SPAIN Law and Practice Contributed by: Xavier Moliner and Juan Martínez, Faus Moliner
1. Product Safety 1.1 Product Safety Legal Framework
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 Nutri - tion (AESAN), which is in charge of the technical requirements and surveillance of food and nutri - tional products. Regional authorities are also responsible for control - ling advertising, performing inspections of manufac - turing 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 disposal of con - sumers and users, within the limits of its activity, must withdraw from the market, suspend marketing or recover from the consumer or user, through effec - tive procedures, any product that does not meet the conditions and requirements of RLD 1/2007 or which, for any other reason, represents a foreseeable risk to personal health or safety on any other grounds. In addition, the competent authorities may adopt all measures as are necessary and proportionate to eliminate the risk, including direct intervention regard - ing the product and direct compulsion of the entity involved. In these cases, all the expenses incurred will be charged to the involved entity whose conduct gave rise to such measures, irrespective of the sanc - tions that may be imposed, if any. The levying of such expenses and penalties may be carried out through the administrative enforcement procedure. Taking into account the nature and severity of the risks detected, public authorities may also inform affected consum - ers and users through the most appropriate means about the existing risks or irregularities, the affected product, the measures adopted and the appropriate precautions, in order to protect themselves from the risk and obtain their collaboration in the elimination of its causes.
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 consolidated text of the General Law on the Protection of Consumers and Users and other complementary regulations. RDL 1/2007 establishes the main rules and obligations 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. The following laws and regulations set forth addi - tional rules and obligations, depending on the type of product and its impact on the health and safety of consumers: • 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 nutrition; • 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 cosmetic products. 1.2 Regulatory Authorities for Product Safety The General Directorate for Consumer Affairs of the Ministry of Consumer Affairs and the competent con - sumer authorities of the autonomous regions of Spain are the main authorities 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, in addition to: • the Spanish Agency for Medicinal Products and Medical Devices (AEMPS), which is the regulatory
240 CHAMBERS.COM
Powered by FlippingBook