corresponding info to verify these packs would not be available in the national repository. This would lead to an inter-market query. the Malta market so the
Difficulties with Malta - 2 Data - No IMS data which makes data collection and analysis very difficult. No economies of scale Complexity of provenance and multi-market nature of packs in Malta imports from a variety of countries which have to be uploaded on the national repository. This could lead to a situation where one of the smallest countries would end up with one of the largest repositories.
MaMVOUpdate MaMVO has already started working on the next steps. Legally setup byend of November. Compiled a job description for the employment of a Project Manager readyto berolled out Finalized budgets for operations. Advanced discussions on financing model Data collection we have contacted a number of associations and organizations so that we can start collating data which will be requiredby theblueprint providers.
