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- Authorisation procedures/ market access
- Compliance
- Contract law
- Copyright law
- Criminal proceedings
- Delimitation / Product Classification
- E-Commerce - Social Media
- Environmental and planning law
- Food crisis
- Government liability and Compensation law
- Labelling
- Litigation
- Product liability
- Public law
- Research & Development
- Studies
- Trademarks / Intellectual Property
- Unfair competition law
Current Events
Competences
Authorisation procedures/ market access
When dealing with regulatory matters in the context of authorisation procedures, too, we cover the wide range from foods to pharmaceuticals and cosmetics. We support our clients facing national and international authorities – if need be with the help of RDA Scientific Consultants GmbH. Key topics with regards to foodstuffs are for example the authorisation of additives (Regulation (EC) 1333/2008), health claims (Regulation (EC) 1924/2006) and novel foods (Regulation (EC) 258/1997). For the pharmaceuticals, the focus is placed on regulatory support in the context of the national or central European authorisation or registration of pharmaceuticals including orphan drugs, as well as conformity assessment procedures for medical devices. We also possess the needed expertise in other regulated market access procedures like compassionate use programmes. Furthermore, we provide assistance to our clients regarding all matters of market access, especially with respect to early benefit assessments for price formation (AMNOG).
Contact
Meisterernst Rechtsanwälte PartG mbB
Herzog-Heinrich-Str. 1, 80336 Munich
References
The competence and expertise of our law firm and our lawyers is also documented by several awards and achievements
Current Events
Cooperations
Our guiding principle „Thinking further“ also applies beyond the work we carry out our very selves. Through permanent cooperations and as part of different networks, our law firm and its lawyers are in constant contact and exchange with other experts.
Networks
Our lawyers inter alia engage in the following institutions:
If need be, our permanent scientific cooperation partner RDA Scientific Consultants GmbH, supports us in complex scientific and regulatory matters. We also collaborate intensively with our colleagues from the law firm Belmont | Legal specialised in commercial and company law.
Whenever legal questions with an implication of foreign law occur, we provide multinational concepts in a time-and cost-effective way thanks to our trusted and straightforward cooperation with befriended foreign colleagues.
Beyond our work for clients, our lawyers also active members in a number of specialist associations and scientific institutions. Our clients profit from the insight and contacts gained from these activities.
In multinational scenarios we work closely together with specialised foreign colleagues and other independent experts. We are therefore able to provide specifically tailored concepts across broders and clarify legal issues with foreign implications early on.
Contact
If you have any questions, don't hesitate calling us or sending an e-mail.