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¤ We are preparing and submitting Marketing Authorization Applications for centralized procedure; now we are helping companies with Blue x requirements and helping companies with checking spelling and other in Slovenian language ¤ We are preparing and submitting Marketing Authorization Applications for mutual Recognition procedure
¤ We are preparing and submitting Marketing Authorization Applications for independent national Procedures
¤ We are preparing and submitting Type I and Type II variations
¤ We offer complete support with creation and submission of wholesale prices at our ARSZMP, Agency For Medicinal Products and Medical Devices of the Republic of Slovenia
¤ We can provide you all information about Rules on Standards for Creating Wholesale Prices of Drugs in English language
¤ We can provide you with application forms and all regulatory requirements in English language
¤ We can supply you with all additional information, which you need to place your product on the market
¤ We can support you with application for drug classification (positive, intermediate, negative list) at the Health Insurance Institute of Slovenia
¤ We can assessing the conformity of medical devices for medical devices of class I as well as for class IIa, IIb and III, we can also supply you with registration forms for the medical devices (also these forms are available in English language)
¤ After registration we can help you with all marketing activities on our market, we have complete nformation and also database of our pharmacies and all doctors on different filed
¤ We also have enough knowledge to help you to successfully launch your product on the Slovenian market
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Submissions and Registrations of Medicinal Products |
