Iran Biosafety Law has been approved in July 2009. Executive regulations of required conditions for the packaging and labeling, transport and transboundary movement of LMOs has been prepared by National Biosafety Coordinating Committee and approved by National Biosafety Council in 19 April 2015. Moreover Ministry of Health and Ministry of Agriculture Jihad (Competent National Authorities) have provided executive ministerial guidelines to implement Iran Biosafety Law.

All pharmaceuticals are strictly regulated by the Ministry of Health and Medical Education.

Research is exempted from the Scope of Iran Biosafety Law but according to  paragraph 3 of article 7 of Iran Biosafety Law, all of the real and legal entities who intend to import, export or transit LMOs for research purposes in the contained environment the nature of the issue has to be clearly defined and name and identity of the sender and recipient has to be specified.

Implementation of articles 7 - 10 is noted by the relevant national competent authorities during decision making procedures according to the article 5 of the National Biosafety Law.

Based on Article 7 of Iran Biosafety law, applicants are obliged to submit risk assessment documents to the Competent National Authorities mentioned in Article 4.

Based on the amendment of article 9 of Iran Biosafety Law: In case of any emergency condition arising from accidents or unintentional release of LMOs, the competent administrative body has the authority of officially notify the certificate holder and withdraw some of the confidential information from the classification status and submit them to other administrative bodies to carry out other necessary actions. In this case, the certificate holder has no right to claim. <br />In addition, specific regulations has been adopted by National Biosafety Council in May 2015 on topic of packaging, labeling and transboundary movement of LMOs.<br />

Executive regulation of Article (7-II) of Iran Biosafety Law has been adopted by National Biosafety Council in May 2015 on topic of packaging, labeling and transboundary movement of LMOs.

Based on Article (4) of Iran Biosafety Law: Issuing, extension and cancellation of activity permission in issues related to modern biotechnology, regarding the regulations of each body, the issue of article (3) are under the responsibility of three competent authorities:<br />a. The Minister of Agriculture in issues related to production in the agricultural sector and natural resources.<br />b. The Minister of Health and Medical Education in the issues related to the health and safety of food, cosmetics and medical materials.<br />c. Department of Environment in issues related to wild life and evaluation of the environmental risk assessment based on scientific documents provided by the applicant.<br />

Iran has officially declared its interest to perform phase III of BCH capacity building poject and is waiting for project to be approved by GEF.<br />BCH focal point attended in: <br />- Third UNEP-KBCH Asian Regional Workshop for Biosafety Clearing House; 18-20 November 2013, Siem Reap, Cambodia.<br />- Global Workshop on BCH responsibilities and sustainability; 26-27 September 2014, Pyeongchang, Republic of Korea.<br />BCH focal point performed several presentations to introduce BCH in:<br />- GLP Workshop Organization by National Institute of Genetic Engineering and Biotechnology (NIGEB); 26 January 2014.<br />- Biosafety Workshop organized by food and drug organization, Ministry of Health, Tehran, Iran, 19 &amp; 26 February 2014.<br />- Theoretical and Practical Workshop on BCH Capacity Building organized by CPB National Focal Point; 12 to 13 March 2015, Kelardasht.<br />Providing a mailing list of more than 100 related stakeholders and sending the latest biosafety news to their email regulatory by BCH focal point.<br />Iran is still in need of support for capacity building in BCH which has a very important role in implementation of the CPB. Therefore Iran&nbsp; hopes could get involved in phase III of BCH project and other international programs to improve nBCH activities.<br />

I.R. Iran has participated in the UNEP-GEF capacity building project for implementation of NBF from September 2012.<br />In order to familiarize different stakeholders with BCH, Iran National Focal Point (NFP) organized a two days workshop on BCH capacity building from 12 to 13 March 2015 in Kelardasht. <br />Secretariat of Ministry of Health and Medical Education Biosafety Committee which is located in Food and Drug Administration held a biosafety meeting from 14 to 18 June 2015, Tehran, I.R. Iran. Dr. Angela Lozan the head of Biosafety department in Ministry of Environment of Moldova participated as consultant at this meeting. <br />In spite of notification from CBD secretariat dated 22 May 2015 (Ref.:SCBD/BS/CG/ABW/84181) and its reminders dated 29 July 2015 and 16 September 2015 and in spite of several communications and applications that CPB NFP of Iran send for the "GEF support for the preparation of the third national reports on the implementation of the Cartagena Protocol on Biosafety", unfortunately all communications were ignored and no official reply was given until the NFP made telephone calls to UNEP secretariat. After that we received an email dated 3 September 2015 with a letter dated 28 August 2015 explaining that they can not fund this activity due to "the geographic scope of the project at this time". Surprisingly 2 weeks after this denial letter again a reminder dated 16 September issued by the secretariat asking NFPs for contacting Mr. Alex Owusu-Biney for support!!. We therefore encountered serious financial problem in inviting experts from different parts of the country for meetings and other related expenses for the preparation of this report. Iran may take this opportunity to ask the secretariat for allocation of time to raise Iran's official complaint against the obvious discremination among member parties during the next COP-MOP to be held in Mexico.<br />

Minisry of Science, Research and Technology that has the responsibility of BCH and nBCH is the main entity for public education and awareness at national level. Based on Article 3 of MSRT Biosafety Committee Regulation, one of the functions of this biosafety committee is to educate, perform public awareness activities and improve biosafety through different means: 1- Registering and uploading related information in BCH and nBCH, 2- Helding national and international Biosafety workshops, 3- Adding Biosafety subject to related university course, encourage performing MSc and PhD in Biosafety, 4- Publication of bulletins and journals on Biosafety.<br />Furthermore, Biosafety Society of Iran and Iran Biotechnology Information Center (IRBIC) are very active in public awareness and education: 1- Publication of Biosafety Newsletter, 2- Publication of Seasonal Journal of Biosafety and Bi-Seasonal Genetic Engineering and Biosafety Journal. 3- Helding National Biosafety Congresses (first in 2009, second in 2011 and third in 2013), 4- Helding national Biosafety workshops using national and international experts.<br />

According to Article 6 of National Biosafety Law: <br />In case that any of the competent administrative bodies observe any violation of any provision of this act by the actions of real and legal entities are obliged to temporarily suspend the permit and forward the issue to the competent judicial authorities for judicial investigation. The judicial authority should investigate the documents out of queue. In case of confirmation of violation by the judicial authority if the violation has caused damage to the rights of other people or caused harm or damage to other people or environment, the guilty person is sentenced to compensate up to 3 times the introduced damage, in case of repeating for a second time, apart from the above method all of the previous permits are cancelled and all of his/her activities are terminated.<br />

In spite of many activities and improvements, Islamic Republic of Iran still needs capacity building in most areas and fields of biosafety especially in Risk assessment and identification of LMOs as well as capacity building in BCH.

The most serious disappointment in filling in this report was the ill treatment of Iran's official communications with CBD secretariat and UNEP secretariat, regarding Iran's application for "GEF support for the preparation of the third national report".