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 Subsecretary of Open Government and Digital Country, dependent on the Chief of Cabinet of Ministers), created the Vacunación COVID-19 database by means of Disposition No. 06/2021, published in the Official Gazette on 21 April 2021. Its purpose is to organize, accelerate and make effective the administration of vaccines authorized by the competent entities and jurisdictions against COVID-19, contributing to the prevention of the virus and the limitation of its health consequences.
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.
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.