Page 24 - PharmBio2122_25June21
P. 24

                                                                                                                                                                                                                                          SINGAPORE PHARMBIO GUIDE 2021/2022
  LICENCES AND PERMITS
Depending on the nature of the pharmaceutical or biotech operation, there are several operating permits and licences that are necessary prior to initiation of business. Some of the more common ones are described below:
GENERAL REQUIREMENTS FOR ALL TYPES OF OPERATIONS
 Factory Registration and Workplace Safety & Health Regulations
Some pharmaceutical and biotech setups may be classified as a Factory under the Workplace Safety and Health Act (WSHA) (accessible online at http://sso. agc.gov.sg). Depending on the type of factory operation, either a notification or registration with the Ministry of Manpower (MOM; www.mom.gov.sg) may be required. Pharmaceutical factories are classified as workplaces requiring registration.
The new Workplace Safety and Health (Major Hazard Installations) Regulations also require workplaces that process, manufacture or bulk store dangerous substances and their mixtures that are equal or exceeding the stipulated threshold quantities to be registered with the Major Hazard Department of MOM.
Furthermore, the WSHA and its Regulations set the legal framework for occupational safety and health (OSH) management at all workplaces in Singapore. Importantly, the WSH
(Risk Management) Regulations 2006 requires all workplaces to conduct a properly documented safety and health risk assessment prior to undertaking any work within the premise. Pharmaceutical factories are required to conduct Safety and Health Management System audits or internal reviews within 2 months from their commencement of operation and to submit their audit reports to the Ministry of Manpower via the LicenceOne portal (https://licence1.business.gov.sg/). We would like to stress the importance of risk assessment as an essential undertaking during the operations planning stage.
Industrial Premise Siting
Prior to any industrial development, in particular a manufacturing plant, one must first obtain planning permission from the Urban Redevelopment Authority (URA) (www.ura.gov.sg). URA administers a land use plan (the latest being Master Plan 2014) that specifies the zones within which the various industries may operate. For example, manufacturing is generally restricted to Business 2 (B2) zones while some types of R&D operations may be located within a Business 1 (B1) zone.
Once URA has issued the Written Permission (WP) for the space use, the design plans must be submitted to the Building and Construction Authority (BCA) for assessment of their compliance to current building and structural safety regulations. BCA’s approval of the design plans is required prior to commencement of building construction works. Companies should also consult other building-related technical government agencies, such as the Fire Safety and Shelter Department (FSSD) of the Singapore Civil Defence Force (SCDF), Development Control and Licensing Department (DCLD) of the National Environment Agency (NEA), Public Utilities Board (PUB) and Energy Market Authority (EMA) and incorporate their additional requirements into the building design plans. All building-related applications should be filed by the Project Architect and Professional Engineers via the CORENET e-submission portal (www. corenet.gov.sg).
The impact of an industrial project on the environment has to be assessed by the National Environment Agency (NEA) (www.nea.gov.sg) prior to
 18





















































































   22   23   24   25   26