National implementation of the Protocol rests on the Law on Genetically Modified Organisms (LGMO) (Official Gazette No. 35/2008, as amended, most recently in 2025) and its implementing decrees and rulebooks. These are supplemented by sectoral legislation on food, feed, seed and planting material, forest reproductive material, plant health, plant protection products, veterinary and human medicinal products, inspection and criminal liability. National measures are reported as partially in place for the following reasons. The two implementing rulebooks under Article 56 of the Law on Food Safety (GM food authorisation, labelling and traceability) were drafted in 2024 but had not been adopted by the end of the reporting period. No implementing rulebook has been adopted under Article 65 of the Law on Feed Safety (approval of GM feed). The conditions for approval of GM forest basic material under the Law on Forest Reproductive Material have not been prescribed. No provision implements the documentation requirement of Article 18.2(b) of the Protocol for LMOs destined for contained use. The fee rulebook for contained-use permits was annulled by the Constitutional Court in December 2023 and has not been replaced. There is no separate budget line for biosafety. The institutions concerned are financed from the national budget, their own revenues, European Union funds and donor projects. GM food controls are planned and financed within the annual Food Safety Monitoring Programme of the Food and Veterinary Agency (FVA). GMOs have not been included in the national feed safety monitoring programmes. These resources are not adequate for the functions required by the Protocol. Four staff members perform functions directly related to biosafety. One officer works in the Department for Biodiversity and Genetically Modified Organisms of the Ministry of Environment and Physical Planning (MoEPP). This officer is also the national focal point for the Protocol and the Biosafety Clearing-House and is responsible for the wider biodiversity portfolio. Two officers work in the Department for Genetically Modified Food of the FVA. One officer works in the Department for National Gene Bank and GMOs of the Ministry of Agriculture, Forestry and Water Economy (MAFWE) and also covers other seed and planting-material duties. This number is not adequate.

Under Article 5(3) of the Law on Genetically Modified Organisms (LGMO), the provisions concerning the placing of GMOs and GMO products on the market and the transboundary movement of GMOs and GMO products do not apply to pharmaceutical products used in human and veterinary medicine that contain, consist of, or are combinations of GMOs. Responsibility for medicines and medical devices rests with the Agency for Medicines and Medical Devices (MALMED), an independent state administration body. Its competences are defined in the Law on Medicines and Medical Devices, which regulates medicines and medical devices for use in human medicine, the conditions and manner of ensuring their quality, safety and efficacy, and the manner and procedures for their production, testing, placing on the market, trade, pricing, quality control, advertising and inspection oversight. The Law does not refer to GMOs by name, but its definitions include the term 'biological medicine', meaning any medicine whose active substance is a biological substance or a substance obtained through a process involving biological systems. A biological substance is any substance produced from or using a biological source, the quality of which requires a combination of physico-chemical and biological testing together with its production process and control - for example, medicines produced by biological or biotechnological processes, including cell cultures and recombinant DNA technology, medicines derived from blood and plasma, and immunological medicines. In addition, the Rulebook on Obtaining Marketing Authorisation for Medicines (203/2015) prescribes the content of the application, the form and content of the required documentation, the procedure for recognising a marketing authorisation issued by an EU Member State, and the procedure for obtaining a conditional marketing authorisation for medicines for human use. Article 6, point 1.6 requires the applicant to provide an environmental risk assessment for medicines containing GMOs. Article 8 lists the information the application must contain, including a requirement for written approval for the release of the GMO into the environment from the competent authority (the Ministry of Environment and Physical Planning, MoEPP). Article 14 specifically provides that, for medicines containing GMOs, the application must also include an environmental risk assessment. The Rulebook on the manner and procedure for clinical trials of medicines (29/2009) extends the deadline for the Ethics Committee opinion to 90 days for medicinal products containing GMOs. The Instruction on the procedure for issuing a marketing authorisation for a finished medicinal product (49/2004) requires environmental risk-assessment data for such products. Veterinary medicinal products containing or consisting of GMOs are regulated by Article 20 of the Law on Veterinary Medicinal Products and by the Rulebook on the information to be contained in the assessment report for veterinary medicinal products (104/2012). The rulebook requires a dedicated chapter assessing the risk to human health and the environment. The application form and conditions are to be prescribed jointly by the Food and Veterinary Agency and the MoEPP.

Under Chapter VI (“Transboundary Movement of GMOs and GMO Products”, Articles 51–58) of the Law on Genetically Modified Organisms (LGMO), transit is regulated as a form of transboundary movement, defined as the import, export or transit of GMOs or GMO products from one country to another. Transport of GMOs by rail, air, land and water is governed by LGMO Article 5(2), which requires it to be carried out in accordance with the international agreements on the transport of dangerous substances ratified by the country. Any transit requires prior notification at least fourteen days before transit and approval from the Ministry of Environment and Physical Planning (MoEPP); MoEPP must issue a confirmation of receipt within three days of a complete notification, and a transit permit no later than three days before transit, copied to the Customs Administration, which will not allow transit unless the permit is attached to the transport documentation. Permit forms are prescribed in the Rulebook on the form and content of the export permit for GMOs and/or GMO products (23/2014). Transit must be accompanied by documentation identifying the cargo as containing LMOs, the safety measures applied, and contingency plans for accidental release. Contained use is regulated in LGMO Chapter IV (Articles 14–25), which builds a graduated procedure around a four-class risk classification: Article 14 sets the scale from Class 1, negligible risk requiring only containment Level 1, up to Class 4, high risk requiring containment Level 4. Before and during any contained use the operator must carry out a risk assessment, reviewed at least annually under Article 15, and the facility itself must be notified to and permitted by the authorities, with Article 16 setting a 90-day decision deadline conditional on an opinion from the Scientific Committee within 30 days. The stringency of the notification procedure then scales directly with the risk class involved. Class 1 contained use may begin without further notification once the facility already holds a permit (Article 17); Class 2 use requires notification with a 45-day permit deadline and a 21-day window for the Committee’s opinion (Article 18); and Classes 3 and 4 require the operator’s explicit written consent, together with a 90-day permit deadline and a 30-day opinion window (Article 19). Operators must also maintain an emergency plan — covering risk assessments, safety equipment, alarm systems, mitigation measures and staff instructions, reviewed at least annually (Article 20) — and any data submitted in the course of these procedures may be treated as confidential (Article 21). MoEPP and the Scientific Committee retain the power to demand further information, order a change of risk class, or temporarily suspend a contained use where warranted (Article 22); operators are under a standing 24-hour duty to report any new risk-relevant information (Article 23) and any accident, the costs of which fall on the operator (Article 24); and where an accident has a transboundary dimension, MoEPP must consult the affected states, report to the Government within three months, and keep the public informed (Article 25). Notification forms for first-time use of a facility are prescribed in the Rulebook on contained use of GMOs (8/2011) and the Rulebook on the form of the notification announcement for contained use of GMOs (150/2012); the methodology, elements and criteria for risk assessment by containment class are prescribed in Rulebook 196/2023. A separate rulebook, adopted under LGMO Article 16(15), prescribed a flat fee of 27,000 denars for each procedure for a facility permit or a permit for contained use of Class 2, 3 or 4 GMOs (Official Gazette No. 3/2023). On 5 December 2023 the Constitutional Court annulled this rulebook on procedural grounds (Decision U.br. 100/2023), because it had been published after the seven-day deadline for publication of legal acts set by Article 52(2) of the Constitution. No replacement fee rulebook had been adopted by the end of the reporting period. No notification or application for the transit or contained use of GMOs was received, and no transit or contained-use permit was issued, during the reporting period.

Under Chapter VI (Articles 51–58) of the Law on Genetically Modified Organisms (LGMO), exporters must notify the competent authority of the Party of import in writing before any intentional transboundary movement. The notification is submitted to the Ministry of Environment and Physical Planning (MoEPP), which forwards it to the importing state’s competent authority requesting acknowledgment within 30 days, with a written reminder copied to the Protocol Secretariat if none arrives within 90 days. MoEPP issues an export permit within 30 days of receiving the importing state’s import approval. Notification content must meet Cartagena Protocol Annex I requirements, detailed further in the Rulebook on the information to be submitted for the export of GMOs (18/2013) and the Rulebook on the form of the export permit (23/2014). Export permits match the validity of the importing country’s approval, and where that is unspecified, are valid for up to five years. Exporters bear full responsibility for the truthfulness, completeness and scientific accuracy of notification dossiers, must immediately report new risk-relevant information, and are subject to misdemeanour fines under the LGMO. Unauthorised handling, transport, import or export of GMOs may also give rise to criminal liability under Article 310 of the Criminal Code. During the reporting period, the MoEPP did not receive any notification of an intentional transboundary movement of LMOs for intentional introduction into the environment and took no import or export decision. The import of GMOs for deliberate release requires the prior written consent of the MoEPP (LGMO Article 51), following the opinion of the Scientific Committee on GMOs. Deliberate release of GMOs into the environment is regulated under LGMO Chapter V (Articles 26–50). Article 26 requires prior notification to MoEPP accompanied by environmental risk-assessment data, the content of which is prescribed in Rulebook 148/2009. Article 29 prohibits the deliberate release of GMOs containing antibiotic-resistance genes. Article 31 (GMO areas/protection zones) is the empowering basis for the Government decrees establishing areas in which GM reproductive material may not be released (112/2009 and its annex 113/2009). Article 34 requires detailed technical documentation. Article 35 sets a 90-day permit-decision deadline, with a Scientific Committee on GMO opinion within 45 days, public hearings potentially extending the procedure by up to 30 days, and permits valid for up to ten years. Article 36 requires an environmental risk assessment prior to notification, with the assessment’s content, scope and methodology prescribed in Government Decree 22/2012. Precautionary safeguards include case-by-case risk assessment reviewed by the Scientific Committee on GMOs; a safeguard clause (Article 30) allowing MoEPP, in agreement with the Ministry of Agriculture, Forestry and Water Economy and the Ministry of Health, to suspend or restrict release, cultivation or market placement if new information creates uncertainty or unforeseen risk; and the spatial exclusion zones described above. Article 32 requires state bodies, universities, the Macedonian Academy of Sciences and Arts and ethics committees to cooperate and exchange information. Where scientific uncertainty cannot be resolved, the MoEPP may withhold consent.

This area is governed jointly by the Law on Food Safety, the Law on Feed Safety and the Law on Genetically Modified Organisms (LGMO). The LGMO’s exclusion clause is Article 5(3), headed “Exceptions to the application of the Law and application of other laws and regulations”. It provides that the provisions of the LGMO relating to the placing of GMOs and GMO products on the market and to the transboundary movement of GMOs and GMO products do not apply to (i) pharmaceutical products used in human and veterinary medicine which contain, consist of, or are combinations of GMOs, and (ii) food and food ingredients used for the production, handling, processing and preparation of food intended for human consumption which contain and/or consist of GMOs or of a combination of GMOs, as regards placing on the market, import and export. These categories are governed instead by the Law on Food Safety and by the legislation on medicinal products, respectively. The Article 5(3) exclusion is expressed in terms of food and food ingredients, and does not in terms extend to feed. Genetically modified feed is nevertheless regulated under its own dedicated regime in Chapter VII of the Law on Feed Safety, which provides that GM feed is subject both to that Law and to the environmental protection regulations, and which requires an approval for market placement issued jointly by the Ministry of Agriculture, Forestry and Water Economy and the Ministry of Environment and Physical Planning. The two regimes are therefore complementary rather than mutually exclusive in the case of feed. For the first part of the reporting period (1 January 2020 to the entry into force of the amendment to the Law on Food Safety published in Official Gazette No. 209/2023), a statutory prohibition on the production, placing on the market and import of GM food applied, and the Article 56 authorisation regime was suspended. For the remaining reporting period, the Article 56 authorisation regime applies, but its two implementing rulebooks, prepared in 2024, remain in draft. For GM feed, the Articles 64–66 regime has applied throughout, without any implementing rulebook adopted. The Rulebook on the conditions for placing on the market and the list of feed materials (18/2014, as amended by 273/2019) nevertheless requires feed business operators to ensure that GMO-derived feed materials comply with the applicable legal requirements; this is a due-diligence obligation, not an approval procedure. Under either regime, no lawful route to the market existed, and no domestic-use or import decision on an LMO intended for food, feed or processing was taken during the reporting period. North Macedonia’s practical response to Cartagena Protocol Article 11.8 (decisions under scientific uncertainty) is therefore better characterised as resting on the authorisation requirement itself — no approval, no lawful market placement — reinforced for the earlier part of the period by an express statutory prohibition, which achieves a precautionary outcome. Exporters and notifiers remain subject to the information-accuracy obligations described under question 30. Import decisions on LMOs for food, feed or processing would draw on two frameworks: LGMO Article 51 (prior written consent of the Ministry of Environment and Physical Planning, following the risk-assessment opinion of the Scientific Committee on GMOs) for the environmental aspects, and the approval procedures under the Law on Food Safety and the Law on Feed Safety for the food and feed use aspects. Provisions of the Law on Food Safety relevant to controls on this category beyond Article 56 itself include Article 4, points 60–62 (definitions of novel food, GM food, and food for special nutritional purposes); the general import-control provisions applicable to all food including GM food; and the provisions on sampling and analysis methods, which confirm that a request for an additional expert opinion does not suspend the powers of the Food and Veterinary Agency (FVA) for emergency risk mitigation. Relevant provisions of the Law on Feed Safety include the general import, export, labelling and traceability framework within which the GM feed provisions of Articles 64–66 operate.

Review of decisions is regulated under the Law on Genetically Modified Organisms (LGMO). The Ministry of Environment and Physical Planning (MoEPP), in consultation with the Scientific Committee on GMOs, may review, amend, suspend or revoke permits and decisions concerning the transboundary movement, transit or use of GMOs. A review may be triggered by new scientific or technical information on risks or by an applicant’s request based on changed circumstances, and follows the general administrative procedure. As no decision on an intentional transboundary movement was taken during the reporting period, no decision was reviewed.

Consistent with its precautionary approach, North Macedonia has not adopted simplified or expedited administrative pathways for LMO imports or transboundary movements. Standard Advance Informed Agreement procedures apply in all cases, requiring full risk assessment, public consultation where applicable, and a decision by the Ministry of Environment and Physical Planning, based on the opinion of the Scientific Committee on GMOs.

No bilateral, regional or multilateral agreement specifically concerning the transboundary movement, handling or use of LMOs has been established by the Republic of North Macedonia with other Parties or non-Parties. All transboundary movements of LMOs are governed under the domestic Law on Genetically Modified Organisms and the default Advance Informed Agreement procedures of the Cartagena Protocol. North Macedonia's international engagement on biosafety instead takes place through the EU accession process (the Stabilisation and Association Agreement and TAIEX technical assistance under Chapters 12 and 27 of the acquis), participation in the Biosafety Clearing-House capacity-building programme, and the joint Aarhus Convention-Convention on Biological Diversity Global Round Table on LMOs/GMOs (Geneva, 11-12 December 2023); none of this cooperation, however, constitutes a bilateral, regional or multilateral agreement within the meaning of Article 14 of the Protocol.

Mandatory, case-by-case environmental risk assessment is required under the Law on Genetically Modified Organisms (LGMO) prior to deliberate release, contained use or market placement, evaluating direct, indirect, immediate, delayed and cumulative long-term risks to human health, biodiversity, flora, fauna and soil fertility, with particular attention to excluding GMOs containing antibiotic-resistance genes. The Ministry of Environment and Physical Planning (MoEPP) submits complete notifications to the Scientific Committee on GMOs within 15 days, and the Committee issues a written opinion within 45 days. The content, scope and methodology of environmental risk assessment are set out in Government Decree 22/2012, empowered by LGMO Article 26(5). This is the domestic instrument that corresponds most closely to Cartagena Protocol Annex III. Its six-step methodology requires: identification of the characteristics of the GMO that may cause adverse effects, assessed against the unmodified organism, covering human and animal disease including allergenic and toxic effects, effects on the population dynamics and genetic diversity of species in the receiving environment, altered susceptibility to pathogens, threats to prophylactic and therapeutic treatments including transfer of antibiotic-resistance genes, and effects on biogeochemical cycles; assessment of the consequences of each potential adverse effect; assessment of the likelihood of each identified effect; risk assessment combining likelihood and severity for each characteristic; application of risk-management strategies; and determination of the overall risk of the GMO. The methodology is expressly grounded in the precautionary principle, requires a case-by-case, transparent and science based approach taking account of GMOs already present in the receiving environment, and requires re-assessment where new information emerges. As no notification has been received, the methodology has not yet been applied in practice. Three further, sector-specific risk-assessment mechanisms are relevant and should not be conflated with the environmental mechanism above. Plant health. The Order of MAFWE implementing “International Standard for Pest Risk Analysis of Quarantine Pests, including Analysis of Environmental Risk and Living Modified Organisms No. 11” (35/2014), made under Article 69, indent 2, of the Law on Plant Health, incorporates ISPM 11 into national law. This is the clearest instance in North Macedonian legislation in which the term LMO, as used in the Cartagena Protocol, has an express regulatory anchor distinct from the LGMO’s own “GMO” terminology, administered through MAFWE’s phytosanitary system rather than by MoEPP. Veterinary medicinal products. Rulebook 104/2012, Article 5(4)–(5) and Annex 3, requires a dedicated human-health and environmental risk assessment chapter in the assessment report for any veterinary medicinal product containing or consisting of GMOs, with specified requirements for molecular characterisation. Food and feed. The GMO Panel of the National Council for Food and Feed Safety is the designated scientific body for GMO risk assessment in the food and feed domain. Its first meeting was held in October 2020 and its expert composition has since been renewed twice; no GMO risk assessment was requested from it during the reporting period. Two expert bodies support risk assessment and management under the LGMO: The GMO Management Commission, established under LGMO Article 62(1) by Government Decision (11/2009), is a fifteen-member body appointed by the Government on MoEPP’s proposal for a four-year term, drawn from social-science, medical, veterinary, forestry and agricultural faculties and institutes of the Ss. Cyril and Methodius University and the State University of Tetovo, the Medical Chamber of Macedonia and the Faculty of Philosophy, together with the Movement of Ecologists of Macedonia, the Macedonian Academy of Sciences and Arts, the Consumer Protection Organisation and the General Secretariat of the Government; it advises the Government and submits annual reports. The Scientific Committee on GMOs, established under LGMO Article 64(1), is a seven-member expert advisory body to MoEPP, appointed for a four-year term, which evaluates notifications and risk assessments and advises on methodological alignment with the Cartagena Protocol. It was first established by Government Decision in 2009 (Official Gazette No. 11/2009), with members drawn from the Medical Chamber of Macedonia, the South East European University, the Faculty of Agricultural Sciences and Food, the Faculty of Veterinary Medicine and the Faculty of Forestry (Ss. Cyril and Methodius University), the Macedonian Academy of Sciences and Arts and the Institute of Occupational Medicine. Its current composition was established by Government Decision published in Official Gazette No. 149/2019. The Committee started work and held three meetings. Because no cost schedule for its work had been adopted, two members asked to be replaced, and the Decision was amended accordingly (Official Gazette No. 227/2022). The mandate of the current Committee expires on 26 October 2026, and a new composition will need to be appointed. The members of the GMO Management Commission were appointed in 2009 for a four-year term, and the Commission needs to be re-established with new membership. Risk methodology on management of crisis is separately governed under the Law on Crisis Management and the Decree on the threat assessment methodology (128/2023). Risk management rests on mandatory authorisation conditions (LGMO Articles 41–42); observation-period requirements addressed case-by-case within the environmental risk assessment rather than through a fixed statutory holding period, since Rulebook 148/2009 and Decree 22/2012 require assessments to evaluate time-dependent variables such as generation time, persistence and multi-generational trait transfer; and the authorisation requirements for food and feed described under question 36. Institutionally, MoEPP is the competent authority supported by the Scientific Committee on GMOs; the phytosanitary services of the Ministry of Agriculture, Forestry and Water Economy applies the ISPM 11 framework; and the Food and Veterinary Agency coordinates the national rapid alert system for food and feed. Prevention of unintentional transboundary movement relies on the mandatory case-by-case environmental risk assessment, which must evaluate accidental escape, pollen drift and cross-border contamination pathways; on mandatory emergency plans for contained use and deliberate release (Rulebook 163/2009); and on the 24-hour notification duty described under question 78.

Articles 24, 25 and 58 of the Law on Genetically Modified Organisms (LGMO) regulate accidental releases. Users must inform the Ministry of Environment and Physical Planning (MoEPP) within 24 hours of an accident. Where there is a transboundary impact, MoEPP must immediately, within 24 hours, inform the public, affected or potentially affected states, Parties to the Convention on Biological Diversity, the Convention Secretariat, relevant international organisations and the Biosafety Clearing House. Rulebook 190/2014 specifies diplomatic notification through the Ministry of Foreign Affairs within 15 days, in English or in the official language of the affected state. Rulebook 163/2009 details the content of the emergency plan, including decontamination, isolation, healthcare planning, public warning protocols and annual review. The State has the legal authority to require operator-funded containment and decontamination. However, the State’s own field-response capacity is limited: there are no dedicated rapid-response cleanup teams; the specialised personnel pool is very small (see question 13); and there is no standing emergency fund for GMO incidents. General emergency response capacity exists under the Law on Crisis Management and the General Plans for Crisis Management for Food and Feed Safety (2013–2018 and 2019–2024 editions), but neither plan addresses an LMO scenario specifically.

LMOs subject to transboundary movement must be handled, packaged and transported under conditions of safety in accordance with Article 50 of the Law on Genetically Modified Organisms (LGMO) and Rulebook 135/2014. These require leak-proof packaging and labelling identifying the product as containing GMOs, its commercial and GMO name, the responsible entity and the GMO Register permit number. A 0.9% threshold for adventitious or technically unavoidable presence applies to products intended for direct processing. On import, information on the presence of GMOs must be entered in the veterinary or phytosanitary certificate (LGMO Article 51(2)). Transport is further governed by the international agreements on the transport of dangerous goods (ADR for road, COTIF/RID for rail) under LGMO Article 5(2). Export notifications for intentional introduction into the environment require documentation identifying the LMO, data on the parental organisms, safe-handling methods and a declaration of conformity with the Cartagena Protocol (Rulebooks 18/2013, 23/2014 and 148/2009). A gap exists for LMOs destined for contained use. No provision in national law requires the accompanying documentation to identify them as LMOs or to specify requirements for their safe handling, storage, transport and use, as required by Article 18.2(b) of the Protocol. Closing this gap is a priority legislative need. Official GMO testing is performed under a contract between the Food and Veterinary Agency (FVA) and the Laboratory for Molecular Analysis of Food and Genetically Modified Organisms of the Food Institute, Faculty of Veterinary Medicine – Skopje. The laboratory is accredited to MKS EN ISO/IEC 17025:2018 (certificate LT-006) for three qualitative real-time PCR methods: screening for the CaMV 35S promoter, the NOS terminator and the FMV promoter, and detection of plant DNA, with limits of detection of 0.01–0.1%. This capacity is sufficient under the current regime, in which no GM food or feed is authorised and any detection is a non-compliance, so no threshold calculation is required. Once the implementing rulebooks under Article 56 of the Law on Food Safety are adopted and national law is aligned with Regulations (EC) No 1829/2003 and No 1830/2003, the 0.9% labelling threshold and event-specific labelling will apply, and quantitative and event-specific detection capacity will become necessary. LMOs can therefore be detected in the country. No method for identifying specific LMO events, and no quantitative method, is yet available in the country; identification and quantification of a positive screening result are carried out by referral to accredited laboratories in the region and in the European Union, as already practised when confirmatory analyses were performed in a European reference laboratory. Developing event-specific and quantitative detection capacity is a priority capacity-building need. The State Phytosanitary Laboratory has a statutory mandate for GMO analysis of plants and plant products but is not accredited for, and does not perform, GMO analyses. No sample tested under the Food Safety Monitoring Programme during the reporting period returned a positive result. The Customs Administration has no GMO-specific targeting criterion, and its laboratory does not perform GMO analyses. GMO-related screening at the border therefore relies on referral to the FVA, the State Agricultural Inspectorate and the phytosanitary services. No customs officers received training specifically on the identification of LMOs during the reporting period.

The Ministry of Environment and Physical Planning (MoEPP) is the sole Competent National Authority formally designated and notified to the Biosafety Clearing-House, and the same office also serves as the joint national focal point for the Cartagena Protocol and for the Biosafety Clearing-House. Functionally, further institutions exercise GMO-related competences under distinct sectoral statutes: the Food and Veterinary Agency (FVA) for GM food, GM feed and official controls; the Ministry of Agriculture, Forestry and Water Economy (MAFWE) for seed, planting material, forest reproductive material and phytosanitary matters; and the Agency for Medicines and Medical Devices (MALMED) for GMO-containing pharmaceuticals. Coordination among these bodies is mandated under Article 32 of the Law on Genetically Modified Organisms and is operationalised through concrete mechanisms, including the joint MAFWE/MoEPP approval requirement for placing GM feed on the market, the joint FVA/MoEPP rule-making power for veterinary medicinal products of GMO origin, and the GMO Panel of the National Council for Food and Feed Safety. The institutions report to the Government and the Assembly at least every three years under LGMO Article 61. The principal constraint on institutional capacity is staffing: the MoEPP Department for Biodiversity and Genetically Modified Organisms, which discharges all Cartagena Protocol functions, has a single employee, who also serves as the national contact point for the Protocol. Strengthening this unit is identified as a priority need for the next reporting period.

The Law on Genetically Modified Organisms (LGMO, 35/2008) is registered and posted on the Biosafety Clearing-House (BCH), so information required for the advance informed agreement procedure is only partially available on the BCH. The substantial body of sector-specific legislation, including the Food Safety Law's provisions on GM food (Article 56), the Law on Feed Safety Chapter VII on GM feed, the seed and planting material legislation, Government Decree No. 22/2012 on the environmental risk-assessment methodology, and Order No. 35/2014 on pest risk analysis, exists and is publicly available domestically but has not yet been uploaded to the BCH.

The Ministry of Environment and Physical Planning (MoEPP) is both the Cartagena Protocol national focal point and the Biosafety Clearing-House national focal point, with both functions discharged by the same officer within the Department for Biodiversity and Genetically Modified Organisms, ensuring de facto coordination between the two roles; inter-institutional coordination with the other competent authorities is further mandated under LGMO Article 32. Because no notification, decision, permit or incident of any kind has arisen under the Cartagena Protocol in North Macedonia during the reporting period, the BCH registries that record decisions, notifications and incidents for the country are necessarily empty. The LGMO is posted on the BCH, but the wider body of sectoral legislation has not yet been uploaded.

The Law on Genetically Modified Organisms (LGMO), Articles 21 and 33, allows an applicant submitting a notification for contained use, deliberate release, or market placement of a GMO to request that specific parts of the documentation be treated as confidential where disclosure would cause significant commercial harm or infringe intellectual property rights. The applicant must expressly mark and justify each confidential item in writing, and MoEPP must decide on the request within 15 days of receiving the notification. Certain categories of information can never be treated as confidential - including the identity of the applicant, the general description and molecular characterisation of the GMO, the location of release or containment, the complete environmental risk assessment, emergency plans, and post-market monitoring data - in order to safeguard public safety, environmental protection and public participation. If a notification is withdrawn, MoEPP and all reviewing bodies remain bound to permanent confidentiality over the data already submitted. As no notification has yet been received during the reporting period, these procedures have not been applied in practice.

North Macedonia has no predictable domestic budget line dedicated to biosafety capacity-building and has relied substantially on externally funded support. Between 2009 and 2025, eight GMO-titled TAIEX activities were delivered, although an eleven-year gap between 2013 and 2024 saw no GMO-specific TAIEX activity, and three planned 2020-2022 GM food activities (an expert mission, a workshop and a study visit) were postponed due to the COVID-19 pandemic and never rescheduled. Engagement resumed in 2024-2025 with a TAIEX Expert Mission (Skopje, August 2024) and a TAIEX Study Visit to Madrid (May 2025) on harmonising national GM food legislation with the EU acquis ahead of accession, directly linked to the two draft implementing rulebooks prepared under Food Safety Law Article 56. North Macedonia also participated in the three phases of the global Biosafety Clearing-House capacity-building programme (2004-2008, 2010-2013, 2016-2020), in JRC/EU Reference Laboratory for GM Food and Feed workshops on GMO detection and analysis (2009, 2014), in Better Training for Safer Food (BTSF) sessions on GM food risk assessment (2021–2022), in risk-analysis workshops for the FVA, the Ministry of Health, the Institute of Public Health and academic institutions under the EU-funded project “Improved Animal Disease Control and Food Safety System Implementation” (2022–2023), and in a national training course and tabletop exercise under the EU-funded Project P100 on front-line biosafety and biosecurity measures (Skopje, June 2025), which brought together the Ministry of Foreign Affairs, the FVA, the Customs Administration, the Border Police and the Institute of Public Health. No GEF national biosafety framework project was implemented during the reporting period; the two national GEF/UNEP projects (2005 and 2011-2015) both predate it - and no GEF STAR allocation for biosafety has been used during the reporting period. Priority capacity-building needs going forward are strengthening the single-officer MoEPP biosafety unit, developing quantitative and event-specific GMO laboratory detection capacity, and obtaining a live or simulated application of the Decree 22/2012 environmental risk-assessment methodology.

Public consultation on LMO decisions is mandatory under Article 12 of the Law on Genetically Modified Organisms (LGMO), comprising publication of notification summaries, a 30-day public comment period, public hearings on request, and published consultation reports; because no notification has been received during the reporting period, this procedure has not yet been exercised in practice. As no decision on LMOs was taken, no decision results were published. Biosafety-related education is offered at university level, principally at the Faculty of Agricultural Sciences and Food, the Faculty of Veterinary Medicine, the Faculty of Technology and Metallurgy and the Faculty of Natural Sciences and Mathematics (Ss. Cyril and Methodius University, Skopje). North Macedonia's public-participation framework for GMO decision-making was also addressed at the Fourth Joint Aarhus Convention-CBD Global Round Table on LMOs/GMOs (Geneva, 11-12 December 2023). No GMO-specific or biosafety-specific national communication strategy, public awareness programme or dedicated website exists; The general environmental communication and awareness strategies of the Ministry of Environment and Physical Planning contain no GMO content, although the periodic State of Environment Report is required by its implementing rulebook to include a dedicated GMO section.

No LMO was imported from or exported to a non-Party to the Cartagena Protocol during the reporting period. All transboundary movements of LMOs are regulated under the domestic LGMO framework irrespective of the Party status of the country of origin or destination, and no bilateral or regional agreement concerning transboundary movement, handling or use of LMOs with a non-Party was identified.

North Macedonia has adopted a three-tier system of domestic measures to prevent and penalise transboundary movements of LMOs carried out in contravention of the Cartagena Protocol. At the administrative level, the Law on GMOs (LGMO) Articles 71-73, substantially revised by Law 150/2021, establish misdemeanour fines tiered by trader size (micro, small, medium and large). These sit alongside sector-specific misdemeanour provisions under the Food Safety Law (violations of Article 56 on GM food), the Law on Phytopharmacy (Article 74, point 9, penalising violations of Article 23) and the Law on Feed Safety. At the most serious level, Criminal Code Article 310 imposes criminal liability - a fine or up to three years' imprisonment for a natural person, and a fine for a legal person - for unauthorised production, handling, transport, import, export or trade in GMOs dangerous to human, animal or plant life. Illegal shipments, whatever the level of liability engaged, must be confiscated, returned to origin or destroyed at the importer's expense. Prevention rests on border checks carried out by the Customs Administration, the Food and Veterinary Agency and the State Agricultural Inspectorate, the latter having express statutory competence over GMOs as both a subject of inspection oversight and a category of goods subject to consignment examination on import and export (Law on the State Agricultural Inspectorate, Articles 11 and 12). No case of illegal transboundary movement of an LMO has been identified during the reporting period.

Socio-economic considerations enter the framework principally through the composition of the GMO Management Commission established under LGMO Article 62, which includes representation from the social sciences, ethics, consumer protection (the Consumer Protection Organisation) and civil society (the Movement of Ecologists of Macedonia), and through the Commission's reporting obligation to the Government and the Assembly under LGMO Article 61. This channel is institutional rather than substantive: no provision was identified that expressly requires socio-economic impacts to be assessed as part of an LMO decision, and no socio-economic assessment methodology, guidance document or completed assessment exists. Socio-economic considerations therefore have an institutional channel but no operative legal requirement or methodology, and none has been applied in practice, since no LMO decision has been taken during the reporting period.

Monitoring and enforcement (Article 33). Article 49 of the Law on Genetically Modified Organisms (LGMO) requires the holder of an authorisation for placing on the market to implement a monitoring plan approved by the Ministry of Environment and Physical Planning (MoEPP) and to enter the monitoring reports, which are public, in the GMO Register. LGMO Articles 67–69 define the powers of the inspectorates — the State Inspectorate for Environment and Nature, the Food and Veterinary Agency (FVA), the State Agricultural Inspectorate, the Forestry Inspectorate and the State Market Inspectorate — to halt operations, order recalls and impose fines. Article 70 of the Law on Food Safety requires multi-annual control plans and an ISO/IEC 17025-accredited official laboratory network, with non-compliant results reportable to the FVA within 24 hours and referee (super-analysis) tests treated as final. Operationally, monitoring during the reporting period consisted of the GM food sub-programme of the annual Food Safety Monitoring Programme of the Food and Veterinary Agency. Samples are taken from products produced or imported and placed on the market at retail outlets, markets and butcher shops. Products are selected on the basis of the European Food Safety Authority list of GM food and of RASFF notifications of unauthorised GM food detected at the borders of the European Union, which provides a risk-based approach to sampling. The sub-programme provided for 50 samples in 2020 and 30 samples in each following year, taken from the same six product categories (soybean, rice, maize, cereal muesli, sausages and pâté). The allocated budget was 260,000 denars in 2020, 156,000 denars in each of 2021, 2022 and 2023, 135,000 denars in 2024 and 63,000 denars in 2025; the allocation for 2026 is 150,000 denars. No sample tested during the reporting period returned a positive result, and the annual reports of the Food and Veterinary Agency state that no GM food was detected on the national market. The national feed safety monitoring programmes for 2020–2026 did not include a GMO parameter. There was no environmental monitoring for GMOs, since it presupposes an authorised release and none has occurred. Reporting to the Government and the Assembly on GMO matters is required at least every three years under LGMO Article 61. A separate, broader reporting channel exists under the Law on Environment. Article 45(1)–(2) requires MoEPP to prepare an annual environmental-quality report, a biennial indicator report and, every four years, a comprehensive State of Environment Report, all adopted by the Government on MoEPP’s proposal, with the State of Environment Report additionally submitted to the Assembly for information; the indicator report and the State of Environment Report must both be made available to the public under the access-to-environmental-information provisions of Chapter VIII (Article 51). The form and content of these reports is prescribed, under the Article 45(4) empowerment, by the Rulebook on the form, content, objectives, method of preparation and the type and sources of data used for preparing the Report (98/2017), whose Article 12 requires the State of Environment Report’s chapter on “Impacts on the Environment” to include a dedicated section on genetically modified organisms, covering legislation, a brief assessment of the situation, GMO use, GMO production, and the achievement of goals and measures set out in strategic and planning documents. This is a distinct, general-environment reporting channel, additional to and independent of the LGMO Article 61 report addressed above. Cooperation. North Macedonia has cooperated with other Parties in the exchange of scientific, technical and institutional knowledge on GMOs, notably through TAIEX expert missions and study visits (2024-2025) on harmonising national GM food legislation with the EU acquis, through JRC/EU Reference Laboratory for GM Food and Feed workshops on GMO detection and analysis (2009, 2014), and through participation in the three phases of the global Biosafety Clearing-House capacity-building programme. It has engaged in bilateral, regional and multilateral activities for implementation of the Protocol, including the 2025 EU-funded P100 project on front-line biosafety and biosecurity measures and delegation participation in CBD COP-MOP 10 (2021-2022). North Macedonia does not have officially recognised indigenous peoples in the sense used by the Protocol, so no mechanism specifically targets indigenous peoples in Cartagena Protocol implementation; the public-consultation mechanism under LGMO Article 12, together with the broad multi-sectoral composition of the GMO Management Commission (representing academia, medical and veterinary professions, environmental NGOs and consumer protection), does provide a general mechanism for involving relevant stakeholders from different sectors.

These are general environmental-liability and GMO-specific instruments - the Law on GMOs (Article 8, polluter-pays principle), the Law on Environment (Chapter XVI, Article 157) and the Rulebook on professional activities giving rise to liability for environmental damage (31/2011), which expressly lists contained use, transport, release and market placement of GMO-containing products as liability-triggering activities - rather than a law or regulation adopted specifically to implement the Nagoya-Kuala Lumpur Supplementary Protocol, to which North Macedonia is not a Party.

North Macedonia is not a Party to the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress, and its ratification is planned in the programme of the Government. Liability and redress for GMO-related damage is nonetheless addressed through general domestic instruments rather than a dedicated Supplementary Protocol implementing act: LGMO Article 8 establishes the polluter-pays principle, and Law on Environment Article 157 establishes liability for environmental damage on the same principle, requiring an operator to take preventive measures, notify the competent authority, remediate damage and bear the costs. The professional activities that trigger this liability are designated in the Rulebook on professional activities giving rise to liability for environmental damage (31/2011), which expressly lists the contained use and transport of products containing GM micro-organisms, and the intentional release, transport and market placement of products containing GMOs. The training curriculum for assessors of environmental damage and value (Programme 35/2012) lists the Law on GMOs among its reference instruments, so professionals who would value any GMO-related environmental damage are trained with specific reference to the GMO framework. No dedicated mandatory insurance or financial-security scheme for LMO operators exists, no competent authority has been formally designated for functions specific to the Supplementary Protocol, and no case of damage resulting from an LMO has occurred during the reporting period. Ratification is also relevant to the country’s alignment with the European Union acquis, the European Union being a Party to the Supplementary Protocol. Technical assistance is needed to support the ratification process, including the designation of a competent authority, the establishment of financial-security arrangements and the preparation of implementing measures.