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Experience in Passing the Format Review on General Notification Once Only
2016-09-20 14:24:26 点击数:
                                                                                                                                         On-line submission for General Notification was launched on April,1st, 2016, which means that all types of new chemicals notification have achieved on-line submission, which will standardize the dossier submission procedure, and will promote the process of the paperless office.
For the notifiers, on-line submission for General Notification means notification form should be signed and sealed again every time it does not meet requirements of format review, which will seriously affect the schedule of obtaining the notification certificate.
Beijing Boarding Card Chemical Regulatory Consulting Co., Ltd.(hereinafter referred to as BC), as a professional consulting agency, sets up an challenging goal of passing the format review once. A dossier of General Notification levelⅡsubmitted by BC on 23, May,2016, successfully passed the format review once only, on which BC is willing to share the experience as follows:
A.      Pay close attention to the relationship of the testing data of the notification substance in the dossier, such as correlation between aquatic biological toxicity data and water solubility, and relationship between acute toxicity and chronic toxicity data.
B.       2. Conduct overall consideration on the consistency of the content of the dossier, such as the risk assessment report, the notification form and its attachments. Once there  are some corrections, all related documents should be correspondingly amended.
C.       3. Sound procedure for internal format review. BC conducts internal format review twice for each dossier, by technical manager and one or two assistants separately, then amends the dossier by technical manager to form the final edition(Sign on and seal the notification form after the internal format review).
Success comes from professionality and details. BC has been engaged in consulting for more than ten years, with its sound professionality and service, serving the general chemical enterprises at home and abroad.