Specialised

Wholesale

The demands of trading in the health sector are becoming ever greater. Almost all special legislation in drugs law from the Narcotics Act, the MDR, food and cosmetic law provide explicit testing, monitoring and action obligations for wholesalers even though not every area has such detailed requirements as the Drug Trade Regulation and the Good Distribution Practice Guidelines.

We advise in particular on all license issues, the engagement of the right personnel, correct product classification, compliance with the requirements on persons acting, dealing with challenging CBD products and on establishing rigorous compliance systems. Wholesalers use our comprehensive experience in the entire health area and the knowledge of the various trading levels on the one hand and the direct contact to the authorities on the other hand.

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.

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.

Cannabis/CBD

Cannabis products are widely discussed. Whether medical cannabis or lifestyle products: the growth in the cannabis and CBD areas is enormous and will be even greater based on current political developments. Many linked legal areas such as the Narcotics Act, the Drugs Trading Act and food law must be considered when giving legally secure advice. We support you therein.

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. Timo Kieser

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

Dr. Katharina Köbler

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

Dr. Christina Koppe-Zagouras

+49 (711) 60187-160
koppe@oppenlaender.de

Dr. Svenja Buckstegge

+49 (711) 60187-188
buckstegge@oppenlaender.de