Best Drugs & Medical Devices Lawyers in Chur

About Drugs & Medical Devices Law in Chur, Switzerland

Chur is the capital of the canton of Graubunden and is subject to the federal regulatory framework that governs drugs and medical devices in Switzerland. Federal law establishes the rules for market authorization, clinical trials, safety monitoring, advertising, manufacturing standards, import and export, and sanctions. Cantonal authorities handle implementation, local healthcare delivery, and some aspects of enforcement. For companies, healthcare professionals and patients in Chur, the most important federal bodies are Swissmedic - the Swiss Agency for Therapeutic Products - and the Federal Office of Public Health. Local cantonal health authorities in Graubunden carry out inspections, licensing for certain facilities, and liaise with federal regulators.

Why You May Need a Lawyer

Legal issues involving drugs and medical devices can be complex, technical and high risk. You may need a lawyer if you face any of the following situations:

- Seeking market authorization or regulatory advice for a new medicine, generic product, over-the-counter product or medical device - especially to navigate Swissmedic requirements and documentation.

- Responding to inspections, regulatory notices, or enforcement actions from Swissmedic or cantonal authorities.

- Handling adverse event reports, product defects, recalls or field safety corrective actions that can trigger liability and reputational risks.

- Managing clinical trials - getting approvals, preparing informed consent forms, addressing ethics committee queries, or dealing with disputes arising from trial conduct.

- Defending or bringing claims for product liability, professional liability, consumer protection or criminal offences resulting from harm allegedly caused by a drug or device.

- Drafting and negotiating commercial agreements such as distribution, manufacturing, clinical trial, licensing, or parallel import contracts.

- Advising on advertising, promotion and information to healthcare professionals and the public to ensure compliance with Swiss rules.

- Addressing cross-border trade issues, importation of personal medication, or customs and controlled-substance regulations.

Local Laws Overview

Key legal elements relevant to drugs and medical devices in Chur reflect national legislation with local implementation:

- Regulatory framework - The Therapeutic Products Act - TPA - and associated ordinances set out requirements for authorization, conformity assessment, manufacturing, labelling, clinical trials, vigilance and market surveillance. Swissmedic is the federal regulator carrying out approvals and supervision.

- Medical device classification - Devices are classified by risk. Higher-risk devices need conformity assessment and Swissmedic oversight. Switzerland has aligned many rules with European device regulations, but Swissmedic remains the deciding authority for national market access.

- Pharmaceuticals - Prescription and non-prescription medicines are regulated differently. Prescription drugs require marketing authorization. Over-the-counter medicines must meet safety and information standards. Controlled substances are regulated under the Narcotics Act and require special permits for handling, prescribing and import.

- Clinical trials - Authorization from Swissmedic and approval from a cantonal or regional ethics committee are both typically required. Trials must follow Good Clinical Practice - GCP - and local ethics requirements.

- Manufacturing and distribution - Good Manufacturing Practice - GMP - and Good Distribution Practice - GDP - standards apply. Facilities may be inspected by federal or cantonal authorities.

- Advertising and promotion - Direct-to-consumer advertising for prescription-only medicines is restricted. Promotion to healthcare professionals must be accurate and not misleading. Specific rules apply to comparative advertising and inducements.

- Pharmacovigilance and vigilance for devices - Manufacturers and authorised representatives must report adverse events and take corrective action when safety issues arise. Swissmedic can order recalls, safety notices, or other measures.

- Liability and enforcement - Product liability claims are typically governed by the Swiss Code of Obligations and tort law. Criminal sanctions can apply in cases of negligent or intentional harm. Administrative fines, suspensions or revocations of authorizations are possible for regulatory breaches.

- Cantonal role - The Canton of Graubunden enforces public health measures, may issue permits for pharmacies and health facilities, coordinates emergency responses, and works with healthcare providers on local implementation and inspections.

Frequently Asked Questions

How do I get a medicine approved for the Swiss market?

Approval requires submitting a marketing authorization application to Swissmedic with clinical data, manufacturing information and labelling. Applications must meet the requirements of the Therapeutic Products Act and related ordinances. The process includes review of quality, safety and efficacy, and timelines vary by product type and completeness of the dossier. A local authorised representative may be needed if the applicant is not established in Switzerland.

How are medical devices registered and evaluated in Switzerland?

Medical devices are assessed based on risk classification. Low-risk devices may only require registration processes and technical documentation. Higher-risk devices need conformity assessment by a notified body recognized by Swiss authorities or an equivalent procedure. Swissmedic oversees market surveillance and can require additional Swiss-specific documentation or actions.

What should I do if I discover a serious adverse event linked to my product?

Report the event promptly to Swissmedic and follow pharmacovigilance or vigilance procedures. Maintain thorough records, perform a risk assessment, and consider any corrective actions such as updates to labelling, safety communications, or recalls. Consult a lawyer experienced in regulatory and liability matters to manage notifications, regulatory dialogue and potential legal exposure.

Can I run a clinical trial in Chur and what approvals are needed?

Yes, clinical trials can be run in Chur with approval from Swissmedic and the appropriate cantonal or central ethics committee. Sponsors must submit trial protocols, investigator brochures, informed consent documentation and safety reporting plans. Trials must adhere to GCP and local legal requirements including insurance and patient protection rules.

Are there restrictions on advertising medicines in Switzerland?

Yes. Advertising for prescription-only medicines to the general public is prohibited. Advertising to healthcare professionals is allowed but regulated - it must be accurate, not misleading, and comply with price transparency, inducement and disclosure rules. Devices have their own advertising standards depending on classification and intended audience.

What legal risks exist if a device malfunctions and harms a patient?

Potential risks include product liability claims under the civil law regime, claims for professional negligence against healthcare providers, regulatory enforcement by Swissmedic, and in severe cases criminal investigations if there was gross negligence. Liability may involve compensation for personal injury, property damage and legal costs. Manufacturers and suppliers should maintain insurance and a risk management system.

Can I import medication for personal use into Switzerland from abroad?

Importation of personal medication is subject to limits and documentation requirements, especially for controlled substances. Small amounts for personal use may be allowed under conditions, but certain drugs require import permits or prescriptions. Customs and cantonal health offices enforce these rules, so check requirements before travelling or ordering across borders.

What happens during a Swissmedic inspection of my facility?

Inspections assess compliance with GMP, GDP, device manufacturing standards, labelling, record keeping and quality systems. Inspectors may review documents, production records and interview staff. If non-conformities are found, Swissmedic can require corrective actions, impose restrictions or suspend operations. Legal support helps prepare for inspections and respond to findings.

Who is liable when a hospital uses an unapproved or off-label therapy?

Liability depends on circumstances. Prescribers may be accountable if they violate professional standards without proper informed consent or justification. Institutions can be liable for inadequate oversight or policies. Off-label use can be lawful when supported by evidence and patient consent, but it increases legal and regulatory scrutiny. A lawyer can assess risk and advise on documentation and defence strategies.

Where can healthcare professionals and companies report quality concerns or suspected counterfeit products?

Suspected quality defects or counterfeit products should be reported to Swissmedic and the cantonal health authority. Timely reporting helps protect patients and triggers investigations. Maintain evidence, batch numbers and distribution records to support the investigation and any subsequent legal action.

Additional Resources

When seeking guidance or making official reports, these bodies and organizations are relevant in and around Chur:

- Swissmedic - the federal agency responsible for market authorization, inspections, vigilance and enforcement for drugs and devices.

- Federal Office of Public Health - responsible for national health policy and some regulatory interfaces.

- Canton of Graubunden - cantonal health office handles local implementation, facility permits and inspections.

- Cantonal ethics committees - for clinical trial approvals and research oversight in the region.

- Swiss Clinical Trials infrastructure and trial registries - for sponsors planning clinical research.

- Industry associations such as national pharmaceutical and medical technology associations - for practical guidance, standards and networking.

- Professional associations and hospital legal departments - for clinical governance and practitioner support.

- Trade and customs authorities - for import-export and controlled substance queries.

Next Steps

If you need legal assistance related to drugs or medical devices in Chur, follow these practical steps:

- Gather documents - Collect contracts, regulatory correspondence, batch records, clinical trial files, adverse event reports and any relevant communication. Organized records make consultations more effective.

- Identify the issue - Be clear whether the matter is regulatory compliance, product safety, clinical trial disputes, commercial contract work, or litigation.

- Seek a specialist lawyer - Look for a lawyer or law firm with experience in life sciences, regulatory law, product liability and healthcare in Switzerland. Local knowledge of Graubunden and practical experience with Swissmedic and cantonal authorities is an advantage.

- Prepare initial questions - Ask about the lawyer's relevant experience, approach to regulatory interactions, likely timelines, estimated costs and whether they work with technical or medical experts.

- Preserve evidence and limit exposure - Secure records, stop further distribution if a risk is suspected and follow regulatory reporting obligations. Avoid making public statements until you have legal and regulatory advice.

- Consider expert support - For technical issues, engage clinical, regulatory or quality experts who can provide reports that will be useful in regulatory responses or litigation.

- Plan next steps - After the first legal consultation, agree a strategy for communication with authorities, remedial actions, and any litigation or dispute resolution if necessary.

Acting promptly and working with specialised legal and technical advisers will help protect patients, comply with Swiss rules and manage financial and reputational risk. If you are unsure where to start, contact a qualified Swiss regulatory or healthcare lawyer in or near Chur for an initial assessment.