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 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 20 January, 2021, part of Law 18/2020 of 28 December to facilitate economic activity, enters into force, following publication in the Official Gazette of the Government of Catalonia on 31 December. The main aim of this law is to facilitate economic activity in an all-digital environment, allowing for a more agile, efficient relationship between the administration and companies, supposedly with fewer administrative burdens for companies, and a more simplified administrative intervention framework.
Royal Decree-Law 36/2020 of 30 December 2020, establishing urgent measures to modernize the public administration and implement the government’s recovery, transformation and resilience plan (“RDL of Modernization”) was published on the last day of 2020 and entered into force on 1 January 2021.
On 26 November 2020, the Spanish Official State Bulletin published the Royal Decree 957/2020, of 3 November, regulating observational studies with medicinal products for human use, which will come into effect on 2 January 2021. This royal decree intends to ease the administrative procedures applicable to observational studies in light of recently adopted instruments at EU level (with the European Medicines Agency-approved guidance on post-authorization efficacy studies) and Spanish level (with the enactment of Royal Decree 1090/2015 on clinical trials with medicinal products, which introduced the legal concept of observational study). Observational studies are an essential tool to gather personal health data on conditions for use, safety and effectiveness of medicinal products, and to ultimately enhance clinical practice in the interest of patients.