Based on the Colombian regulation, a rights transfer is the legal procedure through which the current holder of a sanitary registration transfers its rights (including all the legal responsibilities) before INVIMA to a new holder.
This can occur for various reasons, such as the purchase of the company that owns the registration, the transfer of products between subsidiaries, or when the manufacturer wants to change the holder. Currently, a rights transfer is considered a legal modification according to the Decree 677 of 1995.
Key Stakeholders in the Rights Transfer Process
- Manufacturer: The entity that manufactures the medical device.
- Holder: The entity that currently holds the sanitary registration for the product.
- Legal Representative: In Colombia, this refers to an entity based in Colombia authorized by the holder to submit documentation and perform procedures before INVIMA, the Colombian health authority. The legal representative does not act as the holder but merely as an intermediary for regulatory processes.
The “Legal Representative”
In Colombia, the legal representative (or “apoderado legal“) is an entity appointed by the holder to manage regulatory affairs on their behalf. It is important to note that the legal representative does not hold the sanitary registration; they merely assist with the submission of documents and represent the holder before INVIMA.
Practical Scenarios
Let’s explore some practical scenarios in which a rights transfer or an update to the legal representative is required:
Case 1: Modification of Sanitary Registration
In this case, let’s assume that the manufacturer is the holder of the sanitary registration and wishes to modify the registration to add new product codes. The holder can carry out this technical modification if they are based in Colombia. However, if the holder is not based in Colombia, the modification can be carried out through a legal representative who must be appointed by the holder through a legal modification process.
Steps for this case:
- The holder must request an update to the legal representative with INVIMA through an automatic legal modification.
- Once the legal representative is approved, they can proceed with the technical modification on behalf of the holder.
Note: It is also possible to update the legal representative and carry out the modification within the same procedure.
Case 2: Distributor as Holder
In this scenario, the manufacturer is not the holder of the sanitary registration, but the distributor in Colombia holds the registration. Let’s assume the manufacturer wants to update the sanitary registration by adding a new distributor. Since the distributor is the holder and based in Colombia, they are the only entity authorized to perform this update. The manufacturer and the distributor (who is the holder) must be in agreement to proceed with the update.
Case 3: Transfer of Rights
In this case, the current holder of the sanitary registration wishes to transfer its rights to another entity. There are two possible scenarios:
- Holder based abroad: Before initiating the transfer process with INVIMA, the holder must appoint a legal representative based in Colombia to carry out the rights transfer.
- Holder based in Colombia: The new holder can carry out this procedure, provided that the current holder issues the rights transfer letter.
While these terms may seem confusing, it is important to understand that the holder of the sanitary registration is responsible for the registration’s rights. We recommend that manufacturers maintain a good relationship with the current holder to ensure a smooth process.
Requirements and Necessary Documentation
The documentation required for both the update of the legal representative and the rights transfer is quite similar, though not all documents may apply to the legal representative update. Below is a general list of required documents for both processes:
- Transfer Request Letter: This letter should detail the sanitary registration being transferred, along with information about both the current holder and the new holder. It must be signed by the legal representatives of both the assignor and the assignee.
- Identification and Representation Documents: Certificates of existence and legal representation of the assignor and assignee, issued by the relevant legal authorities in their respective countries. If the current holder is not directly handling the transfer, they must issue a letter authorizing the individual to proceed with the process.
- Transfer Agreement: A contract or transfer agreement signed by both parties, outlining the details of the sanitary registration and the relationship between the manufacturer and the new holder. This document must be apostilled.
Conclusion
While the rights transfer process is explained in general terms here, it is important to recognize that each case can present unique challenges. Factors such as the roles of the stakeholders and their involvement in the process should be considered. It is important to maintain good communication with the current holder of the sanitary registration.
If you require assistance with transferring your sanitary registrations in Colombia, we are happy to provide further details and support throughout the process. Please feel free to contact us at [email protected].
