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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.

Last June, the Superior Court of Justice of the Basque Country delivered a decision with wide repercussion with regards to advertising of medicinal products by pharmaceutical companies. The decision ruled on an appeal filed by Farmaindustria (the Spanish trade association bringing together innovative pharmaceutical companies) against a regional Order regulating the advertising of pharmaceutical products through medical sales representatives in the context of the Basque Health System.

17 December 2021 is the deadline for all Member States to transpose the new Whistleblower Protection Directive 2019/1937, which obliges businesses with over 50 employees to have a reporting channel. It should be noted that the aim of these new regulations is to exploit the potential for whistleblower protection to strengthen enforcement and set standards for strong protection against any reprisals.

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.