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LIFE SCIENCES LAW – Ralph Schäfer – Lawyer – Your partner for legal issues in the life sciences industry
Pharmaceutical law – Legal advice for pharmaceutical, biotech and medtech industries
Lawyer for pharmaceutical law in Munich
Navigating pharmaceutical law – expert, practical, reliable
Pharmaceutical law forms the legal basis for the development, approval, manufacture, distribution, and monitoring of medicinal products. For companies in the life sciences sector, it therefore represents not only a regulatory hurdle but also a key success factor for safe products and sustainable growth.
Life Sciences Law supports companies, start-ups, clinics, and medical and non-medical service providers in navigating the complex landscape of pharmaceutical law with confidence. Benefit from specialized advice that combines in-depth legal expertise with many years of industry experience.
Services in pharmaceutical law
The German Medicines Act (AMG) and European regulations shape every step within a drug's product lifecycle. The requirements are extensive, the interfaces numerous, and the risks high. Companies need clear structures to reliably implement regulatory requirements, risk management, and compliance.
My consulting approach combines legal precision with a deep understanding of the internal processes of pharmaceutical companies. The result: legally compliant solutions that can be practically implemented and support your business objectives.
Drug approval and regulatory support
Drug approval involves complex national and European procedures. Even in the early development phase, key questions arise regarding study strategy, classification, market positioning, and regulatory options.
In addition to national marketing authorization, centralized authorization via the EMA, decentralized procedures, clinical trials, and orphan drug programs play an important role. Generic and biosimilar development, as well as changes or renewals, also require a structured approach.
I will support you particularly with
- Planning and implementation of approval strategies
- Preparation of regulatory documents in the approval process
- clinical trials and interfaces with the ethics committee
- Coordination with BfArM, EMA or PEI
- Orphan drug issues, generic and biosimilar projects
- Change notifications, variations and extensions
- regulatory demarcation decisions
The goal is an efficient approval process that minimizes future risks and provides you with early planning security.
Advertising, marketing and compliance according to AMG and HWG
Advertising for pharmaceuticals is strictly regulated – especially for products aimed at consumers. The German Act on Advertising of Therapeutic Products (HWG), the German Medicines Act (AMG), and industry-specific compliance regulations determine how pharmaceuticals may be presented to healthcare professionals and consumers. At the same time, modern marketing requires flexibility: digital channels, specialist communication, and international strategies.
I will advise you in particular on:
- permissible advertising statements and claims
- Differentiation between advertising to professionals and the general public
- digital advertising measures
- Compliance guidelines and internal coordination processes
- Prevention of corruption and acceptance of undue advantage
The consultation ensures that your communication is legally sound and strengthens your market position at the same time.
Drug safety and pharmacovigilance
Market launch marks the beginning of a crucial phase of pharmaceutical law: the continuous monitoring of risks and side effects. Companies must maintain a robust pharmacovigilance system, record adverse drug reaction (ADR) reports, and submit regular safety reports.
I support you in setting up or optimizing pharmacovigilance structures and in dealing with regulatory requirements.
This includes, among other things:
- Creation and review of risk management plans
- Side effect reporting systems
- Safety reports and Periodic Safety Updates
- Advice on product recalls and market surveillance measures
Sensitive issues such as recalls or product bans are handled with the utmost professionalism and discretion.
Product classification and borderline decisions
Innovative technologies, combination products, and new mechanisms of action often lead to questions of demarcation between pharmaceuticals, medical devices, food supplements, and cosmetics. Innovative products, in particular, cannot always be clearly categorized. However, correct classification is crucial for:
- the regulatory route (AMG / MDR / LMIV / KosmetikVO)
- the market entry costs
- the licensing requirements
- the subsequent marketing strategy
The basis is the examination of the intended purpose as well as the definitions of medicinal products and remedies.
I analyze the function, intended purpose and product presentation and develop a reliable classification according to German and European law.
Administrative procedures, enforcement and risk management
Regulatory conflicts can have significant economic consequences. Authorities conduct audits, inspections, and market surveillance measures, examine advertising claims, or impose restrictions on marketing.
I represent your interests vis-à-vis:
- BfArM
- EMA
- PEI
- State authorities
Typical cases:
- Objections in the approval process
- Restrictions or prohibitions on placing on the market
- Corrective actions and product recalls
- Tests within the framework of drug monitoring
- Fines and criminal risks in pharmaceutical law
The consultation includes both legal assessment and strategic support in the background.
Submit your inquiry now
We will gladly advise you comprehensively and personally on your request.
Submit your inquiry now
We will gladly advise you comprehensively and personally on your request.
Why Life Sciences Law in pharmaceutical law?
Life Sciences Law Ralph Schäfer combines specialized legal advice with genuine leadership experience from the life sciences industry. Admitted to the bar for 27 years, he has held various roles as in-house and external legal counsel and business manager in international companies, including General Counsel and board member of a publicly listed biotech company, as well as in associations.
These include, among others:
- 10+ years as General Counsel and Corporate Counsel international, publicly listed medical technology, biotech and pharmaceutical company
- Long-standing responsibility in senior positions, long-time member of the management team, and as a board member of a listed biotech company, with a focus on law, compliance, strategy and regulation
- Extensive experience as a compliance officer of a publicly listed biotech company
- Extensive experience at the interface of pharmaceuticals, biotech, medtech and health care
- Solution finder, strategy partner and legal guide for executive and supervisory boards
This combination of legal expertise and operational management practice enables the firm to provide advice that is legally precise, economically viable, and practically implementable. The firm stands for personal, pragmatic, and ethically oriented support in the highly regulated life sciences environment.
FAQs – Frequently Asked Questions about Pharmaceutical Law
Pharmaceutical law governs all legal requirements related to the development, approval, manufacture, quality, safety, and marketing of medicinal products. The central law is the German Medicines Act (AMG), supplemented by European regulations and directives. It affects manufacturers, distributors, research institutions, hospitals, and all stakeholders involved with medicinal products.
A product is considered a medicinal product if it has a pharmacological, metabolic, or immunological effect, or if its presentation suggests it is intended to cure or alleviate disease. This classification is crucial because it determines the regulatory framework, licensing requirements, and legal requirements for advertising and distribution. In borderline cases, a thorough legal assessment is essential.
There are various approval pathways, such as national approval via the BfArM or PEI, centralized approval via the EMA, and decentralized or mutual recognition procedures. Which pathway is most suitable depends on the type of drug, the company's strategy, and the planned target markets. A strategic selection saves time and money.n.
Drug approval typically begins with preclinical studies and clinical trials, followed by the preparation of a comprehensive marketing authorization dossier. The competent authority then assesses the drug's quality, efficacy, and safety. Upon completion of the review, marketing authorization is granted, or, if necessary, further measures are required. Thorough preparation ensures a smoother process.
Strict Good Manufacturing Practice (GMP) standards must be followed during production. Companies require a manufacturing license, must have a functioning quality management system, and must fulfill extensive documentation and validation obligations. Audits and regulatory inspections are regular components of the manufacturing process. Violations can lead to production stoppages or regulatory action.
Pharmacovigilance refers to the continuous monitoring of drug safety after approval. Companies must collect, evaluate, and report adverse drug reactions, develop risk management plans, and submit regular safety reports. The goal is to identify risks early and ensure ongoing patient safety. A functioning and robust system is crucial in this regard.
Advertising for medicinal products is subject to strict regulations under the German Medicines Advertising Act (HWG) and the German Medicines Act. Crucially, it is essential to distinguish between advertising aimed at healthcare professionals and the general public, as well as to avoid misleading statements. Digital advertising measures must be coordinated just as carefully as traditional campaigns. Violations can lead to warnings, fines, or distribution restrictions.
Distribution requires a wholesale license and adherence to Good Distribution Practice (GDP). Companies must ensure the integrity of the supply chain and meet strict requirements for storage, transport, and documentation. The import and export of pharmaceuticals is also legally regulated. A stable and legally compliant distribution process is essential for market supply.
Authorities such as the BfArM, EMA, or PEI can order measures such as sales restrictions, recalls, additional requirements, or labeling changes. Depending on the severity of the complaint, fines or further steps may also follow. A swift, expert response is crucial to limit measures and protect the supply chain and the company's reputation.
Legal support is particularly recommended when developing or classifying new products, planning approval processes, implementing regulatory requirements, or reviewing advertising activities from a legal perspective. Companies also benefit from specialized advice on compliance issues, pharmacovigilance, GMP or GDP matters, and communication with regulatory authorities. Early support minimizes risks and facilitates sustainable growth.
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Your law firm LIFE SCIENCES LAW - Ralph Schäfer – Lawyer.
- +49 8151 4466683
- ralph.schaefer@lifescienceslaw.de
-
Munich Street 33
82319 Starnberg