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In Europe

Italy: Regulation EU 2917/746 on in vitro diagnostic medical devices – extension of transitional periods

by 1 Min Read

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.

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In Europe

Italy: AIFA (Agenzia Italiana del Farmaco) – clarifications on the renewal procedure of parallel import licenses

by 2 Mins Read

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.

In ESG

Italy: Technical guidelines for the environmental labeling of packaging

by 1 Min Read

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.

In Cybersecurity, Data and Tech

Russia/Ukraine: Reminder – Baker McKenzie webinar invitation: Russia-Ukraine developments webinar

by , , , , , , and 2 Mins Read

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.

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In Czech Republic

Czech Republic: Recent key legislative changes in energy transition and energy regulation

by and 5 Mins Read

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

In Europe

United Kingdom: HMRC issues compound penalties to ten UK exporters for unlicensed strategic exports

by 2 Mins Read

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.

In Employment

Spain: Royal Decree-Law 32/2021 of 28 December 2021

by , , and 4 Mins Read

Royal Decree-Law 32/2021 of 28 December 2021 contains the measures agreed on 23 December 2021 within the scope of social dialogue between the Spanish government and the most representative trade unions and business organizations state-wide. This new regulation is the result of a reform process undertaken at the initiative of the government and has basically concluded with significant amendments in three regulatory fields: (i) Temporary employment contracts; (ii) collective bargaining, and (iii) internal flexibility measures or temporary lay-offs.

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