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Release of the European Shortages Monitoring Platform
Europe As part of Regulation (EU) 2022/123, an EU platform has been realised to prevent, monitor, and manage any medicine shortages across the EU of centrally authorised medicines. The European Shortages Monitoring Platform (ESMP) has the purpose to facilitate...
Import medicines special needs
Belgium The new article 105/1 of the Royal Decree of 14 December 2006 on medicinal products for human use entered into force on 1 November 2024. This provision allows wholesalers in possession of an authorisation to purchase medicinal products (WDA) to place...
RD 12/09/2024 amending RD 14/12/2006: Addition of two elements regarding the distribution of unauthorised drugs, in case of unavailability
Belgium The Royal Decree published on 30 September 2024, amending the Royal Decree of 14 December 2006 on medicinal products for human and veterinary use, adds two elements concerning the search for substitutes, in the event of unavailability. In the first place, a...
Pharmaceuticals shortages compensation mechanism
Belgium Starting January 1st, 2025, new legislation will come into force that requires the pharmaceutical industry to compensate for the additional costs caused by the unavailability of essential reimbursable medicines. This law aims to ensure patients still have...
Flat Fee 2025
Luxembourg The yearly annual Flat Fee that will be applicable for the FMD operational phase in 2025 in Luxembourg has been fixed. The fee is needed to cover the costs related to the system, participation of LMVO in the costs of the EU Hub… The defined thresholds are:...
Royal decree on the making available on the market and use of biocides
Belgium Royal decree amending the royal decree of April 4, 2019 on the making available on the market and use of biocides (14 JULY 2024). A new royal decree introduces measures to improve the regulation of biocide sales and promotion while enhancing the information...
NEW: Distribution of recall notices by email
The Netherlands From 1 October 2024, recall notices and DHPCs will be distributed by e-mail as much as possible. In the past, marketing authorisation holders send these risk communications by post to healthcare professionals in special “Orange Hand” envelopes (for...
New Belgian Legislation – Royal Decree on the advertising of veterinary medicinal products (SEPTEMBER 22, 2024)
Belgium On October 7, 2024, a long-anticipated Royal Decree concerning the advertising of veterinary medicines was published in The Belgian Official Journal. This RD will enter into force on 1 January 2025. This decree outlines specific rules for promoting...
Update notification form “Meldpunt geneesmiddelentekorten en -defecten”
The Netherlands As of 25 October 2024, a new version of the notification form of the “Meldpunt geneesmiddelentekorten en -defecten” will become available. The new form will include the following changes: The addition of the option to adjust the period indication of a...
The Netherlands: updated maximum hourly fees in 2025
The Netherlands CGR has communicated the updated maximum hourly fees for service agreements for 2025. The updated fees are indicated in the table below and will be in scope for engagements with Dutch HCPs as from 1st of January 2025. Category2025Professor€...
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