Pharmaceutical Law
As a pharmaceutical company, manufacturer of medical devices, or hospital you operate in a highly regulated market. The only constant is permanent change which is influenced by various political tendencies. In the long run, only those who do not act reactively but rather proactively, and who face changes strategically and with foresight remain competitive. Expert consultation is absolutely essential.
We advise national and international, research and generic firms in the health care sector, such as hospitals and pharmacies in terms of developments, manufacturing, and sales of drugs and medical devices. Market access, compliance, and reimbursement are part of our daily business just as is interaction with other medical areas.
We advise our clients in the development phase, support them in maintaining marketability, and give advice in the market phase regarding all questions concerning sales, competitions, advertising laws, and social laws, as well as advice pertaining to the sectorial anti-trust aspects. Internal compliance is obligatory. We advise hospitals and dispensaries on questions regarding cooperation, marketing channels, accounting, planning, and conducting clinical examinations.
Kanzlei am Aerztehaus provides sectoral consultation especially in the areas of:
- Planning and conduction of clinical trials
- Drafting of contracts
- Strategic product orientation
- Marketing Authorisation (national procedure, mutual recognition procedure, decentralized procedure, centralized procedure)
- Reimbursement in field of statutory health insurance
- AMNOG (German Law on the Reorganization of the Pharmaceutical Market): Assessment of drug or price negotiations
- Improvement of distribution channels
- Competition law and pharmaceutical-advertising law
- Cooperation with service providers
- Compliance
- Transparency
- Market Access
- etc.
Kanzlei am Aerztehaus provides sectoral consultation especially in the areas of:
- Certification, CE-mark and clinical trials
- Market launch in Germany and abroad
- Drafting of contracts
- Product liability and surveillance
- Possible prescription and reimbursement of medical devices
- Issues on pharmaceutical-advertising law and competition issues
- Cooperation with service providers
- etc.
Kanzlei am Aerztehaus provides sectoral consultation especially in the areas of:
- Planning and conduction of clinical trials
- Drafting of contracts
- Marketing Authorisation (national procedure, mutual recognition procedure, decentralized procedure, centralized procedure)
- Reimbursement in field of statutory health insurance
- AMNOG (German Law on the Reorganization of the Pharmaceutical Market): Assessment of drugs and price negotiations
- Competition law and pharmaceutical-advertising law
- Possible cooperation with industries and health care providers
- Accounting and consultation on marketing channels concerning in- and outpatient treatment
- Drug liability
- etc.
Kanzlei am Aerztehaus provides sectoral consultation especially in the areas of:
- Planning and conduction of clinical trials
- Drafting of contracts
- Drug registration (national registration, Mutual Recognition Procedure, decentralized procedure, centralized procedure)
- Reimbursement in field of statutory health insurance
- AMNOG (German Law on the Reorganization of the Pharmaceutical Market): Assessment of drugs and price negotiations
- Competition law and pharmaceutical-advertising law
- Possible cooperation with industries and health care providers
- Accounting and consultation on marketing channels concerning in- and outpatient treatment
- Drug liability
- etc.