Regulatory Affairs - phyreg®
Whether you seek a German or EU-wide marketing authorization, an approval based on a well-established use, or a traditional herbal medicinal product registration, PhytoLab will help you plan the right strategy for a successful authorization procedure and targeted implementation. Prior scientific advice with the competent regulatory authorities is the foundation for subsequent success. We can guide you through national procedures, as well as mutual recognition (MRP) or decentralized procedures (DCP).
Our phyreg® Team can also provide you with expert advice concerning other product categories, including health claims for dietary supplements and functional foods, notification of a traditional novel food, foodstuffs for special consumer groups or substance-based medicinal products.
We can develop dossiers for your products tailored to your specifications and in line with current regulatory requirements. The dossiers will be delivered to you as common technical documents (CTDs), the mandatory format for all applications for marketing authorization or registration of herbal medicinal products. We will be happy to take your layout specifications into account. For electronic submissions, we will execute your dossiers in the NeeS (non-eCTD electronic submission) or eCTD formats and also offer you the option to reformat your existing dossiers.
We deliver complete dossiers or individual modules, in hard copy or in electronic form that you can further process in-house.
Traditional herbal medicinal products
The EC Directive on traditional herbal medicinal products provides opportunities to market long-established formulations in new ways. We can assess whether your products may be registered and formulate creative product ideas to expand your portfolio. Based on our comprehensive literature review and product-specific research, we will formulate traditional documentary evidence and collaborate with our Medical Sciences Department to substantiate the plausibility of your product's efficacy and safety.
Our services include complete management and coordination of your product processes, from product design and galenic forms to method development and approval of your herbal medicinal product. We can also assist you in getting food supplements with innovative herbal ingredients or food for special medical purposes (FSMP) ready for market.
We will advise you in the selection of suitable active substances/ingredients, establish contact with eligible contract manufacturers, coordinate the production and storage of stability batches, and ensure that your projects run smoothly through effective networking among all participating partners. You can be certain that all regulatory documents will be prepared on time and all regulatory deadlines will be met. We will be happy to take on the overall planning and deadline coordination of your regulatory authorization processes.
Once a medicinal product has been successfully approved there is still much to do: conditions and renewal deadlines must be met, addendum clinical overviews (ACOs) must be initiated and submitted in a timely manner. Changes to test methods, excipients, packaging materials or the shelf-life the finished product, for example, must be documented in the CTD and submitted to the competent authorities in the form of a variation notification.
PhytoLab can support you in maintaining your marketing authorizations and take the pressure off you by reliably tracking submission deadlines. We will proactively notify you of legal developments and assist you in planning the necessary steps to ensure the sustained marketability of your products.
We can also advise you in the labeling and presentation of foodstuffs and food supplements. Do your products comply with the complex requirements of the Health Claims Regulation? We will provide you with support in all issues related to Regulation (EC) No. 1924/2006 and advice on European positive and negative lists for plant-derived ingredients.