LEGAL AGENT - HOLDER

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Medical product registration in Mexico is a procedure that may end up talking over a year for each proceeding filed before COFEPRIS, which delays the legitimate marketing of products, for which COVELAR offers solutions for your expansion plans in shorter periods of time.

Our offer for foreign companies is mainly based in a platform for the expansion of their brands and products in Mexican territory, assisting in their products’ registration processes, since we have the ability to hold the appointment of the health register to then cede it through a subsidiary of the manufacturer, or through the local distributor which authorizes the commercialization of their products in a legal way.

At our international clients request, we handle all legal procedures to the opening of subsidiaries in Mexico, procedure manuals, customer loyalty and retention strategies, product launch planning, product registration in hospitals, and implementing technovigilance or pharmacovigilance programs to control devices or drugs with current health registration.

The main aim is to reduce expenses both in time and money to our clients, streamlining all proceedings so that as soon as the products are registered, a platform can be presented for them to decide whether they wish to invest by bringing their company to Mexico or initiating negotiations with a national medical trading company already established, to start with a sales plan that will come up as effective and immediate for all parties.

REGISTER HOLDER

SAVINGS

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The Register Holder has the power to get started with all required registrationprocedures before COFEPRIS without the manufacturer having to invest time and money in establishing a subsidiary in Mexico.

INDEPENDENCE

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The manufacturer won’t depend on a distributor in Mexico to manage any of their procedures; if a distributor coordinates such proceedings, it also controls the health registrations.

TECHNOVIGILANCE OR PHARMACOVIGILANCE

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Through implementing a TV or PV Unit, the Holder can keep a database to notify theauthority and follow up any adverse reaction or event in case it may happen.

RESPONSE TIME

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The Holder ensures the optimization of response times before the authority since it's free of the need of triangulating information.

FULL CONTROL

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In case it suits his bestinterests, the manufacturer always has the option of regaining full ownership over the health register through a simple transfer of rights procedure from the Holder.

OPERATION NOTICE

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It is the notification given to the health authority regarding the activities to be performed in an establishment, which may foresee a sanitary risk and, if necessary, the simultaneous notice of a health manager for the required modality. As well as any modification of the general information or its retirement.

Among the services that COVELAR is able to offer in the aforementioned area, you can find:

✔︎ Registration of operation notice

✔︎ Notification of modification or retirement of the operation notice:

   ✔︎ Modification of the register holder information

   ✔︎ Legal representative

   ✔︎ Health manager

   ✔︎ Authorized personnel

HEALTH MANAGER NOTICE

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The health manager is the legal form in charge of securing the use, purity and safety of the products and processes performed in the establishment. It is therefore important to notify the authority about the identity of the person that holds such legal form within the establishment.

Our firm has the ability of offering the service of health manager of the establishment, along with the experience of intervening in quality assurance processes.

Some of the services that COVELAR offers are:

✔︎ Registration of health manager

✔︎ Modification or cancellation of health manager

NEW HEALTH REGISTER

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According to the Regulation of Health Products, drugs, medical equipment, prosthesis, orthosis, functional aids, diagnosis agents, materials for odontology use, surgical materials, healing materials, hygienic products and other medical use devices must have a health register for their production, sale, and distribution.

To obtain a health register it is necessary to submit to COFEPRIS all legal, technical and scientific documentation that verifies the safety and effectiveness of the product in question.

In COVELAR we prepare registration files to obtain the health register of class I, II & III medical devices, food supplements, allopathic drugs, and herbal medicines & remedies according to the requirements and regulations established by COFEPRIS, and for it we offer the following services:

✔︎ Advisory in proceedings to be presented before COFEPRIS

✔︎ Product classification

✔︎ Evaluation of legal, technical, and scientific documentation to form the register file

✔︎ Technical translation from source language to Spanish

✔︎ Production and organization of register file

✔︎ Procedure management before COFEPRIS

NEW HEALTH REGISTER – ASSEMBLING THE DOSSIER

CLASSIFICATION

1

We classify products by families, according to the legal framework in force, and determine the viability of each one of the projects.

EVALUATION

2

We evaluate administrative, technical and legal documents, and issue a report of any missing documents and/or those requiring modifications.

PROCESSING

3

Once the list of documents required by COFEPRIS is complete, we begin the tasks of translating and assembling the registration files.

VERIFICATION

4

When the processing works are finished, we verify the registration files both in form and content prior to submitting them.

PRELIMINARY RULING

5

The dossier is submitted to an Authorized Third Party, for the issuance of a preliminary ruling that will significatively shorten COFEPRIS’ times.

NEW HEALTH REGISTER – OBTAINING THE RESOLUTION

PAYMENT OF FEES

1

Prior to submission, all fees must be paid through an access code that we generate directly with the authority.

SUBMISSION

2

We take care of obtaining the appointment and presenting all files before COFEPRIS.

MONITORING

3

We follow up all submitted procedures and, in case of receiving precautions from COFEPRIS, we work on the replies.

RESOLUTION

4

Once the authority is satisfied with the information in the dossier, the health register is issued, and we deliver it to our clients.

MODIFICATION TO THE REGISTER CONDITIONS

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Once a health register has been issued, modifications to the original registration conditions that were not contemplated at the beginning of the process can be requested from the authority.

Among the modifications to the health register that we can request are the following:

✔︎  Administrative changes

   ✓  Manufacturer or register holder name or address change

   ✓  Incorporation of new licensed distributors

   ✓ Transfer of rights

✔︎  Technical changes

   ✓ Changes in the manufacturing process

    ✓ New product presentations

RENEWAL OF HEALTH REGISTER (EXTENSION)

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If the client requires it, a renewal of a health register approaching delinquency can be requested to COFEPRIS.

To obtain the renewal of the health register the documentation required by the authority to concede such extension must be submitted properly and on time. In COVELAR we take care of scheduling previously required proceedings, thus preparing beforehand all the information and paperwork that is to be presented, as well as managing the procedure itself.

UNIDAD DE TECNOVIGILANCIA O FARMACOVIGILANCIA

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In order to ensure the safety and efficacy of medical devices and drugs marketed in Mexico, it is necessary for the establishment to have a technovigilance unit, in the case of devices, or pharmacovigilance, for drugs; which must keep track of all those reactions or adverse events that are notified, as well as carry out an investigation of the reaction or adverse event and implement the corrective and preventive actions derived from said investigation or by mandate of the Ministry of Health .

At COVELAR, we take care of providing support to companies for the establishment, registration before the authority, operation and functioning of their health technovigilance or pharmacovigilance units.

TECHNOVIGILANCE OR PHARMACOVIGILANCE

HEALTH VIGILANCE

1

COFEPRIS requires establishments to set up a system to notify the authority and follow up any adverse reactions or events that may occur.

SETTING UP A SYSTEM

2

Once a health register is obtained, we design a TV or PV system that meets the needs of the client and the requirements of the authority.

ADVERSE REACTION OR EVENT

3

In case it emerges, we receive the notification, take care of paperwork, evaluate the case filed, and notify the authority.

INVESTIGATION AND REPORT

4

We conduct an ongoing investigation until the case is closed and then we submit a final report before COFEPRIS.

IMPLEMENTING ACTIONS

5

Preventive, corrective or of safety in the field actions are implemented to avoid repetition or increasing frequency of adverse events or reactions, and health vigilance is continued permanently.

TECHNOVIGILANCE OR PHARMACOVIGILANCE REPORT

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As part of the requirements to request before COFEPRIS the renewal of a health register, it is necessary to submit properly and on time the technovigilance or pharmacovigilance report of the commercialization period of the product to be renewed.

COVELAR guides and supports our clients in the making of this report, we also handle all the information required to make this control document, essential to proceed with all the procedures required by COFEPRIS.

Among the services that we can offer to our clients in this area are:

✓ Database management

✓ Product history

✓ Investigation of adverse reaction or event

✓ Implementation of preventive and corrective actions

PROCEDURE MANUALS

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As important as necessary to develop different departments, defining positions and their roles, there are manuals which capture the essence of the objectives of the company and how to reach them; in COVELAR we work hard to express each company’s management ideas to achieve it.

MANAGEMENT OF REGISTRATION IN PRIVATE HOSPITALS

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One of the most important procedures after the acquisition of the health register is processing the registration as a supplier before all of those hospitals with which is desired, said process may take time; COVELAR can counsel you and/or manage your processes prior to the launch of the product so everything is ready to sell your medical devices as soon as possible.

PRODUCT LAUNCH

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In COVELAR we can guide you through the organization of your product launch event, from the choice of guests, mouth to mouth broadcasting of the event to both your target and your current clients, digital media campaign, setting up of Q & A section during the event since the more innovative the device is, the more questions it will generate and you must be prepared for the occasion, e-mailing marketing, among others, so it’s a striking and interesting event for your guests.

TRANSLATION

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At COVELAR we guarantee that the content of each translated text faithfully adheres to the original material. Before submitting a finished work, each page must go through a thorough review and proofreading process.

Our team of translators follows the highest standards to ensure that the end result is a mirror of the original document, both in format and content. This way, our clients do not need to worry about spending additional time formatting their translations.

We can translate a wide range of texts for you: operating manuals, instructions, inserts, scientific studies, articles, medical publications, academic journals, administrative documents, and a great many others.

In the case of legal documents that need to be translated by an expert translator, we take care of the entire procedure, and we make sure that the expert translations are perfect, both in content and format.

ENGLISH-SPANISH TRANSLATION

ACCURACY

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At COVELAR we guarantee that the content of each translated text faithfully adheres to the original material. Before submitting a finished work, each page must go through a thorough review and proofreading process.

MIRRORED

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Our team of translators follows the highest standards to ensure that the end result is a mirror of the original document. This way, our clients don't need to worry about formatting their translations.

VERSATILITY

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We can translate a wide range of texts for you: operating manuals, instructions, inserts, scientific studies, articles, medical publications, academic journals, administrative documents, and a great many others.

EXPERT TRANSLATIONS

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In the case of legal documents that need to be translated by an expert translator, we take care of the entire procedure, and we make sure that the expert translations are perfect, both in content and format.