New classification mechanism for borderline products
23 May 2023
With the new pharmaceutical legislative package, the EU Commission is proposing a new classification mechanism for borderline products. This new mechanism should help clarify whether a product under development should qualify as a drug, medical device, dietary supplement, cosmetic or another similar product.
In April 2023, the EU Commission presented a proposal for a reform of the legislation in the pharmaceutical sector. As part of this, it is proposed to introduce a new mechanism for classifying borderline products, which should help clarify early in the development process whether a product should be classified as a medicinal product, medical device, dietary supplement, cosmetics, or another similar product. The new mechanism is outlined in Article 61 and 62 of the Commission's proposal for regulation (COM/2023/193).
With the European Commission's proposal, developers and national authorities are given the opportunity to request a scientific recommendation from the European Medicines Agency (EMA) regarding the regulatory status of a product.
However, the possibility to request such a recommendation will only be available for products that potentially fall within the mandatory scope of the centralized approval procedure of the European Union.
Based on a well-founded request, the EMA will provide a scientific recommendation on whether the product under development potentially qualifies as a medicinal product. To ensure consistency across the European Union's legal framework, it is recommended that EMA consult with relevant advisory or regulatory bodies in related areas before issuing a scientific recommendation.
If a member state disagrees with the recommendation from EMA, the member state can request the European Commission to assess whether a product should be classified as a medicinal product. Decisions in this regard by the Commission will be implemented through implementing acts, taking into account EMA's scientific recommendation.
Additionally, the Commission will also have the option to request clarification from EMA on specific issues or send the recommendation back to the agency for reconsideration. The Commission can do this based on a well-founded request from a member state raising new scientific or technical questions or on its own initiative.
The purpose of the proposal is to reduce the level of uncertainty associated with the development of products that are at the interface between medicinal products and related products. Uncertainty about a product's regulatory classification can have significant implications since different product categories are subject to different rules.
With the European Commission's proposal, developers and national authorities are given the opportunity to request a scientific recommendation from the European Medicines Agency (EMA) regarding the regulatory status of a product.
However, the possibility to request such a recommendation will only be available for products that potentially fall within the mandatory scope of the centralized approval procedure of the European Union.
Based on a well-founded request, the EMA will provide a scientific recommendation on whether the product under development potentially qualifies as a medicinal product. To ensure consistency across the European Union's legal framework, it is recommended that EMA consult with relevant advisory or regulatory bodies in related areas before issuing a scientific recommendation.
If a member state disagrees with the recommendation from EMA, the member state can request the European Commission to assess whether a product should be classified as a medicinal product. Decisions in this regard by the Commission will be implemented through implementing acts, taking into account EMA's scientific recommendation.
Additionally, the Commission will also have the option to request clarification from EMA on specific issues or send the recommendation back to the agency for reconsideration. The Commission can do this based on a well-founded request from a member state raising new scientific or technical questions or on its own initiative.
The purpose of the proposal is to reduce the level of uncertainty associated with the development of products that are at the interface between medicinal products and related products. Uncertainty about a product's regulatory classification can have significant implications since different product categories are subject to different rules.
