By Emergency Decree No. 031-2021 (“DU 031”), published in the Extraordinary Edition on 10 March 2021, the payment regime for state compensation in favor of people who present an “Effect Supposedly Attributed to Vaccination or Immunization” (ESAVI in Spanish) of severe character was approved.
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.
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.
With a Report published on 21 April 2021, the Italian Medicines Agency (AIFA) made available the preliminary data relating to the Monitoring of the National and Regional Pharmaceutical Expenditure for the year 2020.
In April 2021, the Medical Devices Coordination Group published a new guidance to explain the role of safety and performance standards under the current Medical Device Directives, as well as the new Medical Device Regulation and the In Vitro Diagnostic Devices Regulation.
Following the extraordinary meeting held on 21 April 2021, the EMA’s Management Board confirmed that the clinical trial EU Portal and Database is now fully functional and on track to go live by 31 January 2022.
On 30 April 2021, the Health Sciences Authority Therapeutic Products Branch published its finalized guidance on the e-labeling of therapeutic products in Singapore. The new guidance is effective from 30 April 2021.
Doing Business in Uzbekistan has been prepared as a general guide for companies operating or considering investment in Uzbekistan. The guide is intended to present an overview of the key aspects of the Uzbek legal system and the regulation of business activities in this country.
This handbook Conducting Business in Ukraine 2021 has been prepared by the attorneys of Baker McKenzie’s Kyiv office as a general guide for companies operating or considering investing in Ukraine. It is intended to present an overview of the key aspects of the Ukrainian legal system and the regulation of business activities in the country