All about marketing, manufacturing, packaging & labeling, advertising in Malaysian Pharma. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for USD 99.
1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?
Although it is common for the marketing authorisation of medicines and devices to vest in the PRH, this is not necessarily the case. Where the party marketing the product and the PRH are two different person(s) or companies, the PRH will still be responsible for all aspects of the product, including quality and compliance with the conditions of marketing authorisation.
According to the CDCR 1984, once a product is registered any company intending to manufacture, import or wholesale such products need to have a valid manufacturing licence, import licence and wholesale licence respectively. The relevant licences for purposes of authorising any marketing of registered products in Malaysia would be the wholesaler’s licence which authorises the licensee to sell these products and devices by wholesale or supply the registered product from the address of the business premises specified in the licence.
2. What is the authorization process for the marketing of generic versions of these products?
Please refer to Question 6 of Regulatory, Pricing and Reimbursement regarding the authorisation process of marketing generic drugs.
3. What are the typical fees for marketing approval?
Given that the PRH would pay for the fees incurred in registering the product and the person(s) or company registering any medical devices would incur fees for obtaining an establishment licence, the fees for obtaining marketing approval will be the additional cost of obtaining the wholesale licence. The processing fee for an application of a wholesale licence is RM500.00, which is the same for import licences whereas the fee for manufacturing licence is RM1,000.00.
4. What is the period of authorization and the renewal process?
Refer to Question 5 of Regulatory, Pricing and Reimbursement, in particular, the section on Additional Licences.
5. What are the requirements, if any, for post-approval pharmacovigilance?
All PRHs must ensure that a pharmacovigilance system is in place by the person(s) or company and if necessary, that appropriate action is taken. Such compliance requires a PRH to have at its disposal, an appropriately qualified person responsible for pharmacovigilance activities. The role of this qualified person includes submitting relevant safety information including post-registration study reports and risk management plans (“RMP”) (a pharmacovigilance document).
PRHs are also required to comply with all safety-related directives issued by NPRA. In doing so, all PRHs are responsible for producing a risk management plan which may include the views and recommendations of pharmacovigilance experts.
6. Are foreign marketing authorizations recognized?
Foreign marketing authorisations are not recognised – foreign companies must engage an Authorised Representative (AR) in Malaysia to register a product or device. The AR will then be the PRH for the relevant product. In order to market the product either the PRH or another person(s) or company must have a Malaysian wholesaler’s licence in order to sell the product at a specific place of business.
7. Are parallel imports of medicines or devices allowed?
Any person(s) or company intending to import medicine or devices into Malaysia requires an import licence and all such imports must be registered and imported by a person who holds the appropriate licence. The DCA may require any person(s) or company applying for the registration of imported products to furnish a written declaration made by or on behalf of the manufacturer of the imported product that all requirements imposed by the law of the manufacturer’s country governing the manufacture of the product have been complied with.
Parallel imports for medicines are permitted so long as an AR is appointed and the product is properly registered. Each product that is imported must be registered with NPRA. See Question 6 of Regulatory, Pricing and Reimbursement above.
Parallel imports for medical devices are not permitted as one product can only be registered with one AR or one manufacturer.
8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?
Healthcare professionals are prohibited from accepting any financial benefit or benefit-in-kind (including grants, sponsorships, scholarships, subsidies, support, consulting contracts, or educational or practice related items) in exchange for prescribing, recommending, purchasing, supplying or administering products or for a commitment to continue to do so. Gifts that would inappropriately influence the prescribing practices of a healthcare professional would be prohibited (such as sporting or entertainment tickets, electronic items, social courtesy gifts, etc.)
- Donations for charitable purposes to charitable organisations;
- Grants to support educational programmes so long as they are unsolicited, from an institution organisation, unrelated to prescribing, purchasing, registration of any products, substantiated by written documentation of details of programme and able to withstand public scrutiny;
- Informational or educational items provided to enhance patient care not exceeding RM1,500.00 per year per institution or healthcare professional; and iv) Items of medical utility provided by member companies not exceeding RM500.00 per item per healthcare professional. These items must not offset routine business practice and are beneficial to enhancing the provision of medical services and patient care.
Offering and/or accepting a gratification corruptly for the purposes of inducing or rewarding any act or for showing forbearing to favour or disfavour any person in the course of carrying on business would amount to a criminal offence and upon conviction, such persons could be liable to imprisonment for a term up to twenty (20) years and a fine not less than five (5) times the sum or value of the gratification if it is capable of being valued or alternatively, ten thousand ringgit (RM10,000.00), whichever is higher.
9. How is the manufacturing of medicines and devices regulated and by which agencies?
Manufacturing of medicines and devices are generally regulated by NPRA. However, approvals for manufacturing activities must also be obtained from the Ministry of International Trade and Industry (MITI) and other Federal Agencies (such as the Department of Occupational Safety and Health (DOSH)). Further, manufacturers must obtain a manufacturing licence and comply with the International Good Manufacturing Practice (GMP) and Quality Assurance Programmes.
10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the US Food & Drug Administration (US FDA) and/or the European Medicines Agency (EMA)?
Yes, they are compatible. Please refer to question 6 of Regulatory, Pricing and Reimbursement above.
11. What is the inspection regime for manufacturing facilities?
Manufacturers of registered products in Malaysia must provide acceptable evidence that the manufacturing premises conform to current GMP requirements – this includes foreign manufacturers who are also subject to GMP conformity assessments through inspections.
The application for a foreign GMP inspection should be made by a Malaysian PRH acting on behalf of the foreign manufacturer. The PRH shall then authorise a responsible person (i.e. Chief Executive Officer, Managing Director or Regulatory Manager) to act as the liaison officer with NPRA for all arrangements pertaining to the proposed inspection. Upon submission of relevant documentation by the appointed liaison officer, payment of the processing fee and inspection fee, the inspector will then travel to the foreign manufacturing site. The outcome of the GMP inspection will be tabled to the Committee of Evaluation of Inspection on Premises (“the Committee”). The Committee will then issue a report to the manufacturer through the applicant within 20 work- ing days. The manufacturer is also required to submit a Corrective Action and Preventative Action (“CAPA”) report to NPRA within 30 days of receiving the GMP inspection report. All CAPA must be closed out within 6 months from the date the inspection report is issued.
If the GMP compliance is concluded as ‘acceptable’, the applicant can apply for a GMP certificate to the manufacturer through the applicant and this certificate can then be used for product registration/re-registration/change of manufacturing site with NPRA. If the GMP compliance is concluded as ‘unacceptable’, there is no further consideration or appeal for the GMP compliance of the manufacturer and a new application to NPRA for another inspection on the manufacturing facility must be made.
12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?
Whilst it is mandatory that the NPRA have access to all local manufacturing facilities for the purpose of inspection, manufacturers also have the discretion to allow inspection by other foreign or third-party inspectors.
13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?
Medicines/Products such as Health Supplements, Natural Products/Traditional Medicines and Non-Schedule Poisons (category T, N and X) are permitted to be shrink wrapped, whereas all Scheduled Poisons and medicines/products which contain Scheduled Poisons/ingredients must be stored, packaged and handled as follows:
The storage of any poison must be in a container impervious to the poison and sufficiently stout to prevent leakage from the container arising from the ordinary risks of handling. If the poison is kept for sale, whether by wholesale or retail or for dispensing purposes, it must be kept as such:
- in an unbroken case or package as received from the manufacturer; or
- in a container tied over, capped, locked or otherwise safely secured in a manner different from that in which the container of non-poisonous substances kept in the same warehouse shop or dispensary are secured; or
- in a container readily distinguishable by touch from all containers holding non-poisonous substances; or
- in a container readily distinguishable by touch from all containers holding non-poisonous substances; or
- in a room or cupboard under lock and key set apart from the keeping of poisons;
Where the poison is stored in any dispensary, retail shop or premises used in connection with the poison, it must be stored as such:
- in a cupboard or drawer under lock and key reserved solely for the storage of poisons, or in a part of the premises which is partitioned off or otherwise separated from the remainder of the premises and to which customers are not permitted access; and
- if it is a liquid, to be kept in a container holding 2.5 litres or less, in a container which shall be readily distinguishable by touch from all containers holding non-poisonous liquids.
14. What information must be included in medicine and device labeling?
The general requirements for a label of a product on its outer carton, immediate container or blister/strips are as such:
- product name;
- dosage form;
- name of active substance(s);
- strength of active substance(s);
- batch number;
- manufacturing date;
- expiry date;
- route of administration;
- storage condition;
- country’s registration number;
- name and address of PRH;
- name and address of manufacturer;
- warnings and/or specific labelling (if applicable); xiv) pack sizes (unit/volume);
- name and content of preservative(s) where present;
- name and content of alcohol where present;
- to declare source of ingredients derived from animal origin (active and excipient) including starting materials and gelatine;
- to declare the source of capsule shell (if applicable);
- recommend daily allowance (RDA) for vitamins/multivitamins/mineral preparations u sed as dietary supplements (optional);
- the words ‘keep medicine out of reach of children’ or words bearing similar meaning in both Bahasa Malaysia and English;
- other country specific labelling requirements (if applicable);
- the words “controlled medicine/ubat terkawal” (for scheduled poison only); and
- security label (hologram).
The information on labels for medical devices should include:
- its Malaysian registration number (within 6 months from the date of the registration of the device);
- details of the medical devices (including name and model);
- batch code/lot number or the serial number;
- indication of date until when the medical device may be used safely, expressed as the year and month;
- name and contact details of the manufacturer and AR on the labelling;
- technical details concerning the medical device;
- description and intended use of the medical devices;
- instructions for use of the medical device;
- any undesirable side-effects, limitation, warnings and/or precautions on the safe use of the medical device;
- any necessary post-marketing servicing needs for the medical device; and
- any decommissioning or disposal information.
15. What additional information may be included in labeling and packaging?
The label on medicines (poisons under Regulation 12 of the Poisons Regulation 1952) should include:
- the name and address of the supplier or seller;
- name of patient or purchaser;
- name of the medicine;
- adequate directions of use of such medicine; v) date of delivery of such medicine;
- where such medicine is sold or supplied and entered in a prescription book, with reference to the serial number of the entry in such book relating to such sale or supply.
When a poison or medicine containing any poison is sold or supplied as a dispensed medicine for external use, the container must be labelled conspicuously and distinctly with the words “Not to be taken” or “For external Use Only” in English, Malay, Chinese and Tamil printed in red or on a red background.
For some medical devices the following specific contents must also be included on the labelling:
- identification for a custom-made medical device and a statement that it shall only be used by a qualified practitioner for patient under his care;
- an indication on the external packaging of any special storage and/ or handling conditions that applies;
- verification that a medical device has been properly installed and can operate correctly and safely, the nature and frequency of preventative and regular maintenance, replacement of consumable components, and calibration needed to ensure optimal and safe operation of a medical device;
- further treatment or handling, such as sterilisation, calibration, etc., that is needed before a medical device can be used;
- identification for a sterile medical device, its indication for sterility and precautions and instructions if the sterile packaging is damaged, and where appropriate, description of re-sterilisation methods;
- the requirement for sterilisation of a medical device before it is used and instructions for cleaning and sterilisation processes;
- identification for a single-use medical device;
- identification for a reusable medical device, information and instruction for cleaning, disinfecting, packaging and, where appropriate, the method of re-sterilisation, and any restriction on the number of reuses;
- If the device is intended for research use only, it must be labelled as “research use only”;
- sufficient details to obtain a safe combination for a medical device that is to be installed with or connected to other medical devices or equipment or with dedicated software, in order to operate as required for its intended purpose;
- particular risks in connection with implantation of an implantable medical device;
- the risks of reciprocal interference posed by a reasonably foreseeable presence of a medical device during specific investigation or treatment;
- the details of the nature, type, intensity and distribution of the radiation emitted by radiation emitting medical device;
- indication that the medical device is refurbished medical device. The refurbishment date shall also be indicated.
16. What items may not be included in labeling and packaging?
All labelling for medical devices should exclude any statement, whether directly or indirectly, that the placement in the market or usage or operation of the medical device is being promoted or endorsed by the Authority or MOH or of its organisational bodies. Visuals, graphics and statements are prohibited on labels such as:
- marketing strategies (i.e. “money back guarantee”/“buy 1 free 1”/etc.);
- bundling tactics (i.e. upon consuming Product A, for better result it is recommended that users take Product B);
- consumer testimonies;
- clinical trial results;
- religious references and opinion of prominent figures;
- label design similar to that of another company;
- introduction of founder/manufacturer;
- certificates (such as logo with certification, nutritional claims with analysis cert. attached)
- name/statement/logo/registered trademark which does not satisfy the specifications;
- special technique used/superiority in ingredients;
- pictures (such as gender symbol, graphics of internal organs, indecent pictures, graphics incoherent with the indication, highlighting unnecessary body parts, graphics of plants or animals which may cause confusion);
- negative statements (i.e. “this product is GMO/LMO free”/”free from preservatives”/etc.).
This is not an exhaustive list and the Authority reserves the right to disallow other words, phrases or graphics for label which it opines to be misleading, improper or not factual.
Small labels (5ml and less) used for ampoules/cartridge, vial, eye drops, ear drops and nose drops are exempted from the requirements in Question 14 above.
17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?
Medicine advertisements shall be examined in accordance with laws and regulations, in particular the Medicine (Advertisement and Sale) Act 1956. All advertisements referring to any articles which would be used as a medicine, an appliance or a remedy for the purpose of treatment must be approved by the Medicine Advertisements Board. Upon approval, a serial number will be given and must be displayed on the advertisement.
The types of advertisements which are expressly prohibited are those listed in the Schedule of the Medicines (Advertisement and Sale) Act 1956 as well as those relating to the promotion of contraception among human beings or improving the condition or function of the human kidney or heart or improv- ing the sexual function/performance of human beings. and those relating to abortion or the skill or service of the advertiser.
Medical devices must be registered in accordance with the requirements of the Medical Device Act 2012 before it can be advertised. No person is permitted from making any misleading or fraudulent claims regarding medical devices in any advertisement. There is currently no enactment in Malaysia regulating the advertisement of medical devices however the MDA has prepared a Draft Code of Advertisement for Medical Devices with the aim to help the industry and healthcare professionals navigate this area in accordance with the Medical Device Act 2012.
18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?
Any registered products i.e. medicines and poisons, may be sold and delivered in any manner in Malaysia. Poisons such as those listed in the Poisons List may be imported into Malaysia by letter or parcel post for personal use, including a prepared or packed medicine containing poison(s). This can be done not more often than once a month and not exceeding at any one time, the quantity required for one month’s use by one person.
All medical devices must comply with the Good Distribution Practice for Medical Device (GDPMD) which was implemented pursuant to the Medical Device Regulation 2012. GDPMD specifies the requirements for a quality management system to be established, implemented and maintain when carrying out the activities in the medical device supply-chain to comply with the Malaysian medical device regulatory requirements as stipulated in Medical Device Act 2012. The certification to GDPMD is to be conducted by the registered conformity assessment body. Once the GDPMD is complied with, devices can be sold and delivered through any method, including post.
19. What are the restrictions and requirements for electronic marketing and advertising via email, by internet, social media, and other channels?
Statutory requirements for drug advertising equally apply to marketing medicinal products on the internet. For instance, medicine providers over the internet would still require the necessary licences and approvals i.e. wholesaler’s licence in order to sell medicines and medical devices. All advertisements must be approved by the Medicines Advice Board (“MAB”) and the approval number obtained must be displayed on the published advertisement. The prohibitions on advertising (see question 17 above) would still apply to e-marketing and advertising via the internet. The duty is on the web advertisers to ensure that the materials posted on the internet do not contravene any regulations.
20. May medicines and devices be advertised or sold directly to consumers?
In Malaysia scheduled poisons i.e. prescription drugs meaning those that can be obtained following a prescription from a doctor are prohibited from being advertised openly to the public in any media including social media and the internet. However, some exceptions are made for information advertised by the government or information which would be relevant to parties such as doctors, pharmacist, nurses and members of the local authority or the governing body of a hospital.
21. How is compliance monitored?
The NPRA undertakes regular check-ups on any local and foreign manufacturing companies to ensure that such manufacturers are compliant with the guidelines, rules and regulations issued by the NPRA. This review is also done at the stage of licence renewals by the manufacturers.
The Code of Advertising for Medical Devices has not yet been finalised. Accordingly, we are not aware of any issued regulation for the compliance of advertising for medical devices.
22. What are the potential penalties for noncompliance?
Any contravention of the restrictions stated in Question 17 above may result in a criminal offence and the offender may be liable to summary conviction which would result in a fine not exceeding RM3,000 or to imprisonment for a term not exceeding one year or to both. Following any subsequent convictions, the offender may be liable to a fine not exceeding RM5,000 or to imprisonment for a term not exceeding two years or to both.
Any contravention of advertising as against the provisions of the Medical Device Act 2012, would result in the commission of an offence and the offender shall, on conviction, be liable to a fine not exceeding three thousand ringgit (RM3,000) or to imprisonment for a term not exceeding three years or to both.
Click the following links to read more legal articles from Malaysia:
- Regulatory Pricing and Reimbursement Overview
- Preclinical and Clinical Trial Requirements
- Marketing, Manufacturing, Packaging & Labeling, Advertising
- Traditional Medicines and OTC Products
- Product Liability
- Patents & Trademarks
- Regulatory Reform
- Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs