Best Drugs & Medical Devices Lawyers in Hasselt

About Drugs & Medical Devices Law in Hasselt, Belgium

Drugs and medical devices in Hasselt are governed primarily by European Union rules, implemented and enforced in Belgium by federal authorities. Hasselt is in the province of Limburg, and while local healthcare institutions and businesses operate in the city, the core legal framework is EU wide and Belgian federal. Medicines are regulated under EU legislation and the Belgian Law of 25 March 1964 on medicinal products, along with detailed royal decrees and guidance. Medical devices follow the EU Medical Device Regulation and In Vitro Diagnostic Medical Device Regulation, complemented by the Belgian Act of 22 December 2020 on medical devices and implementing decrees. The Federal Agency for Medicines and Health Products, known in Belgium as FAMHP or FAGG-AFMPS, is the key regulator for authorizations, inspections, vigilance, and enforcement.

Whether you are a patient, healthcare professional, startup, manufacturer, distributor, pharmacy, or hospital in Hasselt, understanding this framework is essential. Issues often involve authorization and CE marking, clinical trials and investigations, advertising and promotion, distribution licenses, vigilance and recalls, pricing and reimbursement, data protection, and liability for adverse events. Because legal and regulatory requirements are detailed and time sensitive, early professional guidance can save time, money, and risk.

Why You May Need a Lawyer

People and organizations in Hasselt commonly seek legal help in these situations:

- Bringing a new medicine or medical device to the Belgian or EU market, including market authorization, CE marking, and conformity assessment.- Setting up a life sciences business in Limburg, including selecting a regulatory pathway, obtaining FAMHP licenses, drafting quality and pharmacovigilance or materiovigilance systems, and supplier contracts.- Conducting a clinical trial or device clinical investigation at local hospitals or research centers, including ethics approval, contracts, insurance, data protection, and safety reporting.- Handling advertising and promotion questions, including meetings with healthcare professionals, samples, digital marketing, and transparency obligations for transfers of value.- Managing distribution, wholesaling, import or export, including Good Distribution Practice compliance, narcotics and psychotropics permits, and online pharmacy requirements.- Responding to safety issues, field safety corrective actions, and recalls, including communications with FAMHP, hospitals, and patients.- Navigating reimbursement and pricing with NIHDI-INAMI-RIZIV and related bodies, including submissions, listing, and compliance checks.- Addressing counterfeit or illegal products, parallel imports, and enforcement actions or inspections.- Advising on data protection for health data under GDPR and Belgian law, including clinical research, registries, and connected devices.- Pursuing or defending product liability and medical malpractice claims, including limitation periods, evidence preservation, expert reports, and settlement.

Local Laws Overview

- Core EU framework: Medicines are regulated by Directive 2001/83, Regulation 726/2004, and related pharmacovigilance and falsified medicines rules. Devices are regulated by Regulation EU 2017-745 and Regulation EU 2017-746, including CE marking, unique device identification, and EUDAMED registration.- Belgian implementation: The Law of 25 March 1964 on medicines and various royal decrees govern authorization, distribution, advertising, and supervision. For devices, the Act of 22 December 2020 and implementing decrees set national obligations, vigilance procedures, and penalties.- Regulator: FAMHP-FAGG-AFMPS authorizes and inspects manufacturing, import, wholesaling, clinical trials and investigations, vigilance, and recalls. The Inspectorate can impose administrative measures and refer cases for criminal prosecution.- Clinical research: The EU Clinical Trials Regulation governs interventional trials on medicines via the CTIS system. Belgium uses recognized ethics committees. For devices, clinical investigations follow the MDR-IVDR and Belgian procedures for ethics and authority approvals.- Advertising and interactions: Advertising of medicines to the public and professionals is strictly regulated. Devices advertising must be accurate and non-misleading. Industry self-regulation and the Mdeon visa system apply to certain interactions with healthcare professionals. Belgium has a transparency regime known as the Sunshine Act that mandates publication of transfers of value to healthcare stakeholders.- Pricing and reimbursement: Prices and reimbursement decisions involve the Federal Public Service Economy and NIHDI-INAMI-RIZIV, advised by commissions such as the Commission for the Reimbursement of Medicines. Compliance with reimbursement conditions is audited.- Distribution and online sales: Wholesalers need FAMHP licenses and GDP compliance. Online pharmacies must be authorized and follow EU common logo rules. Import and export of controlled substances require specific permits.- Product safety and recalls: Pharmacovigilance and materiovigilance reporting to FAMHP is mandatory. For devices, field safety notices and field safety corrective actions must follow strict timelines and formats. For medicines, recall classes and rapid alerts are used.- Liability: Belgium applies strict product liability based on EU law, alongside general civil liability and medical malpractice rules. Limitation periods can be short, so early advice is important.- Local context in Hasselt: Hospitals, clinics, and research centers in the Limburg region host trials and device evaluations, which require local site contracts, insurance, and ethics oversight. Municipal rules may apply to signage, storage facilities, and business permits. Day-to-day practice remains subject to federal and EU health product laws.

Frequently Asked Questions

Who regulates medicines and medical devices in Hasselt?

FAMHP-FAGG-AFMPS is the federal authority for medicines and medical devices across Belgium, including Hasselt. It handles authorizations, inspections, vigilance, recalls, and enforcement. EU bodies such as the European Medicines Agency and the European Commission set and oversee parts of the framework, especially for centralized approvals and EU wide device rules.

What is the difference between a medicinal product and a medical device?

A medicinal product achieves its principal intended action by pharmacological, immunological, or metabolic means. A medical device achieves its principal intended action by physical or mechanical means, often assisted by software. Borderline products require careful assessment because the classification determines authorization, evidence, labeling, and post market duties.

How do I place a medical device on the Belgian market?

Determine device classification, implement a quality management system, generate clinical or performance evidence, complete conformity assessment with a notified body for most Class IIa, IIb, III devices and higher risk IVDs, affix CE marking, register in EUDAMED where applicable, and fulfill Belgian registrations and vigilance obligations. Non EU manufacturers need an authorized representative in the EU and Belgian specific notifications when required.

How do I get a medicine authorized in Belgium?

Options include centralized authorization through the European Medicines Agency, or national, mutual recognition, or decentralized procedures under EU rules. You must submit quality, nonclinical, and clinical data, pharmacovigilance details including a qualified person responsible for pharmacovigilance, and risk management plans. After approval, ongoing safety reporting and variations are mandatory.

Can I advertise my product to the public in Belgium?

Consumer advertising of prescription only medicines is prohibited. Over the counter medicines and most medical devices can be advertised to the public, but strict accuracy, balance, and non-misleading rules apply. Advertising to healthcare professionals is regulated, with limits on hospitality, samples, and inducements. Certain events with healthcare professionals require a prior visa through self-regulatory systems. Always review materials against Belgian and EU rules before publishing.

What are my obligations if a safety issue arises with my device or medicine?

You must assess risk immediately, notify FAMHP without delay when reportable criteria are met, and implement corrective actions. For devices, issue a field safety notice and conduct a field safety corrective action when needed. For medicines, follow recall classifications and rapid alert procedures. Keep full records and timelines, and coordinate communications with hospitals and patients to reduce risk and liability.

Can I sell medicines or devices online in Belgium?

Only authorized pharmacies may sell certain medicines online, and they must display the EU common logo and comply with Belgian requirements. Devices can be sold online if they meet CE marking and other obligations, and advertising rules still apply. Marketing claims must be accurate and supported. Importing from outside the EU without proper authorization can trigger seizures and penalties.

How are clinical trials and device investigations approved?

Interventional clinical trials on medicines use the EU Clinical Trials Information System, with assessment by a recognized Belgian ethics committee and the competent authority. Device clinical investigations follow MDR-IVDR rules, with ethics approval and FAMHP notifications or authorizations depending on risk. Site contracts, insurance, data protection, and safety reporting must be in place before first subject in.

What are the data protection rules for health data?

Health data is a special category under GDPR and the Belgian Law of 30 July 2018. Lawful basis, purpose limitation, data minimization, and robust security are required. For research, additional safeguards, ethics approval, and transparency to participants are needed. Cross border transfers and use of cloud or connected device platforms must be assessed carefully.

If I suffer harm from a medicine or device, can I claim compensation?

Belgian law allows claims under strict product liability and under general civil liability and medical malpractice. Keep the product, packaging, instructions, and all medical records. Notify your insurer if relevant. Limitation periods can be as short as 3 years from when you knew of the damage and the producer, with a 10 year long stop for product liability. Other claims may have different deadlines. A lawyer can assess the best route, experts needed, and potential defendants.

Are there special rules for controlled substances and narcotics?

Yes. The Belgian Drug Law of 24 February 1921 and later decrees tightly control manufacturing, possession, distribution, and import or export of narcotics and psychotropics. Licenses and secure storage are required, inspections are frequent, and penalties are severe for non compliance.

Additional Resources

- Federal Agency for Medicines and Health Products FAMHP-FAGG-AFMPS for authorizations, vigilance, inspections, recalls, and guidance.- European Medicines Agency for centralized medicine approvals and EU safety communications.- European Commission Directorate General for Health and Food Safety for MDR-IVDR implementation and guidance.- Federal Public Service Health, Food Chain Safety and Environment for health policy and certain permits.- NIHDI-INAMI-RIZIV and the Commission for the Reimbursement of Medicines for pricing and reimbursement matters.- Recognized Belgian Ethics Committees for clinical trial and investigation reviews.- Sciensano for health surveillance, vigilance studies, and scientific support.- beMedTech and pharma.be for industry codes and practical guidance on interactions with healthcare professionals.- Mdeon for visa procedures related to hospitality and scientific events.- Hasselt area hospitals and research centers for local clinical research governance and site requirements.

Next Steps

- Clarify your objective and timeline. Are you launching a product, running a study, responding to a safety issue, or seeking compensation?- Gather key documents. Include technical files, CE certificates, trial protocols, contracts, regulatory correspondence, labeling, marketing materials, and any adverse event reports. Patients should collect medical records, prescriptions, invoices, and product packaging.- Map the regulatory pathway. Identify device classification or authorization route, applicable standards, and Belgian specific filings. Determine whether ethics approval and authority authorization are needed.- Secure compliance building blocks. Quality management system, pharmacovigilance or materiovigilance procedures, data protection impact assessment, insurance, and training plans are typical requirements.- Engage early with the regulator when appropriate. Pre submission meetings and scientific advice can reduce later delays.- Consult a lawyer familiar with EU and Belgian health product law and with local practice in Hasselt and Limburg. Ask about scope, timelines, fees, and who will handle regulatory interactions.- Prepare for inspections and audits. Confirm GDP or GMP compliance, supplier qualifications, and documentation integrity.- For claims and disputes, act quickly. Preserve evidence, note deadlines, and consider expert opinions to quantify harm and causation.

This guide is general information. For decisions that affect your rights or compliance posture, seek tailored legal advice from a qualified professional.