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Product Regulation & Liability

Singapore: HSA issues several retail-level recalls of therapeutic products and Chinese proprietary medicines in breach of applicable regulations

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In brief

In the month of August 2022, the Health Sciences Authority (HSA) issued several retail-level recalls in respect of therapeutic products and Chinese proprietary medicines that were in breach of applicable healthcare regulations.

Key takeaways

  • Sellers and suppliers should note that health products must be in line with applicable healthcare regulations.
  • Anyone found to have supplied therapeutic products that are adulterated may be imprisoned for up to three years and/or fined up to SGD 100,000 upon conviction.
  • Anyone found to have supplied Chinese proprietary medicines that are adulterated may be imprisoned for up to two years and/or fined up to SGD 5,000 upon conviction.  

In more detail

In August 2022, the HSA issued product recalls in relation to the following products:

  • Apo-Acyclovir Tablet 800mg Tablets, as such tablets was found to contain impurities above the acceptable level
  • Lorazepam Injection 4mg/ml, as out-of-specification results were observed during testing of samples for the affected batch
  • GINCARE-60 Film Coated Tablet 銀之杏60, due to the detection of ibuprofen, a prohibited substance

Hospitals, clinics and retail and wholesale suppliers have been instructed to stop supplying the affected batches of such products and to return the remaining stocks to the respective companies.  

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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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