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Drugs and medical devices in Amay are regulated primarily by Belgian federal law and European Union rules. The Federal Agency for Medicines and Health Products - known by its initials in French and Dutch as AFMPS - FAGG - FAMHP - is the national authority responsible for market authorization, safety monitoring, inspections and enforcement. European rules such as the Medical Devices Regulation and rules on medicines set baseline requirements that Belgian authorities and courts apply. Local health services, hospitals and professionals in Amay operate within the same national and EU framework, and day-to-day issues often involve a mix of regulatory, civil liability and administrative law.
Legal issues in drugs and medical devices can be complex, technical and time-sensitive. You may need a lawyer in cases such as:
- You were harmed by a medicine or a medical device and want to seek compensation.
- You are a company seeking market authorization, CE marking or regulatory compliance for a product sold or used in Belgium.
- You need help reporting, documenting and responding to an adverse event, vigilance case or safety recall.
- You are a healthcare professional facing a disciplinary or civil claim related to prescribing, implanting or using a device.
- You face an inspection, enforcement action or criminal investigation by authorities such as the FAMHP or public prosecutor.
- You are involved in a clinical trial and need help with approvals, contracts, liability clauses or patient consent procedures.
- You need to challenge an administrative decision, for example a refusal of market authorization or a sanction, before administrative courts.
Key legal elements relevant in Amay and across Belgium include:
- EU framework - Medicines and medical devices are subject to EU regulations and directives. The EU Medical Devices Regulation and In Vitro Diagnostic Regulation set strict requirements for design, clinical evidence, conformity assessment and post-market surveillance.
- Federal oversight - The Federal Agency for Medicines and Health Products (FAMHP) implements EU rules, grants or reviews authorizations, requires vigilance reporting and can order inspections, measures and recalls.
- Market authorization routes - Medicines may be authorized via the central EMA procedure or national procedures. Medical devices receive CE marking via conformity assessment through a notified body and must meet MDR requirements.
- Pharmacovigilance and vigilance - Manufacturers and marketing authorization holders must have systems to monitor, report and act on adverse events for medicines and devices. Serious incidents must be reported to the FAMHP within set timelines.
- Reimbursement and pricing - Decisions on reimbursement for medicines and some medical devices are managed at federal level by the National Institute for Health and Disability Insurance - INAMI - RIZIV. Reimbursement affects market access and patient costs.
- Product liability - Belgium implements the EU Product Liability Directive. Manufacturers, importers and others can face strict liability for defective products that cause personal injury or damage.
- Civil and criminal law - Patients may sue for negligence or breach of duty against manufacturers, hospitals or clinicians. In serious cases criminal charges can arise for endangering public health or fraud.
- Clinical trials and ethics - Clinical research must comply with Belgian law, ethics committee approval and FAMHP authorization. Consent procedures and insurance for participants are required.
- Administrative remedies - Decisions by government agencies can be appealed through administrative procedures and, ultimately, to the Council of State or ordinary courts depending on the matter.
- Language and procedure - Amay is in Wallonia where French is the predominant language. Legal proceedings and official communications will commonly be in French, so choose advisors who can operate in the relevant language.
Medical devices in Belgium follow EU regulation and national enforcement. Devices must meet the EU Medical Devices Regulation requirements, obtain CE marking through a notified body when required, and be registered with the FAMHP when applicable. Manufacturers, importers and distributors have ongoing obligations for labeling, post-market surveillance and vigilance reporting.
Seek immediate medical care. Preserve evidence - packaging, prescriptions, device labels, photos and medical records. Report the incident to the manufacturer and to the FAMHP so authorities can investigate. Contact a lawyer experienced in product liability or medical malpractice to review compensation options.
Adverse events and serious incidents should be reported to the manufacturer and to the FAMHP using the agency's reporting channels. Healthcare providers are often required to report. Reporting helps trigger investigations, corrective actions and possible recalls.
Yes. Belgian law implements strict product liability rules for defective products under the EU directive and also permits claims based on negligence or breach of contract. Liability may attach to manufacturers, importers or distributors depending on circumstances. Timely legal advice is important because limitation periods and evidence requirements apply.
Compensation can include medical expenses, loss of earnings, pain and suffering, and in severe cases long-term care costs. The amount depends on the facts, the strength of proof that the product or treatment caused the harm, medical expert reports and applicable legal standards.
The FAMHP is the principal federal authority responsible for enforcement including authorizations, inspections, vigilance and recalls. Other actors include regional health bodies, hospital regulators and prosecutors when criminal or public health issues arise.
Many medicines require a prescription from a licensed healthcare professional. Over-the-counter medicines are available without a prescription but remain regulated. Controlled substances and certain prescription-only medicines have strict distribution and prescribing rules.
Limitation periods apply to claims and vary by cause - product liability, medical negligence and contractual claims can have different deadlines. Because time limits can bar claims, consult a lawyer promptly to preserve your rights and gather evidence.
Recalls can be initiated by manufacturers or ordered by the FAMHP. A recall process includes notifying users, providing instructions for safe return or corrective action, and monitoring effectiveness. A lawyer can help protect your rights if you were harmed by a recalled product.
Look for lawyers who specialize in health law, product liability or regulatory law and who practise in the Liège region. The local bar association can help identify qualified practitioners. Choose an attorney who speaks the local language, understands medical and technical evidence, and has experience with regulators like the FAMHP.
Useful organizations and bodies to consult or notify include:
- The Federal Agency for Medicines and Health Products (FAMHP) - national regulator for medicines and devices.
- The National Institute for Health and Disability Insurance - INAMI - RIZIV - handles reimbursement and pricing questions.
- Federal Public Service Health - health policy and public health matters.
- European Medicines Agency - for EU-level authorizations and information on medicines.
- Notified bodies and conformity assessment organizations for device certification matters.
- The Barreau de Liège - local bar association for finding specialized lawyers in the Liège and Amay area.
- Local hospitals and university medical centres - for expert medical records and expert witnesses.
- Consumer protection and patient advocacy groups - for support in complaints and collective actions.
- Ethics committees and clinical research units - for clinical trial approvals and oversight topics.
If you need legal assistance with drugs or medical devices in Amay, consider these practical steps:
- Document everything - medical records, prescriptions, device serial numbers, correspondence with manufacturers and any photos or invoices.
- Report the incident - notify the manufacturer and file a report with the FAMHP as soon as possible.
- Seek medical and expert evaluation - obtain a clear medical report that links injury to the product or treatment when possible.
- Contact a specialist lawyer - choose a lawyer with experience in product liability, health law or regulatory matters and who can advise on remedies, timing and evidence.
- Preserve evidence and witnesses - do not discard products or paperwork and obtain statements from treating clinicians.
- Consider alternatives to litigation - mediation, negotiated settlements or complaints to administrative bodies may resolve some disputes more quickly.
- Act quickly - legal and administrative time limits can be strict. Early consultation will protect your options and ensure proper reporting to authorities.
Choosing the right legal partner and informing the competent authorities are the most important first steps. If you are unsure where to start, contact the local bar or a patient support organization in the Liège area to be referred to a suitable lawyer who can advise in French or your preferred language.
