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Latest regulatory changes

Drug-device combinations

Europe The European Medicines Agency have published a Draft guideline on the quality requirements for drug-device combinations. This guideline provides guidance on the documentation expected for Drug-Device Combinations (DDCs) in the quality part of the dossier for a...

EMA’s Annual Report on the EudraVigilance Database

Europe On 27 March 2019, the Annual Report 2018 on the European database for the collection of adverse reactions to medicinal products, Eudravigilance, was published by the EMA. It's a summary of the current status of the database. EudraVigilance is used to registrate...

Amendments as a result of the new financing law of 2019

Belgium On 20 May 2019, the law changing provisions has been published in the Belgian Official Gazette. The new law changes a number of aspects of the function and financing of the Federal Agency for Medicines and Health Products (FAMHP).  The financing law of...

Medicines for veterinary use

Medicines for veterinary use

Belgium There are new Belgian rules from 1 May 2019 for the harmonisation of SPC, labelling and patient leaflet. Marketing authorisation holders and applicants can find the new rules for harmonisation of SPC's, labelling and patient information leaflets on the FAHMP...

Invoices replace advance payments

Invoices replace advance payments

Belgium The FAMHP has published a news item on their website concerning payments to the FAMHP. From now on, the FAMHP will send out invoices with structured message for most of its services. As a result, companies will no longer need to make advance payments (via an...

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