Best Drugs & Medical Devices Lawyers in Gondomar

About Drugs & Medical Devices Law in Gondomar, Portugal

Gondomar sits within the Porto district and is fully governed by Portugal's national and European Union legal framework for medicines and medical devices. Medicines are regulated throughout their life cycle, from research and manufacturing to advertising, sale, and pharmacovigilance. Medical devices are governed by European rules on safety and performance, with oversight of economic operators such as manufacturers, authorized representatives, importers, and distributors. Day to day enforcement and guidance is provided by the national medicines authority and other competent bodies, while local matters in Gondomar often involve municipal licensing of premises, waste management, and inspections of commercial activities.

Portugal applies the European Medicines Agency system for centrally authorized medicines, and national procedures for others. For medical devices, the European CE marking system applies, based on conformity assessment and clinical evidence. Patient safety underpins both areas, with strict rules on reporting adverse reactions and device incidents, traceability, recalls, data protection, and truthful promotion. Businesses operating in Gondomar must align with these rules while also observing local public health and municipal requirements for premises and operations.

Why You May Need a Lawyer

Specialist legal help can save time, reduce risk, and prevent costly disputes. Common situations include the following.

Launching a product in Portugal, for example obtaining a marketing authorization for a medicine or ensuring a device meets MDR conformity and UDI requirements. Structuring clinical trials or clinical investigations, including ethics approvals, contracts with hospitals, data protection and biobank issues. Handling inspections or enforcement by the medicines authority or market surveillance authorities, for example during GDP or GMP inspections, device vigilance checks, advertising audits, or after a reported incident.

Managing recalls, field safety corrective actions, or pharmacovigilance signal investigations. Drafting and reviewing commercial agreements, for example distribution, manufacturing, quality technical agreements, CRO agreements, or software as a medical device licensing. Advising on advertising and promotion, digital channels, events with healthcare professionals, and transparency obligations. Addressing product liability and patient injury claims, insurance notifications, and evidence preservation. Advising pharmacies, clinics, and device retailers on licensing, online sales of non prescription medicines, and compliance programs. Supporting imports and exports, customs issues, and Portuguese language labeling. Navigating data protection for health data, algorithm transparency for digital devices, and cybersecurity by design.

Local Laws Overview

Competent authorities. INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P., is the national authority for medicines and medical devices. Direção-Geral da Saúde sets public health policies and clinical guidelines. ASAE performs market surveillance and can inspect commercial establishments. The National Data Protection Authority, CNPD, oversees data protection. In healthcare provision, ERS regulates private and public providers. Local police and customs support enforcement against counterfeits and illegal imports. In the Porto area, inspections and proceedings are coordinated with these bodies, with cases heard by the courts in the Porto judicial district when litigation arises.

Medicines. The core statute is Decree-Law 176/2006, the Medicinal Products Statute, as amended, together with EU pharmaceutical law. Marketing authorization is required unless a legal exemption applies. Quality, safety, efficacy, pharmacovigilance, manufacturing GMP and distribution GDP are mandatory. Advertising to the public is restricted and prescription medicines cannot be advertised to consumers. Prices and reimbursement with the National Health Service follow specific rules and decisions at national level.

Medical devices. The EU Medical Device Regulation 2017/745 and In Vitro Diagnostic Regulation 2017/746 apply directly. Devices must meet general safety and performance requirements, be supported by clinical evidence, bear CE marking, and use UDI and EUDAMED modules as they become available. Economic operators have defined obligations, including post market surveillance and vigilance reporting. National provisions such as Decree-Law 145/2009, as amended, complement EU law for market surveillance and sanctions.

Controlled substances. Decree-Law 15/93 governs narcotic and psychotropic substances, licensing and record keeping. Possession for personal use is decriminalized under Law 30/2000 within specific quantity limits but remains administratively sanctioned. Healthcare operators must comply with storage and dispensing controls.

Clinical trials and investigations. Clinical trials are governed by the EU Clinical Trials Regulation 536/2014 and national rules. Clinical investigations for devices follow MDR requirements. Both require ethics approval and competent authority authorization, contracts with sites, insurance, and robust consent procedures. Safety reporting timelines are strict.

Online sales. Only community pharmacies may sell non prescription medicines at a distance using an authorized website with the EU common logo. Prescription medicine online sales are prohibited. Device e commerce must comply with device law, consumer law, and market surveillance rules.

Data protection. The GDPR and Law 58/2019 apply. Health data is a special category and requires appropriate legal bases, safeguards, and impact assessments. CNPD guidance should be followed, especially for research and remote monitoring technologies.

Waste, environment, and returns. Pharmacies participate in take back schemes for expired medicines and packaging. ValorMed operates the national system for medicine packaging and expired medicine disposal. In Gondomar, municipal and intermunicipal waste entities handle collection and environmental compliance for businesses, including hazardous healthcare waste from clinics and labs.

Product liability and consumer rights. Portugal applies strict liability for defective products in line with Directive 85/374 through Decree-Law 383/89. Consumers may use courts or consumer arbitration centres in the Porto region. Limitation periods and evidence preservation rules are important in adverse event cases.

Local interface in Gondomar. Although licensing of medicines and devices is national, businesses in Gondomar must meet municipal requirements on land use, construction works, signage, opening hours, and waste contracts. Pharmacies, clinics, and device shops are subject to local inspections for health and safety conditions that complement national healthcare rules.

Frequently Asked Questions

Who regulates medicines and medical devices in Portugal and how does that affect me in Gondomar

INFARMED is the national authority for both medicines and devices. Its decisions apply everywhere in Portugal, including Gondomar. ASAE and other authorities conduct inspections locally. You should expect national level licensing and oversight, with local inspections of your premises and operations.

How does a medicine obtain authorization to be sold in Portugal

Medicines require a marketing authorization issued via an EU centralized procedure or through national, decentralized, or mutual recognition procedures. The applicant must show quality, safety, and efficacy, submit manufacturing and pharmacovigilance systems, and provide Portuguese labeling and leaflets. After authorization, pricing and reimbursement decisions are separate steps.

What must a medical device manufacturer or importer do before placing a device on the market

Under EU MDR a device must meet general safety and performance requirements, complete clinical evaluation, undergo conformity assessment with a notified body where required, affix CE marking, and implement UDI and post market surveillance. Portuguese language instructions and labeling are required. Importers and distributors must verify compliance, maintain traceability, and report incidents.

Can prescription medicines be advertised to the public in Portugal

No. Advertising of prescription only medicines to the general public is prohibited. Advertising to healthcare professionals is permitted under strict conditions. Any advertising must be accurate, not misleading, and consistent with the authorized product information. Promotions and benefits to healthcare professionals are restricted by law and industry codes.

May I buy medicines online in Portugal

Yes, but only non prescription medicines and only from authorized community pharmacies that operate registered websites displaying the EU common logo. Prescription medicines cannot be sold online. Devices can be sold online if they comply with device law and consumer protection rules.

What should I do if I suffer an adverse reaction to a medicine or an incident with a device

Seek medical care first. Report the event to your healthcare professional and to the national reporting system managed by INFARMED. Patients and professionals can report suspected adverse reactions and device incidents. Keep the product, packaging, and any receipts, and record dates and symptoms. Consider legal advice if injury or loss occurred.

How are recalls and safety notices handled

Marketing authorization holders for medicines and manufacturers or importers for devices must evaluate risks, notify INFARMED, and implement recalls or field safety corrective actions where needed. Businesses must cooperate, trace affected lots, and inform customers. Pharmacies and distributors must quarantine and return recalled products. Clear records and prompt action are essential.

Can I bring medicines with me when I travel to Portugal

Yes, for personal use and in reasonable quantities. Prescription medicines should be carried in original packaging with a copy of the prescription. For controlled substances additional documentation may be required under Decree-Law 15/93. Commercial import requires appropriate licenses and customs clearance.

What are my rights if a defective medicine or device causes harm

Portugal applies strict product liability for defective products, which can allow compensation for damage without proving negligence. Other claims may be available, such as contractual or negligence claims. Preserve evidence, medical records, and the product. Time limits apply, so early legal assessment is advisable.

Do apps and software count as medical devices

Software can be a medical device if it has a medical purpose, for example diagnosis, monitoring, or treatment. If so, MDR applies, including classification, clinical evaluation, cybersecurity by design, CE marking, and post market surveillance. Data protection duties are heightened due to processing of health data.

Additional Resources

INFARMED, the national authority for medicines and health products, for licensing, vigilance, and guidance. European Medicines Agency for centralized authorizations and EU pharmacovigilance resources. Direção-Geral da Saúde for public health policies and clinical guidelines. ASAE for market surveillance of commercial activities, including devices and advertising controls. ERS, the Health Regulatory Authority, for matters involving healthcare providers. CNPD for data protection guidance on health data. Ordem dos Farmacêuticos and Ordem dos Médicos for professional standards. ValorMed for take back and disposal of medicine packaging and expired medicines. Consumer dispute and arbitration centres in the Porto region for out of court resolution of product disputes. Local municipal services in Gondomar for premises licensing, waste management arrangements, and environmental compliance.

Next Steps

Define your objective. Be clear whether you need help with a product launch, clinical research, a compliance program, an inspection, a contract, a recall, an injury claim, or a dispute.

Gather documents. Collect authorizations, technical files, clinical evidence, labeling, promotional materials, contracts, SOPs, inspection reports, and any correspondence with authorities. For injury matters, keep the product and all medical records.

Map the rules. Identify which regime applies, for example medicines statute, EU MDR or IVDR, controlled substances, advertising rules, GDP or GMP, GDPR, and municipal requirements in Gondomar for your premises or activity.

Assess risks and timelines. Many procedures have fixed deadlines, such as vigilance reporting, price and reimbursement submissions, or responses to inspection findings.

Engage a specialist. Contact a Portuguese lawyer with experience in life sciences, pharmaceuticals, and medical devices. For activities in Gondomar, confirm any municipal permits and local operational requirements.

Implement and monitor. Put compliance measures in place, train staff, audit distributors and service providers, and establish robust reporting and recall procedures. Review your insurance coverage for product liability and clinical research.

Stay updated. EU and national rules evolve frequently. Monitor guidance from authorities and industry codes, and schedule periodic compliance reviews.