Regulators and policymakers have left emergency measures behind and returned to their reform agendas. In this piece, Baker McKenzie regulatory experts set out the top ten UK developments for financial institutions and fintechs to watch in 2022 covering: good culture, Consumer Duty, BNPL regulation, crypto regulation, AML regulation, appointed representatives regime, financial promotions gateway, operational resilience, ESG regulation, divergence, Future Regulatory Framework Review.
On 30 December 2021, the Health Sciences Authority (HSA) announced that it had detected potent adulterants in five products that were marketed on local e-commerce and social media platforms. The HSA has since removed the affected listing and issued warnings to sellers of said products.
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.
The UK’s Plastic Packaging Tax is due to take effect from 1 April 2022 and will be payable by manufacturers and importers of plastic packaging containing less than 30% recycled plastic content at a rate of £200 per metric tonne where certain thresholds are met.
The Spanish Council of Ministers has passed a preliminary bill that is expected to include additional rules on customer services.