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Letter to Marketing Authorization Holders regarding data upload in the Safety Features repository system (SiMVS)

In order to comply with the Falsified Medicines Directive 2011/62/EU and Delegated Regulation (EU) 2016/161, marketing authorization holders (MAHs) are responsible for ensuring that medicines marketed in the EU carry …

Letter to Marketing Authorization Holders regarding data upload in the Safety Features repository system (SiMVS) Več »

Call for opinions, comments and suggestions for the release of the Rules on fees in the field of medicinal products, blood, tissues, cells and fees for the implementation of professional tasks and services of the JAZMP

Agency of the Republic of Slovenia for Medicinal Products and Medical Devices (hereinafter: Agency) has prepared the new Rules on fees in the field of medicines, blood, tissues and cells …

Call for opinions, comments and suggestions for the release of the Rules on fees in the field of medicinal products, blood, tissues, cells and fees for the implementation of professional tasks and services of the JAZMP Več »

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