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Medicines for veterinary use

Medicines for veterinary use

Belgium As from 1 May 2019, new Belgian rules apply to the harmonisation of SPC, labelling and patient information leaflet. The FAMHP clarifies the rules for harmonisation of SPC’s, labelling and patient information leaflets (PIL) in different countries. Marketing...

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...

Healthcare Transparency Register concept law

The Netherlands  On 30 April 2019, the concept text for the Healthcare Transparency Register law was presented for consultation. With this concept law, the obligation for suppliers of medicines and medical devices to report financial relationships with healthcare...

Google Ads as unacceptable advertising

The Netherlands In the Netherlands, the court has ruled on a case in which a medical search term led to a Google Ad for a food supplement. The court decided that this is unacceptable publicity for medicines. The Google Ad for the food supplement appeared after typing...

Policy adjustment of patient information on the MEB website

The Netherlands The Medicines Evaluation Board (MEB) will no longer publish full product information about the active substance of generic medicines on its website if there is still a patent on one of the indications. A generic drug may not be sold for indications...

EU-US Mutual Recognition Agreement for inspections

EU With the Mutual Recognition Agreement between Europe and the US, inspections are to be mutually recognised in the future. The FDA's approval of the EU Member States proceeds successively. Two more countries have recently been approved: Bulgaria and Cyprus. That...

New law on saving measures 2019

Belgium A new approved law on the saving measures for 2019 will enter into force on 1 April 2019. It contains the legislative amendments necessary for the implementation of the various cost-cutting measures decided in the framework of the National Institute for Health...

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