On 17 November 2021 the EU published a draft Regulation seeking to introduce new due diligence requirements aimed at tackling deforestation and forest degradation.
On 5 November 2021, Turkish Ministry of Trade amended the Customs Regulation. The amendments specify the cases where proof of origin is not required and introduce additional period for the subsequent submission of documents evidencing the origin of the goods.
On October 21, 2021, the MDCG published a new question and answer document on the procedures governing the relabeling and repackaging of medical devices under Article 16 of the MDR and IVMDR.
On November 25, 2021, the AIFA published two new simplified negotiation procedures for (i) the negotiation of generic or biosimilar drugs and reimbursement applications for the extension of indications already reimbursed for the originator, and (ii) the reimbursement of new packages for changes in the primary packaging.
On 27 November 2021, Law No. 175/2021 (“Consolidated Law”) was published in the Official Journal. The Consolidated Law’s main objective is the protection of the right to health of those suffering from rare diseases through measures aimed at ensuring the uniform distribution of services and medicines, including orphan drugs, throughout the Italian territory, the surveillance, diagnosis and treatment of rare diseases as well as the support to research activities.
In October 2021, the Medical Device Coordination Group (MDCG) published the third revision of the MDCG 2019-6 Questions and answers: Requirements relating to notified bodies, which provides clarification on the operating procedures of notified bodies responsible for performing conformity assessment activities under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
On November 17, 2021, the Ministry of Health published a circular letter to clarify certain aspects related to the application of Regulation 2017/745 on medical devices, including those concerning the registration in the national database of medical devices, custom-made devices, and medical device advertising.
According to a parliamentary report dated 14 October 2021, shortages of health products are on the rise. The number of medicines of major therapeutic interest declared out of supply has increased from 404 in 2013 to 1,499 in 2019. As for medical devices, the French Health Agency estimates that, as of 8 October 2021, one essential medical device is currently subject to supply difficulties and has been for more than a month, which jeopardizes the continuity of patients’ care.
For a long time in Poland, governmental bodies did not comment on the legal framework applicable to cooperation with influencers, such as the proper tagging of posts or the liability for sponsored content. The principles of cooperation could only be assessed on the basis of general interpretations of the existing legal regulations. However, in recent weeks the Polish Office for Competition and Consumer Protection has taken steps to organize the sponsored online content market, as it found that much of the commercial content on influencer profiles on social media is either not marked as advertising at all or is insufficiently marked.
On 21 October 2021, the Ukrainian Parliament adopted the Law of Ukraine “On Amendments to Certain Legislative Acts of Ukraine Concerning the Development of Biomethane Production” (“Law”), which supplements the Laws of Ukraine “On Alternative Fuels” and “On the Natural Gas Market”2 with new provisions on biomethane treatment. In addition to the introduction of the “biomethane” definition, the Law establishes grounds for the functioning of the biomethane register and the issuance and circulation of the so-called guarantees of origin of biomethane.