13. 10. 2023
On the provisions concerning detailed rules on safety features to be indicated on the packaging of medicinal products for human use, having regard to Directive 2001/83/EC of the European Parliament and of the Council), manufacturers are obliged to equip Rx medicinal products with safety features through which it should be possible to identify and verify the authenticity of the individual packages of the medicinal product throughout the time it is placed on the market.
ORIWIN assists its customers in several European Union countries to comply with this legislation and to ensure that all monitored products are correctly and timely registered in the European Medicines Verification Organisation's (EMVO) European Central Register (EMVS).
We have created a fully functional SW solution, after the implementation of which the customer will be able to label and verify manufactured/packaged packages of medicines at his workplace using HW equipment for labelling and verification of individual packages of medicines in accordance with the legislation, as well as to fulfil the obligations related to the registration and provision of the necessary data resulting from the EU regulation. The scope of the complete delivery includes the HW device / Mark and Verify Module, Central Serialisation Server, connection and communication with the EU hub as well as operational support.
On the provisions concerning detailed rules on safety features to be indicated on the packaging of medicinal products for human use, having regard to Directive 2001/83/EC of the European Parliament and of the Council), manufacturers are obliged to equip Rx medicinal products with safety features through which it should be possible to identify and verify the authenticity of the individual packages of the medicinal product throughout the time it is placed on the market.
ORIWIN assists its customers in several European Union countries to comply with this legislation and to ensure that all monitored products are correctly and timely registered in the European Medicines Verification Organisation's (EMVO) European Central Register (EMVS).
We have created a fully functional SW solution, after the implementation of which the customer will be able to label and verify manufactured/packaged packages of medicines at his workplace using HW equipment for labelling and verification of individual packages of medicines in accordance with the legislation, as well as to fulfil the obligations related to the registration and provision of the necessary data resulting from the EU regulation. The scope of the complete delivery includes the HW device / Mark and Verify Module, Central Serialisation Server, connection and communication with the EU hub as well as operational support.