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EU Pharma Law Package: Council Position on Reduction of Regulatory Exclusivity Rights

On 4 June 2025, the Council of the EU adopted its position on the EU Pharma Law Package legislative proposal to revise the EU’s general pharmaceutical legislation. The Council, consisting of all the 27 EU Member States and...more

EMA’S NEW WORK PLAN: Leveraging data and AI to encourage innovation and research

The European Medicines Agency (EMA) published a workplan on its ambition to leverage high volumes of data and artificial intelligence (AI). On 7 May 2025, the European Medicines Agency (EMA) published a joint workplan with...more

Scrutiny on health care professional transparency and inducement in the Netherlands

On 8 April 2024, the Dutch Minister of Medical Care sent a letter to Dutch Parliament (in Dutch: “Tweede Kamer”) regarding interactions between life sciences companies and health care professionals highlighting the need for...more

Reduction of EU regulatory data protection, but not as short as the European Commission proposed - European Parliament’s position...

On 10 April 2024 the European Parliament adopted its position on the draft text on the revision of the European Union’s (EU) general pharmaceutical legislation, also referred to as the (proposed) “EU Pharmaceutical Law...more

Medicines shortages: Dutch Ministry publishes Policy Rule; EMA calls for MAHs to register contact

With a goal of ensuring medicinal supply interruptions are better managed, the Dutch Ministry’s Policy Rule regarding ‘iron stock’ sets obligations for marketing authorisation holders and wholesalers to keep a minimum safety...more

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