Best Drugs & Medical Devices Lawyers in Dornach

About Drugs & Medical Devices Law in Dornach, Switzerland

Dornach sits in the canton of Solothurn near the Basel life sciences cluster. Companies and healthcare professionals in Dornach operate under Swiss federal law for medicinal products and medical devices, with oversight by Swissmedic, the national agency for therapeutic products. Switzerland aligns closely with European rules, but there are distinct Swiss requirements for market access, oversight, and responsibilities of manufacturers, importers, distributors, pharmacies, and healthcare providers.

Medicinal products are governed primarily by the Therapeutic Products Act, its ordinances, and Swissmedic guidance. Market authorization, pharmacovigilance, advertising, distribution categories, and integrity and transparency rules are core elements. Medical devices are regulated under the Medical Devices Ordinance and the In Vitro Diagnostic Medical Devices Ordinance, which are largely aligned with EU MDR and IVDR but include Swiss-specific features such as the Swiss Authorized Representative requirement for foreign manufacturers and phased registration in Swiss databases.

Local enforcement and practice aspects are influenced by canton of Solothurn authorities, including the cantonal pharmacist inspectorate and the health department, which supervise pharmacies, wholesalers, hospital supply, and certain public health measures. Ethics committee approvals for clinical research in the region are typically coordinated through the regional ethics structures serving Solothurn.

Why You May Need a Lawyer

Therapeutic product law is technical and fast moving. A lawyer can help you navigate risks, timelines, and documentation to avoid costly delays or sanctions. Common situations include:

- Bringing a new drug, medical device, or in vitro diagnostic to the Swiss market, including strategy for authorization or notification, labeling, and language requirements.

- Acting as or appointing a Swiss Authorized Representative for non-Swiss device manufacturers, and allocating liabilities in CH-REP and importer agreements.

- Importing, wholesaling, or compounding medicinal products in Dornach, including establishment licenses and good distribution practice compliance.

- Conducting clinical trials and device investigations, managing ethics and Swissmedic submissions, data protection, and informed consent under the Human Research Act.

- Setting up post-market surveillance, pharmacovigilance, and materiovigilance systems, and managing field safety corrective actions and recalls.

- Pricing and reimbursement with the Federal Office of Public Health, including Specialty List procedures and negotiations.

- Advertising and promotion review, including rules on prescription-only product advertising, device claims, digital marketing, and fair competition.

- Integrity and transparency in interactions with healthcare professionals and institutions, including discount pass-through and anti-inducement rules.

- Product liability, insurance, and risk allocation across the supply chain, including distributor agreements and clinical trial insurance.

- Data privacy and cybersecurity for connected devices and patient data under the revised Federal Act on Data Protection and sector rules.

Local Laws Overview

- Medicinal products framework: The Therapeutic Products Act and related ordinances govern authorization, manufacturing, import, wholesale, distribution categories, pharmacovigilance, advertising, and sanctions. Prescription categories include A and B, with over-the-counter categories D and E. Controlled substances are regulated by the Narcotics Act, including tightened requirements for cannabis and opioid prescribing. Since 2022, medical cannabis prescribing is possible without exceptional permits, subject to narcotics rules and ongoing data reporting.

- Medical devices framework: The Medical Devices Ordinance and the In Vitro Diagnostics Ordinance align with EU MDR and IVDR classification and conformity principles. Non-Swiss manufacturers need a Swiss Authorized Representative. Importers and distributors have economic operator duties such as verification, traceability, complaint handling, and cooperation with Swissmedic. Language requirements and Swiss-specific identifiers apply. Swissdamed, the national device database, is being introduced in phases, with registration obligations expanding over time.

- Market authorization and notifications: Drugs typically require Swissmedic authorization unless an exemption applies, such as certain magistral preparations. Devices require conformity assessment and CE marking under the aligned Swiss rules, plus Swiss-specific steps such as CH-REP designation and importer identification on labeling. Timelines can vary by product class and completeness of documentation.

- Vigilance and post-market duties: For medicines, companies must collect and report adverse reactions to Swissmedic and maintain a pharmacovigilance system aligned with EU GVP. For devices, manufacturers and others must monitor performance and report serious incidents to Swissmedic. Switzerland follows EU-aligned reporting timelines such as 2 days for serious public health threats, 10 days for death or unanticipated serious deterioration, and 15 days for other serious incidents. Field safety corrective actions require prompt notification and user communication.

- Advertising, integrity, and transparency: Public advertising of prescription-only medicines is prohibited. Claims must be accurate, balanced, and substantiated. For devices, claims must reflect intended purpose and evidence. The Ordinance on Integrity and Transparency in the Therapeutic Products sector sets rules on undue advantages, discounts, documentation, and pass-through to payers. Violations can lead to administrative and criminal consequences.

- Pricing and reimbursement: The Federal Office of Public Health manages reimbursement lists and economic evaluations. Hospitals and insurers may impose additional procurement and coding requirements. Companies should prepare health economics and outcomes evidence tailored to Swiss standards.

- Data protection and research: Health data is sensitive under the Federal Act on Data Protection. The Human Research Act and ordinances govern clinical research involving humans, with ethics approvals and Swissmedic involvement for certain trials and device investigations. Regional ethics committees cover Solothurn and evaluate protocols, consent, and data handling.

- Cantonal enforcement in Solothurn: The cantonal pharmacist inspectorate and health department supervise pharmacies, certain wholesalers, hospital pharmacies, and public health activities. They may inspect premises, review records, and enforce distribution and storage rules. Waste disposal and returns, especially for narcotics and sharps, must meet cantonal environmental and safety requirements.

Frequently Asked Questions

How are medicinal products authorized for sale in Switzerland?

Most medicines require a Swissmedic marketing authorization based on quality, safety, and efficacy. Pathways include full dossiers, generics, hybrids, and well established use. Some pathways allow reliance on foreign assessments in defined situations. Timelines depend on the procedure and completeness of data. Certain magistral preparations prepared in a pharmacy for an individual patient are exempt from authorization but remain subject to professional and quality rules.

Can I sell a CE-marked medical device in Dornach without extra steps?

CE marking and conformity to EU MDR or IVDR are necessary but not always sufficient. Non-Swiss manufacturers must appoint a Swiss Authorized Representative. The Swiss importer must be identified on the device or accompanying documentation and must verify compliance. Registration obligations in Swissdamed are being phased in. Labeling and language rules must be met. Planning for these Swiss-specific steps is essential before placing the device on the market.

What language must appear on labeling and instructions?

Consumer-facing medicinal product information and device labeling generally must be available in the relevant official languages for the intended market area, typically German for Dornach, and often French and Italian depending on distribution. Professional use devices may have different language flexibilities, but safety information must be understandable to users. Advertising materials must follow similar language and content standards.

Do I need a license to import or wholesale medicines into Solothurn?

Yes. Import and wholesale of medicinal products require an establishment license from Swissmedic and compliance with good distribution practice. Facilities in Dornach must meet premises, quality system, documentation, and personnel requirements. Wholesalers and pharmacies are also subject to cantonal supervision by Solothurn authorities.

What counts as prohibited advertising for medicines and devices?

Public advertising for prescription-only medicines is prohibited. All claims must be accurate, balanced, and supported by evidence, with mandatory information included. For devices, promotional content must match the intended purpose and supporting data. Comparative claims must be fair and verifiable. Digital marketing, social media, and influencer content are subject to the same rules. Non-compliance can lead to orders to cease, fines, and reputational risk.

What are my post-market surveillance duties for devices?

Manufacturers must run a proactive post-market surveillance system, collect and analyze data, perform periodic reviews, and implement corrective actions. Serious incidents must be reported to Swissmedic within EU-aligned timelines, and field safety corrective actions require field safety notices. Importers and distributors must keep records for traceability, manage complaints, and cooperate with Swissmedic and the manufacturer.

How is pharmacovigilance handled for medicines?

Marketing authorization holders maintain a pharmacovigilance system, collect reports from healthcare professionals and patients, and submit individual case safety reports to Swissmedic within defined timelines, typically 15 days for serious cases. Periodic safety updates and risk management plans may be required. Companies must have a qualified person responsible for pharmacovigilance and robust signal detection processes.

How are clinical trials and device investigations approved locally?

Clinical trials with medicines and clinical investigations with devices require ethics approval and, where applicable, Swissmedic authorization. Applications must include protocol, investigator qualifications, manufacturing and quality information, consent materials, safety data, and insurance. The regional ethics committee serving Solothurn evaluates ethical and data protection aspects. Multicenter coordination is common in the Basel region.

How are prices and reimbursement decided?

Outpatient drug reimbursement depends on listing by the Federal Office of Public Health and proof of effectiveness, appropriateness, and cost effectiveness. Hospitals use separate procurement and tariff frameworks. Devices may be reimbursed under specific lists, procedure codes, or hospital budgets. Early payer engagement and Swiss real world evidence can improve outcomes.

What are the penalties for non compliance?

Sanctions range from corrective orders and product seizures to administrative fines and criminal penalties, depending on severity. Companies can face suspension or revocation of licenses or authorizations. Individuals may be liable for intent or negligence, including for illegal advertising, distribution of non compliant products, or integrity violations. Early legal advice can reduce exposure and facilitate voluntary corrective actions that regulators often view favorably.

Additional Resources

- Swissmedic - Swiss Agency for Therapeutic Products

- Federal Office of Public Health - Pricing and reimbursement authorities

- Federal Act on Data Protection - Office of the Federal Data Protection and Information Commissioner

- Swissethics - Umbrella of Swiss ethics committees for human research

- Regional Ethics Committee serving the canton of Solothurn

- Canton of Solothurn Department of Health and Cantonal Pharmacist Inspectorate

- Swiss Medtech - Industry association for medical technology

- Interpharma and scienceindustries - Pharmaceutical and chemical industries associations

- Swiss Biotech Association

- Swissdamed - Swiss database for medical devices and economic operators

Next Steps

- Clarify your goal and timeline. Are you launching a product, entering a distribution deal, starting a trial, or responding to a safety issue.

- Map your regulatory status. Identify product classification, authorization pathway, and whether CH-REP, importer identification, or establishment licensing is required.

- Gather documentation. Prepare technical files, clinical evidence, quality certificates, labeling in required languages, vigilance procedures, and draft contracts.

- Engage with local stakeholders. If operating in Dornach, coordinate with the Solothurn health authorities, pharmacies or hospitals as relevant, and the regional ethics committee for research.

- Seek legal advice early. Ask a lawyer to review your regulatory strategy, advertising, contracts, data protection, and integrity policies to prevent issues.

- Implement compliance systems. Train staff, set up pharmacovigilance or post market surveillance, document SOPs, and prepare recall and incident response plans.

- Plan for pricing and reimbursement. Align evidence generation with Swiss payer expectations and timelines.

- Monitor changes. Swiss rules evolve, including phased Swissdamed obligations and integrity requirements. Establish a regulatory watch and update processes accordingly.