A rights transfer is a legal procedure where the Sanitary Registration Holder is changed. In this process the original owner of a Sanitary Registration transfers its rights to another company (the new Holder), as long as critical conditions previously authorized are not changed.
The new Holder acquires the rights for manufacturing, importing, exporting, and marketing the product(s) endorsed by the Sanitary Registration. Other obligations (like surveillance activities) related to the ownership of a Sanitary Registration are also acquired.
In this article we explore the main characteristics of a rights transfer, dividing this process into two parts for a better understanding:
- Rights transfer legal procedure through a public notary.
The rights transfer is performed by means of a contract or written agreement in which the holder of a sanitary registration agrees to transfer the ownership (rights) to a third-party company. Due to the legal nature of this procedure, the agreement must be signed by both parties through a notary.
It is worth mentioning, that there is not a standardized document to carry out such process since the conditions of the agreement may differ in each case. However, there are templates that can be used whenever these contracts are agreed among parties. In addition, there is no need to get an approval by COFEPRIS for this document since civil law is not a field of its competence.
On the other hand, the company that cedes the rights must provide to the new holder, all the original and official documents related with the sanitary registration. This includes, modifications and proof of submission under evaluation by COFEPRIS. Likewise, backups of all the dossiers, either in digital or physical format, must be provided for safekeeping by the new holder.
- Sanitary registration holder modification with the Mexican Ministry of Health
Article 190 of the Health Supplies Regulation indicates that the new holder must communicate any rights transfer to the Mexican Ministry of Health (through COFEPRIS), within a period not exceeding thirty (30) days from the date on which it was made, attaching the public document where the rights transfer is recorded.
On the other hand, general requirements to perform such modification are:
- Updated project label.
- The public deed where the rights transfer is registered (certified copy or original).
- The original sanitary registration.
- Copy of the health license or operating notice of the new holder.
In this procedure, the new holder can change or add importers and distributors. It is only necessary to present the respective operating notice and representation letters approved by the manufacturer.
If you have further questions about how to process a rights transfer for any sanitary registration, please feel free to contact us at contact@veraqueconsulting.com.