FMD places the Commission under obligation for the adoption of delegated acts for setting the various details of safety measures which includes that how the authenticity of medicines can be verified. The Eu Falsified Medicines Directive has introduced new harmonized measures for ensuring that medicines in (EU) European Union are totally safe and secured as well as the trade in medicines are properly controlled also.
Safety Measures of EU Falsified Medicines Directives
• On the medical products an unique identifier code is placed which can be scanned at the fixed point along the supply chain. The UI or unique identifier is a 2D data matrix code as well as the human readable information.
• Anti-tampering devices are available on the packs. The evident features are tampered on the pack.
Features of Unique Identifier (UI) Code
The unique features of UI are as follows:
• The UI comprises of a product code which allows the identification of name of medicines, pharmaceutical form, common name, the pack size, pack type and the strength.
• Consists of Batch Number.
• Has a serial number which is either a numeric or alpha-numeric sequence of maximum 20 characters that are randomly generated.
• Contains the expiry date.
• UI must be printed in such a way that it can be read by human eye.
• The delegated regulation does not specify that which of the tamper evident feature should be used.
• The manufacturers place the safety measured on the packaging of prescription and 2D Barcode will be needed to scan at the various points in supply chain for verifying the authenticity of medicines.
• When supplying the medicines to the patient, the UI must be decommissioned via scan from the FMD system for the prevention of any duplication of legitimate identifier for use on the falsified medicines directives.
• Promises for continuous supply of safe medicines to the patients.
• Follows the flexible approach for enforcement of new legal requirements.
Business Areas of FMD Wholesalers
• Crop Science
• Consumer Health
• Pharmaceuticals
The Fmd Wholesalers are fully dedicated and devoted employees who surely work with full attention and thus ultimately lead to the growth of business. On practical basis, there are three important components which the wholesalers need are as follows:
- Ability to scan the 2D matrix barcodes.
- Software application.
- Ability to capture and record all the events.