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The term FDA normally refers to the United States Food and Drug Administration. In Denmark and the wider European Union, medicine, medical device, food and cosmetic regulation is governed by EU rules and by national Danish law and authorities. If you are in Thisted, Denmark, you are subject to EU regulations and Danish legislation administered by bodies such as Lægemiddelstyrelsen - the Danish Medicines Agency - and Fødevarestyrelsen - the Danish Veterinary and Food Administration. Local municipal authorities, including Thisted Municipality, can also be involved in inspections, local permits and enforcement related to businesses that handle food, health products or chemicals.
- Product approvals and registrations - a lawyer can help prepare and review submissions for medicines, medical devices, cosmetics or food supplements and advise on national versus centralised EU procedures.
- Compliance audits and gap assessments - legal counsel can assess whether your manufacturing, labelling, advertising and distribution comply with EU and Danish rules.
- Regulatory inspections and enforcement - if you face an inspection, notice, administrative sanction or recall, a lawyer can guide responses and represent you in proceedings.
- Advertising and marketing claims - legal advice is important if promotional claims could trigger regulatory action, consumer complaints or cross-border issues.
- Supply, distribution and licensing agreements - drafting and negotiating agreements with suppliers, distributors and licensees often requires regulatory and commercial legal input.
- Clinical trials and research - lawyers assist with trial authorization, contracts with investigators, patient consent rules and data protection requirements.
- Cross-border trade and import - importing products from outside the EU can raise customs, conformity and representative requirements where legal counsel can help.
- Product liability and recalls - in case of adverse events or safety issues, lawyers help manage liability risk, recall strategy and communications.
- Appeals and administrative review - if a regulatory body makes an unfavourable decision, a lawyer can assist with appeals and administrative complaints.
- Data protection and privacy - handling clinical or patient data triggers GDPR obligations that require legal compliance strategies.
- EU framework - many core rules for medicines, medical devices and cosmetics are set at EU level through regulations and directives. These set standards for safety, performance, clinical evidence, labelling and post-market surveillance.
- Danish national implementation - Denmark implements EU rules through national laws and administrative rules. The Danish Medicines Act and related executive orders govern marketing authorisations, pharmacovigilance and manufacturing when Danish procedures apply.
- Medical devices and in vitro diagnostics - the EU Medical Devices Regulation and In Vitro Diagnostic Regulation set conformity and clinical requirements. National authorities supervise market surveillance and notified bodies perform conformity assessments.
- Food, supplements and veterinary products - food labelling, novel food, contaminants and veterinary medicines are regulated under EU law and enforced in Denmark by Fødevarestyrelsen and related agencies.
- Clinical trials - clinical trial authorisations follow the EU Clinical Trials Regulation and Danish administrative practices for review, safety reporting and ethics approvals.
- Good practices - Good Manufacturing Practice - GMP - Good Distribution Practice - GDP - and other quality frameworks are mandatory for many products and inspected by national authorities.
- Advertising and consumer protection - product advertising rules interact with Danish consumer protection law and EU rules, and misleading claims can trigger enforcement.
- Inspections and enforcement - Danish authorities conduct inspections, impose corrective measures, require recalls and can impose fines or criminal charges in serious cases.
- Local municipal roles - Thisted Municipality may be involved in local food business registration, local health and safety inspections and certain business permits.
No. The US FDA does not have legal authority in Denmark. Products sold in Denmark must comply with EU and Danish law. However, US FDA approvals or inspections may be relevant as supporting evidence in regulatory submissions or inspections, and US-exporters may need to meet EU requirements when selling into Denmark.
For medicines and many medical device issues the Danish Medicines Agency - Lægemiddelstyrelsen - is the primary regulator. For food, food supplements and veterinary products the Danish Veterinary and Food Administration - Fødevarestyrelsen - is the main authority. Other national agencies such as Sundhedsstyrelsen - the Danish Health Authority - may also have roles depending on the matter.
You must follow EU and Danish procedures. Some medicines are authorised centrally at EU level through the European Medicines Agency - EMA - while others use national or mutual recognition procedures. Applications require technical dossiers, clinical evidence and quality data. A regulatory specialist or lawyer can help determine the correct route and prepare documentation.
Main risks include non-conformity with technical and clinical requirements, incorrect labelling, inadequate post-market surveillance, misleading advertising claims, failure to register devices or products, and inadequate supplier controls. These can lead to warnings, fines, recalls or civil liability.
Respond promptly and professionally. Preserve records, seek legal advice before providing detailed written responses, and cooperate while protecting privileged communications where appropriate. A lawyer can help craft responses, negotiate corrective action plans and represent you in any proceedings.
For some product categories, such as medical devices and certain cosmetics after the Brexit changes, having a legal or authorised representative in the EU or Denmark is required. The representative acts as a local point of contact for authorities. Legal counsel can confirm whether this applies to your product and help set up appropriate agreements.
Timelines vary widely by product type and procedure. Centralised approvals for medicines may take many months to more than a year if additional data is required. Medical device conformity assessment depends on class and notified body workload. Early regulatory planning and complete dossiers reduce delays.
Penalties range from warnings and mandatory corrective actions to product recalls, suspension of sales, administrative fines and, in serious cases, criminal prosecution. Civil claims from consumers or patients are also possible if harm occurs.
Not automatically. US approval is not sufficient for marketing in Denmark. You must show compliance with EU and Danish requirements, which may include different clinical data, labelling, language requirements and conformity assessments. A gap analysis will show what additional steps are needed.
Administrative decisions can often be appealed through the national administrative complaint routes or the relevant courts. The exact procedure and deadlines vary by type of decision and authority. Legal counsel can advise on grounds for appeal, prepare submissions and represent you in administrative or judicial proceedings.
- Lægemiddelstyrelsen - Danish Medicines Agency - national regulator for medicines and many medical device matters.
- Fødevarestyrelsen - Danish Veterinary and Food Administration - responsible for food safety, supplements and veterinary products.
- Sundhedsstyrelsen - Danish Health Authority - public health guidance and professional regulation.
- European Medicines Agency - EMA - EU-level regulator for centralised medicine approvals and scientific advice.
- Thisted Municipality - local business registrations, food business permits and local health inspections.
- Konkurrence- og Forbrugerstyrelsen - Danish Competition and Consumer Authority - consumer protection and advertising rules.
- Miljøstyrelsen - Danish Environmental Protection Agency - where environmental or chemical waste rules intersect with product regulation.
- Industry associations and trade bodies - consult local pharmaceutical, medical device or food industry associations for practical guidance and networking.
- Identify your issue - clarify whether your concern is about approval, compliance, an inspection, enforcement, contracts or litigation. A focused description helps a lawyer assess the case quickly.
- Gather key documents - product specifications, labelling, clinical data, correspondence with regulators, contracts, inspection reports and any adverse event reports. Bring these to your first meeting.
- Find the right specialist - look for lawyers or law firms with experience in life sciences, pharmacy law, medical devices or food law in Denmark or the EU. Ask about regulatory experience, examples of similar matters, language skills and fees.
- Prepare for an initial meeting - expect to discuss timelines, likely steps, regulatory routes, estimated costs and immediate actions to reduce risk. Ask about conflict checks and whether the lawyer will work with technical consultants.
- Consider interim measures - if a regulator has raised serious concerns, you may need to pause distribution, issue warnings or start a corrective action plan while you seek legal advice.
- Use official resources - while arranging legal advice you can contact the appropriate Danish authority for procedural questions, but avoid making detailed submissions or admissions without counsel.
- Plan for ongoing compliance - regulatory issues are often ongoing. Establish policies for pharmacovigilance, complaint handling, labelling review and quality systems, and schedule periodic legal or regulatory reviews.
If you would like, prepare a short summary of your situation and the documents you have and ask for a list of specific points to bring to a regulatory lawyer in Thisted or a regional firm that handles EU life sciences matters.
