The medicines approval process in Spain explained – Part I: medicinal products

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In order to get a medicinal product approved for commercialisation in Spain, the product must first be authorised by the *Agencia Española de Medicamentos y Productos Sanitarios (*AEMPS, short for Spanish Agency of Medicines and Medical Devices). The AEMPS is the regulatory body responsible for ensuring the safety, efficacy, and quality of medicinal products in Spain. It is also in charge of the regulation and authorisation of clinical trials, as well as the assessment and approval of medical devices.

In Spain, the drug approval process varies depending on the type of product that you wish to market: medicinal products, medical devices, cosmetics, and personal care products. For now, we will focus on the approval process for medicinal products, but we will cover the other categories in future blog posts, so stay tuned.

For the purposes of this post, by medicinal products we mean “a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action”, as per the European Medicines Agency’s definition.

What does the approval process entail?

The approval process typically involves submitting a marketing authorisation application (MAA) to the AEMPS. The MAA must include detailed information about the product, including its composition, manufacturing process, and proposed labelling. The application must also include data from preclinical and clinical trials demonstrating the safety and efficacy of the product. It must also contain detailed information about the medicine, including its composition, manufacturing process, and proposed labelling.

Once the application is submitted, the AEMPS will review the data and may request additional information or clarification. It can also test the product or request to inspect the facilities in which the product is manufactured, in order to make sure that they comply with the requirements.

If the application is approved, the AEMPS will issue an evaluation report, and the product will be granted a marketing authorisation and can be commercialised in Spain. The technical data sheet, package leaflet and Medicines Agency assessment report will be published on its online information portal, known as CIMA (AEMPS’ Information Centre for Medicines). Any subsequent changes to the product must be notified to the AEMPS.

How much does it cost to submit the marketing authorisation application?

The cost to submit a marketing authorisation application in Spain varies depending on the type of product and the complexity of the application. However, it is typically quite expensive, with costs ranging from tens of thousands to hundreds of thousands of euros. For example, as of March 2023, the fee for the MAA is 21,576.36 euros, whereas the fee for the evaluation, authorisation and registration of a new medicinal gas is only 8,776.68 euros. It is important to factor in these costs when planning to market a medicinal product in Spain.

How long is the authorisation valid for?

The marketing authorisation of a medicine in Spain is valid for five years. After that period, it must be renewed to continue being marketed in the country. This has to be done at least 9 months before the initial authorisation expires. The renewal process involves submitting a renewal application, which must include updated information on the product’s safety, efficacy, and quality, as well as any changes made since the initial authorisation was granted.

The cost of renewal is also dependent on the type of product and the complexity of the application. For a medicinal product for human use, the renewal fee is 2,437.84 euros, as of March 2023. Once renewed, the marketing authorisation is valid for an unlimited period of time.

Do I need to apply for marketing authorisation if my product has been authorised by the EMA?

It depends on the type of marketing authorisation that was granted by the EMA. If the marketing authorisation was requested using the National Procedure (in a country other than Spain), the Decentralised Procedure (DCP) or the Mutual Recognition Procedure (MRP), the license will only be valid in the countries involved.

However, if the product was approved using the centralised procedure (CP), then the license for marketing the medicine is granted for all EU and EEA countries. In this case, the license will also be valid in Spain. You will need to apply for a “Código Nacional” (CN) number (i.e., a marketing authorisation number specific for Spain), though.

It is important to note that the approval process can be lengthy and complex, and it is recommended to seek the guidance of a regulatory expert before beginning the process. At Synaptic Translations, we can help you get all the required documentation translated into Spanish. Call us now or book a consultation to discuss this with us.

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