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When people refer to "FDA law" they usually mean the regulatory requirements enforced by the United States Food and Drug Administration - FDA. The FDA regulates products intended for the US market such as medicines, medical devices, biologics, food, dietary supplements, and certain cosmetics. In Moita, Portugal, companies and individuals may need to understand FDA law if they are exporting products to the United States, working with US partners, or handling products that must meet both US and European requirements.
In Portugal the primary domestic regulators are national and EU authorities - for example INFARMED for medicines and certain health products, ASAE for food safety and economic enforcement, DGAV for animal and food controls, and the European regulatory framework including EMA and relevant EU regulations. This guide explains how US FDA requirements interact with Portuguese and EU law and why you may need local legal help based in or near Moita.
Regulatory matters can be complex, technical, and high-risk. A lawyer with regulatory experience helps you reduce legal and business risk when your product, activity, or dispute touches FDA-type requirements. Common situations where legal help is needed include:
- Exporting products from Portugal to the United States - ensuring US registration, product listing, labeling, and documentation meet FDA requirements.
- Importing US-regulated products into Portugal or the EU - managing customs paperwork, safety certificates, and compliance with EU law.
- Product classification and regulatory strategy - determining whether a product is a food, dietary supplement, cosmetic, medical device, or medicine under US and EU law.
- Product labeling, claims and marketing - ensuring promotional materials meet both FDA restrictions and Portuguese consumer law, avoiding misleading claims and enforcement actions.
- Premarket approvals and notifications - 510(k), PMA, NDI notifications, food facility registration, cosmetics notifications, and other premarket steps affecting market access.
- Post-market obligations - pharmacovigilance, adverse event reporting, recalls, corrective actions, and safety monitoring under both FDA and national regimes.
- Inspections, seizures, and enforcement actions - responding to ASAE, INFARMED or FDA inspections, seizures, administrative fines, and potential criminal charges.
- Contract drafting and supply chain controls - preparing distribution agreements, supplier warranties, quality agreements and ensuring compliance with good manufacturing practices.
Portugal follows EU law for most health, food and product safety matters. If you operate in Moita you must comply with the following types of rules in addition to any US FDA obligations:
- Medicines and Health Products - INFARMED is the national competent authority for medicines and certain health products. EU directives and regulations, including GMP requirements and pharmacovigilance obligations, apply to marketing authorizations, clinical trials and post-market surveillance.
- Medical Devices - EU Medical Device Regulation - MDR (Regulation 2017/745) and In Vitro Diagnostic Regulation - IVDR (Regulation 2017/746) govern device classification, conformity assessment, clinical evidence and CE marking. National market surveillance is performed by INFARMED and other designated authorities.
- Food Safety and Animal Products - ASAE and DGAV carry out enforcement of EU food law. Food labelling, traceability, hygiene rules and notifications are governed by EU Regulation 178/2002 and subsequent acts.
- Cosmetics - Regulation (EC) No 1223/2009 sets safety, labelling and product information requirements. Responsible person obligations and safety assessments are mandatory.
- Chemical Safety - REACH and CLP rules regulate chemicals in the EU market, including registration, classification and labelling.
- Consumer Protection and Advertising - national consumer law and EU directives limit unfair and misleading commercial practices and set rules for product claims and guarantees.
- Enforcement and Sanctions - Portuguese authorities can impose administrative fines, order product withdrawals or seizures, and in serious cases pursue criminal prosecutions. Administrative decisions can usually be challenged before national courts and administrative tribunals.
"FDA law" refers to the rules and requirements enforced by the US Food and Drug Administration. For parties in Moita it is relevant when exporting to the US, partnering with US firms, or when US regulatory expectations influence product design, labeling or clinical evidence. You must comply with both US FDA rules for the US market and applicable EU/Portuguese rules for the EU market.
Many products imported into the US require US-specific registrations or notifications. For food, foreign facilities generally must register with the FDA and provide prior notice of shipments. Medical devices may need premarket clearance or listing. Requirements depend on product category and intended use - a regulatory review will identify what is required for your product.
Differences arise in classification, premarket procedures, labelling content, approved claims, clinical data expectations and post-market reporting timelines. For example, the EU uses CE marking and conformity assessment routes, whereas the US may require 510(k) clearance or PMA approval for devices. You should assess both regimes early to align product development and evidence generation.
Risks include shipment refusals at US ports, detention or destruction of goods, financial losses, reputational damage, mandatory recalls, import alerts, and difficulty re-entering the US market. Civil penalties or restrictions on future imports can also follow.
Portuguese authorities enforce national and EU law. They will not enforce FDA rules per se, but similar violations under EU or Portuguese law - such as unsafe products, misleading labelling or hygiene breaches - can lead to actions by ASAE, INFARMED or other bodies. If you fail to meet FDA requirements for the US market, that can still cause commercial and contractual consequences locally.
Cooperate, follow internal procedures, provide requested documentation and take notes of the inspection. If the inspection raises compliance issues, obtain legal advice immediately to manage corrective actions, communications and any administrative proceedings or recalls. Having a pre-established compliance program and legal counsel helps manage inspections with less disruption.
Maintain clear quality management systems, documented standard operating procedures, robust supplier controls, traceability records, and routine internal audits. Ensure staff training, maintain batch records, and have a crisis plan for recalls or adverse event reporting. Legal counsel can help align documentation with both FDA and EU expectations.
Often both. A Portuguese lawyer familiar with EU and national regulations manages local compliance, enforcement and business matters. A US regulatory lawyer or consultant can advise on FDA-specific premarket requirements, submissions and import rules. For cross-border matters choose counsel experienced in international regulatory issues or form a team with both Portuguese and US expertise.
Costs and timelines vary widely by product category. Simple labelling or registration tasks may be handled quickly and at modest cost. Premarket approvals, clinical studies, or complex conformity assessments can take months to years and involve significant expenses. A product-specific regulatory assessment provides a realistic estimate.
Look for lawyers or law firms with experience in life sciences, food law, medical devices, or international trade. Ask about prior work on FDA-related matters, multilingual capabilities, contacts with national authorities, fee structure, and references. Verify membership in the Ordem dos Advogados and consider firms in the Lisbon metropolitan area if specialized expertise is required.
Below are key authorities and organizations you may consult when dealing with regulatory matters in Moita - whether addressing EU rules or US FDA concerns. Contacting these bodies helps you confirm legal requirements and procedural steps.
- INFARMED - national regulator for medicines and certain health products in Portugal - competent on marketing authorizations, pharmacovigilance and clinical trials.
- ASAE - Autoridade de Segurança Alimentar e Económica - responsible for food safety enforcement, market inspections and economic compliance.
- DGAV - Direcao-Geral de Alimentacao e Veterinaria - works on animal and certain food controls, veterinary products and inspection certifications.
- Direcao-Geral da Saude - national public health authority with guidance on certain public health matters.
- EMA - European Medicines Agency - coordinates EU-level scientific review for medicines and provides guidance on regulatory pathways.
- European Commission - responsible for EU product regulations and harmonised rules affecting trade and market access.
- Portuguese Ordem dos Advogados - use to verify lawyers and get referrals for regulatory law specialists.
- US FDA - relevant if you export to the United States - check specific product requirements, registration and submission obligations.
- INPI - Instituto Nacional da Propriedade Industrial - for trademark and patent matters that may impact branding and IP strategy.
If you need legal assistance in FDA-related matters while operating from Moita follow these practical steps:
- Define the issue - Gather key facts about your product, markets, manufacturing process, labels, supply chain and any communications or notices from regulators or customers.
- Perform a regulatory assessment - Have counsel or a qualified consultant identify applicable US FDA and EU/Portuguese requirements and gaps.
- Select appropriate counsel - Choose a Portuguese lawyer experienced in regulatory or administrative law plus US counsel if you are exporting to the US. Ask for relevant experience and a clear fee estimate and timeline.
- Prepare documentation - Compile technical files, quality system records, labels, testing reports and contracts before engaging with authorities or submitting applications.
- Communicate with authorities - Where appropriate, notify or consult the competent authority early. Legal counsel can manage written responses and appeals if enforcement action arises.
- Implement corrective actions - If compliance gaps exist, create and document remediation plans, staff training and supplier controls. Confirm completion with testing or audits.
- Plan for ongoing obligations - Establish monitoring for post-market surveillance, adverse event reporting and periodic renewals or registrations.
Getting regulatory compliance right requires technical, legal and practical coordination. If you are unsure where to start, book a consultation with a regulatory lawyer near Moita who can assess your situation and recommend a clear road map.
