röhrig

Lawfirm

ISERT / ALTENKIRCHEN

Germany

Zum Bongard 1

D - 57612 Isert / Altenkirchen

Tel (+49)-(0) 2681 - 87 976 70

Fax (+49)-(0) 2741 - 87 976 71

Office-Email: Office@Kanzlei-Roehrig.de

 

Areas of Advise

Dr. Brigitte Röhrig (former Friese)

advises in the field of

 

  • Drug Law,

  • Food Law,

  • Medical Device Law,

  • Cosmetic Law,

  • Biotechnology Law.

In the areas of specialisation mentioned above I offer my clients a full service advise including advise in advertisement issues. The advise comprises from the concept of the product, compliance with the requirements for introducing the products into the market, the introduction of the product into the market, the marketing until the end of the marketing or switch of the product into another category.

I support my clients in all issues of the company to third persons, authorities, competitors, cooperation partners including contractual issues. In case of conflicts with authorities and / or competitors I represent your interests inside and outside court proceedings. For small companies which wish to outsource their legal department I take over the respective tasks.

In addition to the advise mentioned above I further  focus on the advise on the development of strategic concepts to introduce medicinal products into the European market. The range of medicinal products comprises bio- and high technology medicinal products as well as medicinal products on the base of a "new chemical entity", herbal and traditional medicinal products, orphan drugs and generics. Due to the cooperation with international advise companies the development of the most successful international strategy is possible.

My clients     a r e

national, european and US-american small and medium-sized companies, as well as multi-national companies of the pharmaceutical-, food-, cosmetic-, medical device and biotechnology industry. In case of mergers I carry out the product specific due diligence.

a d v i s e   my clients with respect to

  • the choice of the marketing authorisation procedure for medicinal products (national, mutual recognition, decentralised and centralised procedure);

  • accompanying measures during the authorisation procedure or other procedures;

  • the concept of the product (i.e. ingredients of the product, claims)

  • the classification of the product as medicinal product, food, food supplement, cosmetic, cosmeceutical, medical device;

  • marketing requirements (applications acc. to §§ 37 and 47a LMBG, authorisation applications, certification);

  • reimbursement issues of the Health Care System and private health insurance;

  • administrative-, fine- and criminal proceedings;

  • advertising and labelling of products;

  • product liability

  • recourse against CHI physicians

The clients are  r e p r e s e n t e d   in

  • administrative conflicts with authorities as well as proceedings before the administrative courts

  • conflicts with competitors;

  • conflicts in civil law,

  • fining proceedings and criminal proceedings

The clients are  s u p p o r t e d   with respect to

  • drawing up of agreements and negotiations

  • transformation of marketing authorisations granted in a mutual recognition procedure 

  • representation of their interest towards authorities, european institutions and associations

 

back to the main page