Counterfeit medicines have long been a topic with global implications, which countries are countering with legal regulations, among other things. Raw materials coming from China or India, there are subsidiaries in Europe and the USA, and the drugs are distributed worldwide. Due to the global networking of the pharmaceutical industry, internationally active companies must comply with very different laws to be globally compliant.
Worldwide, the pharmaceutical industry is one of the most heavily regulated industries. The companies’ international trade connections also give rise to global responsibility, demanded by the legislation of the countries. One aspect is the safety of medicines. Groups of states, such as Europe, or individual countries, like the USA or Russia, are therefore actively fighting against counterfeit drugs. More and more countries are currently working on making their medicines more transparent and thus safer supply chains through track-and-trace and similar measures. Since 2019, this means that pharmaceutical companies in Europe are only allowed to put serialized Rx drugs into circulation (legislation: EU-FMD).
Many countries have individual serialization requirements
Growing and specific regulations do not make it easy for pharmaceutical companies. Especially as large and small companies must meet the same requirements. It becomes increasingly complex meeting the regulations, depending on how many and which regions of the world a company is active in. Around 80% of the world’s governments are working on implementing pharmaceutical serialization as part of their strategy to combat counterfeit drugs and fraud. Currently, the EU, Russia, USA, China, South Korea, and others have specific serialization requirements for the pharmaceutical industry, that pharmaceutical companies must comply with when selling their drugs in these regions. Soon, other countries will follow and introduce their guidelines. These include Saudi Arabia, Abu Dhabi, and Brazil.
The English word ‘compliance’ is also used in German in connection with global supply chains and trade regulations. It describes the conformity of a company with legal requirements in specific geographical or political regions.
With our pharmaceutical serialization portfolio, we currently cover all major serialization regulations. This includes EU-FMD (European end-to-end serialization), DSCSA (serialization regulation in the USA), and Markirovka (Russia serialization). We also support our customers for their compliance with future serialization requirements.