Beste Arzneimittel und Medizinprodukte Anwälte in Österreich

1. About Arzneimittel und Medizinprodukte Law in Austria

Arzneimittel und Medizinprodukte Recht in Austria is primarily shaped by EU medicines and devices rules, implemented through national laws. Austria follows the EU framework for the authorization, manufacture and distribution of medicines as well as for medical devices and in vitro diagnostic devices. The Austrian authorities oversee licensing, conformity assessment, pharmacovigilance and post-market surveillance.

Two central Austrian statutes regulate these areas: the Arzneimittelgesetz (AMG) for medicines and the Medizinproduktegesetz (MPG) for medical devices. The Austrian Federal Ministry of Health and the Austrian competent authority BASG supervise compliance, while AGES supports safety testing and monitoring in certain contexts. In practice, companies and individuals rely on these laws to obtain marketing authorizations, manage recalls, file adverse event reports, and ensure proper device conformity and labeling.

At the European level,Directive 2001/83/EC governs medicines, and Regulation (EU) 2017/745 governs medical devices, with Austria implementing these rules through its national laws and amendments. Since May 2021 the EU Medical Devices Regulation has been applicable across the EU, with national agencies enforcing the rules domestically. The European Medicines Agency (EMA) plays a key role in scientific evaluation and ongoing oversight of medicines and devices at the EU level.

“The EU Medical Devices Regulation MDR 2017/745 became applicable on 26 May 2021, replacing the prior directives for most devices.”

“Directive 2001/83/EC provides the basis for the manufacture, marketing and pharmacovigilance of medicines within the EU-27, including Austria.”

Key takeaway for residents: If you are developing, distributing or using medicines or devices in Austria, you must comply with both your national law and relevant EU rules. Understanding the scope of AMG and MPG, and how MDR and the EU pharmacovigilance framework interact with national provisions, is essential for lawful operation and risk management.

2. Why You May Need a Lawyer

Engaging a lawyer who specializes in Arzneimittel und Medizinprodukte law can help you navigate complex registration, compliance and enforcement processes in Austria. Here are concrete scenarios where legal counsel is often essential.

• Marketing authorization challenges for a new medicine - A pharmaceutical sponsor seeks Austrian MA under the AMG and must coordinate with BASG for requirements, data packages and post-authorization obligations. A lawyer can align the dossier with EU and Austrian expectations and manage any licensing delays.
• Medical device conformity and MDR transitions - A device manufacturer must transition from directives to MDR and update technical documentation, post-market surveillance plans and registration with Austrian authorities. Legal counsel helps plan the transition, assess risk classes and prepare for audits.
• Product recalls or safety issues - A distributor faces a voluntary or mandatory recall due to safety concerns. Lawyers guide the recall process, communication to authorities and market omittance, while preserving regulatory rights and minimizing liability.
• Pharmacovigilance and adverse event reporting - A pharmaceutical company must establish robust PV systems, report serious adverse events to BASG, and manage data privacy and cross-border reporting obligations. Legal advice helps ensure compliance and proper record-keeping.
• Advertising, promotion and labeling compliance - A marketing campaign for a drug or device risks falling foul of strict advertising rules. Counsel helps craft compliant materials, avoid prohibited claims and manage potential penalties.
• Clinical trials in Austria - A sponsor seeks authorization to conduct a clinical trial, requiring national ethics committee approvals, regulatory submission and ongoing reporting. Legal support streamlines documentation and interface with authorities.

3. Local Laws Overview

The Austrian system relies on a core set of laws and subordinate regulations to govern medicines and medical devices, aligned with EU standards. Below are two central statutes with notes on their scope and recent developments.

Arzneimittelgesetz (AMG) - Medicines Act

The AMG governs licensing, manufacture, distribution, marketing authorization, and pharmacovigilance for medicines in Austria. It implements EU Directive 2001/83/EC and sets national procedures for MA applications, labeling, and post-market requirements. Recent updates continue to reflect evolving EU pharmacovigilance expectations and post-authorization changes.

Practical impact: if you plan to bring a medicine to the Austrian market, you must prepare for a structured MA process under AMG and maintain ongoing pharmacovigilance reporting. Austria’s BASG oversees these processes and enforces compliance.

Medizinproduktegesetz (MPG) - Medical Devices Act

The MPG regulates the placing on the market, conformity assessment, registration, post-market surveillance and vigilance for medical devices in Austria. It implements EU Regulation 2017/745 (MDR) and supports device manufacturers, distributors and importers in meeting EU-wide safety standards. The Austrian MPG is periodically amended to reflect MDR requirements and national procedures.

Practical impact: manufacturers must maintain device technical documentation, establish a quality management system, and conduct periodic safety updates with Austrian authorities.

European Medical Devices Regulation (MDR) implemented in Austria

The MDR 2017/745 governs high level requirements for device safety, clinical evidence, post-market surveillance and vigilance. Austria implements MDR through the MPG and national guidance, with authorities conducting inspections and market surveillance to enforce compliance. The MDR became applicable on 26 May 2021, with transitional provisions for certain older devices.

Practical impact: Austrian devices must meet MDR criteria for conformity assessment, labeling, and reporting of adverse events to national regulators and the EU-wide database EUDAMED where applicable.

4. Frequently Asked Questions

What is the AMG and what does it regulate in Austria?

The AMG is Austria's main law for medicines. It governs licensing, manufacturing, distribution, and pharmacovigilance. Compliance with EU directives is mandatory for MA and post-market safety obligations.

How do I obtain a marketing authorization for a medicine in Austria?

You submit a dossier to the BASG, aligning with EU guidelines for quality, safety and efficacy. The process includes scientific evaluation, potential inspections and post-authorization commitments.

When did the EU MDR become applicable and what does that mean for devices in Austria?