In recent months there have been new changes in laws and regulations that had led to an international tender for the consolidated purchase of medicines and health supplies for the public sector in Mexico. This is not the first time such process is made, the key difference is that UNOPS (United Nations Office for Project Services) will be in charge of it.

In this article we provide an updated summary highlighting some key facts about the regulatory requirements.

Overview

Last October the 5^th, took place an open informative session organized by the UNOPS presenting details about the first international tender. As previously announced, the aim of this tender is to reduce costs for public health institutions (IMSS, ISSSTE, Sedena, PEMEX and the 32 states of Mexico). It is also projected that its value is around 100,000 million MXN (around 4,725 million USD).

Regulatory requirements

During this session the COFEPRIS commissioner, Dr. José Alonso Novelo, mentioned that derived to the agreement released on January 28, 2020, the general requirement to participate in this tender is:

• to have a sanitary registration in the country of origin issued by a recognized Regulatory Agency from the following countries:
  • Swiss, EU, USA, Canada, Australia
  • or be included in international programs like the WHO prequalification programs as well as those related to PICS members.
• If a sanitary registration in Mexico is not granted by the time a favorable response is received, the interested manufacturer must show evidence of the sanitary registration submission within the 5 days of the arrival of the products to Mexico.

 Milestones

Based on this report it is programed that from January to April 2021, the Government will start receiving the supplies in Mexico.

 Conclusions

Though, it is not the first time the government in Mexico releases international tenders, this represents the first trial to work with international parties (UNOPS) to improve the efficiency and avoid corruption within the institutions.

In addition, we consider that a major advantage for international manufacturers is that they do not necessarily need a sanitary registration in Mexico. Nevertheless, it has been clarified that it must be eventually requested.

Finally, it is worth mentioning, that if this process represents savings and concludes in an efficient and transparent acquisition. The government in Mexico expects to keep using this tool.

If you are medical device manufacturer interested to participate in this bid or those programmed in the following years, send us an email to contact@veraqueconsulting.com to receive more information about it.

The post Updates about the UNOPS International Tender Binding for Mexico. appeared first on Veraque.

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:

1. 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.

2. 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.

The post What do you need to transfer your sanitary registration in Mexico? appeared first on Veraque.

If you have an approved medical device sanitary registration in Mexico, it is important to consider that any modification have a great significance in this authorization lifecycle. In this article, we explain in which cases is necessary to request a modification to COFEPRIS. This will help you to avoid problems during exportations or marketing activities.

When a modification is necessary

All sanitary registrations for medical devices are issued by COFEPRIS indicating the conditions to market the device. The health supplies regulation indicates that sanitary registration holders must submit the legal, technical and scientific information to support any changes in the following cases:

1. Sanitary registration holder changes
2. Authorized distributor(s) additions
3. New distributor(s) legal address
4. New manufacturer or distributor(s) company name
5. New Manufacturing site (including third party manufacturers- OEM)
6. New product sources (if the new source is a subsidiary or affiliated company)
7. New device classification
8. Primary or secondary packaging materials changes
9. New or different shelf life or sterilization process
10. New models or presentations of the product not involving technological advances (if so, a separate registration is required)
11. New formula
12. New or different commercial name/trademark or catalog/reference numbers

Any changes in the points 1-4 are considered as administrative modifications. Otherwise, modifications in points 5-12 are known as technical modifications. Finally, it is useful to consider that one or more conditions can be modified at a time.

It is worth mentioning that every sanitary registration is approved with a remark stating that the granted authorization can be revoked if terms and conditions are changed. Considering the scope of this remark, and if none of the 12 points mentioned are applicable to your case, our recommendation is to look forward if the authorization in the country of origin has changed. If it is not the case, most of the times, no modification is necessary in Mexico either. If you are not sure, feel free to give us a call to provide a more accurate advice.

When a modification is not applicable and a new registration is required

In case there are modifications in the product related with safety and effectiveness of the medical device. Then a new sanitary registration must be requested. Specifically, the following are the conditions when a new registration is required:

1. New pharmaceutical form or physical presentation.
2. Different active pharmaceutical ingredient or medical device materials
3. Technological advances modifying the purpose of use are presented.
4. New components of the devices having impact in the indication of use
5. Indication or purpose of use is changed

Some extra advices

During the modification process, you can only sell your medical devices under the approved conditions at that moment. For example, if you want to include a new model, you have to wait until the modification is approved and this new model is mentioned in the sanitary registration.

Keep in mind that changing some conditions may complicate its exportation to Mexico, especially those related to the product label. To get certainty of when and how to request a sanitary registration modification and be able to sell the product in Mexico, please contact us for more details at contact@veraqueconsulting.com

The post Sanitary registration modifications in Mexico appeared first on Veraque.