Biosafety Application Procedure (IBC)

A. Overview

Overview on the application procedure

In the general the applicant being the responsible person require to provide vital input throughout the procedures. The integrity of the information provided will ensure a rapid processing towards a successful application. The procedures may be tedious but necessary due to the nature of the materials involved. The NBB stated three separate requirements to be fulfilled by researchers working with different degrees of biological materials. In general the procedures are as illustrated within the flowchart given.

Flowchart: Click Here

Resources

  1. Biosafety Clearing House - Central Portal  (URL-  http://bch.cbd.int/   )
  2. Biosafety Clearing House – Malaysia (URL- http://www.biosafety.gov.my/)
  3. Department of Biosafety, Ministry of Natural Resources and Environment

B. Exemption Procedures

Application for Exemption Procedures

Researcher is advised to fill this form to clarify and declare the biological material to be handled not in any way requiring biosafety approval. Failure to do so compels action by the university in the event of an incident.

Exemption List (First Shcedule) : Click Here

Exemption List (by Minister) : Click Here

Exemption form: Click Here

Please sent your application to Alamat emel ini dilindungi dari Spambot. Anda perlu hidupkan JavaScript untuk melihatnya. & Alamat emel ini dilindungi dari Spambot. Anda perlu hidupkan JavaScript untuk melihatnya. 

C. Notification Procedures

Application for Notification Procedures

Researcher required notifying NBB and it covers these cases:

  1. Contained use activities involving Living modified organism
  2. Importation of living modified organism for the purpose if undertaking a contained use activity
  3. Exportation involving living modified organism

The general flow to notify is as shown here: Click Here

Please use the IBC checklist form as the guide in completing required fields to be submitted to IBC.

  1. Applicant Checklist: Click Here
  2. The research proposal and CVs of research participants submitted as seen fitting and adequate for the applications.
  3. Required to fill Form E (Click Here) 
  4. Risk Assessment Matrix: Click Here
  5. Standard Operating Procedures: Click Here

Please sent your application to Alamat emel ini dilindungi dari Spambot. Anda perlu hidupkan JavaScript untuk melihatnya. & Alamat emel ini dilindungi dari Spambot. Anda perlu hidupkan JavaScript untuk melihatnya. 

D. Approval Procedures

Application for Approval Procedures

A researcher required to apply for “Approval” if involve these cases

  1. R&D purposes in all field experiments
  2. Supply or offer to supply for sale or placing on the market
  3. Any other activity which does not amount to contained use.

Approval applications require fees imposed on researcher as stated here:

Fees for approval: Click Here

  1. Applicant Checklist: Click Here
  2. The research proposal and CVs of research participants submitted as seen fitting and adequate for the applications.
  3. Use one of these approval forms upon deciding based on material involved in research project.
    1. Approval for  release activities of living LMO or importation of LMO that is higher plant: Form A (Click Here)
    2. Approval for release activities of LMO or importation of LMO other than higher plants: Form B (Click Here)
    3. Approval for release activities or importation of LMO that is a higher plant and product of such organism: Form C (Click Here)
    4. Approval for release activities of LMO other than a higher plant and product of such organism: Form D (Click Here)
  1. Risk Assessment Matrix: Click Here
  2. Standard Operating Procedures: Click Here

Please sent your application to Alamat emel ini dilindungi dari Spambot. Anda perlu hidupkan JavaScript untuk melihatnya. & Alamat emel ini dilindungi dari Spambot. Anda perlu hidupkan JavaScript untuk melihatnya. 

E. Other Forms

Other Forms

  1. Notification for export of LMO: Click Here
  2. Incident reporting form: Click Here
  3. Occupational disease / exposure investigation: Click Here
  4. Project extension & notice of termination: Click Here

Please sent your application to Alamat emel ini dilindungi dari Spambot. Anda perlu hidupkan JavaScript untuk melihatnya. & Alamat emel ini dilindungi dari Spambot. Anda perlu hidupkan JavaScript untuk melihatnya. 

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