SPAIN Law and Practice Contributed by: Lluís Alcover, Eduard Rodellar, Joan Carles Bailach and Laia Rull, Faus Moliner
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 procedure is 210 calendar days. The main requirements for the different types of vari- ations 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 vari- ations. Transfers of MAs require prior authorisation by the AEMPS. The application is to be conducted through the Register of Authorisations of Pharmaceutical and Related Companies ( Registro y autorización de espe- cialidades farmacéuticas – RAEFAR), 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 diagnostic medical devices can also be classified into four classes (A–D), taking into account the intended purpose of the devices and their inherent risks, in light of the classification rules in Annex VIII of Regulation (EU) No 2017/746. Except for custom-made devices, medical devices must bear the CE marking to be placed on the market in Spain, which provides evidence of the device’s con- formity with the applicable requirements. The evalu-
ation and variation approval of medical devices are governed at the EU level in accordance with Regula- tion (EU) 2017/745. 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations Medicinal Products Spain has two national exemption schemes, imple- mented under Article 5 (1) of Directive 2001/83, which permit the importation of and patient access to medic- inal products that do not have a valid MA in Spain – the so-called compassionate use and foreign use of medicinal products – both of which are regulated under Royal Decree 1015/2009 on access to medici- nal products in special situations. Compassionate use is allowed for patients with seri- ous or life-threatening conditions when no authorised and commercialised alternatives are available; in such cases, the medicinal product must either be subject to an MA application or be part of a clinical trial. In prac- tice, the AEMPS takes the view that, when a medicinal product already has a valid MA and is commercialised in Spain, no compassionate use programme can be opened for indications under investigation. This may raise issues in practice if companies wish to offer units of the commercialised product to be used for such unauthorised indication free of charge. Meanwhile, the foreign use regime enables the import of medici- nal products approved in other countries but not yet authorised in Spain. Both the compassionate use and the foreign use regimes require prior approval from the AEMPS, which manages these programmes with high efficiency through its website for medicines in special situa- tions ( medicamentos en situaciones especiales MSE), allowing physician and healthcare centres to submit requests for individual or group patient access. Fur- thermore, under Spanish law, such uses are carried out under the exclusive responsibility of the physician and require prior informed consent from the patient or their legal representative, a clinical report justify- ing the need for the treatment and approval from the healthcare centre where it will be administered. The price of the product concerned is fixed by the import- er, normally after negotiation with the pharmacy ser- vice of the healthcare centre. In compassionate use
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