Search for:
Category

Spain

Category

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.

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.

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.