How to manage therapeutic product licence transfer in Singapore
License transfer has been a rising tacky issue for many manufacturers seeking independent license holding. Managing a successful therapeutic product license transfer consists of 3 steps: Seeking inform consent with Distributor , Selection of an independent license holder and Transfer operation. These steps must be followed closely in order to execute a seamless flow.
Please note certain terms that might be used interchangeably in this article content:
Manufacturer =Product Owner
Marketing authorization holder/Distributor/ Partner= Registrant
Seeking inform consent with Distributor
Having been through this phase myself in distributor’s shoes, the impact can be tremendous to a company’s balance sheet. The business framework of most distributors depends on a big single supply of their product portfolio and several other sources consisting of medical devices and supplements. Hence, a timely inform to the respective partner/distributor is essential to allow the distributor /partner to work out an alternative solution for themselves and to divert relevant internal resources to manage this flow. The appropriate timeframe recommended according to most distribution agreement is relatively short of about a few months but what is most practical would be an early year of notification.
During this process, it would be appropriate to discuss the following issues:
- Be honest and upfront about the company’s decision to end this business relationship. Extend your gratitude to your partner for their contribution in building your brand in this market and that it is a hard decision for your company to take internally to progress with this stage.
- Understand about the current state of the regulatory status of all licence taking into account whether there are any pending approvals for variations and upcoming renewal. This is a critical requirement prior to execution of a licence transfer. It is also appropriate to request distributor/partner to transfer the latest regulatory files related to each licence to the designated partner (whether it is internal or an independent licence holder) a month before the actual transfer so that there is time for the designated partner or internally to check upon any missing items. A casual meeting of a 1.5 hours face to face would be appropriate between Manufacturer, designated partner and current partner.
- Set the date of transfer. A final date should be set and agreed mutually between all parties involved to execute the licence transfer.
You can send in enquiry to TRC to check with us on our prior experience first hand so that we can support you in this negotiation as well.
Selection of an independent licence holder
If you do have a regional office locally with regulatory capacity, you might proceed directly with Step 1 and Step 3 mentioned in this article. However if you do not have a local office, you will have to reach out to source for competent and trustable licence holder such as a consultancy partner or another distributor to take on the licences for which the following factors must be considered:
- Assessment of the competency of the next designated party to take on the licences based on past experience, reputation in local market as well as the chemistry between both parties. In any business relationship, we do have to agree that we need to choose a party that can communicate well with you and have the same frequency of mindset to take on this role. They are crucial to your business going forward.
- Establishing clear expectations of the role and responsibilities of the next marketing authorization holder so as to ensure that they will comply with what is required locally to maintain the licence so that the company can continue to function.
- Discussion internally based objectively not just on costs for the selection. Ultimately, we cannot disagree on the fact that the complexity of this situation will only increase when this operation is repeated many times due to a commercial reason tied to volume demand from the manufacturer’s end or from choosing a partner just based on cost. It is appropriate to assume that there should be an increase in number of orders per year as per forecast provided however we need to note that there is always a trend for each market and each product due to situations that cannot be controlled such as losing of tender, prescription pattern of clinics and hospitals and influx of overseas patients (especially true for oncology patients).
Check out TRC’s list of services to see whether it fits your bill to be considered as an independent license holder.
The license transfer operation will require some preparation from Product Owner , current marketing authorization holder ( Existing Registrant) and new current marketing authorization holder (new Registrant) which will be highlighted below:
- Product Owner needs to prepare 2 documents:
- New letter of authorization to appoint the new registrant in which the content should include all the name of therapeutic product licenses and license number: SINXXXXXP , name and address of the new registrant and effective date of the transfer.
- Written confirmation that arrangement has been made between the existing registrant and the new registrant for the hand-over of the relevant product registration file.
- Existing Registrant ( Current Marketing authorization holder) needs to have the following information about the new appointed Registrant:
- UEN (Unique Entity Number) of the new registrant
- Client code of the new registrant
- Email address of the authorized person acting on behalf of the new registrant
- Registration number and name of the therapeutic product(s) for which the registration will be transferred to the new registrant
- New Registrant will need to have the following document and details from the Product owner as per below:
- Letter of Authorization from the Product Owner
- Written confirmation that arrangement has been made between the existing registrant and the new registrant for the hand-over of the relevant product registration file
Once the above is completed and a final confirmation from existing registrant that there is no pending renewal nor variations tied to the licences to be transferred, the existing registrant can log on to the online system known as: PRISM to execute the transfer inputting the details provided by Product Owner. Once the initiation of the transfer is performed, the new registrant will receive an email notification to log on to the system to accept the transfer to upload all the relevant documents and details provided by Product Owner. The process takes about 14 working days and both the new registrant and existing registrant will be notified of the outcome. There is currently no cost tied to this operation officially.
For further information, do check out the link to : Change of Registrant of registered therapeutic product.
The key success factor to seamless licence transfer is to maintain an effective communication between all parties, setting upon a date and performing internal regulatory check on the status of all therapeutic products. Wishing all good luck and success to take forward this operation. If you think TRC can be of help to you, please feel free to get in touch .