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Drug Safety Center(DSC)

Drug Safety Center(DSC)

Drug Safety Center(DSC)
Dr.Mohammed Hamdan Al-Rubaie
Director General of Drug Safety Center(DSC)
The Sultanate of Oman is witnessing a progress in various fields that coincides with efforts from various government departments to meet the goals of Oman’s Vision 2040. The Ministry of Health, represented by Drug Safety Center, seeks to keep pace with this development and to be a part of the government’s success through continuous development and effective progress in the field of medicine and medical devices regulation and completing the construction of the regulatory system to pursue global excellence. This is to support pharmaceutical security and ensure the availability, quality, effectiveness, safety and security of medicines and medical circulating in the Sultanate of Oman.
Mission

Ensuring the quality, safety and security of medicines, devices and medical supplies circulating in the Sultanate by implementing regulatory systems based on scientific methodology and international standards.

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Vision

To be a national regulatory and supervisory authority with global distinction in protecting and promoting public heath

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History

Drug Safety Center is the Regulatory body which is responsible for the Assurance of affective, safe and good quality drugs in Oman whether manufactured locally in Oman or exported from outside the sultanate, and that will be achieved by implementing the pharmacy practice law issued against the Royal Decree No 41/ 91 and its amendments.

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Services

Services Provided

Apply for Exam

Apply for Exam

apply exam request and upload all required certificates Average time taken to complete the service: 7-14 working days Service delivery channels Website The Documents: A recent prometric certificate valid for one year - Dataflow certificate included: Attestation of graduation certificate and experience of not less than 3 years Graduation certificate attested by the Ministry of Foreign Affairs and the Embassy of Oman - Experience certificate of not less than 3 years of experience, and there is no interruption from work for more than a year - Certificate of registration / pharmacy syndicate, certified by the Ministry of Foreign Affairs and the Embassy of Oman - Score sheet - Not convicted by the police -passport copy - Photograph Requirements: That he has not stopped working for more than a year To have 3 years of experience

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licensing request for (pharmacist-assistant pharmacist-medical rep.)

licensing request for (pharmacist-assistant pharmacist-medical rep.)

Request for pharmacist license for pharmacist_assistant pharmacist_medical Rep.) after oral examination(viva) Average time taken to complete the service: 14 working days Service delivery channels: Website. The Documents: ID card / resident card - Visa for non-Omani Insurance against professional errors for two years -A recent personal photo Requirements: The pharmacist/ assistant has passed the oral test (VIVA) in the Directorate And that the medical delegate has been identical before the application

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License renewal

License renewal

Request for renewal pharmacist/assistant,/ medical rep. licenses after 2 years Average time taken to complete the service: Two days -week Service delivery channels: Website, The Documents: - Identity card / resident card - Insurance against professional errors for two years - A valid passport - A recent personal photo Requirements: Attachments Business PDF -A modern pharmaceutical personal photo -pharmacist -medical delegate

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Request for Sponsor Change / Transfer from one establishment to another

Request for Sponsor Change / Transfer from one establishment to another

Request for changing sponsor from one establishment to another. Prerequisites: Sponsor Change / Transfer: For Omanis: (ID card - insurance against professional errors - passport) and for non-Omanis (ـJob card - insurance against professional errors - passport) Terms and Conditions: The pharmacist/ assistant has passed the oral test (VIVA) in the Directorate . Medical representative has been identical before the application All attachments in PDF form except for the personal image JPG form Service Completion Period: 14 working days

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leave application

leave application

APPLY LEAVE REQUEST THROUGH HEALTH PORTAL payments Service Fees: No fees Average time taken to complete the service: 1-3 working days Service delivery channels: Website, The Documents: Vacation request form Requirements: Submit electronic application - Not to be the only pharmacist registered in the branch - The alternative pharmacist has a message approved by the sponsor

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Request Good Standing Certificate for pharmacist and assistant

Request Good Standing Certificate for pharmacist and assistant

Request for Good Standing Certificate(pharmacist and assistant pharmacist ) Terms and Conditions: Complete personal data Ensure that data and dates are correct in the applicant's file Service Completion Period:Two days of work

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Cancel licenses for pharmacists/assistants and medical rep.

Cancel licenses for pharmacists/assistants and medical rep.

cancel licenses for pharmacists / assistants and medical rep. from the establishments Average time taken to complete the service: Service delivery channels: Walk-in Counter,Email,SMS,

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Transfer the pharmacist/assistant pharmacist/Medical Rep. between branches

Transfer the pharmacist/assistant pharmacist/Medical Rep. between branches

The request for change the pharmacist / assistant pharmacist/Medical Representative license from one branch to another in the same establishment Prerequisites: Valid Personal ID Card-Valid Professional Liability Insurance-Personal Photo Terms and Conditions: The license is valid Service Completion Period: 5 days

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Apply for Pharmacy Establishment License

Apply for Pharmacy Establishment License

Apply for Pharmacy Establishment License Service Completion Period: It depends on adhering to the requirements and employing employees of the Pharmaceutical Corporation Prerequisites: The location in which the establishment is to be opened Terms and Conditions: Adherence to the conditions to open a pharmaceutical institution (available on the Ministry's website) It could not be a partner in more than one pharmaceutical institution That the owner or partner be Omani nationality and not less than the legal age

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Confirm Pharmacy License Application

Confirm Pharmacy License Application

Request to ensure that the site where the establishment is to be opened is ready for inspection Prerequisites: The location in which the establishment is to be opened Terms and Conditions: Adherence to the conditions to open a pharmaceutical institution (available on the Ministry's website. Pharmacist recruitment. Service Completion Period: week -2 weeks

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Renew a pharmaceutical establishment

Renew a pharmaceutical establishment

Request to renew a pharmaceutical establishment Service Completion Period: Week-two weeks

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Request for transfer Pharmaceutical Establishment

Request for transfer Pharmaceutical Establishment

Request for transfer Pharmaceutical Establishment from one place to another Prerequisites: Online Submission of the application When requesting the final inspection, submit the application via email to the department Terms and Conditions: Adherence to the conditions to open a pharmaceutical institution (available on the Ministry's website) It could not be a partner in more than one pharmaceutical institution Service Completion Period: Two weeks

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Close the pharmaceutical establishment for a temporary period

Close the pharmaceutical establishment for a temporary period

Request for Temporary Suspension Average time taken to complete the service: 2 days Service delivery channels:Walk-in Counter. :The Documents - Request letter - Copy of the license Requirements: Providing the papers complete

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Request to increase the area of the institution or reduce the area

Request to increase the area of the institution or reduce the area

Request to change in the area of the pharmacy by increasing or decreasing schedule Average time taken to complete the service:A week until the pharmacy is visited and then depends on the applicant when the procedures are concluded The Documents: A letter from the owner of the institution with the mention of the institution's license number Requirements: The area should not be less than the minimum level of the institution, according to the requirements

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Apply for Product Classification

Apply for Product Classification

This service allows the classification of products into pharmaceutical, herbal, health, medical device, banned, or not within the Directorate’s responsibilities, based on the active ingredients in the product’s formulation, the pharmaceutical dosage form, and the medical claims shown in the packaging or internal leaflet attached to the application, and its regulatory status in the reference countries.

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Clearance of medical product

Clearance of medical product

clearance of any medicine registered or not registered before reach country. Prerequisites: Demand bills Operational Analysis Certificate Pharmaceutical registration certificate Local purchase order for government agencies only biological certificate Health certificate that the product is free from dioxin (milk) No-objection certificate in case of importing controlled drugs Terms and Conditions: Purchase bill .Authorization and local purchase order A medical report and a prescription, and that it is not prohibited The representative of the pharmacy is an Omani pharmacist Warehouse (for some requests) The drug is registered The company is registered LPO (local purchase order) Service Completion Period: day to week

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Final customs release request for a medical product

Final customs release request for a medical product

Request to approve to distribute the product to private market Prerequisites: Purchase Invoice Product or Batch Analytical Certificate Health Certificate for Dairy Products (Less than 3 years) or Nutritional Products Approval from the Nutrition Department in the case of dairy products less than 3 years. Terms and Conditions: Submitting samples to the Drug Release and Export Department Service Completion Period: 3 working days

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Clearance /Release of medical devices and supplies

Clearance /Release of medical devices and supplies

Issuance of approval for release and customs clearance. Prerequisites: Purchase invoice Adherence to transportation and storage conditions as per the manufacturer's recommendations Undertaking for the release of medical devices and supplies. Terms and Conditions: Inclusion of all medical equipment and supplies at the Department of Supervision on the appliances and medical supplies Consider the conditions of transportation and storage according to the recommendations of the manufacturer Service Completion Period: a work day

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Listing medical products and devices

Listing medical products and devices

Receiving databases of medical products and devices from the supplier companies and including them in the master list The Documents: Filling out the Excel file for that. Requirements: Complete the aforementioned product data with the Excel file 1- Commercial Register No. 2- The name of the facility 3- Product name 4- Product Description 5- Factory name 6- Factory title (legal manufacturer) 7- The country of origin 8- The address of the manufacturing site (if it is different from the legal manufacturer) 9- Model number 10- Coordinated code 11- Global coding for the nomination of medical devices 12- Category 13- Classification 14- The number of permission to market the Saudi Food and Drug Authority, if any 15- The date of completion of the permission to market the Saudi Food and Drug Authority 16- Does the medical device contain a medicine 17- Are you the local agent?

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Medical Device Reporting

Medical Device Reporting

Receive Medical Device Adverse/ Incident Event Reports, investigate the report and issue a corrective action plan. Average time taken to complete the service:90 working days The Documents: - The form for reporting incidents of medical devices and supplies. Requirements: Fill out the form for reporting the accidents of devices and medical supplies - Sampling

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Listing the companies that supply medical devices and supplies

Listing the companies that supply medical devices and supplies

Receiving databases from the supplier companies and including them in the master list The Documents Filling out the Excel file for that. Requirements Complete the aforementioned company’s data with the Excel file 1. Commercial registry number 2. The company's email 3. The name of the facility 4. The name of the commercial activity as in the commercial registry 5. The type of commercial activity 6. The name of the facility in Arabic 7. Governorate 8. State 9. Region 10. The latest offer 11. Latte coordinates 12. Address 13. The name of the authorized person 14. Phone numbers 15. E -mail of the authorized person

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Application for importation of a non-registered drug.

Application for importation of a non-registered drug.

To get a permit for importing of non registered medicine for the private market and government hospitals Terms and Conditions: The presence of a licensed warehouse

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Application for Exportation of narcotic / Psychotropic drugs.

Application for Exportation of narcotic / Psychotropic drugs.

To get a permit for r exportation of narcotic / psychotropic drugs. Prerequisites: The institution must be licensed to trafficking in narcotic drugs and mental effects Terms and Conditions: Providing the import/export application form electronically Attaching the purchase order from the institution Fees Details: 15 OMR

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Request for Controlled Drugs Import/Export

Request for Controlled Drugs Import/Export

The applicant submit electronic request to obtain a permit to import Narcotic/Psychotropic substances via MOH eportal Prerequisites: The institution must be licensed to trafficking in narcotic drugs and mental effects Terms and Conditions: Providing the import/export application form electronically Attaching the purchase order from the institution Service Completion Period: 7 working days

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Stamping records for data entry of monitored drugs

Stamping records for data entry of monitored drugs

Stamping records for data entry of monitored drugs / narcotics / psychotropic substances: All hospitals/pharmaceutical institutions who deal/trade with narcotic/psychotropic/monitored medicines, should keep registers for those medicines and bring the registers to the DGPA&DC for stamping. payments Service Fees:No fees The Documents: Bring the records that meet the conditions. Requirements: -The doctor’s license/pharmacist to deal/trafficking should be valid

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License to transport narcotic/psychotropic substances

License to transport narcotic/psychotropic substances

Transport permit should be issued against all import/export permit of items that contain narcotic/psychotropic substances payments Service Fees:5 OMR Average time taken to complete the service:7 working days Service delivery channels:Website

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Request for dealing / trading Controlled Drugs Licensing

Request for dealing / trading Controlled Drugs Licensing

All doctor/pharmacist who work in private section before prescribing/dispensing narcotic or psychotropic medicines must apply to obtain dealing / trading license Prerequisites: A valid health/pharmacy institution license A copy of the doctor's/pharmacist's license A copy of the doctor's/pharmacist's ID. A letter of recommendation from the institution A non-conviction letter from the Royal Oman Police, provided that its issuance period does not exceed 3 months In the case of doctors’ licenses, another document must be added, which is a no-objection letter issued by the General Directorate of Private Health Institutions. Terms and Conditions: The required documents are valid (endless) Service Completion Period: 7 working days

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Request for Waste Disposal

Request for Waste Disposal

A request for the destruction of expired items that contain Narcotic or Psychotropic substances. Prerequisites: List of unusable medications -user medicines with their weight on. Terms and Conditions: Enter correct data when submitting the application that the medicines are finished and not suitable for use. Service Completion Period:week

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Licensing\Renew Lic.the manufacture of drugs that contain narcotic drugs /psychotropic substances

Licensing\Renew Lic.the manufacture of drugs that contain narcotic drugs /psychotropic substances

Licensing\Renew Licensing the manufacture of drugs that contain narcotic drugs / psychotropic substances: All local Pharmaceutical establishments, who manufacture narcotics or psychotropic substances must apply for a license valid for one year. Prerequisites: The pharmacy institution license is valid. Copy of the pharmacist's license. .Copy of the pharmacist/manager's ID. Recommendations letter from the institution. Non-conviction letter from the Royal Oman Police, issued within the last 3 months. Service Completion Period: 7 working days

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Purchasing prescription books for narcotic and psychotropic drugs

Purchasing prescription books for narcotic and psychotropic drugs

The private institutes submitted should submit a request to purchase the prescription booklets. After checking the validity of doctors dealing licenses, the booklets can be purchased. payments Service Fees: 5 OMR Average time taken to complete the service: 14 working days Service delivery channels:Email The Documentsp: 1. Official letter from the institution. 2. Valid licenses for physicians to handle. Requirements: 1- The applicant for the request must be licensed to deal with the monitoring medications

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Registration /RE-Registration of herbal medicine/homeopathic,Chinese and Ayruvedic products

Registration /RE-Registration of herbal medicine/homeopathic,Chinese and Ayruvedic products

Application for registration of herbal medicine/ homeopathic product / Chinese and Ayruvedic products The Documents: A copy of a drug warehouse license certificate issued by the Pharmaceutical Licensing Department - General Directorate of Pharmacy and Drug Control - A copy of a commercial agency certificate issued by the Ministry of Trade and Industry - Forms filled according to the attached form -The documents mentioned in the form Requirements: That the beneficiary follow the conditions mentioned in the Articles (62) and (75) of the Ministerial Resolution 113/2020 in the executive regulations of the law to organize the pharmacy profession and pharmaceutical institutions

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Request to Register/Re-Register a herbal medicine company

Request to Register/Re-Register a herbal medicine company

Registration of Herbal companies Prerequisites: A copy of a drug warehouse license certificate issued by the Pharmaceutical Licensing Department A copy of a commercial agency certificate issued by the Ministry of Trade and Industry Forms paid according to the attached form The documents mentioned in the form Terms and Conditions: That the company be licensed by the health authorities in its country To have a good pharmaceutical manufacturing certificate from the country of origin To be subject periodically to technical inspection by the health authorities in the country of origin That her medicines are circulating in generating origin with the same specifications, composition, manufacturing and analysis methods. A judicial ruling has not been issued in the country of the origin against it in the crime of forgery or commercial fraud Record registration fees

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Registration\Re-Registration of health Products

Registration\Re-Registration of health Products

Application for Registration of health Products Prerequisites: A copy of the pharmaceutical warehouse license issued by the Directorate of Pharmaceutical Licenses Directorate General of Pharmaceutical Affairs and Drug Control A copy of the commercial agency certificate issued by the Ministry of Commerce and Industry. A filled-out form according to the attached template. The documents mentioned in the form.

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Request for Registration\RE-registration of pharmaceutical product

Request for Registration\RE-registration of pharmaceutical product

Request for Registration\RE-registration of pharmaceutical product Prerequisites: All documents detailed and specified in the eCTD Guideline. Payment invoice. Terms and Conditions: The file must be submitted in ECTD format All certificates are approved and valid Service Completion Period: 360 working days

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Registration \Re-registration of pharmaceutical company

Registration \Re-registration of pharmaceutical company

Registration \Re-registration of pharmaceutical company Prerequisites: Documents detailed according to Form A . Payment bill Terms and Conditions: Registration documents must be submitted 6 months before the registration ends All certificates provided are approved and valid Service Completion Period: 360 working days for the unsecarantic varieties and 60 working days for innovative companies

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Variations that raises for the registered pharmaceutical products and companies

Variations that raises for the registered pharmaceutical products and companies

Requests for the variations for registered pharmaceutical products and companies. Prerequisites: The documents must be according to what is in the guidelines issued by the Gulf Health Council Payment bill official letter by request Terms and Conditions: The specified number must be submitted for each agent only per week Adding time to submit the application and completing the payment within 5 days of work. Service Completion Period: It depends on the classification of change according to the guiding guide issued by the Gulf Health Council

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Application for additional pack size for registered herbal / health product

Application for additional pack size for registered herbal / health product

additional pack size for registered herbal / health product The Documents: Form for Changing/Adding Packaging Documents mentioned in the form Payment Invoice. Average time taken to complete the service: 90 working days

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application for variations to registered herbal companies and its products

application for variations to registered herbal companies and its products

Applay for the variations for registered herbal companies and its The Documents: Change Form Filled and Signed by the Local Agent Documents Specified in the Form Payment Invoice Average time taken to complete the service 90 working days

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Registration of additional pack size for registered pharmaceutical product

Registration of additional pack size for registered pharmaceutical product

Request for registration of additional pack size for registered pharmaceutical product. The Documents: 1- The documents are detailed according to the Gulf Guide for Changes. 2- Payment invoice. Requirements: 1- The certificates must be certified and valid Average time taken to complete the service 180 working days

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Price Appeals

Price Appeals

Request from agent to appeal on the product price for new or re-registration Prerequisites: A letter from the agent explaining the reasons for the objection to the price attached to the price certificates of 30 countries Service Completion Period: 15 working days

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Amend the price of a registered drug

Amend the price of a registered drug

Request from agent to study and the possibility of adjusting the price after its registration Prerequisites: A letter from the product agent explaining the reasons for requesting a price modification.

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Certificate of Pharmaceutical Product

Certificate of Pharmaceutical Product

Request for issuing a certificate of pharmaceutical product. The Documents: 1-CD contains the certificate form and the data has been filled out by the company 2- An official letter from the company with the request 3-Payment invoice. Requirements: 1- The preparation is registered and a valid registration certificate 2- These certificates are issued to local companies only Average time taken to complete the service: 30 working days.

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Evaluate Hand Sanitizers Documents

Evaluate Hand Sanitizers Documents

Evaluation of hand sanitizer documents by section Registration of Herbal Medicines and Health Products and issuance of approval The Documents: - A formal letter addressed to the Ministry of Health requesting product marketing authorization, including (product formulation name, manufacturer name, package size). - Submission of a comprehensive analysis report of the contents performed by an accredited laboratory (approved by the Ministry of Commerce, Industry, and Investment Promotion). - The product formulation from the manufacturing company. - Providing two samples. - A manufacturing license certificate issued by the relevant authorities. Requirements: - If the sterile contains the active substance, it should be at least 60%. - If the sterilizer contains the active substance ISO-bobbil alcohol, its percentage should be at least 70%.

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Analysis of health and herbal products

Analysis of health and herbal products

assessments of Analysis Requirement Analysis of health and herbal products Issuance of certificate of analysis Service Fees:No fees. Average time taken to complete the service:. month.Service delivery channels:Walk-in Counter.The Documents: The method of analysis Reference materials for effective substance and preservative materials used in the analysis And the final specifications of the product And the certificate of the analysis of the item from the factory or from an external entity

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Microbiological analysis of all items received in the laboratory

Microbiological analysis of all items received in the laboratory

Assessment of Analysis Requirement Analysis of pharmaceutical products (sterile and non sterile drugs) Issuance of certificate of analysis payments Service Fees:No fees Average time taken to complete the service:month The Documents: Methods of analysis Used materials Specifications

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Analysis of complaints samples

Analysis of complaints samples

analysis of complaint samples received from drug control dept, PV, Inspection, clearance and MD dept. payments Service Fees: No fees Average time taken to complete the service: Two weeks to a month Service delivery channels: Email

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Request for legalization of official documents

Request for legalization of official documents

Stamping documents for legalization purposes(registration certificates for pharmaceutical products and company, GMP) The Documents: 1. Official request letter. 2. copies of the original documents to be stamped. 3. Payment invoice. Requirements: 1- The documents should be a copy of a class dish 2- The documents are valid

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Report Non-availability of Drug in Private Sector

Report Non-availability of Drug in Private Sector

The beneficiary can inform the Directorate General of Pharmaceutical and Drug Control for lack of medicine in the private sector. Terms and Conditions: Provides the prescription for the drug. Service Completion Period: 3 days of work.

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Request for registration\Re-Registration of Medical Device Manufacturer

Request for registration\Re-Registration of Medical Device Manufacturer

Receiving and evaluating applications and issuing the certificate Average time taken to complete the service: 60 days. The Documents: commercial register Technical files. Requirements: Provides the quality management certificate for the factory. To be licensed in the country of origin.

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Request for Registration\Re-Registration of medical device

Request for Registration\Re-Registration of medical device

Request for Registration\Re-Registration of medical device Average time taken to complete the service 60 working days The Documents: commercial register Technical files Requirements: Provides the equipment store and medical supplies Provides a special activity for medical devices and supplies in the commercial registry Provides the Trade Agency for Products

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Import non- Registered Medical Devices

Import non- Registered Medical Devices

To get a permit for Importing non - registered Medical Devices for the Private Market and Government Hospitals

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Projects

Ongoing
E-CTD

Submission of file for registration will be through this eCTD

Start Date : 01 May 2014
Estimated Months : 6
Ongoing
Medical Device Registration.

-Application for activation to sell medical devices and supplies -Request for Registration of medical device -Request for RE-Registration of medical device -Request for Registration of Medical Device Manufacturer -Request for Re-Registration of Medical Device Manufacturer -Request for Medical Device Variation

Start Date : 01 February 2024
Estimated Months : 6
Ongoing
Re-engineering the services of the Pharmaceutical Licensing Department in the portal

Re-engineering the services of the Pharmaceutical Licensing Department in the portal

Start Date : 01 February 2024
Estimated Months : 6
Ongoing
Converting the service of Registration of Pharmaceutical Companies\Medicines and Drug pricing to E-service

Data simplification and transformation Medicines

Start Date : 01 March 2023
Estimated Months : 11
Ongoing
Re-engineering the services of the Drug Control Department

Re-engineering the services of the Drug Control Department: Controlled Drugs services Section \Drug Clearance & Export services Section\Product Classification service\Import of Non-registared drug service

Start Date : 01 January 2024
Estimated Months : 6
Future
Medical Device Reporting.

Medical Device Reporting.

Start Date : 01 July 2024
Estimated Months : 6
Future
Electronic transfer of inspection services, pharmaceutical institution data modification service and Pharmaceutical establishment waiver service

Electronic transfer of inspection services, pharmaceutical institution data modification service and Pharmaceutical establishment waiver service

Start Date : 01 July 2024
Estimated Months : 6
Future
Activate some lab services in the E-Portal

Activate some lab services in the E-Portal - Product files to be submitted through the e portal. - The certificate of analysis will be issued through the e portal. - Follow up the samples status after registration. - Clarification to the local agents through the e portal.

Start Date : 01 July 2024
Estimated Months : 6
Future
Activate the service of the Registration of Pharmaceutical Companies\Medicines and Drug pricing in the E-Portal

Activate the services(Registration/Re-registration of pharmaceutical companies,Registration/Re-registration of medicines,drug pricing) in the E-portal

Start Date : 01 March 2024
Estimated Months : 6

About Us


Values

Citizen awareness and guidance \Follow the scientific methodology and professional transparency \Encouraging creativity and innovation \Participatory Promoting and supporting the national pharmaceutical industry

Units:
Pharmacy Licensing Department

Pharmacy Department :- includes three sections (Pharmaceutical Establishments Licensing Section , Pharmacists & Assistant Pharmacists Registration & Licensing Section ,Follow up & Evaluation Section ). Pharmacy department is responsible for licensing and renewal of pharmaceutical establishment licenses , pharmacist and assistant pharmacist as well as carrying out the inspection for the pharmaceutical establishment to assure the enforcement of practice law issued against the royal decree no. 41/ 96 and the ministerial decision inforcing it .

Drug Control Department

Drug control department :- includes five sections Human Drug Registration Section, Herbal Drugs & Health Product Registration Section, Controlled Drugs Section, Drug Pricing Section and Drug Clearance & Export Section. The department regulates the import of medicines into the Sultanate by registering pharmaceutical companies and registering and pricing medicines. It regulates the import, export and circulation of controlled medicines in the health sector. It also undertakes the procedures for releasing all medical products that fall within its jurisdiction from customs ports.

Central Quality Control Department

Central quality control department: - Includes a number of sections: Quality Assurance Section, Chemical Analysis Section, Physical Analysis Section, Herbal Medicine & Health Products Section, Receiving and follow-up analysis requirements Section, Microbiological Analysis Section, Biotechnology & Pharmacological Analysis Section. Quality control lab is carrying out drug analysis including registration samples as well as those imported from outside the country to assure that they meet the standard specification.

Pharmacovigilance and Drug information Department

Department of Pharmacovigilance and Drug Information (DPV&DI): Consist of Three Sections :Pharmacovigilance of Human Medicines Section,Pharmacovigilance of Herbal Medicines & Health Product Section and Drug Information Section.DPV&DI, the National Center for pharmacovigilance in the Sultanate, is committed to post-marketing surveillance of pharmaceuticals/herbals/health products available, ensuring quality medicines. Objectives of the Department: Post marketing surveillance of medicines. Receive, evaluate and analyze reports of side effects/ adverse reactions and problems associated with medication such as quality defects and medication errors and take possible action. Promote awareness on public health and safety by responding to enquiries on information related to medicines and their effects. Coordinate with local health institutions and international Pharmacovigilance collaborating Centres to prevent frequency and adverse effects of drugs. Preparing and circulating periodic and annual reports on the received notifications of advers drug reaction reports in the Sultanate.

Medical Devices Control Department

Medical Devices Control Department includes four sections: Medical Device Registration Section, Surgical Instruments Registration Section, In Vitro Diagnostic Devices Registration Section and Medical Device Vigilance Section. This Department provide the following services: Registration of medical, In vitro diagnostic devices & surgical imported to Oman or items manufactured in Oman, Registration of all medical devices manufacturer. Receiving of all adverse events that may be associated with medical devices & supplies and to set the necessary requirements to ensure the quality of medical devices and supplies in the Sultanate and following up on the obligation of those requirements. In addition, to issue Field Safety Notice and following up with the implementation of corrective action needed to enhance the level of safety of medical devices and thus protect patients and users.

Last updated on : 05 December 2024 - 11:17 AM

Mission

Ensuring the quality, safety and security of medicines, devices and medical supplies circulating in the Sultanate by implementing regulatory systems based on scientific methodology and international standards.

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Vision

To be a national regulatory and supervisory authority with global distinction in protecting and promoting public heath

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History

Drug Safety Center is the Regulatory body which is responsible for the Assurance of affective, safe and good quality drugs in Oman whether manufactured locally in Oman or exported from outside the sultanate, and that will be achieved by implementing the pharmacy practice law issued against the Royal Decree No 41/ 91 and its amendments.

Read More

News


14 December 2023

The 17th Annual Symposium on Good Pharmacy Practice

Ongoing Projects


E-CTD

Submission of file for registration will be through this eCTD

Start Date : 01 May 2014
Estimated Months : 6
Medical Device Registration.

-Application for activation to sell medical devices and supplies -Request for Registration of medical device -Request for RE-Registration of medical device -Request for Registration of Medical Device Manufacturer -Request for Re-Registration of Medical Device Manufacturer -Request for Medical Device Variation

Start Date : 01 February 2024
Estimated Months : 6
Re-engineering the services of the Pharmaceutical Licensing Department in the portal

Re-engineering the services of the Pharmaceutical Licensing Department in the portal

Start Date : 01 February 2024
Estimated Months : 6
Converting the service of Registration of Pharmaceutical Companies\Medicines and Drug pricing to E-service

Data simplification and transformation Medicines

Start Date : 01 March 2023
Estimated Months : 11
Re-engineering the services of the Drug Control Department

Re-engineering the services of the Drug Control Department: Controlled Drugs services Section \Drug Clearance & Export services Section\Product Classification service\Import of Non-registared drug service

Start Date : 01 January 2024
Estimated Months : 6

Future Projects


Medical Device Reporting.

Medical Device Reporting.

Start Date : 01 July 2024
Estimated Months : 6
Electronic transfer of inspection services, pharmaceutical institution data modification service and Pharmaceutical establishment waiver service

Electronic transfer of inspection services, pharmaceutical institution data modification service and Pharmaceutical establishment waiver service

Start Date : 01 July 2024
Estimated Months : 6
Activate some lab services in the E-Portal

Activate some lab services in the E-Portal - Product files to be submitted through the e portal. - The certificate of analysis will be issued through the e portal. - Follow up the samples status after registration. - Clarification to the local agents through the e portal.

Start Date : 01 July 2024
Estimated Months : 6
Activate the service of the Registration of Pharmaceutical Companies\Medicines and Drug pricing in the E-Portal

Activate the services(Registration/Re-registration of pharmaceutical companies,Registration/Re-registration of medicines,drug pricing) in the E-portal

Start Date : 01 March 2024
Estimated Months : 6

Services List


Apply for Exam

Apply for Exam

apply exam request and upload all required certificates Average time taken to complete the service: 7-14 working days Service delivery channels Website The Documents: A recent prometric certificate valid for one year - Dataflow certificate included: Attestation of graduation certificate and experience of not less than 3 years Graduation certificate attested by the Ministry of Foreign Affairs and the Embassy of Oman - Experience certificate of not less than 3 years of experience, and there is no interruption from work for more than a year - Certificate of registration / pharmacy syndicate, certified by the Ministry of Foreign Affairs and the Embassy of Oman - Score sheet - Not convicted by the police -passport copy - Photograph Requirements: That he has not stopped working for more than a year To have 3 years of experience

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licensing request for (pharmacist-assistant pharmacist-medical rep.)

licensing request for (pharmacist-assistant pharmacist-medical rep.)

Request for pharmacist license for pharmacist_assistant pharmacist_medical Rep.) after oral examination(viva) Average time taken to complete the service: 14 working days Service delivery channels: Website. The Documents: ID card / resident card - Visa for non-Omani Insurance against professional errors for two years -A recent personal photo Requirements: The pharmacist/ assistant has passed the oral test (VIVA) in the Directorate And that the medical delegate has been identical before the application

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License renewal

License renewal

Request for renewal pharmacist/assistant,/ medical rep. licenses after 2 years Average time taken to complete the service: Two days -week Service delivery channels: Website, The Documents: - Identity card / resident card - Insurance against professional errors for two years - A valid passport - A recent personal photo Requirements: Attachments Business PDF -A modern pharmaceutical personal photo -pharmacist -medical delegate

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Request for Sponsor Change / Transfer from one establishment to another

Request for Sponsor Change / Transfer from one establishment to another

Request for changing sponsor from one establishment to another. Prerequisites: Sponsor Change / Transfer: For Omanis: (ID card - insurance against professional errors - passport) and for non-Omanis (ـJob card - insurance against professional errors - passport) Terms and Conditions: The pharmacist/ assistant has passed the oral test (VIVA) in the Directorate . Medical representative has been identical before the application All attachments in PDF form except for the personal image JPG form Service Completion Period: 14 working days

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leave application

leave application

APPLY LEAVE REQUEST THROUGH HEALTH PORTAL payments Service Fees: No fees Average time taken to complete the service: 1-3 working days Service delivery channels: Website, The Documents: Vacation request form Requirements: Submit electronic application - Not to be the only pharmacist registered in the branch - The alternative pharmacist has a message approved by the sponsor

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Request Good Standing Certificate for pharmacist and assistant

Request Good Standing Certificate for pharmacist and assistant

Request for Good Standing Certificate(pharmacist and assistant pharmacist ) Terms and Conditions: Complete personal data Ensure that data and dates are correct in the applicant's file Service Completion Period:Two days of work

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Cancel licenses for pharmacists/assistants and medical rep.

Cancel licenses for pharmacists/assistants and medical rep.

cancel licenses for pharmacists / assistants and medical rep. from the establishments Average time taken to complete the service: Service delivery channels: Walk-in Counter,Email,SMS,

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Transfer the pharmacist/assistant pharmacist/Medical Rep. between branches

Transfer the pharmacist/assistant pharmacist/Medical Rep. between branches

The request for change the pharmacist / assistant pharmacist/Medical Representative license from one branch to another in the same establishment Prerequisites: Valid Personal ID Card-Valid Professional Liability Insurance-Personal Photo Terms and Conditions: The license is valid Service Completion Period: 5 days

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Apply for Pharmacy Establishment License

Apply for Pharmacy Establishment License

Apply for Pharmacy Establishment License Service Completion Period: It depends on adhering to the requirements and employing employees of the Pharmaceutical Corporation Prerequisites: The location in which the establishment is to be opened Terms and Conditions: Adherence to the conditions to open a pharmaceutical institution (available on the Ministry's website) It could not be a partner in more than one pharmaceutical institution That the owner or partner be Omani nationality and not less than the legal age

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Confirm Pharmacy License Application

Confirm Pharmacy License Application

Request to ensure that the site where the establishment is to be opened is ready for inspection Prerequisites: The location in which the establishment is to be opened Terms and Conditions: Adherence to the conditions to open a pharmaceutical institution (available on the Ministry's website. Pharmacist recruitment. Service Completion Period: week -2 weeks

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Renew a pharmaceutical establishment

Renew a pharmaceutical establishment

Request to renew a pharmaceutical establishment Service Completion Period: Week-two weeks

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Request for transfer Pharmaceutical Establishment

Request for transfer Pharmaceutical Establishment

Request for transfer Pharmaceutical Establishment from one place to another Prerequisites: Online Submission of the application When requesting the final inspection, submit the application via email to the department Terms and Conditions: Adherence to the conditions to open a pharmaceutical institution (available on the Ministry's website) It could not be a partner in more than one pharmaceutical institution Service Completion Period: Two weeks

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Close the pharmaceutical establishment for a temporary period

Close the pharmaceutical establishment for a temporary period

Request for Temporary Suspension Average time taken to complete the service: 2 days Service delivery channels:Walk-in Counter. :The Documents - Request letter - Copy of the license Requirements: Providing the papers complete

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Request to increase the area of the institution or reduce the area

Request to increase the area of the institution or reduce the area

Request to change in the area of the pharmacy by increasing or decreasing schedule Average time taken to complete the service:A week until the pharmacy is visited and then depends on the applicant when the procedures are concluded The Documents: A letter from the owner of the institution with the mention of the institution's license number Requirements: The area should not be less than the minimum level of the institution, according to the requirements

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Apply for Product Classification

Apply for Product Classification

This service allows the classification of products into pharmaceutical, herbal, health, medical device, banned, or not within the Directorate’s responsibilities, based on the active ingredients in the product’s formulation, the pharmaceutical dosage form, and the medical claims shown in the packaging or internal leaflet attached to the application, and its regulatory status in the reference countries.

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Clearance of medical product

Clearance of medical product

clearance of any medicine registered or not registered before reach country. Prerequisites: Demand bills Operational Analysis Certificate Pharmaceutical registration certificate Local purchase order for government agencies only biological certificate Health certificate that the product is free from dioxin (milk) No-objection certificate in case of importing controlled drugs Terms and Conditions: Purchase bill .Authorization and local purchase order A medical report and a prescription, and that it is not prohibited The representative of the pharmacy is an Omani pharmacist Warehouse (for some requests) The drug is registered The company is registered LPO (local purchase order) Service Completion Period: day to week

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Final customs release request for a medical product

Final customs release request for a medical product

Request to approve to distribute the product to private market Prerequisites: Purchase Invoice Product or Batch Analytical Certificate Health Certificate for Dairy Products (Less than 3 years) or Nutritional Products Approval from the Nutrition Department in the case of dairy products less than 3 years. Terms and Conditions: Submitting samples to the Drug Release and Export Department Service Completion Period: 3 working days

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Clearance /Release of medical devices and supplies

Clearance /Release of medical devices and supplies

Issuance of approval for release and customs clearance. Prerequisites: Purchase invoice Adherence to transportation and storage conditions as per the manufacturer's recommendations Undertaking for the release of medical devices and supplies. Terms and Conditions: Inclusion of all medical equipment and supplies at the Department of Supervision on the appliances and medical supplies Consider the conditions of transportation and storage according to the recommendations of the manufacturer Service Completion Period: a work day

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Listing medical products and devices

Listing medical products and devices

Receiving databases of medical products and devices from the supplier companies and including them in the master list The Documents: Filling out the Excel file for that. Requirements: Complete the aforementioned product data with the Excel file 1- Commercial Register No. 2- The name of the facility 3- Product name 4- Product Description 5- Factory name 6- Factory title (legal manufacturer) 7- The country of origin 8- The address of the manufacturing site (if it is different from the legal manufacturer) 9- Model number 10- Coordinated code 11- Global coding for the nomination of medical devices 12- Category 13- Classification 14- The number of permission to market the Saudi Food and Drug Authority, if any 15- The date of completion of the permission to market the Saudi Food and Drug Authority 16- Does the medical device contain a medicine 17- Are you the local agent?

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Medical Device Reporting

Medical Device Reporting

Receive Medical Device Adverse/ Incident Event Reports, investigate the report and issue a corrective action plan. Average time taken to complete the service:90 working days The Documents: - The form for reporting incidents of medical devices and supplies. Requirements: Fill out the form for reporting the accidents of devices and medical supplies - Sampling

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Listing the companies that supply medical devices and supplies

Listing the companies that supply medical devices and supplies

Receiving databases from the supplier companies and including them in the master list The Documents Filling out the Excel file for that. Requirements Complete the aforementioned company’s data with the Excel file 1. Commercial registry number 2. The company's email 3. The name of the facility 4. The name of the commercial activity as in the commercial registry 5. The type of commercial activity 6. The name of the facility in Arabic 7. Governorate 8. State 9. Region 10. The latest offer 11. Latte coordinates 12. Address 13. The name of the authorized person 14. Phone numbers 15. E -mail of the authorized person

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Application for importation of a non-registered drug.

Application for importation of a non-registered drug.

To get a permit for importing of non registered medicine for the private market and government hospitals Terms and Conditions: The presence of a licensed warehouse

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Application for Exportation of narcotic / Psychotropic drugs.

Application for Exportation of narcotic / Psychotropic drugs.

To get a permit for r exportation of narcotic / psychotropic drugs. Prerequisites: The institution must be licensed to trafficking in narcotic drugs and mental effects Terms and Conditions: Providing the import/export application form electronically Attaching the purchase order from the institution Fees Details: 15 OMR

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Request for Controlled Drugs Import/Export

Request for Controlled Drugs Import/Export

The applicant submit electronic request to obtain a permit to import Narcotic/Psychotropic substances via MOH eportal Prerequisites: The institution must be licensed to trafficking in narcotic drugs and mental effects Terms and Conditions: Providing the import/export application form electronically Attaching the purchase order from the institution Service Completion Period: 7 working days

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Stamping records for data entry of monitored drugs

Stamping records for data entry of monitored drugs

Stamping records for data entry of monitored drugs / narcotics / psychotropic substances: All hospitals/pharmaceutical institutions who deal/trade with narcotic/psychotropic/monitored medicines, should keep registers for those medicines and bring the registers to the DGPA&DC for stamping. payments Service Fees:No fees The Documents: Bring the records that meet the conditions. Requirements: -The doctor’s license/pharmacist to deal/trafficking should be valid

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License to transport narcotic/psychotropic substances

License to transport narcotic/psychotropic substances

Transport permit should be issued against all import/export permit of items that contain narcotic/psychotropic substances payments Service Fees:5 OMR Average time taken to complete the service:7 working days Service delivery channels:Website

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Request for dealing / trading Controlled Drugs Licensing

Request for dealing / trading Controlled Drugs Licensing

All doctor/pharmacist who work in private section before prescribing/dispensing narcotic or psychotropic medicines must apply to obtain dealing / trading license Prerequisites: A valid health/pharmacy institution license A copy of the doctor's/pharmacist's license A copy of the doctor's/pharmacist's ID. A letter of recommendation from the institution A non-conviction letter from the Royal Oman Police, provided that its issuance period does not exceed 3 months In the case of doctors’ licenses, another document must be added, which is a no-objection letter issued by the General Directorate of Private Health Institutions. Terms and Conditions: The required documents are valid (endless) Service Completion Period: 7 working days

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Request for Waste Disposal

Request for Waste Disposal

A request for the destruction of expired items that contain Narcotic or Psychotropic substances. Prerequisites: List of unusable medications -user medicines with their weight on. Terms and Conditions: Enter correct data when submitting the application that the medicines are finished and not suitable for use. Service Completion Period:week

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Licensing\Renew Lic.the manufacture of drugs that contain narcotic drugs /psychotropic substances

Licensing\Renew Lic.the manufacture of drugs that contain narcotic drugs /psychotropic substances

Licensing\Renew Licensing the manufacture of drugs that contain narcotic drugs / psychotropic substances: All local Pharmaceutical establishments, who manufacture narcotics or psychotropic substances must apply for a license valid for one year. Prerequisites: The pharmacy institution license is valid. Copy of the pharmacist's license. .Copy of the pharmacist/manager's ID. Recommendations letter from the institution. Non-conviction letter from the Royal Oman Police, issued within the last 3 months. Service Completion Period: 7 working days

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Purchasing prescription books for narcotic and psychotropic drugs

Purchasing prescription books for narcotic and psychotropic drugs

The private institutes submitted should submit a request to purchase the prescription booklets. After checking the validity of doctors dealing licenses, the booklets can be purchased. payments Service Fees: 5 OMR Average time taken to complete the service: 14 working days Service delivery channels:Email The Documentsp: 1. Official letter from the institution. 2. Valid licenses for physicians to handle. Requirements: 1- The applicant for the request must be licensed to deal with the monitoring medications

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Registration /RE-Registration of herbal medicine/homeopathic,Chinese and Ayruvedic products

Registration /RE-Registration of herbal medicine/homeopathic,Chinese and Ayruvedic products

Application for registration of herbal medicine/ homeopathic product / Chinese and Ayruvedic products The Documents: A copy of a drug warehouse license certificate issued by the Pharmaceutical Licensing Department - General Directorate of Pharmacy and Drug Control - A copy of a commercial agency certificate issued by the Ministry of Trade and Industry - Forms filled according to the attached form -The documents mentioned in the form Requirements: That the beneficiary follow the conditions mentioned in the Articles (62) and (75) of the Ministerial Resolution 113/2020 in the executive regulations of the law to organize the pharmacy profession and pharmaceutical institutions

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Request to Register/Re-Register a herbal medicine company

Request to Register/Re-Register a herbal medicine company

Registration of Herbal companies Prerequisites: A copy of a drug warehouse license certificate issued by the Pharmaceutical Licensing Department A copy of a commercial agency certificate issued by the Ministry of Trade and Industry Forms paid according to the attached form The documents mentioned in the form Terms and Conditions: That the company be licensed by the health authorities in its country To have a good pharmaceutical manufacturing certificate from the country of origin To be subject periodically to technical inspection by the health authorities in the country of origin That her medicines are circulating in generating origin with the same specifications, composition, manufacturing and analysis methods. A judicial ruling has not been issued in the country of the origin against it in the crime of forgery or commercial fraud Record registration fees

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Registration\Re-Registration of health Products

Registration\Re-Registration of health Products

Application for Registration of health Products Prerequisites: A copy of the pharmaceutical warehouse license issued by the Directorate of Pharmaceutical Licenses Directorate General of Pharmaceutical Affairs and Drug Control A copy of the commercial agency certificate issued by the Ministry of Commerce and Industry. A filled-out form according to the attached template. The documents mentioned in the form.

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Request for Registration\RE-registration of pharmaceutical product

Request for Registration\RE-registration of pharmaceutical product

Request for Registration\RE-registration of pharmaceutical product Prerequisites: All documents detailed and specified in the eCTD Guideline. Payment invoice. Terms and Conditions: The file must be submitted in ECTD format All certificates are approved and valid Service Completion Period: 360 working days

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Registration \Re-registration of pharmaceutical company

Registration \Re-registration of pharmaceutical company

Registration \Re-registration of pharmaceutical company Prerequisites: Documents detailed according to Form A . Payment bill Terms and Conditions: Registration documents must be submitted 6 months before the registration ends All certificates provided are approved and valid Service Completion Period: 360 working days for the unsecarantic varieties and 60 working days for innovative companies

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Variations that raises for the registered pharmaceutical products and companies

Variations that raises for the registered pharmaceutical products and companies

Requests for the variations for registered pharmaceutical products and companies. Prerequisites: The documents must be according to what is in the guidelines issued by the Gulf Health Council Payment bill official letter by request Terms and Conditions: The specified number must be submitted for each agent only per week Adding time to submit the application and completing the payment within 5 days of work. Service Completion Period: It depends on the classification of change according to the guiding guide issued by the Gulf Health Council

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Application for additional pack size for registered herbal / health product

Application for additional pack size for registered herbal / health product

additional pack size for registered herbal / health product The Documents: Form for Changing/Adding Packaging Documents mentioned in the form Payment Invoice. Average time taken to complete the service: 90 working days

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application for variations to registered herbal companies and its products

application for variations to registered herbal companies and its products

Applay for the variations for registered herbal companies and its The Documents: Change Form Filled and Signed by the Local Agent Documents Specified in the Form Payment Invoice Average time taken to complete the service 90 working days

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Registration of additional pack size for registered pharmaceutical product

Registration of additional pack size for registered pharmaceutical product

Request for registration of additional pack size for registered pharmaceutical product. The Documents: 1- The documents are detailed according to the Gulf Guide for Changes. 2- Payment invoice. Requirements: 1- The certificates must be certified and valid Average time taken to complete the service 180 working days

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Price Appeals

Price Appeals

Request from agent to appeal on the product price for new or re-registration Prerequisites: A letter from the agent explaining the reasons for the objection to the price attached to the price certificates of 30 countries Service Completion Period: 15 working days

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Amend the price of a registered drug

Amend the price of a registered drug

Request from agent to study and the possibility of adjusting the price after its registration Prerequisites: A letter from the product agent explaining the reasons for requesting a price modification.

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Certificate of Pharmaceutical Product

Certificate of Pharmaceutical Product

Request for issuing a certificate of pharmaceutical product. The Documents: 1-CD contains the certificate form and the data has been filled out by the company 2- An official letter from the company with the request 3-Payment invoice. Requirements: 1- The preparation is registered and a valid registration certificate 2- These certificates are issued to local companies only Average time taken to complete the service: 30 working days.

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Evaluate Hand Sanitizers Documents

Evaluate Hand Sanitizers Documents

Evaluation of hand sanitizer documents by section Registration of Herbal Medicines and Health Products and issuance of approval The Documents: - A formal letter addressed to the Ministry of Health requesting product marketing authorization, including (product formulation name, manufacturer name, package size). - Submission of a comprehensive analysis report of the contents performed by an accredited laboratory (approved by the Ministry of Commerce, Industry, and Investment Promotion). - The product formulation from the manufacturing company. - Providing two samples. - A manufacturing license certificate issued by the relevant authorities. Requirements: - If the sterile contains the active substance, it should be at least 60%. - If the sterilizer contains the active substance ISO-bobbil alcohol, its percentage should be at least 70%.

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Analysis of health and herbal products

Analysis of health and herbal products

assessments of Analysis Requirement Analysis of health and herbal products Issuance of certificate of analysis Service Fees:No fees. Average time taken to complete the service:. month.Service delivery channels:Walk-in Counter.The Documents: The method of analysis Reference materials for effective substance and preservative materials used in the analysis And the final specifications of the product And the certificate of the analysis of the item from the factory or from an external entity

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Microbiological analysis of all items received in the laboratory

Microbiological analysis of all items received in the laboratory

Assessment of Analysis Requirement Analysis of pharmaceutical products (sterile and non sterile drugs) Issuance of certificate of analysis payments Service Fees:No fees Average time taken to complete the service:month The Documents: Methods of analysis Used materials Specifications

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Analysis of complaints samples

Analysis of complaints samples

analysis of complaint samples received from drug control dept, PV, Inspection, clearance and MD dept. payments Service Fees: No fees Average time taken to complete the service: Two weeks to a month Service delivery channels: Email

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Request for legalization of official documents

Request for legalization of official documents

Stamping documents for legalization purposes(registration certificates for pharmaceutical products and company, GMP) The Documents: 1. Official request letter. 2. copies of the original documents to be stamped. 3. Payment invoice. Requirements: 1- The documents should be a copy of a class dish 2- The documents are valid

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Report Non-availability of Drug in Private Sector

Report Non-availability of Drug in Private Sector

The beneficiary can inform the Directorate General of Pharmaceutical and Drug Control for lack of medicine in the private sector. Terms and Conditions: Provides the prescription for the drug. Service Completion Period: 3 days of work.

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Request for registration\Re-Registration of Medical Device Manufacturer

Request for registration\Re-Registration of Medical Device Manufacturer

Receiving and evaluating applications and issuing the certificate Average time taken to complete the service: 60 days. The Documents: commercial register Technical files. Requirements: Provides the quality management certificate for the factory. To be licensed in the country of origin.

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Request for Registration\Re-Registration of medical device

Request for Registration\Re-Registration of medical device

Request for Registration\Re-Registration of medical device Average time taken to complete the service 60 working days The Documents: commercial register Technical files Requirements: Provides the equipment store and medical supplies Provides a special activity for medical devices and supplies in the commercial registry Provides the Trade Agency for Products

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Import non- Registered Medical Devices

Import non- Registered Medical Devices

To get a permit for Importing non - registered Medical Devices for the Private Market and Government Hospitals

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Content Resources


Timing and Interview Results

Date and results of interviews for pharmaceutical staff

Drug prices

List of registered and priced pharmaceutical medicine

Banned /Adulterated Products

List of Banned /Adulterated Products in Oman : Virility Products ,Body Building Products,Slimming Products,Cosmetics Products AND Miscellaneous Products.

List of registered pharmaceutical Manufactures & products

- List of registered pharmaceutical Manufactures - List of products under registration by Active Ingredients. -List of required pharmacutical product for registration (SHORTAGE LIST)

List of registered Hearbal Companies & products

List of Herbal Companies List of Registered Herbal Medicines

List of Registered Health Products

List of Registered Health Products

List of Registered Medicated Medical Devices

List of Registered Medicated Medical Devices

List of VAT Zero-Rated Medical Equipment

List of VAT Zero-Rated Medical Equipment

Antigen Rapid Test Conditional Approval Requirements

Antigen Rapid Test Conditional Approval Requirements

List of Licensed Medical Stores.

List of Licensed Medical Stores.

Drug Safety Center Forms

Application Form for medicated Medical Device APPLICATION FORM FOR HEALTH PRODUCT (HP) Application Form for Registration of Herbal company/ Herbal Medicine Submission of Variation Application form of Medicated Cosmetic Products

List of Bioequivalence Centers Approved Locally

List of Bioequivalence Centers Approved Locally currently (2024)

Pharmaceutical Newsletter

The pharmaceutical newsletter is the first professional newsletter in Ministry of Health which started in 1992, it use to be issued in quarterly basis (every 3 months), targeting the pharmacist working in the government as well as in the private sector, as a continuing pharmaceutical education material . it is also distributed to the other health professionals for the same purpose.

Periodical Reports

DSC's Annual and quarter Reports

PharmacovigilanceAnnual Report

Adverse Drug Reaction , Quality Problems & Medication Errors Annual Report

Pharmacovigilance Monthly Report

Adverse Drug Reaction , Quality Problems & Medication Errors Monthly Report

Registration of pharmaceutical products

eCTD Guideline: eCTD Guideline version 3 (Oman) - Draft eCTD Guideline version 2 (Oman) eCTD GCC M1 Specifications

Requirements of Medical Device Establishment

No Information Available At The Moment

Guidelines


Pharmacy Licensing Department
MoH Main logo

Law of organization of pharmacy practice and pharmaceutical establishments no 35/2015

Pdf
MoH Main logo

Pharmacy Practice Law , Bylaws Number (113/2020)

Pdf
MoH Main logo

Guidelines for Licensing Manufacturing Plant for Human Medicines , Herbal Medicines and Medical Devices

Pdf
MoH Main logo

Attachment (1) Application for Initial Approval for Manufacturing Plants for Human Medicines Herbal Medicines Medical Devices

Pdf
MoH Main logo

Guideline For The Practice Of Pharmacy Profession In The Community Pharmacy.

Pdf
MoH Main logo

Guideline for the practice of pharmacy profession in medical store

Pdf
Drug Control Department
MoH Main logo

Guideline for importing of non-registered medicine

Pdf
MoH Main logo

GUIDLINE FOR IMPLEMENTATION OF THE REVISED PRICES FOR PHARMACEUTICAL PRODUCTS

Pdf
MoH Main logo

Guideline for Medicines and Pharmacetical Products Recall Procedure - Version 1, Septemper 2019

Pdf
MoH Main logo

Guide to Management of Narcotics & Psychotropic Substances in Health Institutions and Pharmaceutical Establishments

Pdf
MoH Main logo

Guidelines for Product Classification

Pdf
MoH Main logo

Guidelines on Drug Pricing Control Policy-Cir. 55 of 2012

Pdf
MoH Main logo

Guidance for Importing Medical Products into Oman for personal use.

Pdf
MoH Main logo

GHC Drug Barcoding Specifications

Pdf
MoH Main logo

Guideline for Biological Products Registration

Pdf
MoH Main logo

Guidelines For Variation 6.2

Pdf
Medical Devices Control Department
MoH Main logo

Medical Device Reporting Guidance(draft)

Pdf
MoH Main logo

GD3 - Requirements of High Risk Medical Devices Registration

Pdf
MoH Main logo

GD5 - High Risk IVD Registration

Pdf
MoH Main logo

GD7 - IVD Low Risk registration

Pdf
MoH Main logo

GD9 - Requirements of Low Risk Medical Devices Registration

Pdf
MoH Main logo

GD14 - Medical Devices Bundling Grouping Criteria

Pdf
MoH Main logo

Listing Guidance

Pdf
MoH Main logo

Storage Conditions for Medical Device Warehouse

Pdf
Pharmacovigilance and Drug information Department
MoH Main logo

Guide for Reporting Adverse Drug Reactions & Quality Problems

Pdf
MoH Main logo

Guideline on Good Pharmacovigilance Practices in Oman

Pdf
MoH Main logo

Guide for Good Pharmacovigilance Practice in Oman for MAHs / Pharmaceutical Companies Supplement to Chapter 11 - Educational Materials

Pdf
MoH Main logo

Guide for Direct Healthcare Professional Communications (DHPCs)

Pdf

Contact Numbers and Locations


Address

Al-Khuwair

Office Numbers
DG OFFICE
Drug Control Department
Central Quality Control Lab. Department
Pharmaceutical Licensing Department
Pharmacovigilance & Drug Information Department
Medical Devices & Equipment. Department
Pharmaceutical Industry Section
Fax Numbers
Opening Hours
All Services
Sunday-Thursday, 07:30 AM - 02:30 PM
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