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Paving the Way for Successful Approval

Whether you want to market your products in Germany or across the EU, or are aiming for approval with reference to “well-established use” or registration as a traditional herbal medicinal product – PhytoLab will work with you to develop the right strategy for a successful approval procedure and will make sure that this strategy is implemented effectively.

The suitable approval process

We will guide you through mutual recognition procedures (MRP), where approval first takes place in one EU state, and is then recognised in other EU states. We will of course also advise you on selecting the suitable reference member state (RMS), the country that carries out the initial assessment of the approval procedure. And we will be your partner for decentralised procedures (DCP), where applications are submitted in several member states at the same time, and ensure that the procedure is implemented within the time limits allowed. What’s more, we will provide you with comprehensive support in preparing, implementing and following-up scientific consultations with the authorities involved.

Proof of quality for traditional herbal pharmaceuticals

Directive 2004/24/EC for Traditional Herbal Medicinal Products offers the opportunity to remarket classic recipes. On your behalf, we will check whether or not your products can be registered. Based on our extensive literature resources and product-related research, we will compile the evidence of traditional use and, in cooperation with our Medical Affairs department, document the plausibility of the product’s effectiveness and safety.