Competent authority notification

Detailed guidance for the request of authorization of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial. October 2005. http //ec.europa. eu/enterprise/pharmaceuticals/eudralex/vol-10/ll ca 14-2005.pdf... 

Protection of clinical trial subjects 3. Protection of clinical trial subjects Detailed guidance for request for authorization of clinical trial to competent authorities, notification of substantial amendments and... 

Where necessary the manufacturer must carry out, or arrange for, safety testing. Many countries operate mandatory premanufacturing and premarketing notification schemes of which safety testing is the cornerstone. Within the European Community under Directive 67/548/EEC and its sixth amendment 79/831/EEC, Competent Authorities must be... 

Priority substances were selected, which are considered to be of particular concern to human health and/or the environment. The suppliers of these priority substances had to provide any missing studies to complete a EU notification Base Set (Table 1). A rapporteur Competent Authority evaluates the full review dossier on behalf of the EU. The final output is a risk assessment (see Section 14), with final recommendations on how to deal with the substance i.e., it may be of no concern, require risk reduction or restriction, or further data may be needed before a decision is made. 

The Board welcomes the fact that, in accordance with the standard operating procedures of Project Prism, the competent authorities of China are now sending pre-export notifications for safrole in the form of sassafras oil. In 2004, those notifications resulted in the suspension of a shipment of over 1.5 tons of sassafras oil to Canada, which was subsequently released upon completion of the legal requirements. 

The possibility of diversions being facilitated in such ways raises two important issues for competent authorities to address. Firstly, when a pre-export notification appears with the name of a well-known company with a licit requirement for the substance, the notification should not be responded to before actually checking with the company concerned whether it had actually placed the order. Secondly, when such a diversion attempt is detected, full investigations should be launched by the authorities in both the importing and exporting countries to determine how and from whom the order was received. 

If the substance is a new substance, it should be checked whether or not it is manufactured and/or imported in an amount of 1 tonne/year or less or whether it is assumed to be little released into the environment (e.g. intermediate, chemical substance used in the closed system). If the substance falls under either of such categories, simple notification canbe made for it. In simple notification, a chemical substance is reviewed only by information such as chemical name, structural formula and manufacturing flow and, if there is no problem, manufacture and/or import of the substance is permitted. After registration, however, the actual quantities manufactured/imported and uses of the substance which is assumed to be little released into the environment must be reported to the competent authority (the Ministry of Economy, Trade and Industry). A new substance that does not fall under these categories must normally be notified. 

Such a new substance is subjected to a biodegradation test before notification. If the substance is biodegradable, it is notified to the competent authority (the Ministry of Economy, Trade and Industry) with the test results and necessary documents without carrying out additional safety evaluation. If there is no problem, the substance is registered as a new chemical substance approximately 3 months after notification. There is neither a duty to report the manufactured and/or imported amount of the substance nor regulation on the use, etc. of the substance and, therefore, it can be freely manufactured, imported or used as a non-regulated substance. 

Under the Industrial Safety and Health Law, unlike the Chemical Substances Control Law, all chemical substances including a chemical substance regulated by other laws, such as the Food Sanitation Law in lapan and the Pharmaceutical Affairs Law, and used exclusively for the purpose permitted by such laws must be notified. Notification of a substance is accepted if it shows a negative result for the test and the notification document is complete. On acceptance, the substance can be manufactured and / or imported. If the substance shows a positive result for the test, the competent authority requires that additional tests be performed, such as a chromosomal aberration test, and the provision to workers who handle the substance with the information on safety, handling methods and emergency measures for the substance described in a Material Safety Data Sheet (MSDS). 

Between 1 November 2006 and 31 October 2007, the competent authorities of 24 exporting countries and territories provided 1,331 pre-export notifications to 114 importing countries and territories, involving a total of 28,888 tons of potassium permanganate. 

Related to the foregoing observations, the Board again recommends to all Governments that they should send pre-export notifications for shipments of pharmaceutical preparations containing ephedrines, control such preparations in the same way as they control the raw material and adopt adequate controls over the licit manufacture and distribution of precursors. The Board also draws the attention of competent authorities to the non-scheduled substances that traffickers search for when the monitoring of scheduled substances frequently used in illicit drug manufacture has been strengthened. 

Each State Party shall make known to the Agency and to other States Parties, directly or through the Agency, its competent authorities and points of contact responsible for issuing and receiving the notification and information referred to in Article 2. Such points of contact and a focal point within the Agency shall be available continuously. 

All operators of establishments coming under the scope of the Seveso II Directive need to send a notification to the competent authority, and need to... 

Complaints and product recall - record keeping and arrangements for notification of competent authority. 

Not surprisingly, there are many synthetic chemicals and formulations commercially available. In Europe alone more than 100000 chemicals (not formulations) are on the European Inventory of Existing Commercial Chemical Substances (EINECS), which lists chemicals on the market before September 1981. This list differentiates between existing and all new chemicals produced since 1981 that have to be notified. During the period between 1981 and 2000 more than 2700 new substances were notified in Europe (Figure 1.3). For new substances, the obligatory notification system requires the manufacturer or importer to provide information suitable for risk assessment to be submitted to the competent authorities. The details required are dependent on the production volume or import quantities of the chemical. 

All new chemicals placed on the market in Europe require notification to the competent authority of a Member State. The notification sets out the information requirements, including toxicity testing, and this information is used to conduct risk assessments. Will be replaced by REACH. 

Enacting part of the UK competent authority, on behalf of DEFRA and together with the Health and Safety Executive (HSE), for the notification of new substances and undertaking environmental risk assessments on existing substances. 

Part of UK Competent Authority to assess hazards and risks of substances under the Existing Substances Regulation and the Notification of New Substances... 

Practical information for competent authorities on adherence to the 1988 Convention, the submission of information, seizure data, requests for pre-export notifications and the licit and illicit uses of scheduled substances is contained in annexes I-IX. 

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