Singapore has become an important hub for pharmaceutical research and manufacturing companies during the last few years. Some of the greatest pharmaceutical companies in the world have an established presence in Singapore due to the clear regulatory environment. Singapore’s health system ranked 6th in the World Health Organization’s report for 2013. The main factors contributing to the development of the pharmaceuticals industry were the developed infrastructure and logistics network and the Government’s support for biomedical companies in Singapore.
Our experts who can help investors open a company in Singapore can also offer information on the legislation related to the pharmaceutical sector.
Pharmaceutical regulations and approvals in Singapore
All drug companies in Singapore are required to obtain a product license before exporting or selling pharmaceutical products. The product license application must be submitted with the Singapore Health Sciences Authority (HSA) and must have the Association of Southeast Asian Nations (ASEAN) Common Technical Document format or the Common Technical Document (CTD) format designed by the International Conference on Harmonization (ICH). Companies may obtain both generic drug licenses and new drug licenses in Singapore.
The registration of medicinal products in Singapore
Before obtaining all necessary permits and licenses, the founders must register the company with the Singapore Trade Register. After the registration procedure our experts in company registration Singapore can help you with, the medicinal products to be manufactured or sold must be registered with the HSA. According to the Medicines Act in Singapore, a medicinal product is any substance or article with the following characteristics:
- – will be administered to humans for medicinal purpose,
- – uses ingredients used for medicinal purposes,
- – treats or prevents diseases.
The product license is required before the Singapore pharmaceutical company starts operating and may be issued for a single product only. The product license is issued:
- – for a product using a specific name,
- – with a certain composition,
- – with a particular dosage,
- – with specific indications for use.
All pharmaceutical products produced or sold by Singapore companies fall under the following forensic classes:
- – prescription only medicine (POM),
- – pharmacy only medicine (P),
- – general sale list medicine (GSL).
Our Singapore company formation agents can assist with the registration procedure of pharmacies.
Retail pharmacies in Singapore
Foreign investors may also set up retail pharmacies in Singapore which must respect less stringent requirements. These types of pharmacies are allowed to sell over-the-counter drugs, which are pharmaceutical product released without a prescription. However, this type of pharmaceutical company must also obtain the approval of the HSA.
Singapore retail pharmacies can sell specified health products such as:
- – therapeutic products;
- – oral dental gums;
- – pharmaceutical products which are on the General Sale List.
However, these products must be sold by pharmacists. Also, a retail pharmacy in Singapore must undergo an inspection and an audit conducted by the HSA prior to receiving its operational license. Among the licenses required to set up a retail pharmacy in Singapore are the wholesale retailer’s and import or export permits. The pharmacy must also obtain a healthcare institution license.
Registration of pharmacists in Singapore
As mentioned above, all pharmacies in Singapore, including biomedical and life sciences companies which deal in the production of medicines must hire specialized personnel. The personnel can be made of pharmacists registered with the Singapore Pharmacy Council. Both foreign and Singapore citizens can register with the Council based on certain requirements. Foreign citizens must have their qualifications acknowledged by the Pharmacy Council which will issue a Practicing Certificate.
For information about the legislation on medicinal product registration or for complete details on how to open a company in Singapore in this sector, please contact our company formation consultants.