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Amendment RD Plants

Amendment RD Plants

Belgium An amendment of the Belgian Royal Decree regarding the manufacture and trade of foodstuffs composed of, or containing, plants or plant preparations (RD August 31, 2021) has been published on 30 January 2024. The RD has come into force on 9 February 2024...

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NIHDI posts new FAQ on tenders for biologicals

NIHDI posts new FAQ on tenders for biologicals

Belgium Hospitals must, according to the Royal Decree of 13 September 2023, issue a tender for biological and biosimilar medicines within nine months after a first biosimilar pharmaceutical speciality, authorized in accordance with the law of March 25, 1964 on...

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Data basic training Keuringsraad

Data basic training Keuringsraad

The Netherlands Koag Kag/Keuringsraad has published the data for their basic training on the codes for promotion towards general public regarding medicinal products, medical devices and health products. This training takes place in Breukelen, The Netherlands, at...

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Update Adverse drug reaction reporting details

Update Adverse drug reaction reporting details

Luxembourg On January 17th, EMA published the newest version (v28) of QRD Appendix V. In this version, the contact details for reporting adverse drug reactions in Luxemburg has been changed, to include the German version of the address. Luxembourg/Luxemburg [French]...

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Publication Royal Decree on Nutrivigilance

Publication Royal Decree on Nutrivigilance

Belgium Since 03 December 2023, a new royal decree has been published regarding the reporting of adverse reactions related to the use of food supplements. This Royal Decree defines the legal framework for Nutrivigilance, but not its mode of operation in...

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Code of conduct GMH and CGR tightens the rules  

Code of conduct GMH and CGR tightens the rules  

The Netherlands As previously announced, the Foundation for the Code for Pharmaceutical Advertising ("the CGR") and the Foundation for the Code of Conduct for Medical Devices (“the GMH”) have decided to further tighten their rules as of January 1st, 2024. We now have...

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Reasonable maximum hourly rates for 2024

Reasonable maximum hourly rates for 2024

The Netherlands As of 1 January 2022, a new system came into force in the Netherlands providing for annual indexation of the reasonable maximum hourly rates for the remuneration of professionals for services rendered. We would like to inform you about the rates for...

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