SPAIN Law and Practice Contributed by: Lluís Alcover, Eduard Rodellar, Laia Rull and Pablo Mansilla, Faus Moliner
classified as a medicinal product if it achieves its intended effect by means of a pharmacological, immunological or metabolic action (medicinal product by function), or if it is presented as hav- ing therapeutic properties typical of medicinal products (medicinal product by presentation). These are alternative conditions, meaning that a given substance or combination will be consid- ered a medicinal product if either or both defini- tions apply to it. The AEMPS is responsible for attributing the status of a medicinal product to a substance in Spain. This can occur within the framework of a national marketing procedure or, subsequently, within the scope of the market surveillance func- tions of the AEMPS. However, in the centralised procedure, it is the European Medicines Agency (EMA) that deter- mines whether a substance is a medicinal prod- uct. Moreover, the EMA has the power to inter- vene in disputes arising during decentralised authorisation procedures. The AEMPS is also responsible for the qualifi- cation and classification of medical devices in Spain. 3.2 Granting a Marketing Authorisation for Biologic Medicinal Products The granting of an MA for biologic products is governed by the same obligations as for other medicinal products. Biosimilar medicinal prod- ucts have to demonstrate comparability in efficacy, safety and quality through an abbre- viated clinical and non-clinical development programme. Biological and biosimilar medicinal products developed by means of biotechnologi- cal processes, as described in Regulation (EU) No 726/2004, must be authorised by the Euro- pean Commission through the centralised pro-
cedure. Other biological and biosimilar medicinal products may optionally undergo the centralised procedure or decentralised/national procedures. Advanced therapy medicinal products (which can also be biologic products) that are non- industrially manufactured are regulated by Royal Decree 477/2014, which sets out that their indi- vidual use and manufacture must be authorised by the AEMPS on a case-by-case basis. 3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or The MA of a medicinal product is valid for an initial period of five years. The marketing authorisation holder (MAH) may apply for MA renewal, pursu- ant to Article 27 of Royal Decree 1345/2007, at least nine months before expiration. Medical Devices Medicinal Products Once renewed, the MA will be valid for an unlim- ited period, unless the AEMPS requires an addi- tional five-year renewal based on duly justified pharmacovigilance-related reasons. An MA shall be revoked if the product it refers to is not mar- keted for three consecutive years (ie, sunset clause). Once the MA is granted, Royal Decree 1345/2007 imposes an obligation on the MAH to keep the market duly supplied. In practice, each October the MAH shall declare whether they intend to market the product during the following year. If they do not do so, they will be deemed to have requested a suspension of the validity of the MA. Royal Decree 1345/2007 also empowers the AEMPS to keep MAs in force for reasons of public health interest, such as the creation of a treatment gap, either in the market in general or in the pharmaceutical provision of the NHS.
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