Best FDA Law Lawyers in Spain

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LBO Legal
Seville, Spain

Founded in 2012
10 people in their team
Spanish
English
We are a law firm that was born in Seville in 2012 under the brand LBO Abogados and whose bases are the resolutive capacity, professional honesty and full availability to our portfolio of clients to whom we offer legal, tax, labor and personal data protection services.If there is one thing we are...
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Almar Lawyers
Ibiza Town, Spain

English
Almar Lawyers, based in Ibiza's central square, Vara de Rey, is a distinguished law firm founded by Ibizan natives Alejandro Bonet Templeton and Nadine Schröder. With extensive experience in major law firms across the Balearic Islands and mainland Spain, they established Almar Lawyers to...

English
Rochina Abogados & Asesores, located in Adeje, Santa Cruz de Tenerife, offers comprehensive legal and business advisory services. The firm specializes in various areas of law, including civil, criminal, labor, commercial, and tax law, as well as business consulting services such as accounting,...
RASSEEN LAW FIRM
Madrid, Spain

Founded in 2020
20 people in their team
English
Spanish
A Saudi company using the latest technologies in the world of law, in line with the Kingdom's vision 2030. Its core is the aware and educated youth who graduated of the most advanced programs in the field of law and consultations.The company obtained an approval to legal practice and provide legal...

English
Duarte & Julián Abogadas is a multidisciplinary law firm based in Salamanca, Spain, offering specialized legal services to individuals, self-employed professionals, and businesses. The firm provides personalized legal solutions across various areas of law, including inheritance and succession,...
Vanguard Law Associates

Vanguard Law Associates

30 minutes Free Consultation
Marbella, Spain

Founded in 2023
5 people in their team
Spanish
English
Swedish
Italian
Vanguard Law Associates | Expert Real Estate & Property Lawyers in MarbellaVanguard Law Associates is a premier law firm based in Marbella, specializing exclusively in real estate and property law. With a strong reputation for legal excellence, we provide comprehensive solutions for property...
BJ Abogado
Seville, Spain

Founded in 2000
50 people in their team
Spanish
English
WE CARE ABOUT YOUR PROBLEMSWe are a law firm in Seville that aims to provide an agile and quality response to each of our clients. We are aware that we live in an increasingly technologically advanced society and, therefore, speed in providing a response is one of our most valued qualities.At BJ...
Vosseler Abogados
Barcelona, Spain

Founded in 1997
50 people in their team
Spanish
English
Vosseler Abogados was born in 1997 with the intention of creating a dynamic and current firm. A law firm close to clients, where in addition to working with the utmost professionalism to defend their interests, the necessary complicity and a closer relationship between lawyer and client is...
UNIVE Abogados
Madrid, Spain

Founded in 2006
200 people in their team
Spanish
English
Unive Abogados was created in 2006 as a result of an important project initiated by a group of university professors who decided to take the definitive step in their attempt to transfer the university way of work to the business or professional field.The fundamental pillars on which the service...
Mariscal & Abogados
Madrid, Spain

Founded in 2001
50 people in their team
Spanish
English
OUR MISSIONMiguel Mariscal‘s vision for founding Mariscal & Abogados was to offer exceptional legal advice to companies, particularly those with an international presence in Spain. To achieve this goal, he gathered a team of exceptionally skilled lawyers fluent in Spanish, English, French,...
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About FDA Law in Spain

In Spain, the regulation of food, drugs, and medical devices is primarily managed through a combination of national and European Union laws. Although Spain does not have an agency directly equivalent to the US Food and Drug Administration (FDA), its functions are largely carried out by the Spanish Agency of Medicines and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) and other governmental bodies. FDA Law in Spain refers to the legal framework that governs the research, manufacturing, marketing, import, export, safety, and labeling of food products, medicines, and health-related items within the country. These regulations are intended to ensure public health, consumer safety, and compliance with EU standards.

Why You May Need a Lawyer

There are many scenarios in which individuals or companies may need legal assistance concerning FDA Law in Spain. Common situations include:

  • Navigating the regulatory approval process for pharmaceuticals and medical devices
  • Ensuring compliance with food safety laws and labeling requirements
  • Responding to product recalls, enforcement actions, or regulatory investigations
  • Resolving disputes related to intellectual property or regulatory exclusivity
  • Dealing with import and export controls for drugs and medical devices
  • Advising on advertising, marketing, and sponsorship of regulated products
  • Managing clinical trial approvals and compliance
  • Assisting with product registration and licensing procedures

An experienced lawyer can help you navigate the complex regulatory landscape, minimize risks, and address any legal challenges that may arise.

Local Laws Overview

Spain's system for regulating food, medicines, and health products involves several key legal components:

  • The Law on Guarantees and Rational Use of Medicines and Health Products (Ley de Garantías y Uso Racional de los Medicamentos y Productos Sanitarios) governs the authorization, manufacture, and distribution of medicines and medical devices.
  • The General Food Law and related royal decrees regulate food safety, labeling, traceability, and hygiene, incorporating EU food regulations.
  • AEMPS is responsible for authorizing medicines and medical devices, pharmacovigilance, and oversight of clinical trials.
  • The Spanish Agency for Food Safety and Nutrition (AESAN) oversees food safety, monitoring, and response to food crises.
  • Strict requirements exist for product labeling, advertising, and the reporting of adverse reactions.
  • There are established procedures for product recalls, import-export controls, and enforcement actions when regulations are not followed.

Compliance with both Spanish and EU laws is essential for anyone involved in the food, pharmaceutical, or healthcare industries in Spain.

Frequently Asked Questions

Who regulates medicines and medical devices in Spain?

The Spanish Agency of Medicines and Medical Devices (AEMPS) is the main regulatory body responsible for the control, approval, and monitoring of medicines and medical devices in Spain.

What is required for the approval of a new medicine in Spain?

To market a new medicine, companies must submit a comprehensive application to AEMPS, including clinical data, safety and efficacy information, manufacturing details, and labeling proposals. Approval may be granted at the national or EU level depending on the product.

Are there specific labeling requirements for food products?

Yes, food products must be labeled in Spanish and comply with stringent requirements regarding ingredients, allergens, nutritional information, expiration dates, and origin, in accordance with both Spanish and EU regulations.

How are medical devices authorized for sale in Spain?

Medical devices require registration with AEMPS, and most must bear a CE marking attesting conformity with EU medical device directives. Some devices may also undergo additional national assessments.

What are the penalties for violating FDA-related laws in Spain?

Penalties can include administrative fines, product recalls, suspension of licenses, or criminal prosecution depending on the severity and type of violation.

How are clinical trials regulated?

Clinical trials must be authorized by AEMPS and an appropriate ethics committee before they can be conducted in Spain. There are strict requirements regarding participant consent, data protection, and reporting of adverse events.

Can food supplements be marketed without approval?

Food supplements generally need to be notified to the competent authorities before being launched, and they must meet legal standards for composition, labeling, and advertising.

What should I do if my product is subject to a recall?

You must act quickly to comply with instructions from AEMPS or AESAN, notify affected parties, and implement corrective actions. Timely legal advice is important to manage risks and fulfill obligations.

Are there restrictions on advertising medicines and medical devices?

Advertising of prescription-only medicines to the general public is prohibited. All promotional activities must adhere to strict guidelines set by AEMPS and the Ministry of Health.

How can I get legal help in FDA Law matters?

You can consult specialized law firms or legal professionals with expertise in health, food, and pharmaceutical law who understand both Spanish and EU regulations.

Additional Resources

The following organizations and resources may be helpful for those seeking guidance or information on FDA Law issues in Spain:

  • Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) - National authority for medicines and medical devices
  • Spanish Agency for Food Safety and Nutrition (AESAN) - Responsible for food safety and nutrition
  • Ministry of Health - Supervises overall health policy and regulation
  • Official State Gazette (Boletín Oficial del Estado, BOE) - Publishes all relevant laws and regulations
  • Pharmaceutical industry associations and professional bodies may provide sector-specific information and guidance

Next Steps

If you require legal assistance with FDA Law matters in Spain, consider the following steps:

  • Identify your specific legal issue or question related to food, medicines, or medical devices
  • Gather all documentation, such as licenses, notices, product information, or correspondence from regulatory authorities
  • Contact a legal professional or law firm specializing in health, pharmaceutical, or food law
  • Be prepared to explain your situation clearly and provide any supporting documents for review
  • Follow the advice of your legal counsel regarding compliance, communication with authorities, and necessary corrective actions

Early legal intervention can help prevent regulatory problems, ensure you meet your obligations under Spanish and EU law, and protect your interests.

Lawzana helps you find the best lawyers and law firms in Spain through a curated and pre-screened list of qualified legal professionals. Our platform offers rankings and detailed profiles of attorneys and law firms, allowing you to compare based on practice areas, including FDA Law, experience, and client feedback. Each profile includes a description of the firm's areas of practice, client reviews, team members and partners, year of establishment, spoken languages, office locations, contact information, social media presence, and any published articles or resources. Most firms on our platform speak English and are experienced in both local and international legal matters. Get a quote from top-rated law firms in Spain - quickly, securely, and without unnecessary hassle.

Disclaimer:
The information provided on this page is for general informational purposes only and does not constitute legal advice. While we strive to ensure the accuracy and relevance of the content, legal information may change over time, and interpretations of the law can vary. You should always consult with a qualified legal professional for advice specific to your situation. We disclaim all liability for actions taken or not taken based on the content of this page. If you believe any information is incorrect or outdated, please contact us, and we will review and update it where appropriate.