On 24 October 2022, the National Securities Market Commission issued a communication regarding investment recommendations made by influencers on social media. If such influencers are recognized as ‘experts’ under EU standards, they will be contacted by the CNMV and be made to comply with applicable regulations established under the framework of Regulation (EU) 596/2014 on market abuse and its Delegated Regulation (EU) 2016/958.
On 27 September 2022, the Ibero-American Network for the Protection of Personal Data published the Guide for the Implementation of Standard Contractual Clauses for the International Transfer of Personal Data, which sets out certain aspects to be considered when making international transfers of personal data through the use of standard contractual clauses. The Guide includes non-binding guidance for those who make ITPD from member countries of the RIPD to non-adequate jurisdictions.
The Spanish Ministry for Health, Consumer Affairs and Social Welfare have published the Draft of the Reference Price Order of 2022 with the aim of updating the reference prices set forth in previous orders, establishing new groups and removing those that do not meet the applicable requirements.
The Spanish Agency for Medicinal Products and Medical Devices has launched a new application with the aim of facilitating the registration and improving the communication of biocidal products and of personal care products, as well as regarding facilities that manufacture, import and store biocidal products within the Spanish territory.
Through the EU Directive on Restructuring and Insolvency of 20 June 2019 (EUR 2019/1023, “Directive”), the European Union has imposed an obligation on its member states to offer a more attractive and flexible restructuring scheme in their respective local law. The initial deadline to do so had been 17 July 2021. Only a handful of countries (most notably Germany and The Netherlands) had implemented the Directive within the initial deadline, whilst the other countries made use of the possibility to ask for a one year extension.
On 4 March 2022, the Government approved the Draft Law on the protection of persons who report infringements of regulations and the fight against corruption, aimed at transposing Directive (EU) 2019/1937 on whistleblowers’ protection.
Baker McKenzie’s Sanctions Blog published the alert titled “Russia imposes a ban on foreign aircraft flights from 36 states” on 1 March 2022. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
The Spanish Data Protection Authority has recently approved the first industry code of conduct under the General Data Protection Regulation. This industry code has been promoted by Farmaindustria and it governs the processing of personal data in the field of clinical trials and other clinical research and of pharmacovigilance, when they are conducted in Spain.
On 2 February 2022, the Madrid Regional Council passed the Draft Open Market Bill, which is currently undergoing a parliamentary procedure at the Madrid Assembly and is expected to be passed by June 2022. Once it is passed, it will become enforceable three months after it is published in Madrid’s Official Regional Gazette. The approval of this Draft Bill takes place in a context in which the European Union has urged the Member States to adopt measures to eliminate obstacles to the free movement of goods and services, particularly after the economic and social crisis caused by the COVID-19.
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.