The International Council of Chemical Associations (ICCA) launched the “Global Product Strategy” (GPS) in 2006. With this voluntary initiative, which exceeds the legal requirements, the chemical industry is making another important contribution to safe chemicals management. It should reduce the disparity in risk assessment and safe handling of chemicals that exists between developing, emerging and industrialized nations. GPS aims to create a globally uniform standard for assessing product safety.
The Global Product Strategy is a fundamental element of the Responsible Care® Global Charter that Merck signed in 2007.
Comprehensive drug safetyWe test the efficacy and safety of drugs extensively in
clinical trials. We follow the Good Clinical Practice guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), a project being carried out by the regulatory authorities of the EU, Japan and the United States, as well as by the pharmaceutical industry. In addition, the Global Drug Safety unit is responsible for the safety of pharmaceutical products. It ensures drug safety monitoring – both during research and development and after marketing authorization (pharmacovigilance), in close contact with the health authorities. The purpose of ongoing and systematic monitoring of drug safety is to identify, evaluate and understand adverse effects so that we can take appropriate measures to minimize risk. Following a suspected serious adverse reaction to Stimuvax®, we temporarily suspended the clinical study program in March 2010, but were able to resume it again three months later. In 2010, as a precaution we recalled batches of Vigantol® from pharmacies and wholesale distributors in some European markets due to an impurity.
Safe handling of chemicalsIn the Chemicals division, product safety means complying with all regulatory requirements relating to the manufacture, handling, import, marketing and recycling or disposal of chemicals. Our efforts cover international and national chemical regulations, for instance
GHS , the EU chemicals regulation REACH, the U.S. Toxic Substances Control Act (TSCA), and the federal German law on protection from hazardous substances (ChemG). Product safety also comprises legal standards that relate to the transport of hazardous substances, on biocides, cosmetics, chemicals used in food and animal feed, etc.
With respect to the European guideline RoHS (restriction of hazardous substances), we provide our customers with suitable declarations and analytical reports so that they in turn can fulfill their legal obligations.
Above and beyond the statutory requirements, Merck also takes voluntary actions to ensure the safety of its products, e.g. through its voluntary commitment to
Global Product Strategy and the resulting provision of
Product Safety Summaries.
With the Merck Group Policy Product Safety Chemicals, we have established global processes to define, steer and implement product safety and the management structures to ensure the safety of products from the Chemicals business sector. A Group function is responsible for product safety at the global level. Furthermore, our sites and companies around the world bear local responsibility. In 2010, we also founded the Group Product Safety Committee with ultimate responsibility for all issues relevant to the product safety of our chemicals.
