Herbal Medicines
Herbal medicines are a natural and scientifically recognized alternative in the field of healthcare. At Pharmanager Development, we support you through every step necessary to ensure market authorization (MA) for your products, in compliance with Directive 2001/83/EC and Directive 2004/24/EC.
Our expertise helps you navigate regulatory and strategic challenges, ensuring that your products meet safety, quality, and efficacy requirements. Whether your goal is to enter the European market or international markets, we are here to ensure the success of your projects.
Preparation of MA Dossier Modules
Preparation of MA Dossier Modules
Enregistrement des dossiers
Gestion de toutes les démarches administratives et réglementaires.
Interface with Competent Authorities
We manage communications with the ANSM, EMA, or other international organizations.
Response to Instruction Measures
We analyze and address the questions raised by the authorities.
Development of New Products
- In traditional use (in accordance with Directive 2004/24/EC).
- In well-established medical use (WEM).
Regulatory and Strategic Monitoring
Continuous monitoring of regulatory developments in the EU and beyond.
Pharmanager Development assists you in:
We support you at every key stage of your product’s lifecycle, from initial conception to market launch, whether in Europe or on other international markets.
With our expertise, we ensure that each product strictly adheres to the applicable regulatory requirements, while incorporating the latest legislative and normative developments.
Our commitment guarantees complete, personalized support to ensure your product compliance and maximize its success in an ever-evolving environment.
Discover our case studies
Our answers to your questions
What are the regulatory pathways for bringing herbal medicinal products to the European Union (EU) market?
In the EU, there are three main regulatory pathways for herbal medicinal products:
- Traditional Use Registration (Article 16a(1) of Directive 2001/83/EC): This pathway is for products with a history of at least 30 years of medicinal use, including at least 15 years within the EU. No clinical tests are required, but sufficient safety data and plausible efficacy must be demonstrated. These products are intended for use without medical supervision and are not administered by injection.
- Well-Established Use Marketing Authorisation (Article 10a of Directive 2001/83/EC): This applies to products whose active substances have been in well-established medicinal use within the EU for at least ten years, with recognized efficacy and an acceptable level of safety.Assessment is based on bibliographic data.
- Stand-Alone or Mixed Application (Article 8(3) of Directive 2001/83/EC): This route requires safety and efficacy data from the company’s own development or a combination of own studies and bibliographic data.
Companies should apply to the national competent authority of a Member State for national, mutual recognition, and decentralized procedures.
What is the role of the European Medicines Agency (EMA) in the regulation of herbal medicinal products?
The EMA, through its Committee on Herbal Medicinal Products (HMPC), provides scientific opinions on the quality, safety, and efficacy of herbal medicines to harmonize information across the EU. The HMPC prepares Community herbal monographs and lists of herbal substances, preparations, and combinations thereof, which serve as a basis for the simplified registration or marketing authorization of herbal medicinal products.
What are the quality requirements for herbal medicinal products in the EU?
Regardless of the regulatory pathway, all herbal medicinal products must meet comprehensive quality standards. This includes adherence to good manufacturing practices (GMP), ensuring the consistent quality of products, and compliance with specifications outlined in the European Pharmacopoeia or other relevant pharmacopoeias. Quality aspects cover the control of starting materials, manufacturing processes, and finished products.
How does the EU define a ‘traditional herbal medicinal product’?
A traditional herbal medicinal product is defined as a medicinal product that has indications exclusively appropriate for traditional herbal medicinal products, is intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment, and has been in medicinal use for at least 30 years, including at least 15 years within the EU. These products are not administered by injection.
Pouvez-vous gérer les échanges avec les autorités compétentes ?
Oui, nous agissons en tant qu’interface entre vous et les autorités, comme l’ANSM, pour faciliter la validation de vos dossiers.