SINGAPORE Law and Practice Contributed by: Tony Yeo and Benjamin Gaw, Drew & Napier LLC
chemical characteristics, biological activity, safety and efficacy needs to be established. 3.3 Period of Validity of Marketing Authorisations Registrations of therapeutic products and medical devices generally remain valid for a year and may be renewed by paying an annual retention fee, unless the registration is suspended by the HSA or cancelled by either the HSA or the product registrant. There is no requirement to market the health product once it is registered by the HSA. However, under the Singa- pore Association of Pharmaceutical Industries Code of Conduct, the first use of all promotional materi- als circulated to the market may not occur more than two years from the date of approval. Materials used beyond this time period are required to be re- approved. The registration of a health product may be suspend- ed or cancelled by the HSA on the following grounds: • the registration has been obtained by fraud or mis- representation; • the registrant of the health product has contra- vened or is contravening any provision of the HPA, any condition attached to the registration, or any other prescribed requirement; • the formulation, composition, design specification, quality, safety or presentation of the health product has changed in such a way as to render it unsuit- able to continue to be registered; • the health product no longer complies with a pre- scribed requirement; or • it is in the public interest to do so. 3.4 Procedure for Obtaining a Marketing Authorisation Therapeutic Products Registration procedure • Pre-submission: at the pre-submission stage, applicants may submit a pre-submission enquiry to the HSA for any clarification, and may also request a pre-submission meeting with the HSA where necessary to address specific submission issues. • Application submission: the application form must be submitted online via the HSA’s portal, PRISM, and the technical dossier accompanying the appli-
cation must then be submitted within two working days of the PRISM application submission. • Application screening: the application is screened to ensure that the application type is correct and the technical dossier is complete. Where any changes are required or where there are deficien- cies in the application, the HSA will request that the applicant take the necessary action via an Input Request. In the case of certain major deficien- cies, applicants will be requested to withdraw the application. • Application evaluation: the evaluation stage begins when the application is accepted. Evaluation que- ries may be issued to the applicant if clarification or additional information is required. The applicable evaluation route depends on the type of therapeu- tic product and whether the therapeutic product has received reference agency approvals. Please see 4.1 Fast-Track Registration Routes for more details. • Regulatory decision: the HSA will notify the applicant of whether their application has been approved, is approvable or non-approvable, or has been rejected, after evaluation. Where the applicant receives an approvable regula- tory decision, they will be informed of the conditions for approval and will receive a grant of a final approval if the conditions are fulfilled within a stipulated time- frame. Where the applicant receives a non-approvable regula- tory decision, they will be informed of the deficiencies leading to said decision. The applicant may address the specified deficiencies by furnishing a response based on the original data set submitted to the HSA within the stipulated timeframe in order to continue
with the application. Variation procedure
Variation applications of registered therapeutic prod- ucts are split into major variation applications (MAV) and minor variation applications (MIV). Each applica- tion type may be subject to different evaluation routes and different variation procedures.
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