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ELC Group approved by Romanian Medical Agency (NAMMD) to conduct Patient Information Leaflet (PIL) Readability Testing for products targeting Romanian market
Cambridge, UK, 23rd April, 2013 – ELC GROUP, one of the fastest-growing providers of regulatory affairs consulting services, today announces that the National Agency for Medicines and Medical Devices (NAMMD) has issued ELC Group with accreditation to conduct Readability Testing in Romania. ELC Group is one of only three companies currently authorised to test patient information leaflet (PIL) readability for products targeting the Romanian market.
A European Directive which came into force in 2005 requires marketing authorisation holders of medicines to have all patient information leaflets for their products readability tested, ensuring that product information is legible, clear and easy to use.
Following a lengthy accreditation process, the NAMMD approval allows ELC Group to conduct PIL readability testing in accordance with the latest EU and national requirements. Pharmaceutical companies and Marketing Authorisation Holders (MAH) can now engage ELC Group to help launch products across Europe, now including the difficult to access Romanian market.
ELC group has developed extensive knowledge of readability testing and PIL writing experience since early 2007. ELC’s PIL review and editing service complies fully with QRD (Quality Review Document) and Readability Guidelines for optimal readability.
Commenting on the NAMMD accreditation, Marco Rubinstein, CEO of ELC Group said: “With our new accreditation from NAMMD, we are proud to be one of only three companies with permission to currently test readability in Romania. We have been working with Romanian and EU Commission authorities to secure accreditation for nearly three years, so I am very pleased to announce this expansion of our EU reach. This will allow ELC to offer a fast and efficient regulatory compliance service for pharmaceutical customers worldwide with an interest in engaging in Romania.”