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LIFE SCIENCES LAW – Ralph Schäfer – Lawyer – Your partner for legal issues in the life sciences industry
Pharmacy law – legal advice for pharmacies, branch networks and healthcare providers
Lawyer for pharmacy law in Munich
Navigating pharmacy law – legally compliant, economical, future-oriented
Pharmacy law forms the basis for a safe, proper, and economically viable supply of medicines in Germany. It regulates the establishment, operation, and supervision of pharmacies, including branch pharmacies and mail-order pharmacies, and sets out detailed requirements for dispensing processes, documentation, drug safety, quality management, and professional obligations.
Life Sciences Law supports pharmacies, chain stores, mail-order pharmacies, hospitals, and other healthcare providers in reliably implementing regulatory requirements and making legally sound business decisions. The firm combines legal expertise with a deep understanding of pharmaceutical care and the special responsibilities of pharmacies within the German healthcare system.
Services in pharmacy law
Pharmacy law is dynamic and constantly evolving due to digitalization, telepharmacy, e-prescription models, and new forms of care. At the same time, the requirements for documentation, drug safety, professional practice, and compliance are increasing. Economic issues such as pharmacy valuation, pharmacy retail prices, and pharmacy contracts also play a central role in practice.
Establishment, Acquisition & Structuring of Pharmacies
Starting a pharmacy requires a clear legal framework – regardless of whether it's a new establishment, a branch pharmacy, or the acquisition of an existing business. Location, pharmacy valuation, lease agreement, and legal structure are crucial for long-term success.
Important aspects include:
- Licensing & Site Inspection
- Evaluation and structuring of purchase and acquisition processes
- Pharmacy lease agreement & pharmacy contract law
A professional structure creates security and strengthens the economic foundation of the business.
Operation, Organization & Pharmacy Operating Regulations
The daily operation of a pharmacy encompasses a wide range of regulatory tasks – from storage and dispensing to documentation. The Pharmacy Operations Ordinance provides the binding framework for these tasks.
This includes:
- Quality management and documentation
- Storage, prescription verification and dispensing guidelines
- Interfaces with drug safety
Structured processes ensure that the supply is reliable, legally compliant and efficient.
Dispensing regulations, drug safety & narcotics law
Pharmacy dispensing is highly regulated. Every dispensing, inspection, documentation, and decision has legal implications. This is especially true for narcotics and sensitive areas such as compounding and extemporaneous preparation.
Relevant focus areas:
- proper pharmacy dispensing
- Drug testing & quality assurance
- Handling of narcotics
Regulatory safety protects patients, employees, and pharmacy operations alike.
Digital pharmacy: e-prescription, telepharmacy & new care concepts
Digitalization is fundamentally changing the supply of medicines. Telepharmacy, e-prescriptions, and digital platform models are opening up new opportunities – and creating new regulatory challenges.
Key themes include:
- Secure processes for e-prescriptions
- digital consulting & pharmaceutical services
- Data protection and organizational requirements
Modern supply routes are thus designed in a legally compliant manner and implemented efficiently.
Advertising, Marketing & HWG Compliance
Pharmacy marketing must comply with legal regulations while still being economically effective. Professional regulations, competition law, and the German Medicines Advertising Act set clear parameters.
The following are essential:
- permissible advertising measures online and offline
- Positioning and visibility in the local market
- Avoiding misleading statements
Legally compliant communication strengthens your profile and protects you from legal warnings.
Contracts, collaborations & pharmacy networks
Cooperation models, networks and joint procurement structures are gaining in importance, but are encountering limits under professional and competition law.
Key concerns include:
- Contracts in purchasing groups and alliances
- Franchise or cooperation models
- Employment law issues in pharmacy operations
- Clear contractual structures reduce risks and promote growth.
Pharmacy liability, supervision & compliance
Regular audits by regulatory authorities, clawbacks or complaints require fast, reliable answers.
Key areas:
- Pharmacy supervision & inspections
- Liability issues & professional regulations
- internal compliance systems
A well-structured compliance organization strengthens security and stability.
Pharmacy disputes, conflicts & economic challenges
Disputes often arise regarding location issues, contractual relationships, collaborations, or billing.
Typical occasions:
- Retaxations
- Conflicts with landlords or cooperation partners
- professional and competition law disputes
A clear positioning protects economic success and reduces operational burdens.
Pharmacy succession, sale & future security
The transfer of a pharmacy is complex and involves economic, legal, and structural issues. Topics such as the pharmacy's sale price, valuation, and legal continuity determine the success of the transfer.
Key aspects:
- Succession planning & valuation
- Purchase agreements and transitional arrangements
- Security of organization & personnel
A structured succession plan protects economic assets and secures the future of the team and its employees.
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 pharmacy 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 Pharmacy Law
Pharmacy law regulates the establishment, operation, supervision, and responsibilities of pharmacies. It defines dispensing rules, quality requirements, documentation obligations, and the professional standards for pharmacists. The goal is a safe, high-quality, and economically viable supply of medicines.
To establish or take over a pharmacy, a license to practice pharmacy, the necessary approval from the relevant authority, and a suitable location are required. Furthermore, structural, organizational, and personnel requirements must be met to comply with the regulations governing pharmacy operations.
The German Pharmacy Operations Ordinance (ApBetrO) stipulates how a pharmacy must be structured and operated. It contains detailed regulations regarding laboratory procedures, storage, hygiene, documentation, and quality management. Compliance with these regulations is fundamental to ensuring the proper supply of medical products to the population.
Advertising is subject to the German Act on Advertising of Therapeutic Products and professional regulations. Strict limits apply, particularly to health-related claims, discount campaigns, and digital marketing measures. Violations can lead to warnings and regulatory action.
The electronic prescription (e-prescription) is fundamentally changing the supply of medicines. Pharmacies must implement secure processes for digital dispensing, documentation, and billing. Data protection and technical security play a central role.
Narcotics are subject to strict regulations regarding dispensing, documentation, and storage. Violations can have criminal or professional consequences. Therefore, thorough internal processes are essential.
During a pharmacy inspection, authorities check whether legal requirements are being met. In particular, documentation, storage conditions, quality management, and dispensing processes are examined. Any deficiencies must be rectified promptly and transparently.
Pharmacies must bill correctly and comply with the health insurance companies' regulations. Reimbursement reductions occur, for example, if formal or substantive dispensing rules are not met.
Cooperations, alliances, or franchise models must be structured in accordance with professional regulations. Crucially, the independent practice of the profession must be preserved and no violations of competition or professional law should occur.
Legal advice is particularly useful when dealing with product development, safety assessments, the review of advertising claims, handling cease-and-desist letters, import and distribution issues, or the legal aspects of new beauty trends such as CBD cosmetics or personalized products. Life Sciences Law supports you in all these areas with specialized, practical, and legally sound advice.
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Your law firm LIFE SCIENCES LAW - Ralph Schäfer – Lawyer.
- +49 8151 4466683
- ralph.schaefer@lifescienceslaw.de
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Munich Street 33
82319 Starnberg