The EU Pharma Package - what will, and what will not, change following adoption

the EU Pharma Package has not yet been adopted, but it will be soon. The final European Parliament vote is anticipated for November 2026.

It is unlikely that there will be any fundamental changes in the provisions of either the current draft Directive that will replace Directive 2001/83/EC or, the current draft Regulation that will replace Regulation (EC) No 726/2004 prior to adoption.

While the new provisions will result in substantial changes to the existing rules governing medicinal products in the EU, there are provisions that will remain unchanged.