Competent advice inDrug Law
Do you need help with a pharmaceutical matter?
- Admission / Registration
- In-house and contract manufacturing
- Drug advertisement
- Distribution and price law
- Drug safety
We are pleased to assist!
If you have any questions regarding drug law, please contact us by email at
Of course you can also reach us by phone at +49 (40) 33443690.
The development, approval, manufacture, distribution and, not least, dispensation of medicines are shaped by a variety of regulations. The European Union and national legislators are constantly making their contribution to the growing volume of regulations with new developments. Safety and quality requirements are constantly increasing. This is not always an easy thing for those involved to deal with, especially with national and European supervisory authorities placing great emphasis on such regulations.
We see our task as bringing your interests, projects and plans into harmony with the legal framework conditions and highlighting and supporting you with the existing opportunities for the development, approval and distribution of your medicines.
Our consulting service focuses on the following areas:
- Classification and delimitation of products (foods, medicines, medical products, cosmetics)
- Research and development contracts
Approval / registration
- Approval of finished medicines and homeopathic medicines – European approval, mutual recognition, German approval, off-label use, unlicensed and compassionate use
- Registration of homeopathic medicines
- Manufacturing authorisation – including necessity of an expert, your personal requirements and your liability
- AMWHV (German directive on the production of medicines and active substances), GMP, WHO, GLP, contract manufacturing and contract testing
- Labelling of containers and outer packaging
- Product information texts (§§ 10, 11 AMG (German medicines act)), packaging sizes
- Good sales practice, sales channels (wholesale, hospitals, pharmacies, retail, mail order), licensed sales, co-promotion, co-marketing and co-distribution, medicinal product advertising, cooperation with specialist groups
- Cost reimbursement for medicines
- Aspects under company law – joint ventures
Medicinal product advertising
- Medicinal product advertising (HWG (German medicinal product advertising act))
- General competition law (UWG (German fair trade act))
- Cooperation with specialist groups
- Industrial property protection – trade marks, utility models and design patents
DIEKMANN Rechtsanwälte is a member of the BAH (German association of pharmaceutical manufacturers) and PLCD (Pharma Licence Club Deutschland)
PharmSec Internattional GmbH, founded in cooperation with the law firm DIEKMANN Rechtsanwälte, advises companies in particular in the areas of medicinal products and narcotics (BtM) and supports them in applying for and maintaining permits (e.g. for wholesale trade in medicinal products pursuant to § 52a of the German Medicinal Products Act (AMG) or for trade in narcotics pursuant to § 3 of the German Narcotics Act (BtMG)).
The brains behind the company are, in addition to Dr. Fabinne Diekmann, Mr. Stefan Heinz, who has many years of experience in QA/GMP/GDP - most recently as head of quality assurance at Mundipharma GmbH in Limburg (Lahn). In addition, he has many years of experience in conducting quality audits (3rd party audits) and inspections by authorities in the national and international environment.
In addition, PharmSec offers its own training courses and acts as a speaker on various platforms.