Biotechnology Law at North Macedonia
North Macedonia's biotechnology legal framework is evolving, aligning with European Union standards while addressing national priorities in biosafety, intellectual property, and environmental protection.
📜 Key Biotechnology Legislation
Law on Genetically Modified Organisms (GMOs)
Enacted in 2008 and amended in 2013, this law regulates the use, import, and marketing of GMOs, aligning with EU directives. It prohibits the cultivation of GMOs for food and feed purposes until EU membership is achieved, reflecting the country's commitment to biosafety and public health.
Regulation on Restricted Use of GMOs
This regulation, in accordance with the GMO Law, prescribes the form and content of notifications for the deliberate release of GMOs into the environment, ensuring compliance with biosafety standards.
Law on Protection of Plant Variety Rights
This law governs the protection of new plant varieties, providing a legal framework for breeders' rights and encouraging innovation in plant biotechnology.
Law on Industrial Property
This law regulates the acquisition, exercise, and protection of industrial property rights, including patents, trademarks, and geographical indications, essential for protecting biotechnological inventions.
🧬 Biosafety and Environmental Protection
Law on Nature Protection (2004)
This law outlines general principles and measures for biodiversity conservation, including provisions relevant to biotechnology and the sustainable use of natural resources.
Regulation on the Content of Information for Conducting Risk Assessment of GMOs
This regulation specifies the necessary information for conducting risk assessments of GMOs, ensuring environmental safety in biotechnology applications
🌐 International Commitments
Cartagena Protocol on Biosafety
North Macedonia is a party to this protocol, which aims to protect biological diversity from the potential risks posed by living modified organisms resulting from modern biotechnology
⚖️ Legal Assistance in Biotechnology
For legal guidance in biotechnology matters, including compliance with national and EU regulations, intellectual property rights, and biosafety standards, consider consulting professionals listed on platforms
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