REPUBLIC OF ESTONIA AGENCY OF MEDICINES

• Consulting on European Union (EU) and local legislation - Medicinal Products Act, Ethical Code ​• Communication with Republic of Estonia Agency of Medicines (Ravimiamet) • Preparation and assistance in submission of regulatory affairs applications (National, MRP, DCP procedures, Centrally Authorised products (CP) translations), including new applications, variations and renewals to Republic of Estonia Agency of Medicines • Post-authorisation support and marketing authorisation maintenance procedures • Translations and linguistic reviews of product information: Summary of Product Characteristics (SPC), Patient leaflets (PIL), labelling text • Management of local translations for submission to Republic of Estonia Agency of Medicines • Update and maintenance of product packaging in line with the marketing authorisation requirements and appropriate local legislation • Consulting and communication with Republic of Estonia Agency of Medicines regarding permissions for use foreign language..

Primary location: Tallinn Estonia