regulator

Different approaches are taken for smooth registration and handling of the products after registration from release of the manufacturing facility through warehouses of distribution companies to the trollies of medical centers and finally patients.

During all these processes, regulatory considerations have to be taken care of in order to get a pharmaceutical product safe and sound from manufacturer to patients.

Constant contact with partner companies and MOH experts are required to make sure the products comply with regulatory guidelines of MOH.

Registration of products is a responsibility of regulatory affairs which generally involves below steps:

General steps for registration of a medicinal product after entering into exclusive agreement with a supplier include:

1- First Step: Submitting of a Letter of Authorization and an APP1 form in order to get MOH preliminary approval. This can take up to one month or more.

2- Second Step: After receiving preliminary approval, below documents must be submitted

  • Legalized Letter of Authorization
  • Legalized CPP(Certificate of a Pharmaceutical Product)
  • Legalized GMP
  • Legalized APP3: A form about registration and distribution status of the product in different countries
  • APP4: A form containing product information such as names and details of manufacturers of API, excipients, etc.

*Legalization means the documents need to be asserted by chamber of commerce and Iran embassy in the country of origin.

3- CTD Study: CTD will be submitted and MOH queries should be properly replied to.

Through successful completion of the above three steps, an Iran Registration Code (IRC) will be issued which means the product is successfully registered.

Regulatory Affairs