Falsified medicine directive (FMD) is a set of rules to protect people from fake medicines and it helps to prevent fraud of prescription medicines entering the pharmaceutical supply chain in some countries. FMD covers not only fraud medicines, but also false information about a medicine's source. It includes additional anti tempering security on packaging and tracking of medicines using a unique identifier, like a bar code. But, FMD does not cover non-prescribed medicines, with the single exception of some medicine which used in the treatment of gas that decreases the amount of acid produced by the stomach. From several years, some countries have been concerned about the increasing threat of fraud or false medicine to public health and safety. Then these countries started work to amend directive to address these concern under the falsified medicine directive. It is designed to protect the patient by minimizing the chances of fraud medicines entering into the established medicines supply chain across these countries. It will enable manufactures, wholesaler, distributor and everyone who supplies to patients to verify the authenticity of a medical product, identify individual packs, and check whether the outer packaging of medicines has been damage.
To add on, the Sop's introduce a system to track the medicine which confirming to the law from manufacturer will be grateful to apply safety features to each pack a tamper-proof security seal as well as a barcode. The barcode enables each pack to be serialized with a unique randomized number, which will be authenticated before giving out medicines. The FMD will affect everyone along the supply chain because they will need to command with the new law. The pharmacist will need to have an awareness of the law, as with any changes in the law and they will have to become familiar with the new software but it's not a heavy burden. If everything works well, patients should not be affected. But if fraud is found just prior to authorize there might be a delay in the patient obtaining their medicine.
Besides this, Standard Operating Procedure (SOPs) is documents, which describe in detail the necessary steps to perform an experimental or management procedure task so that the task is carried out correctly. Here, SOPs is designed to ensure that FMD requirements are followed as part of the wholesale distributor, as per the delegated FMD regulations, wholesalers are not required to verify packs of medicine if they have been received directly from the manufacturer, or from a wholesaler holding the marketing authorization or from a wholesaler who designated by the manufacturer to distribute the products on their behalf. The FMD Sops process for medicine verification should be carried out immediately after the receipt of the medicinal products process but before the goods have been relocated to their storage area.