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In Product Regulation & Liability

Spain: The AEMPS speeds up the application process for centrally authorized medicinal products

by and 3 Mins Read

The Spanish Agency for Medicines and Health Products has streamlined the procedure for applying for the national code (NC) of centrally authorized medicinal products. In order to have more efficient management, this change has been included in a guide containing information on the documents required for the assignment of the NC. From now on it will be possible to send the NC application as soon as the final texts have been adopted by the applicant and the regulatory agencies. Finally, it will also be possible to present the European Commission’s decision in English.

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In AML & Financial Services Regulatory

Spain: CNMV intensifies control on financial services marketing on social media

by 3 Mins Read

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.

In

Multijurisdiction: Ibero-American Network for the Protection of Personal Data – Standard contractual clauses for the international transfer of personal data

by , , and 3 Mins Read

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.

In Austria

Europe: The New European Restructuring Schemes – Update May 2022

by , , , , , , , and 1 Min Read

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.

In Cybersecurity, Data and Tech

Spain: Spanish Data Protection Authority approves the first industry code of conduct to enable compliance of clinical research and pharmacovigilance with the GDPR

by 4 Mins Read

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.

In Covid-19

Spain: The Madrid Regional Government is preparing the Open Market Act

by , , and 5 Mins Read

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.

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