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In brief

The Health Sciences Authority (HSA) adopts different forensic classifications, with varying degrees of access controls, for therapeutic products in Singapore.

In May 2024, the HSA issued an update on the reclassification of certain medicines, which would consequently affect the level of access controls that are required.

Companies engaging in the distribution or sale of such reclassified medicines in Singapore should ensure that their distribution and sale processes account for the different levels of restrictions that would apply following this reclassification of medicines.


In more detail

There are three forensic classifications for therapeutic products in Singapore, as follows, which determine the corresponding level of access controls for such products in Singapore:

  • Prescription Only Medicines (POM): This refers to therapeutic products available only with a prescription from a doctor or dentist. The condition being treated must be diagnosed and managed by a doctor. Additionally, use of such therapeutic products can have significant side effects that necessitate a doctor’s supervision or follow-up.
  • Pharmacy Only Medicines (P): This refers to therapeutic products that are available from pharmacists at retail pharmacies. They are suitable for self-limiting conditions and can be assessed and treated by pharmacists.
  • General Sale List (GSL): This refers to therapeutic products that can be freely obtained from retailers. They are safe for public use without medical supervision and are only intended for short-term self-treatment.

For pharmacy only medicines, pharmacists are legally obliged to keep sufficient records when dispensing such products over the counter. Members of the public may be required to provide their name, identification number (e.g., NRIC/FIN No.) and contact details when purchasing pharmacy only medicines from their pharmacists. This ensures that there are adequate safeguards for proper use of therapeutic products.

The HSA recently reclassified a list of medicines based on the three levels of access controls set out above. The full list of reclassified medicines may be found here.

The reclassification exercise shows that the HSA is active across the therapeutic products available in the Singapore market, and it will not hesitate to take necessary steps to ensure that all therapeutic products in Singapore are compliant with applicable laws and fall under the appropriate classification. 

The HSA has broad powers to, on its own volition, recategorize or reclassify therapeutic products and cause such amendments to be made in its register. Before such recategorization or reclassification, the HSA must give written notice to the registrant of the therapeutic product. If the registrant agrees to the recategorization or reclassification of the therapeutic product, fails to show cause within the prescribed period, or fails to show sufficient cause as to why the therapeutic product should not be recategorized or reclassified, the HSA may proceed with the recategorization or reclassification.

Registrants who fail to take the steps specified by the HSA to secure the necessary changes to the presentation and advertisement of the therapeutic product so as to bring them in conformity with the new category or class may be liable on conviction to a fine of up to SGD 20,000 and/or imprisonment for up to 12 months. Registrants who do not wish to have their health product recategorized or reclassified may apply to the HSA to cancel the product registration.

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Author

Andy Leck is the head of the Intellectual Property and Technology (IPTech) Practice Group and a member of the Dispute Resolution Practice Group in Singapore. He is a core member of Baker McKenzie's regional IP practice and also leads the Myanmar IP Practice Group. Andy is recognised by reputable global industry and legal publications as a leader in his field. He was named on "The A-List: Singapore's Top 100 lawyers" by Asia Business Law Journal 2018. In addition, Chambers Asia Pacific notes that Andy is "a well-known IP practitioner who is highlighted for his record of handling major trade mark litigation, as well as commercial exploitation of IP rights in the media and technology sectors. He's been in the industry for a long time and has always been held in high regard. He is known to be very fair and is someone you would like to be in the trenches with you during negotiations." Furthermore, Asian Legal Business acknowledges Andy as a leading practitioner in his field and notes that he “always gives good, quick advice, [is] client-focused and has strong technical knowledge for his areas of practice.” Andy was appointed by the Intellectual Property Office of Singapore (IPOS) as an IP Adjudicator to hear disputes at IPOS for a two-year term from April 2021. He has been an appointed member of the Singapore Copyright Tribunal since May 2010 and a mediator with the WIPO Arbitration and Mediation Center. He is also appointed as a Notary Public & Commissioner for Oaths in Singapore. He previously served on the International Trademark Association’s Board of Directors and was a member of the executive committee.

Author

Ren Jun Lim is a principal with Baker McKenzie Wong & Leow. He represents local and international clients in both contentious and non-contentious intellectual property matters. He also advises on a full range of healthcare, as well as consumer goods-related legal and regulatory issues. Ren Jun co-leads Baker McKenzie Wong & Leow's Healthcare as well as Consumer Goods & Retail industry groups. He sits on the Law Society of Singapore IP Committee and on the Executive Committee of the Association of Information Security Professionals. He is also a member of the Vaccines Working Group, Singapore Association of Pharmaceutical Industries, a member of the International Trademark Association, as well as a member of the Regulatory Affairs Professionals Association. Ren Jun is ranked in the Silver tier for Individuals: Enforcement and Litigation and Individuals: Prosecution and Strategy, and a recommended lawyer for Individuals: Transactions by WTR 1000, 2020. He is also listed in Asia IP's Best 50 IP Expert, 2020, recognised as a Rising Star by Managing IP: IP Stars, 2019 and one of Singapore's 70 most influential lawyers aged 40 and under by Singapore Business Review, 2016. Ren Jun was acknowledged by WTR 1000 as a "trademark connoisseur who boasts supplementary knowledge of regulatory issues in the consumer products industry." He was also commended by clients for being "very responsive to enquiries and with a keen eye for detail, he is extremely hands-on. His meticulous and in-depth approach to strategising is key to the excellent outcomes we enjoy."

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