Rulebook on More Detailed Conditions and Manner of Entering a Medicine into the Register of Traditional Herbal Medicines (Montenegro)

Title Rulebook on More Detailed Conditions and Manner of Entering a Medicine into the Register of Traditional Herbal Medicines (Montenegro)
Short description of the practice The Rulebook on Traditional Herbal Medicines establishes a comprehensive regulatory framework for the registration, quality control, safety, and traditional use of herbal medicinal products in Montenegro. It defines clear procedures and standards for the use of herbal substances and preparations based on long-standing traditional knowledge, while aligning national practice with European Union pharmacopoeia and regulatory requirements. The Rulebook supports the sustainable and responsible use of medicinal plants by ensuring traceability, safety, and quality, while preserving traditional practices.
Keywords Traditional herbal medicines, medicinal plants, regulation, sustainable use, quality control, traditional knowledge
Organisation in charge of the good practice Ministry of Health of Montenegro
Agency for Medicines and Medical Devices of Montenegro (CInMED)
Implementation level of the practice Level:  National, with local relevance

Country: Montenegro

Region: Komovi mountain area / Municipality of Andrijevica
Website https://cinmed.me/en/about-cinmed/
Detailed information on the practice The Rulebook regulates the conditions and procedures for entering traditional herbal medicines into the national Register, ensuring that products placed on the market are safe, of verified quality, and based on documented traditional use. It defines herbal substances and preparations according to the European Pharmacopoeia, requires precise botanical identification, and establishes standards for harvesting, processing, storage, and manufacturing.

A key requirement of the Rulebook is proof of long-term traditional use (at least 30 years, including 15 years within the EU), which protects and formalizes traditional knowledge while preventing unsafe or unsustainable practices. The Rulebook also introduces quality control mechanisms, Good Manufacturing Practice standards, and environmental considerations related to the sourcing of herbal raw materials.

For rural mountainous areas such as Komovi, where the collection of medicinal and aromatic plants represents both a cultural tradition and a potential economic activity, the Rulebook provides a legal framework that supports sustainable harvesting, value-added processing, and responsible commercialization, while reducing the risk of overexploitation of sensitive species and habitats.
Timeframe Adopted in 2015 and continuously applicable
Approximate cost Public administration and regulatory implementation costs at national level; compliance costs depend on producers and applicants
Results achieved
  • Improved safety and quality standards for traditional herbal medicines
  • Legal recognition and protection of traditional herbal knowledge
  • Increased alignment with EU regulatory and pharmacopoeial standards
  • Stronger basis for sustainable use and controlled harvesting of medicinal plants
Potential for learning or transfer This practice demonstrates how regulatory instruments can balance biodiversity conservation with traditional and economic uses of medicinal plants. It is transferable to other countries and regions with rich ethnobotanical heritage and pressures from unregulated harvesting. Key success factors include alignment with EU standards, clear documentation requirements, and integration of environmental considerations. Challenges include administrative complexity and limited capacity of small local producers.
Additional material Rulebook on More Detailed Conditions and Manner of Entering a Medicine into the Register of Traditional Herbal Medicines (Official Gazette of Montenegro No. 04/15)
Contact person Name: Snežana Mugoša

Affiliation: Agency for Medicines and Medical Devices of Montenegro (CInMED)

Email: snezana.mugosa@cinmed.me