On 12 August 2021, the Spanish Agency of Medicinal Products and Medical Devices published a briefing note on the new regulatory framework applicable to antiseptics intended for the disinfection of the surgical site prior to surgery or to the injection point. Said products had been regarded by the Spanish regulator as biocidal products until the publication of a Resolution dated 2 June 2021 which reclassified them as medicinal products.
On January 19, 2021, the US Commerce Department published an interim final rule (“Interim Rule”) to implement Executive Order 13873, “Securing the Information and Communications Technology and Services (“ICTS”) Supply Chain.” The Interim Rule was issued following the public comment period’s closure on January 10, 2021 on the proposed rules issued on November 27, 2019.
On 30 July 2021, the Official Journal of the European Union published the Commission Implementing Regulation (EU) 2021/1248 of 29 of July 2021, as regards measures on good distribution practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (“Implementing Regulation”). The Implementing Regulation applies to holders of manufacturing authorizations performing wholesale distribution of veterinary medicinal products covered by that manufacturing authorization, and to holders of a wholesale distribution authorization, including those established or operating under specific customs regimes, such as free zones or customs warehouses.
The Spanish association of pharmaceutical companies (“Farmaindustria”) has updated the Code of Good Practice for the Pharmaceutical Industry (“Code”), which came into force last 1 January 2021. This amendment is mainly aimed to introduce to section 14.2 of the Code a new definition and regulation for non-interventional studies in accordance with the provisions of the new Royal Decree 957/2020, of 3 November, which regulates non-interventional studies with medicines for human use (“RD 957/2020”). The RD 957/2020 came into force last 2 January 2021.
The Spanish Ministry of Health has adopted a new draft of the Royal Decree on Industrially Manufactured Veterinary Medicinal Products (“Royal Decree on Industrially Manufactured Veterinary Medicinal Products”). The new draft establishes specific provisions for the application in Spain of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products (“Regulation 2019/6”), which, together with Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, represents the legislative framework adopted in the middle of the European One Health Action Plan against antimicrobial resistance.
On 14 July 2021, the Spanish Ministry for Health, Consumer Affairs and Social Welfare (Ministerio de Sanidad, Consumo y Bienestar SociaI) published the draft of the new Reference Price Order. The ministry must update the reference price of the medicinal products annually. This new draft updates the reference prices set forth in the previous orders, establishes new groups and removes those that do not meet all of the applicable requirements due to supervening causes. To be included in a specific reference group, medicinal products must have the same Level 5 ATC code and an identical administration route. Interested parties have 15 days to allege what they deemed convenient for their best interests. The deadline is 4 August 2021.
On 13 July 2021, the EU Council of Ministers approved the national recovery and resilience plans (RRPs) of 12 Member States. This means that Austria, Belgium, Denmark, France, Germany, Greece, Italy, Latvia, Luxembourg, Portugal, Slovakia and Spain are now able to tap into the EU recovery and resilience funding. This will allow them to start spending the money on projects and reforms for national economic recovery and resilience, as well as the green transition and digital transformation.
Tax Fraud Prevention Act 11/2021, was published on 10 July 2021. This act transposes Council Directive (EU) 2016/1164, dated 12 July 2016 (Laying Down Rules against Tax Avoidance Practices that Directly Affect the Functioning of the Internal Market), which amended various tax laws and gambling regulations. This new Act amends a vast number of regulations and affects almost every aspect of the Spanish tax system (both for companies and individuals, international taxation, indirect taxation, general tax rules…).
The Legal Office of the Spanish Data Protection Agency (the “SDPA”) has issued on 17 June 2021 a legal report addressing various issues related to the processing of data in the context of health research in the form of clinical trials. Specifically, this report analyzes the legal position of the sponsor, the monitor and the healthcare centers in relation to the processing of trial patient data, and in particular of the clinical history.
The Spanish Ministry of Health is working on a project for a new royal decree regulating medical devices following the adoption of a new framework at the European level through Regulation (EU) 2017/45 of the European Parliament and the Council of 5 April 2017 on medical devices.