SPAIN Law and Practice Contributed by: Lluís Alcover, Eduard Rodellar, Laia Rull and Pablo Mansilla, Faus Moliner
located. This authorisation will specify the dis- tribution activities the entity is authorised to perform, in accordance with the European for- mat. Additionally, these entities must notify the AEMPS before starting their activities. To grant this WDA, the regional authority will verify that such entities have the appropriate personnel, material and operational means to guarantee the correct development of their activity, as well as the capability to provide a quality service. In addition, a physical inspection of the premises will be carried out. The regional authority must notify its decision within 90 days of receiving the application. If no decision is made within this period, the applicant can con- sider their application approved. The authorisation is valid indefinitely. However, it may be suspended in the following circum- stances: • if the entity does not fully, effectively and con- tinuously carry out all the distribution activi- ties for which it has been authorised one year after the authorisation is granted; or • when the entity no longer meets the require- ments that were considered to grant such authorisation or fails to comply with the legally established obligations. Medical Devices Distributors and other entities engaged in the sale of medical devices must submit prior noti- fication of the start of their activity to the health authority of the autonomous region where the company’s registered office is located. They must also notify the health authority of the region where the warehouses are located, if they are in different regions. The notification must include:
• identification of the distribution establish- ment; • the types of products it distributes or sells; and • identification and qualification of the respon- sible technician, where applicable. In addition, the distributor must be registered in the AEMPS Marketing Register prior to the start of its activity. This register is currently in the design phase and is not operational. When the European Database on Medical Devices (EUDAMED) is fully functional, all devices, except custom-made medical devices, will be reported in the new Medical Device Market Register. 6.2 Different Classifications Applicable to Pharmaceuticals Concerning the importer of record of pharma- ceuticals and medical devices, please see 1.3 Difference Categories of Pharmaceuticals and Medical Devices . 7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies The importation and exportation of medicinal products and medical devices is governed by Royal Legislative Decree 1/2015 (in particular, Articles 72 and 73, relating to exports) and Royal Decree 824/2010. The AEMPS applies and enforces regulations regarding the import, export and intra-commu- nity trade of medicinal products and medical
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