Pre-market services

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  1. Policy & Plan (planning, coordination, communications, information, M&E and drafting legislative documents)

This section is responsible for planning and developing policies for NMHRA. Planning, reporting, monitoring and evaluation, ensuring coordination, communications with national and international organizations, exchange of information and compilations, updating legislative documents in coordination with relevant organizations are the main responsibilities of this section, this section consists of the following departments:

  • Plan and evalauion department
  • Coordination, communications and information department
  • Drafting legislative documents department
  1. Licensing

The licensing section, in cooperation with technical committees and inspection section will be responsible for issuing license to productions, importations, distribution and retail sale of medicine and health products in the public and private sector after assessing the standards relevant to the establishments. This section, considering its volum of work, required expertise, will be at least made up of four departments:

      • Issuing license to manufacturing enterprises following the laws and guidelines on good production practices
      • Issuing license for the medicine importation companies and distributors following the laws and guidelines on good production practices, distribution, medicine storage and certain other relevant legislative requirements
      • Issuing license to medical stores following guidelines on good practices of medicine storage, dispensing to the patient and certain other relevant legislative requirements
      • Issuing license to pharmacy workers in medical stores, distributors, and manufacturing factories
  1. Permit to market supply and pricing (valuation)

This section will be responsible for issuing permit for the importation pharmaceutical products according to the annual national required amount,quarantining the products, taking sample from the products arrived at the customs or products at the local industries, sending them to the quality control department, issuing permit to market supply and setting price for the products. Considering the type of its activities, this unit will at last have the following departments:

  • Department of market supply permit issuance
  • Pricing department
  • Medicine and health product evaluation and registration

The medicine and health product evaluation and registration section, with the cooperation from relevant technical committee and inspection and quality control sections, will take up the responsibility for technical study and evaluation of medicine and health products quality, effectiveness and safety before their registration, inspection of place of production and quality test of the products. This section according to the type of products, required expertise, will consist of following departments:

    • The medicine registration department with cooperation of relevant technical committee, will be responsible for pharmaceutical products evaluation and registration
    • Health product registration department will be responsible for the evaluation and registration of medical eqipments, medical tools, and cosmetics, like shampoo, soaps, and certain other products according to the definitions of health product law.
    • Biological products registration system will be responsible for the evaluation and registration of biological products used by mankind
    • Traditional medical products department is resposnbile for evaluation and registration of supplementary products such as homeopathy products, herbals, chinees, ayurvedic, and registration of natural and herbal products and food items supplementaries according to the legislative documents and regulatory guidelines.
       
  1. Regulation and control of clinical studies

The regulation and control of clinical studies section is responsible for the evaluation and approval of the clinical studies protocols considering the technical standards of study and monitoring the conformity of operations against good study practices guidelines.