Product Regulation

In an average German supermarket, consumers will find up to 25,000 different products. The legal field behind it, the law on foodstuffs, is no less complex. Our experts assist you in keeping an overview on national and European regulations, industry standards, and internal guidelines.

We have been advising clients from the food industry for many years, from small start-ups to established medium-sized companies and major international corporations. As sector specialists, we like to look beyond the legal horizon to find the best and most practical solution for you and your product.

Our food experts accompany your product from initial development steps to market launch and marketing and also provide the necessary legal protection in competition afterwards (for instance against any lookalikes).

Our key advisory areas include:

• product labeling requirements and certification
• compliance with consumer protection requirements
• packaging labeling
• legal support of advertising activities (particularly Act against Unfair Competition and Health Claims Regulation)
• registration, monitoring and enforcement of trademarks and designs
• warnings and product protection against competitors in Germany and abroad
• temporary injunctions and assertion/defense of claims before civil and administrative courts
• drafting commercial and distribution contracts and general terms and conditions
• product liability and product recalls
• compliance measures
• in-house training for staff

The medical device industry is booming. Big Data, Crispr, or more recently cannabis, are the raw materials from which tomorrow’s innovative products are created. Artificial intelligence, virtual reality, eHealth apps, robotics – those terms are not foreign to us, but legal challenges that we are solving on behalf of your company. There is hardly any other sector that involves so many exciting legal questions at the interface of IP, data protection, and current ethical debates.

For many years SKW Schwarz has had large expertise in all issues relating to the healthcare sector. In addition to start-ups in eHealth, our clients include several medium-sized manufacturers, for instance in the field of food supplements or medical technology.

Our experts do not only offer legal finesse, but also the necessary element of technical and medical expertise. It is our objective to provide legal protection for your medical device and to be at your side as a strategic advisor at all times.

At the very beginning of our consultation, we frequently have to select: Medical device? Medicinal product? Or something entirely different? We carry out this important distinction for you and show you the future legal steps.

The subject areas include in particular:

• classification as medical device and differentiation from other product groups
• support in national and European certification systems and conformity assessment procedures
• negotiations with supervisory authorities and licensing bodies
• support with product marking and labeling
• legal support of advertising activities (especially Act against Unfair Competition and Advertising of Medicines Act)
• reviewing privacy requirements
• registration, monitoring, and enforcement of trademarks and designs
• warnings and product protection against competitors in Germany and abroad
• temporary injunctions and asserting/defending claims before civil and administrative courts
• drafting commercial and distribution contracts and general terms and conditions
• product liability and product recalls
• compliance measures
• in-house training for staff

The law relating to medical devices is in constant motion and frequently the subject of renewed debates. Our IP experts and our peers from the Life Sciences team are well connected and informed about the industry. Even though the date of effectiveness of the new European Medical Device Regulation has been postponed until May 26, 2021 due to COVID-19, legal advice on medical devices remains important daily business at SKW Schwarz.

Pharmaceutical law is shaped by strict national and European regulations. And that is not without reason – after all, these products have a direct effect on the human or animal body and can sometimes cause considerable damage. This affects safety and quality requirements, but also advertising and marketing. Although the regulations are largely harmonized at the European level, the associated legal issues are frequently highly complex. Thanks to our many years of experience in advising pharmaceutical companies, we have an open eye for particular challenges and can, if necessary, involve experts from science or other fields (including antitrust law, life sciences, etc.).

We advise you on the following topics:

• classification as medicinal product and differentiation from other product groups
• support in national and European certification systems and in approval procedures
• quality assurance of production processes (Good Manufacturing Practice)
• support with product marking and labeling
• application, monitoring ,and enforcement of trademarks, designs, utility models, and patents
• legal support of advertising activities (especially Act against Unfair Competition and Advertising of Medicines Act)
• warnings and product protection against competitors in Germany and abroad
• temporary injunctions and asserting/defending claims before civil and administrative courts
• drafting research and development contracts
• drafting trade and distribution agreements
• product liability and product recalls

The business related to beauty is on the road to success: the global market for beauty products is estimated at more than $530 billion. On average, German women own 40 care products. It is therefore no wonder that the law relating to the cosmetics sector is quite extensive.

Essential requirements for cosmetic products have been governed by the EU Cosmetics Regulation since 2013. They include the raw materials used, animal testing, labeling requirements, and product advertising. Our experts have been advising in this sector for many years and are familiar with the specific challenges. In connection with industry trends such as sustainable or vegan cosmetics, we can use our experience to legally secure your product. We particularly focus also on advertising for cosmetics, which is becoming increasingly important, predominantly in social media and in connection with influencer marketing.

Our main advisory areas include:

• classification as a cosmetic product and differentiation from other product groups
• support in national and European notification procedures with the competent authorities
• quality assurance of production processes (Good Manufacturing Practice)
• support in drafting the safety report in accordance with the EU Cosmetics Regulation
• support with product marking and labeling
• legal support of advertising activities (in particular Act against Unfair Competition and EU Cosmetics Regulation)
• application, monitoring, and enforcement of trademarks, designs, utility models, and patents
• warnings and product protection against competitors in Germany and abroad
• temporary injunctions and asserting/defending claims before civil and administrative courts
• import and export of cosmetics
• drafting trade and distribution agreements
• product liability and product recalls

Our experts do not have to consult Wikipedia for acronyms such as REACH, CLP, PIC, or RoHS or the provisions of the German Detergents and Cleaning Products Act. We will safely guide you through the multitude of national and European regulations in chemicals law.

Many times, the starting point with chemicals is to differentiate: Is a product to be classified as a chemical, biocide, or detergent and cleaning product – and is it covered by the relevant EU Regulations and Directives? This is where scientific and legal questions usually overlap, which does not always allow for a clear-cut differentiation. Our specific sector expertise and many years of experience with clients from the chemical and hygiene industries facilitate and accelerate this work.

In the chemical industry, our advice includes the following topics:

• classification as chemical, biocide, or detergent and differentiation from other product groups
• support in national and European authorization and registration procedures with the competent authorities
• REACH Testing
• support with product marking and labeling
• legal support of advertising activities (in particular Act against Unfair Competition and CLP Regulation)
• warnings and product protection against competitors in Germany and abroad
• temporary injunctions and asserting/defending claims before civil and administrative courts
• drafting trade and distribution agreements
• product liability and product recalls