Royal Decree 192/2023 on Medical Devices, which adapts Spanish national regulations to the provisions of Regulation (EU) 2017/745, was published on 22 March 2023. The new Royal Decree identifies the competent authority in Spain for medical devices, expands the scope of some of the provisions to new kind of products and introduces provisions regarding the manufacture of in-house products and the reprocessing of single-use products, among other significant changes.
The publication of the July 2022 version of the European Commission’s Blue Guide on the implementation of European Union product rules aims to adapt to changes in European legislation on the marketing of products within the EU. In this sense, the aim is to improve the understanding of EU legislation and its application in the fields that make up the single market. The Guide is for guidance only, which means that it has no legal force. Among the most relevant changes are the introduction of specific sections on product repairs, software, online sales and Brexit.
With the entry into force of Regulation (EU) 2019/1009 on fertilizer products, the regulatory framework for fertilizer products within the European Union has been updated. However, national regulations may continue to be used on an optional basis. This Regulation has extended the categories of fertilizers covered and it also provides for a number of obligations for manufacturers, importers and distributors of fertilizers, including the declaration of conformity and the CE marking. Finally, guidelines have also been established for the conformity assessment of these products.
Spanish Official State Gazette published Law 2/2023 on 20 February 2023, which transposes the EU Whistleblower Directive (Directive (EU) 2019/1937 of the European Parliament and of the Council of 23 October 2019 on the protection of persons who report breaches of European Union law) into Spanish law.
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.
The Spanish Ministry for Health, Consumer Affairs and Social Welfare have published the Draft of the Reference Price Order of 2022 with the aim of updating the reference prices set forth in previous orders, establishing new groups and removing those that do not meet the applicable requirements.
The Annual Compliance Conference begins next week and attracts over 6,000 in-house senior legal and compliance professionals from across the world. This leading compliance conference will be held across five weeks from 6 September – 6 October 2022. We will be virtually delivering our cutting-edge insights and guidance on key global compliance, investigations and ethics issues. Our global experts will provide practical insights and analysis on significant developments:
• corruption and economic crime
• customs and FTAs
• ESG, supply chain and product compliance
• antitrust and competition
• export controls, sanctions and foreign investment
Click here to view the full agenda and register your interest in joining us virtually at this must attend global compliance conference for senior in-house legal and compliance professionals.
Annual Compliance Conference
Our popular Annual Compliance Conference, which attracts over 6,000 in-house senior legal and compliance professionals from across the world, will be held across five weeks from 6 September – 6 October 2022. We will be virtually delivering our cutting-edge insights and guidance on key global compliance, investigations and ethics issues. Our global experts will provide practical insights and analysis on significant developments across:
– corruption and economic crime
– customs and FTAs
– ESG, supply chain and product compliance
– antitrust and competition
– export controls, sanctions and foreign investment
Click https://www.bakermckenzie.com/en/insight/events/2022/10/annual-compliance-conference to register your interest in joining us virtually at this must attend global compliance conference for senior in-house legal and compliance professionals.
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.
On 23 February 2022, the European Commission gave the green light to the proposal for a Directive of the European Parliament and of the Council on Corporate Sustainability Due Diligence and amending Directive (EU) 2019/1937. The Proposal aims to promote sustainable business behavior with regard to supply chains, in particular activities affecting human rights and the environment. To this end, the Proposal introduces a legal obligation to conduct due diligence in the field of human rights and the environment.