On 26 February 2021, Malaysian Prime Minister, Tan Sri Muhyiddin Yassin became the first person in Malaysia to get vaccinated against Covid-19. Malaysia targets to have at least 80% of our population vaccinated to obtain herd immunity.
The Covid-19 vaccine is regulated under the Poisons Act 1952 and its Regulations and Sale of Drugs Act 1952 and the Control of Drugs and Cosmetics Regulations 1984. Thus, the importation, sale, supply, storage, and distribution of the Covid-19 vaccines must be per the respective Acts and Regulations' requirements.
Our article aims to educate the general public on the importation process of the Covid-19 vaccine into Malaysia.
Covid-19 Vaccine in Malaysia: From Importation to Storage
The Covid-19 vaccine goes through a stringent process before it is approved for use in Malaysia. The National Pharmaceutical Regulatory Agency (NPRA) is the body that is responsible for evaluating the vaccines entering Malaysia. The Drug Control Authority (DCA) of Malaysia will then approve the vaccine based on NPRA's recommendation. Subsequently, all vaccines' strains will be monitored based on the World Health Organization standards (WHO).
When all this is done, how does the vaccine enter Malaysia?
We take you on the entire journey and requirements for the vaccine to arrive.
Pre-Requirement
Before getting registered to import the Covid-19 vaccine to Malaysia, a company needs to ensure that they are a registered pharmacist with a Type A licence issued under the Poisons Act 1952 (wholesale and retail or wholesale only). They will be required to have an Import License for registered vaccines issued under the Control of Drugs and Cosmetics Regulations 1984.
Personnel Requirement
All personnel involved in handling the Covid-19 vaccine will be given the exact list of products to know their handling. The temperature measures that are vital to keeping the vaccines' quality intact will also be shared with all personnel.
Anyone involved in handling the vaccine must undergo rigorous training to ensure no compromise to the vaccine's quality.
There must be clear Standard Operating Procedures (SOPs) and response to emergencies given to all personnel.
To ensure compliance, every company must be able to produce their training and regulations records at any time to the authorities upon request.
Point of Entry
As per the Customs Act 1967, the important part is to appoint a forwarding agent to declare and clear the goods (vaccines). For the import declaration, the importer must submit exportation documents to their appointed forwarding agent.
The following are the documents needed for declaration and clearance at the entry point:
Type A Licence
Import Licence
Invoice
Packing List
Airway Bill
The forwarding agent must then submit all the documents and an import document (K1 form) at the entry point.
Facilities and Equipment
Firstly, there must be sufficient storage facilities for Covid-19 vaccines to avoid overcrowding. The companies are to adopt a First In-First Out (FIFO) or First Expired First Out (FEFO) system in storing the vaccine.
The facility should conduct all due diligence and produce them as needed qualification documents to the authority whenever required.
The equipment requirements are as follows:
Refrigerators and Freezers – Vaccine must be stored in pharmaceutical refrigerators and freezers. Should the company want to use household style units, the units have to comply with temperature control requirements of a recognised standard for pharmaceutical refrigerators or freezers.
Locked Facilities – Vaccine has to be stored in locked facilities and areas.
Alarm system – The alarm system has to be fitted in the cold room, freezer room, refrigerator and freezer.
Power system – There must be an alternative power system to ensure consistent and continuous temperature even in the event of a power trip.
An annual inspection – There must be an annual inspection for all equipment's calibration and temperature monitoring functions, including alarms and other related equipment.
Maintenance – There must be a fixed periodic maintenance program for all temperature-controlled rooms, cold rooms, freezer rooms, refrigerators and freezers.
Monitor – There must be contact monitoring of maximum and minimum temperature and humidity (if needed) for all temperature-controlled rooms, cold rooms, freezer rooms, refrigerators and freezers.
Finally, the company has to conduct a temperature mapping study to determine the suitability of a location for placing temperature sensors in all temperature-controlled rooms, cold rooms, freezer rooms, refrigerators, and freezers used to store the vaccine.
Stock Receiving and Handling
Once the vaccine arrives at the location, qualified personnel need to check and ensure no sign of tampering or damage to the vaccine, packaging material, labels, or the container they arrive in. The guidelines also require personnel to ensure conformity to the temperature.
Upon confirmation of the above, the personnel is to document evidence of the compliance. A second person is to ensure that the personnel is following the correct procedures.
As the vaccine needs to be maintained at a specific cool temperature, handling of ice packs and dry ice must have a proper procedure. This ensures no accidental usage of cool packs at the wrong temperature, expired cool packs and direct contact of dry ice with the vaccine.
There must be continuous monitoring of the temperature indicator or calibrated temperature monitoring device. This is why importers of the vaccine include the WHO Prequalified Temperature Monitoring Devices for transportation and shipping of their products.
The vaccine must have unambiguous labels. Anyone should be able to easily identify them from other products that come within the same delivery. The package labelling has to follow the International Air Transport Association (IATA) regulations for air freight delivery.
All these procedures also apply to vaccines that will be returned (if not meeting any of the requirements).
Transportation
To transport the vaccine, the importer needs to ensure that the transport has validated conditions. The temperature range needs to remain as per the product label. To help with this, the importer may conduct stimulation studies to consider the possible scenarios during transportation.
The importer shall also preplan the delivery route and keep the Covid-19 vaccine clearly labelled and separate from other products. Additionally, a "Keep Frozen" label is also required on the vaccines.
Lot Release Requirement
The importer will need to submit the Lot Release application to vaccinecqc@npra.gov.my with the following documents:
Batch Release Certificate from National Regulatory Authority of the country of origin for the vaccine batch
Manufacturer's summary protocol for the batch (lot summary protocol)
Packing list
Air Waybill
Once the product has entered Malaysia, the important shall arrange for cold chain inspection through vaccinecqc@npra.gov.my.
The final process is for sample submission for testing, which is done in the NPRA laboratory.
Should for any reason the Lot Requirement is not fulfilled, in that case, the importer will need to quarantine the vaccine and subsequently replace them.
Summary
All Covid-19 vaccines go through a stringent process and checks before being released for vaccination. The vaccines which will be administered in Malaysia complies with:
Poisons Act 1952 (Act 366) and its regulations
Sale of Drugs Act 1952 (Act 368) and its regulations
Drugs and Cosmetic Control Regulations 1984
Infectious Disease Prevention and Control Act (Act 342)
The Covid-19 pandemic has impacted us all in various ways. As we deal with the effects of the pandemic on ourselves, our families and businesses, it is essential we look forward to better days with the roll-out of the vaccine. You can read more on the guideline for vaccination in this article. At the same time, if you need legal advice on dealing with any of the impacts, our lawyers are always available to help.
Note: This article does not constitute legal advice to any specific case. The facts and circumstances of each case will differ and, therefore, will require specific legal advice. Feel free to contact us for complimentary legal consultation.
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