MOH (Oman)

Oman MoH (Ministry of Health — Sultanate of Oman) — operating through the Directorate General of Pharmaceutical Affairs and Drug Control (DGPA&DC) — is the Sultanate of Oman's national regulatory authority for human medicines + biologicals + vaccines + medical devices + IVDs + cosmetics + dietary supplements + pharmacy practice + controlled substances. Oman MoH operates under Royal Decree 35 of 2015 (Pharmacy Profession + Pharmaceutical Establishments) + Royal Decree 41 of 1996 (Health Law) + Royal Decree 17 of 1999 (Narcotics + Psychotropics — substantively aligned with UN Single Convention 1961 + Conventions 1971 + 1988) + Royal Decrees + Ministerial Decisions + DGPA&DC Decisions + Guidance Documents.

Oman MoH organisational structure includes:

• Minister of Health — political head appointed by Royal Decree.
• Undersecretary for Health Affairs + Undersecretary for Planning Affairs.
• Directorate General of Pharmaceutical Affairs and Drug Control (DGPA&DC) — pharmaceutical + medical-device + cosmetic + dietary-supplement regulator.
• Drug Registration Department — drug + biological + vaccine + biosimilar + generic-medicine registration.
• Pharmaceutical Inspection Department — GMP + GDP + GPP + GVP + GLP inspections of Omani + foreign manufacturing facilities.
• Pharmacovigilance Department — Oman National Pharmacovigilance Programme + WHO PIDM coordination.
• Medical Devices Department — medical-device + IVD registration + matériovigilance.
• Pharmacy Practice Department — pharmacy + pharmaceutical-establishment licensing.
• Cosmetics + Dietary Supplements Section — cosmetic-product + dietary-supplement notification.
• Controlled Substances Section — narcotics + psychotropics framework coordination with INCB + Royal Oman Police.
• International Affairs Section — WHO + EMA + FDA + GHC + Arab League + ICH coordination.
• Central Quality Control Laboratory — central pharmaceutical QC laboratory; ISO/IEC 17025 accredited; pursuing WHO PQ-Lab designation.
• Oman National Pharmacovigilance Centre — integrated PV + matériovigilance + cosmétovigilance centre.

Oman MoH is distinct from + complementary to: the Tender Board (centralised public-sector pharmaceutical procurement); the Diwan of Royal Court (Royal Diwan medical services); the Royal Oman Police Customs Directorate (importation enforcement); the Ministry of Commerce, Industry and Investment Promotion (MoCIIP — commercial registration + manufacturing licensing); Oman Vision 2040 healthcare programme coordination; and Omani pharmaceutical importer/distributor companies. Oman's pharmaceutical environment is characterised by: substantial pharmaceutical import dependency (~90% of pharmaceuticals imported); emerging domestic manufacturing through Duqm Special Economic Zone + Sohar Industrial Port + Salalah Free Zone; dominant public-sector procurement via Tender Board + MoH applying Reference Country pricing + Most-Favoured-Nation pricing references; substantial growing biotechnology + clinical-research focus via Sultan Qaboos University Hospital + The Royal Hospital + Oman Medical Specialty Board + National Genetic Centre; + strategic Vision 2040 healthcare-investment programme positioning Oman as a regional health-tourism + clinical-research + pharmaceutical-manufacturing hub.

Oman MoH is a Gulf Health Council (GHC) Member State authority + an active GCC Drug Registration co-leader (alongside SFDA + MoHAP + Kuwait MoH + Bahrain NHRA + Qatar MoPH) + a League of Arab States Council of Arab Ministers of Health pharmaceutical-harmonisation co-leader + an active WHO Prequalification Collaborative Registration Procedure (CRP) participating authority + a PIC/S Pre-Accession Candidate + an ICH Observer Candidate + an IMDRF Observer + holds substantial bilateral cooperation with EMA + FDA + Health Canada + TGA + Swissmedic + MHRA + MFDS.

Omani pharmaceutical regulation operates under a layered framework of Royal Decrees + Ministerial Decisions + DGPA&DC Decisions + Guidance Documents:

• Royal Decree 35 of 2015 — Pharmacy Profession + Pharmaceutical Establishments framework.
• Royal Decree 41 of 1996 — Health Law framework.
• Royal Decree 17 of 1999 — Narcotics + Psychotropics framework substantively aligned with UN Single Convention 1961 + Conventions 1971 + 1988.
• Royal Decrees + Ministerial Decisions on Medical Devices + Cosmetics + Dietary Supplements.
• DGPA&DC GMP Guide — substantively aligned with PIC/S GMP Guide + EU GMP + ICH Q7 + WHO TRS 986 Annex 2 + GCC GMP.
• DGPA&DC GDP Guide — substantively aligned with WHO + EU GDP + GCC GDP.
• DGPA&DC GCP Guide — substantively aligned with ICH E6(R2) + GCC GCP.
• DGPA&DC GVP Guide — substantively aligned with ICH E2 + EU GVP + GCC GVP.
• GCC Pharmacopoeia + recognises British Pharmacopoeia + USP + European Pharmacopoeia + Arab Pharmacopoeia.
• GCC Drug Registration framework — substantively harmonised registration procedure across GCC Member States.
• DGPA&DC Medical Devices framework — Class I-III risk-based classification substantively aligned with EU MDR + GHTF/IMDRF + GCC-MD.
• DGPA&DC Cosmetics framework — substantively aligned with EU Cosmetics Regulation including INCI ingredient listing + safety substantiation.
• DGPA&DC Variations + 5-year Drug Registration Renewal framework.
• Oman Tender Board pharmaceutical procurement framework with Reference Country pricing + Most-Favoured-Nation pricing references.

The Central Quality Control Laboratory is DGPA&DC's central pharmaceutical + medical-device quality-control laboratory + is ISO/IEC 17025 accredited. The Laboratory is pursuing WHO PQ-Lab designation, which would position it alongside Saudi SFDA Central Laboratory + Egypt EDA NODCAR + Morocco LNCM + Tunisia LNCM + Jordan JFDA Central Laboratories as a WHO-prequalified pharmaceutical QC laboratory in the MENA region. Oman additionally benefits from GCC Pharmaceutical Inspection cooperation — harmonised GCC-Member-State pharmaceutical inspection providing efficient cross-Member-State inspection coordination + reliance + recognition.

• ISO/IEC 17025 Accreditation — the Central Quality Control Laboratory is ISO/IEC 17025 accredited across multiple testing scopes including pharmaceutical chemical + microbiological + biological testing.
• WHO PQ-Lab Candidate — the Laboratory is pursuing WHO PQ-Lab designation; would provide Oman with WHO-recognised pharmaceutical QC capacity.
• GCC Pharmaceutical Inspection — Oman participates in GCC harmonised pharmaceutical inspection providing efficient cross-Member-State inspection coordination + reliance + recognition with Saudi SFDA + UAE MoHAP + Kuwait MoH + Bahrain NHRA + Qatar MoPH.
• GCC Centralized Drug Registration — substantively harmonised registration procedure across GCC Member States.
• Vaccine lot release — the Laboratory conducts vaccine lot-release testing for DGPA&DC + Oman National Immunization Programme.
• Pharmaceutical pre-registration + post-market testing — pre-registration quality testing + post-market surveillance + targeted enforcement testing.
• Medical-device + IVD testing — pre-market + post-market quality testing.
• Cosmetic-product + dietary-supplement testing — safety + ingredient compliance testing.
• Counterfeit-medicine forensics — forensic analytical support for DGPA&DC + Royal Oman Police + Oman Customs investigations + WHO Global Surveillance & Monitoring System contributions.
• Capacity-building — hosts GHC + Arab League + WHO capacity-building programmes + training for GCC + Arab-region pharmaceutical analysts.
• GMP Inspectorate support — provides scientific + technical support for DGPA&DC + GCC harmonised GMP inspections of Omani + foreign manufacturing facilities.
• Duqm + Sohar + Salalah free-zone coordination — Special Economic Zone manufacturing inspection coordination.

DGPA&DC medical-device + IVD regulation operates under DGPA&DC Medical Devices framework with Class I-III risk-based classification substantively aligned with EU MDR + GHTF/IMDRF + GCC-MD. Foreign manufacturers must appoint an Omani Authorised Representative.

• Risk-based Classification (Class I / IIa / IIb / III) — substantively aligned with EU MDR + GHTF/IMDRF + GCC-MD; IVDs classified under separate Oman IVD framework.
• Omani Authorised Representative — Oman-resident legal entity required for foreign manufacturers; bears post-market vigilance responsibility + DGPA&DC regulatory interface.
• ISO 13485:2016 — recognised by DGPA&DC as QMS evidence framework; Oman-specific overlay required.
• Reliance pathways — DGPA&DC accepts CE Mark + FDA 510(k) + FDA PMA + Health Canada + TGA + Swissmedic + MFDS + Japan-approval evidence as supporting evidence under reliance framework.
• GCC Medical Devices Harmonisation — Oman participates in GCC harmonised medical-device framework providing reliance + harmonised technical-file requirements across GCC Member States.
• Arab League Medical Devices Harmonisation — Oman participates in Council of Arab Ministers of Health medical-device harmonisation.
• Post-market vigilance — DGPA&DC operates medical-device adverse-event reporting through the Oman Matériovigilance System coordinated by Oman National Pharmacovigilance Centre.
• IVD Réactovigilance — DGPA&DC operates IVD réactovigilance reflecting Oman's growing clinical-laboratory infrastructure including Sultan Qaboos University Hospital + The Royal Hospital + Khoula Hospital + Armed Forces Hospital.
• Cosmetic Notification — cosmetics require DGPA&DC Cosmetic Notification + Arabic + English labelling; INCI-aligned ingredient listing + safety substantiation; substantively EU-aligned framework.
• Dietary Supplement Registration — DGPA&DC Dietary Supplements framework; substantively aligned with EU food-supplement framework + Codex Alimentarius.
• Oman UDI — DGPA&DC is progressively implementing UDI requirements substantively aligned with FDA UDI + EU EUDAMED UDI.
• Importation Permit — DGPA&DC Importation Permit required in addition to product registration for foreign-manufactured devices + drugs entering Oman; coordination with Royal Oman Police Customs.
• Duqm + Sohar + Salalah free-zone coordination — Special Economic Zone medical-device manufacturing + re-export coordination.

DGPA&DC operates the Oman National Pharmacovigilance Programme through the Oman National Pharmacovigilance Centre. Oman is a WHO Programme for International Drug Monitoring (PIDM) member + contributes ADR data to VigiBase via Uppsala Monitoring Centre (UMC). The Oman National Pharmacovigilance Centre operates Oman's integrated pharmacovigilance + matériovigilance + cosmétovigilance centre.

• Oman National Pharmacovigilance Centre — integrated PV + matériovigilance + cosmétovigilance centre operating under DGPA&DC Pharmacovigilance Department coordination.
• WHO PIDM Member — Oman is a WHO PIDM member + contributes ADR data to VigiBase via Uppsala Monitoring Centre.
• Oman Pharmacovigilance Network — coordinated national network with effector centres in major Omani hospitals (Sultan Qaboos University Hospital, The Royal Hospital, Khoula Hospital, Armed Forces Hospital, Royal Hospital of Salalah, Suhar Hospital, Nizwa Hospital) + Marketing Authorisation Holders.
• Online ADR Reporting — DGPA&DC operates online ADR reporting via the DGPA&DC portal; available for healthcare professionals + consumers + Marketing Authorisation Holders.
• E2B(R3) ICSR — DGPA&DC accepts E2B(R3) format ICSR submissions substantively aligned with ICH E2B(R3); 15-day SUSAR reporting timeline for clinical trials + post-market.
• PSUR / PBRER — periodic safety update reports substantively aligned with ICH E2C(R2); DGPA&DC-specific submission timeline.
• Risk Management Plans (RMP) — DGPA&DC requires ICH E2E-aligned Pharmacovigilance Plan + Risk Management Plan for new drugs + biosimilars + vaccines + high-risk products.
• Active surveillance — Oman National PV Centre operates targeted active-surveillance programmes including for diabetes therapeutics + oncology + COVID-19 vaccines + biologicals + sentinel-site hospital surveillance.
• AEFI Surveillance — Omani vaccine adverse-event surveillance aligned with WHO methodology; central to Oman National Immunization Programme + COVID-19 vaccine safety monitoring.
• Matériovigilance + Cosmétovigilance — DGPA&DC operates parallel matériovigilance for medical devices + cosmétovigilance for cosmetics through the integrated National Pharmacovigilance Centre.
• GCC Pharmacovigilance Network — Oman participates in GCC harmonised pharmacovigilance network providing efficient cross-Member-State safety signal sharing.
• Vision 2040 PV capacity-building — substantial pharmacovigilance capacity-building investment under Vision 2040 healthcare modernisation programme.

• WHO Listed Authority Candidate — DGPA&DC is a WHO Listed Authority candidate; substantial WHO PQ CRP participation + WHO PIDM membership + GCC Drug Registration co-leadership support trajectory.
• WHO PQ CRP Participating Authority — DGPA&DC is an active WHO Prequalification Collaborative Registration Procedure (CRP) participating authority.
• WHO PQ-Lab Candidate — Central Quality Control Laboratory is pursuing WHO PQ-Lab designation.
• GHC Member State — Oman MoH is a Gulf Health Council (GHC) Member State authority + active GCC Drug Registration co-leader alongside Saudi SFDA + UAE MoHAP + Kuwait MoH + Bahrain NHRA + Qatar MoPH.
• Arab League Council of Arab Ministers of Health Co-leader — DGPA&DC is an active pharmaceutical-harmonisation co-leader alongside Egyptian EDA + Saudi SFDA + Jordanian JFDA + UAE MoHAP + Morocco DMP + Tunisia DPM/ANPM + Algeria ANPP + Lebanese MoH + Kuwait MoH + Bahrain NHRA.
• EMA Bilateral — DGPA&DC holds substantial bilateral cooperation with EMA covering information exchange + reliance + clinical-trial harmonisation.
• FDA Bilateral — DGPA&DC holds substantial cooperation with FDA reflecting US-Oman pharmaceutical trade.
• MHRA Bilateral — DGPA&DC holds substantial cooperation with MHRA reflecting historical UK-Oman regulatory cooperation + UK-trained Omani pharmaceutical professionals.
• Health Canada + TGA + Swissmedic + MFDS Bilateral — DGPA&DC holds bilateral cooperation reflecting Stringent Regulatory Authority reliance practice.
• PIC/S Pre-Accession Candidate — DGPA&DC is on PIC/S Pre-Accession Candidate trajectory; GMP Guide substantively aligned with PIC/S GMP + EU GMP + ICH Q7.
• ICH Observer Candidate — DGPA&DC is exploring ICH Observer status; ICH guidelines extensively implemented in Omani regulatory practice including ICH Q7 + Q8 + Q9 + Q10 + Q11 + E2A-E + M4.
• IMDRF Observer — DGPA&DC is an IMDRF Observer + draws on IMDRF guidance for medical-device regulation.
• ICDRA + EMRO participation — active International Conference of Drug Regulatory Authorities + WHO Eastern Mediterranean Regional Office (EMRO) participant.
• Vision 2040 regulatory cooperation — substantial international regulatory cooperation under Oman Vision 2040 healthcare modernisation programme.

• Omani Authorised Representative not properly designated — application rejected at DGPA&DC intake or post-approval compliance failure; Omani Authorised Representative must be Oman-resident legal entity with appropriate licensure.
• Arabic + English labelling deficiencies — Arabic + English labelling required; many applicants provide insufficient Arabic-language patient leaflet.
• DGPA&DC + GCC GMP gaps — applicants assuming EU GMP / PIC/S GMP / FDA GMP compliance is automatically sufficient without addressing Oman-specific DGPA&DC + GCC GMP clarifications.
• Oman climate-zone stability data missing — Oman is Climate Zone IVb (hot/humid coastal — Muscat / Sohar / Salalah / Sur) + IVa (hot/dry interior — Nizwa / Ibri / Buraimi); requires substantial zonal-specific stability data particularly for Oman summer ambient conditions (often >45°C in interior).
• Bioequivalence centres + biowaiver — DGPA&DC + GCC Biowaiver Guidance provides BCS-based biowaivers; applicants frequently submit BE studies where biowaivers would suffice.
• WHO PQ CRP reliance under-utilised — WHO-PQ-approved products eligible for accelerated DGPA&DC CRP review (90-day target); under-utilised by many applicants.
• GCC Drug Registration reliance under-utilised — GCC harmonised registration procedure provides substantial acceleration; under-utilised by many applicants.
• EMA bilateral reliance under-utilised — DGPA&DC-EMA cooperation provides substantial acceleration for EMA-approved products.
• FDA / Health Canada / TGA / Swissmedic / MHRA / MFDS reliance under-utilised — DGPA&DC operates substantial reliance on Stringent Regulatory Authority decisions; particularly MHRA reliance given historical UK-Oman regulatory cooperation.
• Arab League harmonisation not leveraged — Council of Arab Ministers of Health pharmaceutical-harmonisation reliance under-utilised for Arab-Reference-Authority-assessed products.
• Essential Medicines + Vital Medicines accelerated pathway not leveraged — accelerated Registration under-utilised; 90-120 working day target.
• Tender Board procurement strategy missing — Oman's dominant public-sector pharmaceutical procurement via Tender Board applying Reference Country pricing + Most-Favoured-Nation pricing references requires specific pricing-strategy planning frequently overlooked.
• Duqm + Sohar + Salalah free-zone manufacturing opportunities missed — emerging pharmaceutical manufacturing through Special Economic Zones frequently overlooked by foreign manufacturers considering Oman as purely an import market.
• Variations strategy not planned — variations procedure substantively similar to EU + GCC but with Oman-specific timelines + fee structure.
• Registration renewal timing missed — 5-year renewal must be filed within prescribed window before expiry; missed deadline triggers de-registration.
• Clinical trial ethics coordination steps — Oman clinical trials require DGPA&DC CTA + Oman Research & Ethical Review & Approval Committee (OREC) approval + coordination with Sultan Qaboos University Hospital / The Royal Hospital / Oman Medical Specialty Board.

V5 Ultimate provides the operational infrastructure Omani + foreign-supplier sites need for Royal Decree 35 of 2015 + Royal Decree 41 of 1996 + DGPA&DC + GCC GMP + Medical Devices framework + WHO PQ CRP + EMA bilateral + GHC + Arab League + Oman National Pharmacovigilance Programme + Tender Board readiness.

• DGPA&DC + GCC GMP control framework — PIC/S + EU GMP + ICH Q7 + GCC GMP-aligned controls with ALCOA+ data-integrity + Oman-specific clarifications + Climate Zone IVa/IVb stability monitoring.
• DGPA&DC Registration dossier packaging — Oman CTD-aligned dossier structure with Oman Module 1 specifics + Module 3 stability + Arabic + English patient leaflet + Authorised Representative declarations + Royal Decree 35 of 2015 + Royal Decree 41 of 1996 framework.
• WHO PQ CRP workflow — DGPA&DC-as-CRP-participating-authority packaging with reduced dossier + accelerated DGPA&DC review (90-day target).
• GCC Drug Registration workflow — GCC harmonised registration procedure packaging supporting cross-Member-State market access across all six GCC Member States.
• EMA bilateral reliance workflow — DGPA&DC-EMA cooperation packaging for EMA-approved products.
• FDA / Health Canada / TGA / Swissmedic / MHRA / MFDS reliance workflow — Stringent Regulatory Authority reliance packaging particularly MHRA reliance reflecting historical UK-Oman regulatory cooperation.
• Arab League workflow — Council of Arab Ministers of Health pharmaceutical-harmonisation packaging.
• Tender Board procurement workflow — Oman Tender Board pharmaceutical procurement + Reference Country pricing + Most-Favoured-Nation pricing references packaging.
• Duqm + Sohar + Salalah workflow — Special Economic Zone manufacturing + re-export coordination packaging for emerging Omani pharmaceutical-manufacturing investment.
• Essential Medicines + Vital Medicines accelerated workflow — Oman National Essential Medicines List + public-health emergency product packaging.
• Omani Authorised Representative workflow — foreign-manufacturer Authorised Representative designation + role-management + Oman-specific post-market surveillance.
• Omani clinical-trial workflow — DGPA&DC CTA + OREC coordination + Sultan Qaboos University Hospital / The Royal Hospital / Oman Medical Specialty Board coordination + Oman SUSAR reporting via Oman National PV Centre.
• Oman National PV Centre Pharmacovigilance integration — E2B(R3) ICSR generation + 15-day SUSAR timeline + PSUR / PBRER packaging + Arabic + English ICSR + Oman PV Network coordination + VigiBase upload + Risk Management Plan packaging + AEFI vaccine adverse-event reporting.
• Matériovigilance + Cosmétovigilance workflow — parallel matériovigilance + cosmétovigilance packaging coordinated through Oman National PV Centre.
• Medical-device + IVD + cosmetic + dietary-supplement workflow — DGPA&DC frameworks dossier packaging + Class I-III classification + ISO 13485 + Authorised Representative + post-market vigilance.
• Vision 2040 alignment — Oman Vision 2040 healthcare modernisation + pharmaceutical-manufacturing + clinical-research + health-tourism programme alignment.
• GCC + Arab League regional bridging — for companies operating across GCC + MENA, V5 surfaces DGPA&DC + Saudi SFDA + UAE MoHAP + Kuwait MoH + Bahrain NHRA + Qatar MoPH + Jordan JFDA + Egyptian EDA harmonised dossier-element reuse alongside national-specific extensions.