![]() ![]() The finished product manufacturer of the therapeutic product to be imported or.Such proof of approval must be provided in the form of website screenshot and URL (of the website) for confirmation that the therapeutic product to be imported is registered in the exporting country.Ĭ) A copy of the supplier’s invoice from the exporting country indicating the batch number of the therapeutic product to be imported.ĭ) A certificate of analysis (CoA) of the consignment batch to be imported issued by either: The information stated on the website must be in English, and must allow the confirmation of the product’s identity and product’s ownership. Reference to any register / listing published by the authority on its website.Approval letter issued by the drug regulatory authority of the exporting country or.You will need to submit the following documents as supporting documents in your application:Ī) A colour scanned copy of the documentary evidence issued by the regulatory authority of the exporting country which confirms that the exporting company is licensed to carry out export business for pharmaceutical products in the exporting country.ī) Proof of approval of the therapeutic product in the exporting country: In addition to the consignment approval, your company must hold a Therapeutic Product Importer's Licence and Therapeutic Product Wholesaler's Licence. ![]() Your company needs to be registered in Singapore with the Accounting and Corporate Regulatory Authority (ACRA) to apply for this SAR.Please note that each application is limited to only one consignment of a specific batch of one therapeutic product (registration number specific). The package insert supplied with the product must be the same as the currently approved for the registered therapeutic product in Singapore.ī) The therapeutic product must not contain any controlled drug specified under the Misuse of Drugs Act and its Regulations.Ĭ) Importation must be carried out within 6 months from the date of the approval of the application.ĭ) The approval is only valid if the therapeutic product is still registered in Singapore at the point of importation.Į) The imported batches may be subject to testing by HSA under the Product Quality Surveillance Programme and failure to meet the CMC standards as approved by HSA for the registered therapeutic product will result in the cancellation of the approval for the special consignment.The chemistry, manufacturing and controls (CMC) standards must be the same as the registered therapeutic product in Singapore and.Conditions for using this special access route (SAR)Ī) The therapeutic product to be imported must be the same in all aspects as the product that is currently registered in Singapore. Importers who are neither the registrants nor authorised by the registrant and intend to import a registered therapeutic product under Regulation 5(1)(b)(vii) of the Health Products (Therapeutic Products) Regulations 2016 will need to apply for an approval for each consignment of the registered therapeutic product to be imported. ![]()
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