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Medicines for Europe represents manufacturers of off-patent medicines supplying close to 70% of dispensed prescription medicines in Europe. The pharmaceutical legislation should foster access to follow-on off-patent medicines on day-1 after IP expiry by extending the scope and harmonising the Bolar exemption to cover API supply and all administrative steps needed to effectively launch generic/biosimilar medicines.

Medicines for Europe, representing manufacturers of generic, biosimilar and value added medicines across Europe, welcomes the proposals to review the EU general pharmaceutical legislation. As the off-patent sector accounting for 70% of medicines dispensed in Europe covering 80% of therapeutic areas, we fully share the goals of ensuring that all patients across the EU have timely and equitable access to safe…

Medicines for Europe, representing manufacturers of generic, biosimilar and value added medicines across Europe, welcomes the proposals to review the EU general pharmaceutical legislation. As the off-patent sector accounting for 70% of medicines dispensed in Europe across 80% of therapeutic areas, we fully share the goals of ensuring that all patients in the EU have timely and equitable access to safe, effective and…

The LIF welcomes the Commission’s initiative for a modernised regulatory framework for medicines that can be more easily adapted to technological and medical developments. The LIF considers that the Commission’s objective of creating more equal access to new medicines between EU Member States is important. On the other hand, the proposal contains several elements to which Lif has strong objections.

Filed in Swedish · English published by the European Commission

Replies to the EU Commission deadline 7 November 2023 Lif welcomes the Commission’s initiative for a modernised regulatory framework for medicines that can be more easily adapted to technological and medical developments. The LIF considers that the Commission’s objective of creating more equal access to new medicines between EU Member States is important.

Filed in Swedish · English published by the European Commission

Medicines for Europe welcomes an opportunity to comment on the concept of the EMA fees revision. Despite the fact that the current EMA fee system is complex due to many different categories and types of fees, the feedback from the Medicines for Europe’s membership is that EMA fees system is not that difficult to apply it and it is quite predictable.

Lif Sweden is the trade association for the research-based pharmaceutical industry in Sweden. Lif welcomes the opportunity to comment on the EU Commissions EMA fees proposal. The up-coming revision of the EU regulatory system is an opportunity to make the system faster, more efficient and flexible and thereby strengthen EU global competitiveness.

Medicines for Europes comments of the EMA fees regulation. Medicines for Europe supports a cost-based EMA fee system with a simpler fee structure. For generic medicines with very low margins, regulatory costs can be critical to maintain older products (with low to zero profitability) or supply products to small markets.