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New Annex 21 for EU GMP published

New Annex 21 for EU GMP published

Europe The new Annex 21 (C(2022) 843 final) was published by the European Commission on 16 February 2022 and will enter into force six months after its publication on 21 August 2022. The document provides a guideline on the import of medicinal products from...

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Expansion disclosure Transfers of Value based on the GMH* code

Expansion disclosure Transfers of Value based on the GMH* code

The Netherlands As of February 1, data on financial relationships between suppliers and healthcare professionals can be submitted to the Transparency Register for Healthcare (“Transparantieregister Zorg” or TRZ) for the year 2021. Compared to previous years the...

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FAMHP new Financing Law

FAMHP new Financing Law

Belgium On 03.02.2022, the Federal Parliament approved a law that adjusts the financing of the Federal Agency for Medicines and Health Products (FAMHP). This has been published in the Belgian Official Journal and will come into force soon. The law introduces new taxes...

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EU: Strengthening the EMA

EU: Strengthening the EMA

Europe A regulation strengthening the role of the EMA in crisis preparedness and management for medicinal products and medical devices has been published in the Official Journal of the EU (Regulation (EU) 2022/123 "on a reinforced role for the European Medicines...

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