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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.

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.

Law 16/2021 of December 14 was published on December 15, which modifies Law 12/2013, of August 2, on measures to improve the functioning of the food chain. This new reform intends to respond to the continuous claims of farmers in the agricultural and food sector, taking advantage of the framework of the transposition of the Spanish legal system of Directive (EU) 2019/633 of the European Parliament and of the Council, of April 17, 2019, related to unfair business practices in relationships between companies in the agricultural and food supply chain.

As every year since the creation of the reference price system back in 2014, the Spanish Ministry of Health published the new Reference Price Order Order SND/1308/2021 (“Order”) on 29 November 2021. The reference price system consists of the annual revision of the maximum price at which medicinal products included in the National Health System portfolio are financed. Our team already analyzed the draft Order published on 14 July 2021, and the final text barely differs from the draft.

In March 2021, the EU approved new reporting rules in a directive known as DAC7. The directive will require the operators of online platforms for the sale of goods and certain services, to collect, verify and share data on their sellers and their transactions concluded on the online platform. EU member states have until 31 December 2022 to implement DAC7 into national law. Certain platform operators will become a reporting platform and will need to start collecting and verifying data points in compliance with the DAC7 reporting requirements. The collected data points must be reported to the tax authorities of the relevant EU member state annually.

As a consequence of Spain’s late implementation of the 5 AML Directive, the Registry of Crypto Exchanges and Custodian Wallet Providers at the Bank of Spain has only been recently activated. Since the end of October 2021, the procedure together with the necessary forms are now available at the Bank of Spain’s website to apply for registration as Exchange Providers of Virtual Currency into Fiat and Electronic Wallets Service Custodians, as provided for in the Spanish Act 10/2010, dated 28 April, on anti-money laundering and terrorism financing.

In April, Royal Decree-Law 7 of 27 April 2021 was passed. It introduced major amendments to Royal Legislative Decree 1 of 16 November 2007, approving the revised text of the General Consumer and User Protection Act and other supplementary acts, which we analysed in our May newsletter.

Please join us for upcoming webinars on important developments in the Consumer Goods & Retail industry. Please note that the webinar series will be held in German only