SPAIN Law and Practice Contributed by: Lluís Alcover, Eduard Rodellar, Laia Rull and Pablo Mansilla, Faus Moliner
This could contravene the provisions of Directive 2001/83/EC, which allows marketing cessation if notified two months in advance. In practice, AEMPS has adopted a rather strict position on this matter and is taking actions against compa- nies that cease supplies or that are not able to meet market demand if they cause a therapeutic gap. Medical Devices The certificate of conformity for medical devices issued by the notified bodies is valid for a max- imum of five years, in line with provisions set out at the EU level. The validity of the certificate may be extended for further periods, each not exceeding five years, based on a re-assessment conducted in accordance with the applicable conformity assessment procedures. 3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and The AEMPS is in charge of granting MAs in Spain, which are regulated by Royal Decree 1345/2007. Some provisions of the Royal Decree also affect medicinal products authorised by the European Commission pursuant to the centralised proce- dure. The AEMPS shall authorise a specific product if it: • fulfils the established quality requirements; • is safe under normal conditions of use; • is effective in the therapeutic indications; • is correctly identified; and • provides the patient with the necessary infor- mation. Medical Devices Medicinal Products
The positive therapeutic effects of the medici- nal product shall be assessed from a risk-benefit perspective. The key stages of the authorisation procedure are as follows: • submission of the application to the AEMPS; • validation and acceptance of the submission; • issuance of the evaluation report; and • resolution of the application and granting, where appropriate, of the MA. The maximum period to notify the applicant about the resolution of the authorisation proce- dure is 210 calendar days. The main requirements for the different types of variations of MAs of medicinal products (ie, types IA, IB and II, and extensions) are regulated in Royal Decree 1345/2007. Applications for variations must be submitted to the AEMPS, which has 30 days to approve or deny type IA and type IB variations, and 60 days for type II variations. Transfers of MAs require prior authorisation by the AEMPS. The application is to be conducted through the RAEFAR platform, where the data and documentation supporting the proposed transfer must be uploaded. Medical Devices Medical devices are divided into four classes (III, IIb, IIa and I) depending on the risk posed by the device, which is mainly determined according to its level of invasiveness, the part of the body it is in contact with and the duration of such contact, according to the classification rules of Annex VIII of Regulation (EU) No 2017/75. In vitro diagnos- tic medical devices can also be classified into
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