En estos cuatro meses se debería aprobar la Ley de los medicamentos y productos sanitarios, la Ley de gestión pública e integridad del SNS, el Real Decreto sobre productos sanitarios in vitro, el Real Decreto sobre publicidad de productos sanitarios, el Real Decreto de evaluación de tecnologías sanitarias, el Real Decreto de financiación y fijación de precios de medicamentos y su inclusión en la prestación farmacéutica del SNS, el Real decreto sobre financiación selectiva de los productos sanitarios con cargo a la prestación farmacéutica del SNS para pacientes no hospitalizados, el Real Decreto de condiciones para la elaboración y dispensación de fórmulas magistrales tipificadas de preparados estandarizados de cannabis; el del Estatuto de la Agencia Estatal de Salud Pública, el de publicidad y marketing de productos sustitutivos de la lactancia materna; y alguno que otro más. Por no hablar de la Ley para el buen uso y gobernanza de la inteligencia artificial, la Ley del estatuto marco del personal estatutario de los servicios de salud; y todo esto sin contar con lo que nos venga desde la Unión Europea.

No teman, el Plan Normativo de 2026 seguro que incluirá alguno de éstos. De hecho, el Plan Normativo de 2025 arrastra ya alguno de los objetivos para el 2024. Es un poco aquello de la organización del desgobierno a la que se refería el Profesor Alejandro Nieto; está todo muy bien previsto pero luego pasará lo que pase y seguiremos adelante. Bueno, seguiremos adelante los que no nos hayamos cansado, porque tampoco me queda duda alguna de que muchas ilusiones, iniciativas y proyectos que podrían recalar en España o incluso en Europa acaban en otros continentes; porque si a algo tiene aversión el capital es a la incertidumbre en torno a las normas por las que se va a regir su actividad.

Pues eso, a descansar, a renovar neuronas, rellenar los depósitos de glucógeno, y nos vemos a la vuelta. Un último apunte: la agenda legislativa y regulatoria está muy cargada; pero en el mundo del medicamento las normas importantes no se renuevan a fondo más que cada 20-25 años, es importante que lo que se apruebe sea cualitativamente robusto.

La entrada A descansar que en Otoño… aparece primero en Faus Moliner.

Products that objectively improve patient outcomes or offer a strategic advantage to the National Health System (NHS) – such as a new indication, lower dosage, new pharmaceutical form, pharmacokinetic benefit, or any other relevant feature – may benefit from one of these two options. Strategic medicinal products may also qualify for a price increase. Applying these measures requires a decision by the Interministerial Committee on Medicine Prices (“CIPM”, by its Spanish acronym), with the participation of the Autonomous Regions.

This legal change is a long-awaited development, given the negative side effects caused by a rule that, until now, had been excessively strict. From a legal standpoint, we believe it is important to make two comments.

Effects on the 2025 Reference Price Order

This new provision takes effect the day after its publication. Currently, pursuant to Article 5 of Royal Decree 177/2014, the MOH is working on the 2025 Order updating reference prices, based on the information in its database (Nomenclator) as of April 1st. The new Article 98 of the LGURMPS can, and should, be applied to this 2025 Order, regardless of the fact that the process for its approval was initiated using the April 1st data in the Nomenclator data. That fact is not relevant in this context.

Companies that wish to benefit from the new mechanisms should file a motivated request for the application of Article 98. In addition, the MOH could also initiate the procedure ex-officio.

The role of the CIPM

It is noteworthy that the new provision grants the CIPM the authority to decide whether a product should be excluded from the reference pricing system or benefit from a price increase.

The CIPM’s decision-making process should not be viewed as a mere procedural formality, but rather as a full administrative procedure, in which interested parties are entitled to the rights provided under Law 39/2015. These include the right to make allegations, which must be considered when drafting the proposed resolution. It is also possible that the Directorate-General of the MOH will continue managing this procedure, since it is empowered to provide technical and administrative support to the CIPM in all matters related to setting maximum ex-factory prices for medicinal products, as well as reviewing the prices of those already on the market.

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This landmark CJEU judgment concludes that the general and absolute ban on the advertising of pharmacies and their activities, as established in Article 94a of Poland’s Pharmaceutical Law, infringes EU law.

The case originated from proceedings brought by the European Commission, arguing that the Polish law breached Article 8 of Directive 2000/31/EC on electronic commerce and Articles 49 and 56 of the Treaty on the Functioning of the European Union (TFEU), which guarantee freedom of establishment and the free provision of services.

Advertising of regulated professions

In EU law, the ability of regulated professionals (such as pharmacists or lawyers) to promote their services has long been debated.

On the one hand, the CJEU has held that Article 8 of Directive 2000/31/EC aims to ensure that “all” members of a regulated profession may use information society services to promote their professional activities. At the same time, it has acknowledged that these commercial communications may be subject to compliance with applicable professional rules (e.g. professional secrecy or loyalty towards clients and colleagues).

However, according to the CJEU, the effectiveness of Article 8 would be undermined if professional rules could impose a blanket ban on all online advertising by regulated professionals. The Court has stated that, while such professional rules can define the content and format of commercial communications referred to in Article 8(1) of that Directive, they cannot impose a general and absolute prohibition of such communications.

In light of this case law, Poland argued that its legislation did not impose a general and absolute prohibition on the promotion of the professional services of pharmacists because it did not affect “all” of them, but only those working in a pharmacy. Pharmacists working in universities, hospitals or pharmaceutical companies, were able to promote their services.

However, the CJEU rejects this argument, noting that around 70% of pharmacists in Poland work in pharmacies or retail outlets; that the Polish law banned pharmacies from advertising online sales; and that only basic information, such as location and opening hours, was allowed to be advertised. Given these facts, the Court ruled that the Polish legislation was incompatible with EU law.

Advertising and protection of public interests

With regard to the possible impact on the principles of freedom of establishment (Article 49 TFEU) and freedom to provide services (Article 56 TFEU), Poland acknowledged that its legislation could constitute a restriction, but argued that this was justified by an overriding reason of public interest – namely, the aim of reducing overconsumption of medicinal products and preserving the professional independence of pharmacists.

The CJEU recalled that, under settled case law, any restriction on freedom of establishment or services must be justified by an overriding reason of public interest and must be proportionate.

After reviewing Poland’s arguments, the Court found these conditions were not met.

Regarding the aim of curbing overconsumption of medicinal products, the CJEU considers that Poland failed to demonstrate how allowing pharmacies to advertise would lead to overuse of medication. The CJEU also notes that Poland had not demonstrated that its law had succeeded in reducing the consumption of medicinal products. Furthermore, it considers that advertising might simply shift market share between pharmacies, without increasing overall use.

In addition, the Court emphasises that non-prescription medicinal products in Poland are also sold outside pharmacies – in shops, supermarkets, news-stands or service stations – without any equivalent advertising ban. Therefore, the CJEU concludes that prohibiting advertising by pharmacies is not an effective measure to curb overconsumption of medicinal products. On the contrary, advertising could benefit consumers by allowing them to compare prices or discover additional services offered by different pharmacies.

Regarding pharmacists’ professional independence, Poland claimed the ban protected pharmacists from commercial pressure by pharmacy owners to increase sales. The Court dismisses this argument, finding that such protection could be achieved through less restrictive means – such as regulating the content of advertisements.

Conclusion

This CJEU judgment reaffirms that the protection of public health – through the promotion of the rational use of medicinal products – and the preservation of professional independence cannot be invoked in a general manner to justify disproportionate restrictions on the freedoms guaranteed by EU law.

Member States must have objective, evidence-based and sufficiently substantial reasons to justify any restriction of the freedom of establishment or to provide services. Therefore, before introducing absolute prohibitions that may compromise these freedoms – as is the case with the general ban on pharmacy advertising – a rigorous analysis must be carried out to determine whether the proposed measure effectively and proportionately contributes to the protection of public health.

Possible impact in Spain

This judgment may have an impact on regional pharmaceutical regulations in Spain, as some Autonomous Regions have similar bans on pharmacy advertising.

In light of this recent CJEU judgment, it is worth noting the Spanish Constitutional Court’s Order 13/2018 of 7 February, which addressed the constitutionality of Article 30 of the former pharmacy law in Madrid. That provision prohibited pharmacy advertising. The issue raised was the right of healthcare professionals to promote their services, as recognised in Article 44 of Law 44/2003 on the regulation of healthcare professions.

Although the Spanish court found no conflict between the two laws at the time, the CJEU has now identified a clear conflict between professionals’ rights to advertise their services (as guaranteed by Article 8 of Directive 2000/31/EC) and the Polish ban on pharmacy advertising. This could pave the way for regulatory changes in regions like Galicia, Murcia, or the Canary Islands, where similar bans exist.

It will be important to monitor how Spain’s Autonomous Regions respond to this development, especially given how broad the concept of “promotion” can be. For example, in another recent CJEU judgment (27 February 2025, DocMorris, C-517/23), the CJEU ruled that a marketing campaign offering immediate rewards (like discounts or vouchers) for presenting prescriptions at an online pharmacy did not constitute medicinal product advertising. Instead, it was deemed pharmacy advertising, as its purpose was to influence consumers’ choice of pharmacy.

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These procedures apply to companies that import or export medicinal products to or from countries outside the European Economic Area (EEA). As the Instruction 1/2025 reminds, this includes operations involving Switzerland, Andorra, or the United Kingdom.

Below, we highlight some of the most relevant updates concerning medicinal products for human use.

Definition of “registered medicinal product”

One issue that created legal uncertainty was the lack of clarity around the term “registered medicinal product”, as neither the previous version nor Royal Decree 824/2010 provided a definition. According to Royal Decree 1345/2007, a registered medicinal product is one that has received marketing authorisation and is entered into the AEMPS medicinal product registry. However, doubts have arisen as to whether this includes products that are authorised but not yet registered, pending pricing/reimbursement decision, or with suspended authorisation.

Instruction 1/2025 clarifies that a medicinal product will be considered “registered” if it has the same active substance and excipients, the same pharmaceutical form, and the same manufacturers (both of the active substance and the finished product) as a product registered in Spain; regardless of differences in trade name, presentation, packaging format, or marketing authorisation holder (MAH) in the destination country. The Instruction also explicitly confirms that products with suspended marketing authorisation still qualify as registered medicinal products.

Our view, based on these clarifications, is that the reimbursement status of a product in the National Health System is irrelevant for the purposes of considering it a registered medicinal product.

Importation

The previous version of the Instruction did not clearly define the roles of different entities involved in the import/export process. This created confusion around which entities could physically carry out these operations and which were authorised to request the relevant approvals or submit notifications to AEMPS.

The new Instruction clarifies these roles.

For the importation of finished medicinal products, intermediates, or bulk products, only authorised importers (as defined in Royal Decree 824/2010) or the MAH may carry out the import. For investigational medicinal products, importation must be carried out by an authorised importer.

On the other hand, the request for prior authorisation for each import – which is granted per shipment and for a specific quantity of product – may be submitted by other entities, depending on the type of product:

• Finished medicinal products (excluding plasma derivatives, which follow a separate procedure): by authorised importers, the MAH, or – as newly recognised by the Instruction – the MAH’s local representative in Spain.

• Intermediates or bulk products: by the authorised importers or the MAH.

• Investigational medicinal products: by the authorised importers or the clinical trial sponsor.

These authorisations are valid for one year, during which multiple shipments may be made up to the approved total quantity; unless the conditions that led to the authorisation change.

Exportation

Exportation may be carried out by authorised manufacturers, the MAH, or distributors.

Instruction 1/2025 clarifies that for registered finished medicinal products, the export notification may be submitted by the MAH, the manufacturer or the distributor. For bulk products, only the manufacturer may submit the notification.

In the case of products with suspended authorisation, the exporter must inform the recipient of the suspension. Exports must take place within two months from the date of that notification.

The export of investigational medicinal products for use in clinical trials conducted in other countries participating in a clinical trial authorised in Spain remains unchanged from the 2015 Instruction. It still requires prior authorisation from AEMPS and may involve multiple shipments until the authorised quantity is reached.

Likewise, prior authorisation is required from AEMPS for the export of unregistered medicinal products in Spain; their intermediates or bulk forms; and investigational medicinal products intended for clinical trials not authorised in Spain, whether for another EU country or a third country. Where such products are manufactured in Spain for export, a manufacturing authorisation issued by AEMPS is required. As a new development, this authorisation is now valid for three years (previously two). It also includes the issuance of an export certificate for the destination country.

Additionally, for unregistered medicinal products intended for other EEA countries, only one manufacturing authorisation will now be required, and it will be valid across all EEA countries.

Samples

Instruction 2/2025 maintains the position that the import or export of samples does not require prior authorisation from AEMPS. However, it strengthens the conditions for their use.

The interested company must provide documentation to the Pharmaceutical Inspection Services at AEMPS justifying the intended use of the samples. As a new requirement, the Instruction requires that: the sample size must be consistent with the declared purpose, the intended use must be clearly justified, and any unused quantities must be destroyed through a licensed waste disposal company.

Only authorised importers or manufacturers may import samples; unless the destination is a preclinical or research study, in which case universities, hospitals, research centres, or pharmaceutical companies may also carry out the import.

Returns

The new Instruction includes a section on returns.

It states that the import of previously exported medicinal products requires prior authorisation from AEMPS. The information provided in the import request must match the details recorded in the corresponding export authorisation or notification.

By contrast, the return of active substances for human use does not require prior authorisation, but it is subject to pharmaceutical border control.

Humanitarian donations

Finally, Instruction 1/2015 sets out the procedure for exporting medicinal products as humanitarian donations, a subject of increased relevance during recent emergencies such as the COVID-19 pandemic or armed conflicts.

All such exports require prior authorisation from the Department of Inspection and Control of Medicinal Products at the AEMPS. The authorisation is valid for three months and must be requested through Labofar or the AEMPS electronic registry.

The authorisation may only be requested by pharmaceutical companies, distributors, hospitals, NGOs, or humanitarian aid foundations that comply with applicable regulations. In every case, the applicant is responsible for the export.

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El anteproyecto de ley de los medicamentos, como señala la CNMC, pretende regular diversos escenarios, entre otros los siguientes tres: (a) productos desfinanciados (i.e., productos que estaban financiados y dejan de estarlo, con precio libre sujeto a comunicación); (b) unidades de medicamentos financiados para pacientes no hospitalizados pero que no son a cargo del SNS (i.e. productos que adquieran los pacientes privados, con posibilidad de regular el precio si ello es necesario para la protección de la salud poblacional en los casos y condiciones establecidos en la Ley); (c) medicamentos y productos sanitarios no sujetos a prescripción, o no financiados (i.e. OTC’s o productos no incluidos en la prestación farmacéutica; con precio libre pero con posibilidad también de regular su precio en base parámetros objetivos y transparentes).

¿Siguen aquí? Si están a punto de dejar de leer, créanme que les comprendo. Menudo galimatías. A mí me parece que sería mucho más sencillo señalar, sin más, que la intervención administrativa sobre los precios de los medicamentos se limita a las unidades de productos incluidos en la prestación farmacéutica del SNS que son dispensadas con cargo al SNS a través de receta oficial o de orden de dispensación hospitalaria. En el caso de productos con indicaciones financiadas y no financiadas, la receta oficial o la orden de dispensación hospitalaria no podrían emitirse para una indicación no financiada, pudiendo en su caso aplicarse la reserva singular de visado. Se podría añadir, obviamente, lo que ya dice la Ley actual: cuando exista una situación excepcional sanitaria, con el fin de proteger la salud pública, la Administración podrá fijar el importe máximo de venta al público de cualquier medicamento o producto sanitario por el tiempo que dure dicha situación excepcional.

Es cierto que limitar la intervención, y abrir la puerta a la convivencia generalizada entre precio libre y precio intervenido plantea interrogantes en el caso de productos que llegan al paciente a través de las oficinas de farmacia; pero por lo que más quieran, no caigamos en la trampa de siempre: se aprueba la ley previendo que la información requerida para su gestión “se obtendrá a través del Sistema que se determine”; la Ley no se desarrolla, todo queda en un limbo, y luego a correr, como sucede con la Orden sometida a consulta previa.

La entrada Sobre precios intervenidos y precios libres aparece primero en Faus Moliner.

La entrada Faus Moliner participates in «Chambers Global Practices Guides – Product Liability & Safety 2025» aparece primero en Faus Moliner.

Se trata de una iniciativa que busca acelerar, a través de un procedimiento “fast-track”, la aprobación de nuevos medicamentos desarrollados por compañías farmacéuticas que demuestren estar alineadas con determinadas “prioridades nacionales” de EEUU en el ámbito de la salud pública. Entre estas “prioridades nacionales” se incluyen las siguientes: abordar crisis sanitarias en EEUU; poner a disposición del pueblo estadounidense posibles terapias innovadoras; abordar necesidades de salud pública no cubiertas; y reforzar significativamente la seguridad nacional de EEUU.

A través de estos vales, no transferibles, las compañías podrán acortar los periodos de revisión de sus solicitudes de aprobación, de hasta 10-12 meses a tan solo 1-2 meses. La FDA ha anunciado además otras medidas en la misma línea, como el cese de transferencias de datos genéticos de ciudadanos estadounidenses a países considerados como hostiles. Estas acciones buscan, en conjunto, impulsar la innovación, reducir la burocracia y reforzar la autonomía estratégica del país en el ámbito biomédico.

En este contexto, en el ámbito europeo se está discutiendo la adopción de diversas medidas para estimular, asimismo, la innovación en el ámbito farmacéutico. Entre estas medidas, incluidas dentro del paquete legislativo sobre medicamentos de la Unión Europea, se incluyen los bonos de exclusividad transferibles (TEV), la ampliación de los periodos de protección de datos y de mercado para productos que cubran necesidades médicas no cubiertas o de medicamentos huérfanos, diversas medidas de acceso temprano, los planes de prevención contra la escasez de medicamentos, obligaciones de suministro para ciertos medicamentos, y reformas en la EMA (Agencia Europea de Medicamentos) orientadas a ganar eficiencia, entre otras.

Cada vez es más evidente cómo la normativa farmacéutica se está convirtiendo en una herramienta al servicio de objetivos de interés general más amplios. Tanto en Estados Unidos como en la Unión Europea se están introduciendo reformas regulatorias que van más allá del marco tradicional de autorización y control de medicamentos. En ambos casos, se recurre a incentivos —ya sea acortando plazos de aprobación o ampliando periodos de exclusividad— para fomentar la innovación, reforzar la producción local o garantizar el suministro. Estas iniciativas muestran cómo la política regulatoria está asumiendo un papel más estratégico en la definición de prioridades públicas.

Esta evolución obliga a replantear el modo en que concebimos la regulación farmacéutica: ya no solo como un instrumento técnico al servicio de la salud pública, sino también como una palanca de política industrial, económica y geoestratégica. Si se gestiona con equilibrio y transparencia, esta nueva dimensión puede aportar valor a los ciudadanos, al sistema sanitario y al tejido productivo. Pero también implica riesgos: el uso instrumental de la regulación no debe desvirtuar su esencia ni debilitar sus garantías. El reto está, precisamente, en encontrar ese punto de equilibrio.

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La entrada Retos y oportunidades del Anteproyecto de Ley de medicamentos y productos sanitarios aparece primero en Faus Moliner.

Background

A pharmaceutical company filed a complaint with the competent regional authority regarding unlawful advertising and misrepresentation of an allergenic medicinal product owned by another pharmaceutical company. The complaint was submitted following the procedures established by law, so that the authorities could take ex officio action if deemed appropriate.

The company being reported was not part of Farmaindustria’s self-regulatory system. Therefore, the complaint was submitted to the regional authorities, rather than to the Code of Practice Authority.

The regional authority referred the case to the Spanish Agency for Medicines and Medical Devices (AEMPS), which then initiated an ex officio review to determine whether the product was being marketed in accordance with the applicable regulations.

After examining its presentation and suspecting that it could be an industrially manufactured product without a marketing authorisation, the AEMPS opened an administrative proceeding to cease its marketing and ordered the withdrawal of the product through a preliminary injunction. This interim measure remained in place, and the main proceeding was not closed, until the company under investigation modified the product presentation to correct the irregularities identified by the AEMPS.

The complainant never made public the fact that a complaint had been filed, nor did it make any statements in the market that could have led consumers and/or healthcare professionals to suspect that the product in question might be unlawful.

However, once the reported company discovered the identity of the complainant upon reviewing the administrative file, it filed an unfair competition action, alleging that the complaint constituted acts of disparagement and deception regarding its medicinal product, which had caused damages that should be compensated.

The Commercial Court fully dismissed the lawsuit.

No acts of disparagement

The Court began by recalling that, in order for there to be an act of unfair disparagement, the defendant must have made and/or disseminated public statements capable of damaging the market reputation of the plaintiff’s product, and that such statements should be inaccurate, untrue, or inappropriate.

The plaintiff argued that the defendant (the complainant) had engaged in unfair disparagement by filing a complaint that, in its view, was false and aimed solely at removing the product from the market and damaging its image.

The Court dismissed this argument and ruled that the conduct of the complainant could not be considered an act of denigration nor an act of unfair disperagement.

First, the Court found that the complaint filed by the defendant was neither false nor unfounded.

According to the Court, the complaint was grounded and filed through legally established channels to inform the competent authorities of the identified irregularities so that they could take ex officio measures, which in fact occurred and were not lifted until the irregularities were corrected by the reported company.

Second, and no less important, the complaint was never disclosed or disseminated in the market.

No acts of deception

The Court also rejected the claim that the complainant’s actions could be considered a deceptive practice prohibited by the Unfair Competition Law.

First, as already noted, the Court found no evidence that the complaint was false.

Moreover, the Court emphasised that the complaint was addressed to the competent regulatory authority, not to a consumer. A consumer, upon learning of the complaint, might have changed their behaviour toward the product. However, since the complaint was not directed at consumers, the legal requirement that an unfair competition activity must “mislead recipients and be likely to alter their economic behaviour” could not be considered fulfilled.

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In this context, the Spanish Data Protection Authority (AEPD) has issued two sanctioning decisions. One decision was against a scientific society, and the other against a group of researchers. Both decisions followed a security breach suffered by a technology service provider engaged by those entities.

These decisions provide valuable practical guidance to help reduce the risk of penalties in similar circumstances.

Deficiencies identified by the AEPD

In both cases, the sanctioned organisations were acting as study sponsors, one for a patient registry and the other for an observational study. To manage the platform where the health data were stored, they had engaged a service provider acting as a data processor. The security breach involved unauthorised access to the processor’s information systems. The AEPD found that the processor had failed to implement appropriate technical and organisational measures, such as data encryption, to safeguard the data.

Furthermore, in one of the cases, the AEPD concluded that there was an absence of clear contractual definition regarding the respective roles of data controller and data processor between the sponsor and the participating sites. This lack of clarity contributed to the inadequate handling of the incident. The AEPD also considered the response to the breach insufficient, as affected individuals were notified only through the website and the participating sites, with no direct communication to the study participants.

Proactive responsibility of the sponsor

In clinical research, it is essential to apply the principle of privacy by design. This requires a risk-based and accountability-driven approach, including the careful selection of service providers who can ensure the protection of participants’ privacy throughout the study and beyond its conclusion.

In clinical trials and related studies, this proactive responsibility rests with the sponsor, who is regarded as the data controller. Under the General Data Protection Regulation (GDPR), the controller is the entity that determines the purposes and means of the data processing. However, organisations that fund a study may also be considered controllers, even if they are not the formal sponsors, such as in the case of Investigator-Initiated Studies, where access to personal data may occur in the context of the research.

Selection of the processor and oversight measures

The AEPD emphasises that Article 28 of the GDPR requires the data controller to engage only those processors who offer sufficient guarantees to implement appropriate technical and organisational measures that ensure compliance with the Regulation. A processor’s adherence to an approved code of conduct or certification scheme (such as a data protection seal or mark) may support the demonstration of such guarantees.

The same article obliges the controller to put in place appropriate contractual arrangements with the processor and to exercise effective oversight of the technical and organisational measures applied. This oversight also extends to any sub-processors engaged by the processor. Therefore, according to the AEPD, the controller cannot absolve itself of responsibility for the actions of its processors and must ensure both appropriate selection and ongoing supervision.

Further Lessons from the AEPD’s Decisions

First, when a data controller appoints a processor, it is not sufficient to rely solely on standard contractual clauses or the processor’s reputation. The controller has a duty of diligence, which includes verifying that the processor’s measures are appropriate to the specific risks involved and that they are kept up to date through audits, compliance documentation, periodic reviews, checklists, risk reports, and other relevant means.

Second, it is crucial to maintain internal procedures for managing data breaches. These must be clearly communicated, regularly reviewed, and updated as necessary. Such procedures should specify the reporting channels for incidents, the notification obligations towards both the AEPD and affected individuals, and outline the roles, responsibilities, and designated personnel involved in handling the breach.

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