As part of its updated 2020 Industrial Strategy, the EU Commission noted that the pandemic has highlighted the trading bloc’s technological and industrial strategy dependencies, which need to be analysed and addressed as part of Europe’s economic recovery.
The Turkish Medicine and Medical Devices Authority (TİTCK) published a critical announcement covering the topic of new practices for the registration and evaluation process of medical devices post-Brexit.
The Turkish Medicine and Medical Devices Authority (TİTCK) published two announcements covering critical topics on certain procedures concerning the Product Tracking System (ÜTS).
On 30 April 2021, the draft of a regulation for completely new clinical trials of medicinal products for human use, which implements Regulation 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repeals Directive 2001/20/EC, was published for public consultation.
On 28 April 2021, the Turkish Medicine and Medical Devices Authority (TİTCK) announced the suspension of product promotion representatives’ visits to pharmacies and health organizations during the full lockdown as part of the measures against the COVID-19 pandemic.
On 6 April 2021, the Italian Medicines Agency (Agenzia Italiana del Farmarco or AIFA) published a document updating the requirements to be reported in the outer labelling of centralized medicinal products placed on the Italian market (so-called “Blue Box”). In this respect, it should be noted that the Blue Box is that area, marked by a blue border, included in the label of a medicinal product intended to contain specific information relevant for each Member State in whose territory the product is marketed.
In its press release No. 642 of 12 April 2021, the Italian Medicines Agency (AIFA) indicated a substantial increase of reports concerning medicinal products purchased online from unauthorized channels that were found to be falsified or illegal. The most recent cases include purchases of products with anti-cellulite activities and medicines used in the treatment of erectile dysfunctions.
On 5 May 2021, the European Commission (“Commission”) published a proposed Regulation, along with an impact assessment report, aiming to address potential distortions caused by foreign subsidies in the Single Market (“Proposed Regulation”). This Proposed Regulation will create substantial new obligations for companies if adopted in its current form.
With judgment No. 4816 of 26 April 2021, the Administrative Court ruled on an appeal for the annulment of the final award of a Framework Agreement for the supply to public hospitals of digital mammography devices, related services, equipment and optional services. The appellant claimed that the successful bidder should have been excluded for the tender procedure for having unlawfully used a continuous cooperation agreement, pursuant to art. 105, paragraph 3, letter c-bis), of the Code of public contracts.
Anahita Thoms, Head of International Trade, Germany, speaks with Omid Nouripour, Member of the German Bundestag and Spokesperson for Foreign Affairs for the Green Party, about the global fight against climate change, economic sanctions as a foreign policy tool, and the proposed new Supply Chain Act in Germany.