Biotechnology Law at Armenia
Armenia has established a comprehensive legal and regulatory framework governing biotechnology, focusing on biosafety, intellectual property, clinical research, and bioethics. This framework aligns with international standards and aims to ensure the safe and ethical application of biotechnological advancements.
⚖️ Key Biotechnology Laws and Regulations
1. Law No. HO-11-N on Genetically Modified Organisms (GMOs)
Enacted in 2023, this law regulates the use of GMOs in Armenia, emphasizing biosafety and environmental protection. Key provisions include
Prohibited Uses: The use of GMOs for reproduction or other purposes is prohibited, except for scientific research and demonstration in isolated systems as per government regulations.
Import and Testing: Plant organisms intended for reproduction imported for GMO identification must undergo laboratory examination by the authorized state body conducting border control.
Monitoring: All processes involving GMOs are subject to monitoring to prevent adverse effects on the environment, human health, and biodiversity
The law aims to prevent violations of biosafety principles in GMO usage.
2. Law on Medicinal Products
This law governs the distribution of drugs, pharmaceuticals, herbal raw materials, and investigational medicinal products in Armenia. Key aspects include:
Regulatory Authority: The Ministry of Health oversees
Clinical Trials: Conducted in compliance with "Good Clinical Practice" guidelines, requiring approval from the Ministry of Health and the Ethics Committee for Clinical Trials.
Manufacturing Licenses: Required for the production of medicinal products, with penalties for unlawful trafficking as specified in the Criminal Code
3. Law on Patents
This law applies to patents in Armenia, including those related to biotechnology. Key points include:
Patentability Criteria: Inventions must be new, involve an inventive step, and be industrially applicable.
Biotechnological Inventions: Biotechnological products and processes can be patented if they meet the patentability criteria.
4. Dual-Use Goods and Export Control
Amendments to the laws on dual-use goods and licensing aim to improve the business environment for technological and engineering companies. Key changes include:
Export Control: Establishing a list of goods that have been examined and not classified as dual-use or military, facilitating customs formalities.
Licensing: Amendments to the licensing law to streamline processes for technological companies.
🌐 International Cooperation and Standards
Armenia collaborates with international organizations to align its biotechnology regulations with global standards:
Council of Europe: Armenia is working towards ratifying the Oviedo Convention on Human Rights and Biomedicine, aiming to align its legal norms and law-enforcement practices with European human rights and ethical standards in biomedicine. gned the 1925 Geneva Protocol, which prohibits the use of chemical and biological weapons in war, reflecting its commitment to biosecurity.
✅ Summary
Armenia's biotechnology legal framework is characterized by:
Strict Biosafety Regulations: Prohibiting most uses of GMOs, with exceptions for controlled scientific research.
Comprehensive Patent Laws: Allowing for the protection of biotechnological inventions under national and international patent treaties.
Ethical Standards in Biomedicine: Aligning with international conventions to ensure the protection of human rights in biomedicine.
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