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Many people use the phrase "FDA law" to refer broadly to regulatory rules that govern food, drugs, medical devices, cosmetics and related products. The United States Food and Drug Administration - FDA - is the US regulator. In Italy and the European Union those matters are governed by a different set of institutions and rules. For products placed on the Italian market the main authorities are the Italian Medicines Agency - AIFA - the Ministry of Health, the Istituto Superiore di Sanità and regional health authorities such as the local Azienda Sanitaria Locale - ASL - for the province of Caserta, which has operational responsibility near Santa Maria Capua Vetere. EU-wide rules - including EU regulations and directives on medicines, medical devices, food safety and clinical trials - also apply directly or via national implementing measures. If you are dealing with export or import to or from the US, you may also need to follow FDA requirements in addition to Italian and EU law.
Regulatory issues in the life sciences and food sectors are technically complex and legally consequential. You may need a lawyer when you face any of the following situations:
- Applying for marketing authorization for a medicine, biologic or medical device in Italy or the EU.
- Preparing or managing clinical trials, including contracts with hospitals and investigators and regulatory filings.
- Responding to AIFA inspections, ASL inspections or enforcement notices from authorities.
- Handling product recalls, safety notifications and pharmacovigilance or vigilance obligations.
- Managing regulatory compliance for advertising and promotion directed at Italian consumers or health professionals.
- Importing or exporting regulated products, including customs and cross-border compliance with both FDA and EU rules.
- Defending against administrative sanctions, civil liability claims or criminal investigations related to public health or product safety.
- Drafting agreements - supply, distribution, manufacturing, licensing and clinical trial agreements - that allocate regulatory risk clearly.
- Protecting intellectual property and trade secrets while maintaining regulatory transparency with authorities.
- Addressing data privacy and cybersecurity issues connected to health data - for example in clinical trials or medical devices with connectivity.
Key legal frameworks that are particularly relevant in and around Santa Maria Capua Vetere include EU-wide regulations and Italian implementing acts. The most important elements to know are:
- EU regulations that apply directly in Italy - for example the clinical trials regulation, the Medical Devices Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746). These set safety, performance and conformity rules for placing devices on the market.
- EU food law - Regulation (EC) No 178/2002 - sets the general principles of food safety, traceability and responsibility for food business operators.
- Italian Legislative Decree 219/2006 - the main Italian law implementing EU medicines rules - governs marketing authorization, manufacture, distribution, pharmacovigilance and penalties for medicinal products.
- Pharmacovigilance and vigilance obligations - companies and sponsors must report adverse reactions and safety signals to AIFA and the European Medicines Agency according to EU rules.
- Regional and local health authorities - the Regione Campania and ASL Caserta enforce hygiene, public health and local licensing requirements, and they supervise clinical trial sites and health facilities in the area around Santa Maria Capua Vetere.
- Criminal and administrative liability - Italian criminal code provisions and administrative statutes can apply in cases of serious public health risks, fraud, falsification of documents or noncompliance with safety standards. Administrative sanctions can be imposed by regulatory agencies.
- Consumer protection and advertising law - the Italian Consumer Code and specific rules on promotion of medicines and health claims control how products can be marketed to the public and to healthcare professionals.
- Data protection - the EU General Data Protection Regulation - GDPR - and Italian privacy laws govern processing of personal and health data in clinical trials, patient registries and product monitoring.
People often use "FDA law" to mean regulation of food, drugs and devices in general. In Italy that function is carried out by Italian and EU authorities - primarily AIFA, the Ministry of Health and EU institutions. FDA rules only apply when you are dealing with the US market, US imports or US regulatory interactions.
No - to sell in Italy you must meet EU and Italian requirements, including conformity with the Medical Devices Regulation and appropriate CE marking. However, if you also plan to sell in the US you will need to satisfy FDA requirements as well, which are separate.
Medicines for the Italian market may be authorized through national procedures with AIFA or through centralized EU procedures handled by the European Medicines Agency. The route depends on the product, therapeutic area and strategic considerations. A lawyer or regulatory consultant can help prepare the application, including quality, non-clinical and clinical documentation.
Cooperate respectfully, provide requested documentation and follow proper internal protocols. Immediately notify your legal and compliance team. If the inspection results in a report or enforcement action, consult a lawyer promptly to review findings, prepare responses and negotiate remedies or appeal administrative measures if appropriate.
Import rules vary and generally importation of prescription medicines for personal use is restricted. There are narrow exceptional procedures, but you must check national rules and possibly obtain authorization from the local ASL or Ministry of Health. A lawyer or pharmacist can advise on the correct route.
If you are a manufacturer, distributor or sponsor you have regulatory reporting obligations - pharmacovigilance for medicines and vigilance for devices. Timelines are strict and typically require prompt notification to AIFA and to the EU authorities where applicable. Legal counsel can help ensure proper documentation and defensible procedures.
Risks include administrative fines, suspension or revocation of authorizations, product seizures and mandatory recalls. In severe cases there may be civil liability claims or criminal prosecution, particularly if public health is endangered or there is fraud or falsification of records.
Costs depend on the scope and complexity - routine compliance advice or contract drafting may be hourly or fixed-fee, while defending enforcement actions or managing a product approval can be significantly more costly. Request a clear fee estimate and scope of work before engagement.
Look for lawyers with specific experience in life sciences regulation, medicines or medical devices, and familiarity with AIFA and EU procedures. Experience with local authorities - ASL and Regione Campania - and knowledge of clinical trial and pharmacovigilance practice are important. Ask for references and examples of similar matters.
Bring a clear summary of the issue, product technical files, correspondence with regulators, copies of marketing materials, contracts with suppliers or sponsors, inspection reports and any adverse event logs. The more documentation you provide, the faster the lawyer can assess risks and propose next steps.
Useful bodies and organizations to contact for information or assistance include:
- Agenzia Italiana del Farmaco - AIFA - the national medicines agency responsible for authorizations and pharmacovigilance.
- Ministero della Salute - Italian Ministry of Health - national health policy and oversight.
- Istituto Superiore di Sanità - ISS - national public health research and technical advice.
- Regione Campania - regional health policies and local implementation.
- Azienda Sanitaria Locale - ASL Caserta - local health authority covering public health oversight near Santa Maria Capua Vetere.
- European Medicines Agency - EMA - for centralized EU procedures and guidance documents.
- Ordine degli Avvocati locale or provincial bar association - for referrals to qualified lawyers in the Caserta area or Santa Maria Capua Vetere.
- Chamber of Commerce and local business associations - for companies needing help with market entry, customs and local licensing.
If you need legal assistance with regulatory matters concerning food, drugs, medical devices or related products - whether for the Italian market, EU compliance, or interactions with the US FDA - follow these steps:
- Prepare a concise dossier of facts and key documents - product specifications, regulatory correspondence, contracts and inspection reports.
- Identify whether your issue is primarily national, regional or EU in scope - this affects the procedural route and competent authority.
- Contact a specialised lawyer or law firm with experience in life sciences regulation and local practice in Campania or Caserta. Use the local Ordine degli Avvocati for referrals if needed.
- Discuss fees, timelines and a clear scope of work before engagement. Ask for a plan that identifies immediate priorities - for example meeting reporting deadlines or stopping an enforcement action - and longer-term compliance steps.
- Implement corrective measures recommended by counsel and maintain clear records of actions taken - this helps mitigate administrative penalties and civil exposure.
Disclaimer - This guide provides general information and does not constitute legal advice. For advice tailored to your situation contact a qualified lawyer in your jurisdiction.
