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Product Registration
Under Malaysia’s Control of Drugs and Cosmetics Regulations 1984 (“the Regulations”), it is mandatory to obtain approval (in the form of product registration) for any drugs or pharmaceutical products, traditional medicines and veterinary products before they can be manufactured, supplied, sold or imported into Malaysia (unless specifically exempted by the Regulations). Such products must be registered with the National Pharmaceutical Regulatory Agency (“NPRA”) (formerly known as National Pharmaceutical Control Bureau).
A registered product is one that has been approved by the Drug Control Authority (DCA) for sale/use in Malaysia, after being evaluated and tested for efficacy and safety. Every registered product is given a registration number (starting with MAL) which must be printed on its label or package.
A Product Registration Holder (PRH) must be a locally incorporated company, corporate or legal entity, with permanent address and registered with Companies Commission of Malaysia (with the scope of business related to the health/pharmaceutical products). As such, a foreign company will have to appoint a Market Authorization Holder (MAH) as their local representative to obtain product registration. The PRH will then be responsible for all matters relating to product quality, safety and efficacy.
A different procedure applies to cosmetics. Since 01 January 2008, the online registration procedure for cosmetic products was replaced with the online notification procedure. Under the Regulations, the NPRA must be notified about cosmetic products before they can be manufactured, sold, supplied or imported into Malaysia. A cosmetic product introduced into the market must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use. Notified cosmetic products must meet all stipulated regulations and guidelines for cosmetic products.
Should you have any cosmetic, beauty and skin care products to introduce into the Malaysian market, we are able to advise, consult and assist with submitting notifications for such products to the NPRA. Please contact us at pr@henrygoh.com.
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The Leading Firm of Patent, Trademark and Design Agents in Malaysia.
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Choose us for unmatched expertise, tailored solutions, and client-centric service. With a global perspective and local insight, we are committed to protecting your intellectual property and empowering your innovation.
Unmatched Expertise
Our team of intellectual property specialists brings a wealth of knowledge and a proven track record of success to protect your most valuable assets.
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We understand that each client’s needs are unique. Our bespoke solutions are designed to align with your specific goals and challenges.
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With a deep understanding of both global trends and local nuances, we navigate the complexities of IP law to your advantage, wherever you operate.
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At Henry Goh & Co, your vision is our mission. We work tirelessly to ensure your intellectual property is defended, managed, and optimized for success.
No matter who you are, we’ve got you protected.
For almost half a decade Henry Goh & Co has been one of the benchmarks in the trademark area in Malaysia. The longstanding, close-knit team of over 20 multilingual experts deftly devises holistic trademark solutions, encompassing not only Malaysia, but also Singapore and Brunei. The technology-savvy outfit offers innovative and modern solutions, made with deep knowledge of the local legal practices and the mindset of the trademark examiners. Personable and seasoned general manager Sau Yin Tham has over three decades of experience; her in-depth knowledge of legal intricacies allows her to dispense on-point advice and successfully represent clientele in non-contentious matters. As the agency’s most senior and accomplished registered trademark agent, she oversees the practice, ensuring that the work conforms to the highest standards. Cosmopolitan trademark head Azlina Aisyah Khalid is a formidable leader and versatile practitioner with a knack for dispensing insightful pre-litigation, licensing and enforcement advice. Her skills, together with a good relationship with the IP office, allow her to see prosecution matters through to a successful conclusion. Strategically minded Eng Leong Lim is highly sought after for his effective portfolio management solutions and brand protection advice. He smoothly collaborates with external solicitors to enforce clients’ brands in Malaysian courtrooms.
On the local patent scene for almost 50 years, Henry Goh & Co is a prolific filer with a knack for dispensing tailored and practical non-contentious solutions. The outfit boasts a well-established team of more than 20 seasoned practitioners and has recently added to its ranks, hiring a physicist with more than a decade of patent experience and two paralegals. The team’s wide range of technical and linguistic capabilities allows it to handle complex technical matters not only in Malaysia, but also abroad, especially in Brunei and Singapore. Spearheading the patent team, business-savvy microbiologist Yen Yen Oon dispenses insightful advice on non-contentious matters, ranging from patentable inventions identification to prosecution, and is especially strong in issues pertaining to chemistry and biotechnology. Also valued for his effective counsel and strong technical acumen, seasoned engineer Jason Cheah considers prosecution of internet-related and mechanical inventions his forte; he is active both in Malaysia and foreign jurisdictions such as Japan, Australia and the United States. Cosmopolitan engineer Andrew Siew leads the high-technology, electrical and electronics group. His strong technical acumen and cross-cultural awareness allow him to deftly handle prosecution and infringement opinions for both local and international clients. He is also a capable drafter, excelling especially in the field of cutting-edge information technology such as blockchain, and other complex inventions like photovoltaic systems. As the head of the firm’s Brunei prosecution division, computational physicist and electronics virtuoso Pei Chun Yan drafts, prosecutes and handles portfolios for patrons ranging from academic institutions to major multinationals.
