In the complex world of medical devices and pharmaceutical products, obtaining a sanitary register is a fundamental step before being able to introduce a product to the Peruvian market. In this process, the role of a Regulatory Representative who provides the License Holder service is essential so that regulatory compliance and the security of achieving the expected results for your company in the shortest possible time are guaranteed. Let’s delve into its importance and specific processes.
What is a License Holder in the context of the Sanitary Register?
In the field of sanitary register of medical devices, pharmaceuticals and other related products, the Regulatory Representative is the Peruvian company (Droguería) legally authorized to request, obtain and maintain the register of a product before the relevant regulatory authorities. This Representative assumes legal and regulatory responsibility for the same.
Key responsibilities of the Regulatory Representative in the Sanitary Registration process
The Regulatory Representative, also called “Sanitary Register Holder,” performs a number of crucial responsibilities in the sanitary register process, including:
- Registration application and management: The Regulatory Representative is responsible for preparing and submitting the registration application to the competent authorities. This involves collecting all required documentation and complying with the specific requirements established by health regulations.
- Regulatory compliance: Throughout the sanitary register process, the Regulatory Representative must guarantee strict compliance with the regulations and standards applicable in the country.
- Management of changes and renewals: Once the product is registered, the Regulatory Representative can manage any changes to the sanitary register, at the request of the Manufacturer. Furthermore, he is responsible for renewing the registration periodically according to the deadlines established by the regulatory authorities.
Importance of the License Holder in the Sanitary Register
The role of the Regulatory Representative in the sanitary register
process is essential for several reasons:
- Security and confidentiality: Your sanitary registers will be protected under the secure platform of our Droguería. We protect confidential information related to your registers.
- Regulatory Compliance Guarantee: A License Holder service ensures compliance with all local regulations and standards, which is crucial for obtaining and maintaining sanitary register.
- Facilitation of access to the Peruvian market: By obtaining the sanitary register, the License Holder facilitates the product’s access to the market, which is essential for its marketing and distribution. In this way, you can have one or more authorized Distributors, who will not have access to the sanitary register.
- Legal and Regulatory Responsibility: The License Holder assumes legal and regulatory responsibility for the registers, which provides a clear liability structure and protects all parties involved.
What is our License holder service like?
In our commitment to maintaining the integrity and security of our clients’ sanitary registers, our role as Regulatory Representative takes on fundamental importance. Through this service, we are committed to safeguarding the sanitary registers of your products with complete security and confidentiality, guaranteeing at all times compliance with current health regulations.
Our Regulatory Registers Representation service is designed to offer solid protection to our clients’ registers. Under the custody of our Droguería platform, we carry out rigorous control and care of CONFIDENTIAL INFORMATION related to products and registers. This includes the management of sensitive documentation and the implementation of security measures to protect the privacy and confidentiality of our clients.
To offer this service efficiently and safely, our Droguería meets the highest regulatory and quality standards. We have the health operating authorization issued by Digemid, which guarantees that our operations meet the requirements established by the competent authorities. In addition, we maintain current Good Practices Storage (GPS), ensuring that our Droguería meets the most demanding quality and safety standards.
In summary, through our Regulatory Representation service (License Holder), we offer our clients the peace of mind of knowing that their sanitary registers are in good hands. We are committed to protecting the confidentiality of information and guaranteeing regulatory compliance at all times, providing a reliable and quality service in the field of health and the pharmaceutical industry.
CONTACT US NOW and let us be your best ally in this project.
Have a good day,
Juan Medina