Note: This translation is unofficial. We are not responsible for any errors or ambiguities.  There may be updates not included in this version. The Iranian text always prevails.

              Sunday 03 January 2016

• Food and Drug Organization
• Division of Pharmaceutical and Narcotic Affairs
• Title: Regulation of registration and importation of natural medicinesDate of Issue:
• Document No. : NM-RU-10-01
• Name of Office:    Natural Medicines and supplements
• Islamic Republic of Iran
• Ministry of Health and Medical Education
• Deputy of Food and Drug
• Pharmaceutical and narcotic affairs division
• Document Number
• NM-RU-1-01
• Document Title
• Regulations of Registration and Importation of Natural medicines
• Covering Page
• For the last modification of this regulation refer to new regulation of pharmaceutical registration (natural products section)
• In accordance with the third section of the laws and regulations of medical and pharmaceutical affairs in the fourth chapter of the law of conditions of poduction and import of drugs and biologic and laboratory products passed on 1955/06/19 and modified on 1988/4/12 by the Iranian Parliament, and in accordance with the objectives of the ministry of health and medical education for enhancement of use and rational consumption of natural drugs, quantitative and qualitative improvement of dosage forms of natural drugs and development of a dynamic competition for manufacture and provision of these products, the rules and regulations of importation of natural products are hereby announced:
• Definition of natural drug: Drugs which originate from plants, animals and minerals or their products, whether raw or processed, and are used for prevention and treatment of disease (physical and mental) in human.
• Note: Products prepared from one pure natural active ingredient are subject to regulations of Iranian chemical drugs.
• Article 1: Importation of any natural drug into Iran is conditioned to regulations of pharmaceutical registration and importation, and its discharge from customs and distribution requires prior approval from the "pharmaceutical and narcotic affairs division".
• Article 2: The legal committee of production and importation (subject of article 20 of the law of medical and pharmaceutical affairs and comestible items) is responsible for issuance of authorization of importation of natural drugs.
• Article 3: Importation authorization is issued for those natural drugs which are permitted to provision and usage in the Iran by the council of Iranian natural products.
• Article 4: The import authorization of natural products is valid for a period of 4 years, which is renewable.
• Note 1: In case of incompatibility of the imported goods with previously submitted formulation properties, the Authorization/license will be suspended.
• Note 2: Request for license renewal must be submitted to the "pharmaceutical and narcotic affairs division" 6 months prior to expiry.
• Article 5: If during the validity period, "pharmaceutical and narcotic affairs division" considers the natural product is unsafe to the social health, the authorization will be canceled by verdict of the legal committee.
• Article 6: importer Condition:
• Any legal person may import natural products after acquisition of preliminary approval for importation from the "pharmaceutical and narcotic affairs division"  in accordance with regulations of drug registration and importation.
• The importer must submit the company’s constitution and its official gazette includung the subject of importation of natural products to the "pharmaceutical and narcotic affairs division"
• The importing company must be able to offering exclusive representation of a valid company/ companies or the exclusive right of sales for requested pharmaceutical product in Iran.
• The importing company must introduce one qualified pharmacist as technical responsible person.
• After acquisition of primary approval, the importing company must acquire separate authorization for each requested product.
• The importing company may contract one of the authorized local distributing companies or distribute its items by itself in accordance with related regulations.
• The company should follow advertising regulation for introduction and advertising its items.
• Article 7: Regulations for registration and importation of natural drugs by drug-importing companies
• Original certificate of exclusive representation or exclusive sales rights from the manufacturing company
• Original certificate of pharmaceutical product (CPP) issued by component  pharmaceutical regulatory authority of the country of origin in accordance with the structure suggested by World Health Organization (appendix 1) confirmed by the Iranian embassy in that country
• Original certificate of purchasing countries, including generic name, dosage form, name of countries purchasing the product, brand name of the product in those countries, registration number in those countries, registration date in those countries, date of registration, date of discontinuation (if discontinued), confirmed by trade chamber of the country of origin or the purchasing country
• List of branches of the manufacturing company with precise addresses
• In case of request by the "pharmaceutical and narcotic affairs division", sufficient sample  should submitted to national control laboratories with certificate of analysis, technical dossier , relevant reference standards and lab approval should received.  
• Completed natural medicines importing application form (NMIAF) (appendix 2)
• Submission of drug master file(DMF)
• Completed form of drug price by the importing company in two copies (appendix 3), confirmed by the managing director of the importing company
• Completed evaluation form of importing drug files which precisely completed and confirmed by the importing company’s technical responsible (appendix 4)
• GMP certificate of the manufacturer, by competent regulatory authorities of the country of origin
• Note: If applicable, the product manufacturing site will be subjected of GMP inspection.
• After submission, evaluation and approval of the above documents and, if necessary, submission of sample  to laboratory and reception of affirmative response from the national drug control laboratories, the observance of the following items will result in submission of the subject to the legal committee:
• The requested product is acceptable with the same brand name and from the same factory as sold and consumed in the country of origin.
• The requested product must be sold and consumed with the same brand name in other countries as in the country of origin.
• Drug registration conducted from authentic sources in countries of west Europe, North America, Canada, Australia and Japan.
• Note: If the registration is requested from other countries than those mentioned in above paragraph, the application could be evaluated with submission of the following documents:

1. Submission of GMP certificate from the competent drug authority of the country of origin and GMP compliance of the manufacturer by the "pharmaceutical and narcotic affairs division"
2. Submission of registration certificate by authentic international centers (e.g. FDA, TGA, EMEA, etc.)
3. Exportation of the requested product to the countries mentioned in paragraph c above.

• In this stage, the importing company must pay the registration fee in accordance with the law. After assessment of the above documents and confirmation of the legal committee, the result will be communicated to the importing company. Subsequently, Iran registration code (IRC) will be announced and authorization/license will be granted. Hence, the importing company will be permitted to produce proforma in accordance with the relevant regulations.
• Remark 1: Persian translation of the brochure and labeling, confirmed by the technical responsible person of the importing company, must be submitted to the "pharmaceutical and narcotic affairs division". Any responsibility regarding the contents of the translated brochure and labeling lies with the importing company.
• Remark 2: It is mandatory to mention IRC on imported drug labeling alongside introduction of brochure and labeling in Persian and English.