Best Drugs & Medical Devices Lawyers in Goslar

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About Drugs & Medical Devices Law in Goslar, Germany

Drugs and medical devices are regulated in Germany through a mix of European Union regulation and national law. In practice this means companies, health professionals and patients in Goslar must follow EU rules - for example the EU Medical Device Regulation - as well as German statutes and administrative requirements. National authorities such as the Federal Institute for Drugs and Medical Devices and state and local health offices oversee market access, safety monitoring, authorisations and enforcement. Legal issues in this area commonly involve regulatory compliance, product safety and liability, controlled-substance rules, clinical trials and reimbursement or insurance disputes.

Why You May Need a Lawyer

A specialised lawyer can help when legal or regulatory complexity exceeds what you can safely manage on your own. Common situations in Goslar where people seek legal help include:

- Allegations of harm from a medicine or medical device and possible product liability or compensation claims.

- A manufacturer or distributor facing enforcement action, recall orders, or market access questions from national authorities.

- Disputes arising from clinical trials, investigator agreements or consent documentation.

- Problems with controlled substances - licences, permits, inspections or criminal investigations under the narcotics law.

- Pharmacy, hospital or prescribing disputes, including disciplinary matters for healthcare professionals.

- Advertising or labelling compliance issues under advertising and medicinal advertising law.

- Contractual disputes with suppliers, distributors, hospitals or insurers, including reimbursement or warranty claims.

- Assistance with reporting adverse events, preparing responses to regulator queries, or appealing administrative decisions.

Local Laws Overview

Key legal frameworks and local factors that matter in Goslar include:

- EU Medical Device Regulation (MDR - Regulation (EU) 2017/745) and national rules implementing it - these set requirements for conformity assessment, CE marking, clinical evaluation, post-market surveillance and vigilance obligations for devices.

- Arzneimittelgesetz (AMG) - the German Medicines Act setting rules for authorisation, manufacture, distribution, prescription and pharmacovigilance of medicinal products.

- Betäubungsmittelgesetz (BtMG) - the German narcotics law regulating controlled substances, prescribing, authorisations and criminal offences for illegal handling of controlled drugs.

- Produkthaftungsgesetz - product liability law for defective products, which allows injured persons to claim compensation from producers under strict liability principles.

- Bürgerliches Gesetzbuch (BGB) - civil code provisions affecting contracts, torts and compensation claims.

- Heilmittelwerbegesetz (HWG) - rules governing advertising for medicines and certain devices.

- Pharmacy and healthcare professional regulation - state-level and federal rules governing pharmacies, practitioners and hospitals, including inspections and disciplinary procedures.

- Local enforcement and administrative bodies - in Goslar this includes the Landkreis Goslar health office for public-health questions and local permits, along with regional courts for civil or criminal proceedings and the national competent authorities for regulatory matters.

Note - many procedural details, timelines and competent authorities are federal or EU-level. Local authorities in Lower Saxony, including the Gesundheitsamt des Landkreises Goslar, are where some permits, inspections and health notifications will be handled on the ground.

Frequently Asked Questions

What should I do first if I suspect a drug or device caused harm?

Secure medical care immediately for anyone injured. Preserve any products, packaging and documentation such as prescriptions, invoices and device identifiers. Write down dates, symptoms and witnesses. Report the incident to your treating physician and consider notifying the relevant authority - for drugs that is usually the Federal Institute for Drugs and Medical Devices or the Paul-Ehrlich-Institut for biologicals, and for devices it is the national competent authority responsible for device vigilance. Contact a lawyer experienced in product liability or medical law early to assess possible claims and preserve evidence.

Who enforces safety and market rules for drugs and devices in Germany?

Primary enforcement is at the federal level by the Federal Institute for Drugs and Medical Devices (BfArM) and, for certain biologicals and vaccines, the Paul-Ehrlich-Institut. The European Medicines Agency plays a role for centrally authorised medicines. State and local health authorities - including the Gesundheitsamt in Landkreis Goslar - assist with inspections, public-health measures and local enforcement.

Can I sue for compensation if a medical device harmed me?

Yes, you may have civil remedies. Compensation claims can be based on product liability law, tort law under the BGB, or contract law if there was a direct contractual relationship. Product liability can allow recovery without proving negligence in some cases. Time limits apply for bringing claims, so consult a lawyer promptly to evaluate your case and meet deadlines.

How do drug approvals and device approvals differ?

Medicines are approved through centralised EU procedures or national marketing authorisations under the AMG, with assessment of quality, safety and efficacy. Medical devices rely on conformity assessment and CE marking under the MDR, often via a Notified Body for higher-risk devices. Devices do not receive a centralised marketing authorisation like many medicines, but must meet regulatory requirements and be registered with authorities where applicable.

What are the rules for prescribing or supplying controlled substances in Goslar?

Controlled substances are regulated by the Betäubungsmittelgesetz. Prescribers, pharmacies and hospitals must hold the required licences and follow strict documentation, storage and dispensing rules. Misuse, unauthorised distribution or failure to follow BtMG obligations can lead to administrative sanctions, fines or criminal charges. If you are involved in an investigation, seek legal advice immediately.

How can a manufacturer register a medical device or drug in Germany?

For drugs, follow the AMG and either apply through the national procedure or, for certain products, the EU centralised procedure. For devices, ensure conformity with the MDR, engage a Notified Body if required, compile technical documentation and maintain a quality management system. National registration or notification obligations and local liaison with the Bundesinstitut or state authorities may also be necessary. A regulatory lawyer or consultant can help with applications and compliance systems.

What is a recall and how is it handled locally?

A recall is an action to remove or correct a product that poses a health or safety risk. Recalls can be initiated voluntarily by the manufacturer or ordered by authorities. In Germany, the competent federal authority and local health offices coordinate recall communications and practical steps. Affected businesses should act quickly, notify authorities, implement corrective actions, and cooperate with enquiries. Legal counsel can advise on obligations, communications and liability exposure.

How long do I have to bring a claim for injury caused by a product?

Limitation periods vary by the type of claim. Civil claims often require action within a statutory period that begins when you knew or should have known about the damage and the responsible party. Product liability rules and other statutes may set different time limits or long-stop periods. Because deadlines can bar your claim, consult a lawyer promptly to determine applicable time limits in your case.

Can a doctor or hospital in Goslar be held liable for using a defective device?

Yes. Healthcare providers owe duties of care to patients. Liability can arise from negligence in selecting, using or monitoring a device, failure to obtain proper informed consent, or not following safety procedures. Liability may also attach to the device manufacturer under product liability law. Each situation is fact-specific, so legal advice is important to assess responsibility and recovery options.

How do I find a lawyer in Goslar who specialises in drugs and medical devices?

Look for lawyers with experience in regulatory law, product liability, medical law or pharmaceutical law. You can contact the Bundesrechtsanwaltskammer for guidance on finding local counsel, ask the Gesundheitsamt or local hospitals for recommendations, or consult specialist directories and associations. When you contact a lawyer, ask about relevant experience, fees, case examples and whether they have handled matters in administrative proceedings, courts or with authorities like BfArM.

Additional Resources

Helpful organisations and authorities to contact or research include:

- Federal Institute for Drugs and Medical Devices - Bundesinstitut fuer Arzneimittel und Medizinprodukte (BfArM) - national competent authority for many medicines and devices.

- Paul-Ehrlich-Institut - national authority for vaccines and certain biological medicines.

- European Medicines Agency - for centrally authorised medicinal products and EU-level guidance.

- Landesgesundheitsamt Niedersachsen and Gesundheitsamt des Landkreises Goslar - state and local health authorities for regional inquiries, inspections and public-health measures.

- Unabhaengige Patientenberatung Deutschland (UPD) - independent patient advice on healthcare rights and claims in Germany.

- Verbraucherzentrale Niedersachsen - consumer advice and support for product complaints and consumer law questions.

- Bundesrechtsanwaltskammer (BRAK) - for information on lawyers and regulatory specialisms in Germany.

- Professional associations such as the Ärztekammer Niedersachsen and the local chamber for pharmacists - for professional regulation and disciplinary questions.

- Notified Bodies and conformity assessment organisations - for device manufacturers seeking assessment under the MDR.

Next Steps

If you need legal assistance in Goslar for drugs or medical devices, follow these practical steps:

- Preserve evidence - keep samples, packaging, labels, prescriptions, photos and all medical records.

- Document everything - write a clear timeline of events, names of healthcare providers, dates and communication with manufacturers or authorities.

- Report adverse events - notify your treating physician and consider reporting to the national competent authority or the local Gesundheitsamt as appropriate.

- Contact a specialised lawyer - seek counsel experienced in regulatory, product liability or medical law to assess your case and advise on options, deadlines and likely outcomes.

- Check insurance - notify your health insurer and any legal expenses insurer as they may cover legal costs or provide support.

- Act quickly - statutory deadlines and preservation of evidence are important. Early legal involvement can protect rights and preserve claims.

Legal matters in drugs and medical devices can be complex and time-sensitive. A local lawyer can explain your rights under German and EU law, help with administrative procedures, represent you in negotiations or litigation, and guide interactions with regulators and health authorities.

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Disclaimer:
The information provided on this page is for general informational purposes only and does not constitute legal advice. While we strive to ensure the accuracy and relevance of the content, legal information may change over time, and interpretations of the law can vary. You should always consult with a qualified legal professional for advice specific to your situation. We disclaim all liability for actions taken or not taken based on the content of this page. If you believe any information is incorrect or outdated, please contact us, and we will review and update it where appropriate.