Competent advice inDrug Law

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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:

Development

• 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

Manufacture

• 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

• Labelling of containers and outer packaging
• Product information texts (§§ 10, 11 AMG (German medicines act)), packaging sizes

Distribution

• 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

Medicine safety

• Pharmacovigilance

• Liability

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)