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Aegate has welcomed the adoption of the Delegated Act on safety features appearing on the packaging of medicinal products for human use, supporting the implementation of the Falsified Medicines Directive (FMD).
The FMD provides a real opportunity to protect patients in Europe from the damage which falsified medicines can cause, and the Delegated Act on safety features will play an integral role in its success. The draft was published in August of this year and the Act has now been adopted by the European Commission.
Commenting, Aegate Chief Executive Mark De Simone said:
'We are delighted that the Delegated Act has now been adopted. This is an important day in the battle to stop falsified medicines, out-of-date medicines and recalled products from falling into the hands of patients across Europe. Publication is expected to follow quickly, so stakeholders should use this time to accelerate their decisions.'
'The steps taken by pharmaceutical manufacturers and related organisations over the next few months are now vital to the success of the FMD. When the Delegated Act is published in the Official Journal of the European Union, we will have a short three year window to get every Member State FMD ready - time is of the essence.'
'Much attention is being placed on the implementation of the serialisation and new 2D barcodes, which dramatically affect the manufacturing process, but the real complexity isthe testing of the new codes within the authentication system. With thousands of manufacturers in each country, a phased approach will be necessary and therefore three years is by no means a long period of time. Without the authentication systems in place to verify the products, the falsified medicines directive cannot be met. Our primary concern must be to ensure effective, efficient and timely implementation, while minimising the impact on pharmaceutical manufacturers, hospitals, pharmacies and, most importantly, the patients themselves.'
'Aegate is the market leader in medicine authentication systems. We are the only company specialising solely in authentication technology with operational experience and a fully functioning system already in place, across nine Member States to date. Our expertise is unique and we are well placed to help stakeholders leverage our extensive practical experience.'
'I am convinced that our service not only meets but, in many areas, exceeds the standards called for by the Act. We will continue to do everything we can to work with stakeholders to ensure that pharmacies and other dispensing agencies across the European Union are FMD ready.'
Aegate is the leading expert in medicines authentication and its best-in-class authentication technology is already in place in pharmacies across nine European countries. (Belgium, Italy, Greece, Ireland, Cyprus, Poland, Netherlands, Romania & UK)
