Cosmetics are product defined as “any substance or preparation intended to be placed in contact with various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition” by NPRA Guidelines for Control of Cosmetic Product in Malaysia – version February 2017.
In the ASEAN region, there has been a harmonization since 2008 among the various regulatory bodies whereby cosmetics are only controlled via a notification procedure (registration) to the regulatory body. In Malaysia, the regulatory body would be NPRA
This cosmetic registration / notification is mandatory for any cosmetics to be sold in Malaysia, whether imported in to Malaysia or manufactured in Malaysia and has a validity of 2 years. Only a local company with a QUEST3+ USB Token would be allowed for submitting for cosmetic registration / notifications to NPRA. (To understand the process on obtaining a QUEST3+ USB Token, please refer to article “Registration System By NPRA”)
To obtain the cosmetic registration / notification, there are three to four basic documents required to be submitted to NPRA. Further to that, if the foreign manufacturer is not listed in current NPRA database, listing of the manufacturer details would have to be done as well.
Once cosmetic registration / notification is obtained, NPRA at any point can request for PIF (Product Information File) of the product. PIF encompasses the complete documentations related to the cosmetic (eg, manufacturing process, COA of raw material etc).
Do contact us for a competitive quote for both cosmetic registration / notification and PIF preparation.
Generic Product Registration: Generic Product is defined by NPRA as a product that is essentially similar to a currently registered product in Malaysia. The first company to register a product or a molecule in Malaysia would be given the status of “innovator”. As this company would need to provide documents and supporting clinical trials to NPRA to establish the need of registering the product in Malaysia. Any other registration of the similar product or molecule would be done via the Generic registration route. Generic registration would not have such extensive document requirements for registration as an “innovator” would. However, NPRA still requires sufficient number of documents to establish the product’s quality and efficacy as compared to the “innovator”.
In Malaysia, a generic product registration is divided to two classes of registration, whereby it is separated by the active ingredient. If the active ingredient is listed in the Poison Act 1952, it would be filed under Generic Scheduled Poison. If the active ingredient is not listed in the Poison Act 1952, it would be filed under Generic Non-Scheduled Poison or also called as Over The Counter Product.
In recent years, NPRA has been imposing many new regulations to regulate the generic registrations in Malaysia. The strategy to obtain a generic product registration in Malaysia is no longer as direct as it used to be. NVS’s consultant is well aware of the latest NPRA requirement and would guide the company to filing the generic product registration in Malaysia and ultimately, obtaining registration.
Health Supplement Registration: Health Supplement product is defined by NPRA as a product that is used to supplement a diet and to maintain, enhance and improve the health function of human body. It may contain one or more of the following combination:
i) Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, and other bioactive substances;
ii) Substances derived from natural sources, including animal, mineral and botanical materials in the forms of extracts, isolates, concentrates, metabolite
iii) Synthetic sources of ingredients mentioned in (i) and (ii) may only be used where the safety of these has been proven.
Requirements of a health supplement registration is comparatively less stringent (lesser document requirements) compared to Generic registration.
For the product to be classified under Health Supplement registration, there are several factors that NPRA considers such as the proposed indication, active ingredients, content of Vitamins/Minerals and dosage form used. If the product does not meet the requirement under a Health Supplement, the product would then need to be registered under Generic Non-Scheduled Poison registration.
NVS’s consultant has the necessary experience to guide the company on routes to register the product under Health Supplement (if it abides by the factors stated above).
Herbal product is defined by NPRA as any product used in the practice of indigenous medicine, in which the drug consists solely of one or more naturally occurring substances of a plant, animal or mineral, of parts thereof, in the unextracted or crude extract form, and a homeopathic medicine. The current perception for registration of herbal products in Malaysia is to be an easier/straight forward process compared to other classes of product registration. However, in reality, it is far different then the common perception. There can be numerous documentation requirements as compared to other countries. Further, in some cases, some of the herbs in the product are not listed in NPRA system which which warrants additional hurdle before the actual submission of the product registration. NVS’s consultant have been evaluating many herbal product dossiers over the years and has advised the companies/manufacturer on the best way/route to obtain herbal registration. NVS’s consultant has also developed our own herbal dossier template to aid in the dossier preparation by the companies/manufacturer.
It is important to note that only a local company with a QUEST3+ USB Token would be allowed for submitting for herbal product registration to NPRA. (To understand the process on obtaining a QUEST3+ USB Token, please refer to article “Registration System By NPRA”)
NPRA regards pharmaceutical distribution as an important activity in the integrated supply-chain management of pharmaceutical industry. With the globalisation of the pharmaceutical industry, there are multiple parties/individuals involved in handling, storage and distribution of pharmaceutical products. Which warranted NPRA to release an updated guideline focusing only on Good Distribution Practice (GDP). The guideline released lays down principles and practices required by NPRA for pharmaceutical distribution activity in Malaysia. Currently, NPRA is actively conducting audits for GDP requirements concurrently with other license requirements. This is more important for cold chain products such as vaccines and blood plasma products. Companies should not neglect or take such GDP audit lightly. NVS’s consultant are trained to provide GPD training to local companies, be it from a manufacturer or a distributor.
NPRA defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems. Pharmacovigilance is one of the most important aspect, if not the most important aspect in a pharmaceutical product life cycle. There are many parts to pharmacovigilance, starting from the reporting of adverse drug reaction right to submission of periodic benefit risk evaluation (PBRER). In Malaysia, for all local companies holding registration of pharmaceuticals, it is required by NPRA for the company to establish an appropriate system of pharmacovigilance. As part of the PV system, one of the most important requirement by NPRA is to have a permanent qualified person responsible for PV (QPPV). NVS’s consultant has the relevant expertise to provide consultation on developing a PV system as well as being appointed as QPPV for the companies.