The European market is one of the most important destinations for exporting herbal medicines and health-related products.
The European market is one of the most important destinations for exporting herbal medicines and health-related products. However, entering this market is not possible without meeting strict regulations. One of the key requirements is obtaining the CE mark, which indicates compliance with the European Union’s safety, quality, and performance standards. This certification is a prerequisite for placing products on the EU market.
To obtain the CE mark, manufacturers of herbal medicines and related products must go through several essential steps:
Identifying relevant EU directives and regulations
Each herbal or pharmaceutical product must be assessed according to the applicable EU laws and directives.
Conducting technical tests and evaluations
The product’s safety, quality, and efficacy must be tested in accredited laboratories, with full documentation of results.
Preparing technical documentation
A complete technical file, including product specifications, test results, manufacturing processes, and quality control systems, must be compiled.
Certification by Notified Bodies
Accredited EU Notified Bodies are responsible for reviewing the technical file and issuing final approval for CE marking.
Obtaining the CE mark is not just a legal requirement but also a strategic advantage. CE-certified herbal medicines can be placed on pharmacy shelves and health markets across Europe, helping companies gain customer trust and strengthen their brand reputation internationally.
Entering the European market without CE certification is impossible. Therefore, startups and companies in the herbal medicine sector must integrate international compliance and certification processes into their commercialization strategy from the very beginning. Working with professional consultants and specialized accelerators can greatly facilitate CE approval and open new opportunities for export.
