Specialised

Cannabis/CBD

Lifestyle products form a major part of the cannabis and CBD market. We support companies in the manufacture, distribution and the labelling and advertising of cannabis and CBD products. The initial assessment whether a narcotic is concerned is fundamental. If that is answered in the negative, the classification as either cosmetic, food or medical product arises. We guide you, legally securely, through the regulatory provisions, judgments and administrative practice.

The import and distribution of medical cannabis are major challenges for wholesalers and pharmacists. We support companies from participation in tenders to advice and communication with official bodies around the establishment and conduct of wholesaling business.

Weitere Schwerpunkte aus der Expertise "Health"

Drugs

We support individual and chain pharmacies on their establishment and ongoing business.

Pharmacies

We support individual pharmacies and pharmacy chains on the commencement and further operation of business.

Compliance

The compliance requirements in the health system have intensified massively in recent years. We advise on legally secure cooperations in the health sector from the observation of applications to benefits, so that cooperation is not equated with corruption.

Medical Products

Medical products constitute a wide spectrum and have been, for some time, subject to the intensified requirements of the MDR (Medical Devices Regulation) and/or the IVDR (Invitro Diagnostic Regulation) and a meanwhile unmanageable number of implementation regulations. Whether radiation appliances, apps, material medical products or diagnostic products: we support you to keep abreast and to market products in a legally secure manner. We advise manufacturers, importers, providers of and traders in medical products of all classes.

Cosmetics

We clarify questions of demarcation, design and advertising of cosmetic products and uphold the interests of companies in the industry before courts and authorities.

Food Law

We advise in this complex and highly regulated area whether you produce and/or distribute “classical“ nutritional products, nutritional supplements, diet food, “functional foods“ or novel food.

Doctors

We act in the establishment of doctors‘ and professional training communities and provide support in conflicts with SHI accredited doctors‘ associations, statutory health insurers and chambers.

Platforms

The digitalisation in the health system is proceeding rapidly. The most varied partners are joining together on platforms in order to intensify customer focus. High regulatory requirements encounter complex contractual structures and the P2B Regulation. Our advice is experienced and secure in that complex area.

Wholesale

Pharmaceutical wholesalers benefit from our detailed industry know-how, our experience in product demarcation and our expertise in regulatory and logistic matters.

Health Data Protection Law

Processing health-related data is necessarily inherent in the business of companies in the pharmaceutical and health areas. The data protection legal requirements on the processing of such sensitive data are onerous. At the same time, discussions about the more intensive use of health data for the improvement of treatment and research become louder. With our experience in the industry, we advise on all health data protection law issues and the possibilities for safe use of sensitive data.

Health System Procurement Law

We have been from the beginning at the forefront of the development of health system procurement law. In particular, we have achieved a number of important leading judgments for our clients on discount agreement invitations to tender, drugs procurement and the statutory health insurers’ Open-House model.

Your team

Dr. Katharina Köbler

+49 (711) 60187-164
koebler@oppenlaender.de

Dr. Timo Kieser

+49 (711) 60187-230
kieser@oppenlaender.de