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New classification mechanism for borderline products
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.
Article - 23.05.2023
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ENLI makes several clarifications in the guidance to the Promotion Code
ENLI has made several changes and clarifications in its guidance to the Promotion Code. Plesner provides a brief overview of the changes here.
Article - 16.05.2023
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New pharmaceutical legislation focusing on access to medicine and sustainability
On 26 April 2023 the European Commission has put forth a proposal for a new Directive and new Regulation that will revise and replace the existing general pharmaceutical legislation.
Article - 27.04.2023
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Extension of price cap agreements on hospitals and pharmacy-restricted medicinal products
The Ministry of the Interior and Health of Denmark as well as the Danish Regions and the Danish Association of the Pharmaceutical Industry (LIF) have all agreed to extend the existing price cap agreements on medicinal products for hospitals and pharmacy medicine eligible for reimbursement.
Article - 11.04.2023
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From 22 June 2023, the Medical Device Regulation (MDR) will also apply to certain types of devices without a medical purpose
The rules of MDR will from 22 June 2023 apply to more types of products. The changes are implemented on the background of the EU Commission's Implementing Regulation of 2 December 2022 laying down common specifications for devices without a declared medical purpose which are covered by Annex XVI of the MDR.
Article - 31.03.2023
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New interesting decisions from ENLI
In connection with the publication of ENLI's newsletter on 20 March 2023, a number of interesting decisions have been published. These concern, among other things: The boundary between information material and advertising, clarification of new practice on statements on environmental and climate issues in relation to the concept of professionalism, invitations to training events should be addressed to management, distribution of donated equipment to patients and sponsorship of podcast.
Article - 22.03.2023
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New judgment from the Court of Justice of the European Union on borderline products
In its decision of 2 March 2023, the Court of Justice of the European Union (“the CJEU”) has considered the borderlines between A) medicinal products and food for special medical purposes as well as B) food for special medical purposes and food supplements.
Article - 09.03.2023
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The deadline for the certification of certain medical devices extended
Manufacturers of medical devices can now for a while breathe a sigh of relief. The European Parliament have finally adopted a proposal for extending the certification deadlines as stipulated in the Medical Device Regulation ("the MDR").
Article - 20.02.2023
