Iran (Islamic Republic of) | BCH-LAW-IR-108886 | Biosafety Law, Regulation, Guidelines and Agreements | Biosafety Clearing-House

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Biosafety Law, Regulation, Guidelines and Agreements (LAW)
  |  
BCH-LAW-IR-108886-2   |   PDF   |   Print   |  
last updated: 07 May 2023
Amendment
No
General Information
Rules for Registration and Import of Biological Products
EN
Legislative details
Regulation or administrative measure
National / Federal
Under the law, manufacture or import of any pharmaceutical or biological products and their offer and sale in the country or their export require permission from Ministry of Health, and Medical Education and getting license and permission is compulsory.
Aim
This guidelines has been complied for executing of drug registering regulation which was approved in Jan. 2015, by Food and Drug Administration of Iran.
Scope:
This guidelines is for the execution of registration process of biological products and familiarization with stages and documents required for applying registration in biologic office of Food & Drug ِِAdministration.




EN
16 Jul 2015
Regulatory contact information