SPAIN Law and Practice Contributed by: Lluís Alcover, Eduard Rodellar, Joan Carles Bailach and Laia Rull, Faus Moliner
EMA has the power to intervene in disputes arising during decentralised authorisation procedures. The AEMPS is also responsible for the qualification and classification of medical devices in Spain. 3.2 Marketing Authorisation for Biologic Medicinal Products The granting of an MA for biologic products is gov- erned by the same obligations as for other medicinal products. Biosimilar medicinal products have to dem- onstrate comparability in efficacy, safety and qual- ity through an abbreviated clinical and non-clinical development programme. Biological and biosimilar medicinal products developed by means of biotech- nological processes, as described in Regulation (EU) No 726/2004, must be authorised by the European Commission through the centralised procedure. 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 manu- factured are regulated by Royal Decree 477/2014, which sets out that their individual use and manufac- ture must be authorised by the AEMPS on a case-by- case basis. 3.3 Period of Validity of Marketing Authorisations Medicinal Products 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, pursuant to Article 27 of Royal Decree 1345/2007, at least nine months before expiration. Once renewed, the MA will be valid for an unlimited period, unless the AEMPS requires an additional five- year renewal based on duly justified pharmacovigi- lance-related reasons. An MA shall be revoked if the product it refers to is not marketed for three consecu- tive 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 inter- est, such as the creation of a treatment gap, either in the market in general or in the pharmaceutical provi- sion of the NHS. This could contravene the provisions of Directive 2001/83/EC, which allows marketing ces- sation if notified two months in advance. In practice, AEMPS has adopted a rather strict position on this matter and is taking actions against companies 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 maximum of five years, in line with provisions set out at the EU lev- el. 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 Medicinal Products 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 Com- mission pursuant to the centralised procedure. 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 informa- tion. The positive therapeutic effects of the medicinal prod- uct shall be assessed from a risk-benefit perspective.
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