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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. To be a national regulatory and supervisory authority with global distinction in protecting and promoting public heath. Request for changing sponsor from one establishment to another. 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. 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. 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. Request to renew a pharmaceutical establishment Service Completion Period: Week-two weeks. 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. Request for Temporary Suspension Average time taken to complete the service: 2 days Service delivery channels:Walk-in Counter. 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. 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. 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. 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. 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. Average time taken to complete the service 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. Receiving databases from the supplier companies and including them in the master list The Documents Filling out the Excel file for that. 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 The latest offer Latte coordinates Address The name of the authorized person Phone numbers E -mail of the authorized person. 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. Terms and Conditions: The required documents are valid endless Service Completion Period: 7 working days. 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. Prerequisites: The pharmacy institution license is valid. Copy of the pharmacist's license. 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. 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. Official letter from the institution. Valid licenses for physicians to handle. Requirements: 1- The applicant for the request must be licensed to deal with the monitoring medications. 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. 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. Payment invoice. 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: working days for the unsecarantic varieties and 60 working days for innovative 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. Average time taken to complete the service: 90 working days. Request for registration of additional pack size for registered pharmaceutical product. Requirements: 1- The certificates must be certified and valid Average time taken to complete the service working days. 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. 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. 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. 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. Average time taken to complete the service:. 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. 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. Stamping documents for legalization purposes registration certificates for pharmaceutical products and company, GMP The Documents: 1. Official request letter. Requirements: 1- The documents should be a copy of a class dish 2- The documents are valid. 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. 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. Submission of file for registration will be through this eCTD. Re-engineering the services of the Pharmaceutical Licensing Department in the portal. Data simplification and transformation Medicines. Medical Device Reporting. Electronic transfer of inspection services, pharmaceutical institution data modification service and Pharmaceutical establishment waiver service. Activate some lab services in the E-Portal - Product files to be submitted through the e portal. 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. 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. 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. Objectives of the Department: Post marketing surveillance of medicines. 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. 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. The pharmaceutical newsletter is the first professional newsletter in Ministry of Health which started in , 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. Add Reason choose at least one. Mohammed Hamdan Al-Rubaie. 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. Read More. 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. Vision To be a national regulatory and supervisory authority with global distinction in protecting and promoting public heath Read More. Apply for Exam. License renewal. Request Good Standing Certificate for pharmacist and assistant. 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 Read More. 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. Service Completion Period: week -2 weeks Read More. Renew a pharmaceutical establishment. Renew a pharmaceutical establishment Request to renew a pharmaceutical establishment Service Completion Period: Week-two weeks Read More. 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 Read More. 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. 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 Read More. Apply for Product Classification. Clearance of medical product. Clearance of medical product clearance of any medicine registered or not registered before reach country. 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 Read More. 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: 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 Read More. 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: Fill out the form for reporting the accidents of devices and medical supplies - Sampling Read More. 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. E -mail of the authorized person Read More. 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 Read More. Stamping records for data entry of monitored drugs. Request for Waste Disposal. Request for Waste Disposal A request for the destruction of expired items that contain Narcotic or Psychotropic substances. Service Completion Period:week Read More. Service Completion Period: 7 working days Read More. 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. Requirements: 1- The applicant for the request must be licensed to deal with the monitoring medications Read More. 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 Read More. 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: working days for the unsecarantic varieties and 60 working days for innovative companies Read More. 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. Average time taken to complete the service: 90 working days Read More. 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. Requirements: 1- The certificates must be certified and valid Average time taken to complete the service working days Read More. 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 Read More. 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. Certificate of Pharmaceutical Product. Certificate of Pharmaceutical Product Request for issuing a certificate of pharmaceutical product. 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. 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. 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 Read More. 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 Read More. Analysis of complaints samples. Analysis of complaints samples analysis of complaint samples received from drug control dept, PV, Inspection, clearance and MD dept. 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. Requirements: 1- The documents should be a copy of a class dish 2- The documents are valid Read More. Report Non-availability of Drug in Private Sector. Import non- Registered Medical Devices. Start Date : 01 May Estimated Months : 6. Medical Device Registration. Start Date : 01 February Re-engineering the services of the Pharmaceutical Licensing Department in the portal Re-engineering the services of the Pharmaceutical Licensing Department in the portal Read More. Start Date : 01 March Estimated Months : Start Date : 01 January Start Date : 01 July 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 Read More. 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. About Us. Central Quality Control Department. Pharmacovigilance and Drug information Department. Medical Devices Control Department. Ongoing Projects. Future Projects. Services List. Content Resources. Timing and Interview Results Date and results of interviews for pharmaceutical staff Select file to download 03 09 Results. View Download Share. List of Licensed Medical Stores. Select file to download Medical Store List of non-Omani pharmacist graduated from Oman's colleges List of non-Omani pharmacists graduated from Oman's colleges Select file to download List of non-Omani pharmacist graduated from Oman's colleges. Pharmaceutical Newsletter The pharmaceutical newsletter is the first professional newsletter in Ministry of Health which started in , 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. Select file to download 3 1 2 1 2 1 2. Pharmacy Licensing Department. Guideline for the practice of pharmacy profession in medical store Pdf. Guideline for importing of non-registered medicine Pdf. Guidelines for Product Classification Pdf. Guidance for Importing Medical Products into Oman for personal use. Guideline for Biological Products Registration Pdf. Medical Device Reporting Guidance draft Pdf. Listing Guidance Pdf. Contact Numbers and Locations. Muscat Get Direction. Address Al-Khuwair. Office Numbers Drug Control Department. Central Quality Control Lab. Pharmaceutical Licensing Department. Pharmaceutical Industry Section. Fax Numbers Opening Hours All Services. Was this page helpful? Be the first to evaluate this page. I found the page useful and clear. I was able to access the information easily. The wording of the content is elaborate on this page. Navigating the page is convenient and easy. The content is incomprehensible. I could not find the information to be obtained. I encountered a technical problem. I found this page difficult to read. Other reason. Submit Cancel.