SPAIN Law and Practice Contributed by: Xavier Moliner and Juan Martínez, Faus Moliner
1. Product Safety 1.1 Product Safety Legal Framework Royal Legislative Decree 1/2007 (RLD 1/2007) is the main law setting out the legal regimen for product safety in Spain. It approves the consoli - dated text of the General Law on the Protection of Consumers and Users and other complemen - tary regulations. RDL 1/2007 establishes the main rules and obli - gations that, in general, must be respected by companies that make products available on the market to guarantee the protection of the health and safety of consumers and users. Other laws and regulations set forth additional rules and obligations depending on the type of product and its impact on the health and safety of consumers. This is the case with the following laws and regulations: • Royal Legislative Decree 1/2015, which approved the consolidated text of the law on guarantees and rational use of medicinal products and medical devices; • Law 17/2011, regarding food safety and nutri - tion; • Law 14/1986, on general public health; • Royal Decree 1801/2003, on general product safety; • Royal Decree 1345/2007, which regulates the authorisation, registry and dispensation conditions of medicinal products for human use prepared industrially; • Royal Decree 192/2023, which regulates medical devices; and • Royal Decree 85/2018, which regulates cos - metic products.
1.2 Regulatory Authorities for Product Safety The General Directorate for Consumer Affairs of the Ministry of Consumer Affairs and the competent consumer authorities of the auton - omous regions of Spain are the main authori - ties responsible for ensuring that the products made available to consumers and users meet the requirements established to provide a high level of health and safety at the same time as they respond to demands related to quality. Other key sector-specific regulators are also in charge of ensuring that the specific products made available to consumers and users meet the requirements established to provide a high level of health and safety at the same time as they respond to demands related to quality. Such regulators include: • the Spanish Agency for Medicinal Products and Medical Devices (AEMPS), which is the regulatory authority in charge of the technical requirements and surveillance of medicinal products, medical devices, cosmetics and personal care products; and • the Spanish Agency for Food Safety and Nutrition (AESAN), which is in charge of the technical requirements and surveillance of food and nutritional products. Regional authorities are also responsible for controlling advertising, performing inspections of manufacturing and distribution premises, and performing all necessary controls to ensure that products comply with the applicable regulations. 1.3 Obligations to Commence Corrective Action According to the provisions of RLD 1/2007, any entity involved in placing a product at the dis - posal of consumers and users, within the limits
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