As of 1 January 2022, Germany has set up a mandatory public lobbying register. Its broad scope covers – similar to the EU transparency register – every entity which regularly communicates with the German federal executive or legislative to represent and further its interests. As a result, every company with a public affairs department may fall under its scope. Such companies will need to complete their initial registration by 28 February 2022.
As a result of the EU Commission’s decision not to proceed any further with updating the Mutual Recognition Agreement with Switzerland (MRA) with effect from 26 May 2021, Switzerland no longer has access to the European single market for medical devices on an equal partnership basis but is since treated as a “third country”.
On 24 December 2021, the Council of the Eurasian Economic Commission proposed to extend the availability of national registration of medical devices in parallel with union-wide registration for one more year, until 31 December 2022 rather than until 31 December 2021, as it was set to happen previously .This extension requires an amendment into the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices in the Eurasian Economic Union (EAEU) dated 23 December 2014. As a result, all EAEU member states should now ratify this amendment.
On 29 December 2021, the new Royal Decree 1157/2021 of 28 December, regulating industrially manufactured veterinary medicinal products (“Royal Decree 1157/2021”), was published in the Official State Gazette. This regulation replaces the existing Royal Decree 1246/2008 of 18 July 2008, regulating the procedure for the authorization, registration and pharmacovigilance of industrially manufactured veterinary medicinal products and also complements Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (“Regulation 2019/6”). Both Regulation 2019/6 and Royal Decree 1157/2021 will enter into force on 28 January 2022.
On 20 December 2021, the European Parliament and the Council adopted a Regulation amending the transitional provisions set forth in Regulation EU 2017/746 on in vitro diagnostic medical devices (“IVDR”). In particular, the amending Regulation provides for the introduction of longer transitional periods with respect both to the validity of the certificates issued by notified bodies in accordance with Directive 98/79/EC (“IVDD”) and for the placing on the market and putting into service of in vitro diagnostic medical devices pursuant to the IVDD.
On 23 December 2021, the AIFA published a note providing clarifications on the renewal procedures for parallel import licenses of medicinal products (“AIP”). In this respect, the note clarifies that AIP holders must submit to the AIFA a renewal application for each authorized package at least nine months before the expiry of the validity of the relevant AIP, whose duration is five years from the date of publication in the Official Journal of the granting decree.
As known, Article 11 of Decree Law No. 228/2021, entered into force on 31 December 2021, provided for the further suspension, until 30 June 2022, of the environmental labeling obligations of packaging pursuant to Article 219, paragraph 5, of Legislative Decree No. 152/2006. In this respect, of special relevance is paragraph 2 of Article 11 above, which entrusts the Ministry of the environmental transition with the tasks of adopting, within thirty days of the date of entry into force of Decree Law No. 228/2021, the technical guidelines for the environmental labeling.
Baker McKenzie are pleased to invite you to two follow up webinars of 30 minutes focused specifically on the latest developments and operational considerations on the ground in Ukraine and in Russia. Webinar 1 – on 10 February 2022 – will focus on Ukraine and Webinar 2 – on 15 February 2022 – will focus on Russia.
The Czech Republic has recently significantly amended existing legislation in the field of energy transition and energy regulation as a follow-up to the Renewable Energy Directive Recast (RED II), with the aim of counteracting unfair business practices towards consumers. The majority of these changes became effective on 1 January 2022, with the rest becoming effective later in 2022 or 2023. This is a significant step towards decarbonisation in line with EU goals and it creates many opportunities for the energy market players
The Department for International Trade and the Export Control Joint Unit published a notice to exporters on 10 January 2022 regarding compound penalties imposed on ten UK exporters for unlicensed exports of dual-use and military items and breaches of export license conditions between March and November 2021. The compound penalties imposed by HM Revenue & Customs ranged between GBP 1,000 and GBP 54,000 and related to unlicensed exports of dual-use goods, military goods and related activity controlled by The Export Control Order 2008.