By: Olga Torres de Gochez
Partner and Regional Director of Life Sciences
In the 2018 Pharmacy Division of the Nicaraguan Ministry of Health, I announce its migration to an online system called KARPLUS. This system is launched as part of the automation process of the Ministry of Health with the objective of guaranteeing the population safe access to medicines.
Among the main advantages that the Health Authority promised with respect to this application, is that the registration processes would be expedited and, in turn, would guarantee compliance with all the requirements for opening a pharmacy in a timely manner. That would allow the evaluator to dedicate more time to the process as such and not to the typing of documents and also verifies in real time the moments of execution of each process.
In October 2018, the massive training for the use of the application began, through which all the procedures were supposed to be carried out in order to improve the services provided and shorten the response times to requests.
Entering the system is simple, you must request a username and password for access, you must be a registrar registered with the Pharmacy Directorate to obtain them. A screen with six columns containing: request, category, type of product, trade name, country, origin and situation is taken off as shown below:
However, although access to the portal is easy, its administration is not.
Along the way, the system has presented multiple disadvantages that have not allowed the best experience with the user, such as system crashes, loss of information, incomplete platform, which leads to having to request MINSA to include a manufacturer, principle asset or owner In addition to the fact that the system has a limit of requests to generate, defined days and a restricted schedule to load information.
The system performs a pre-review and a time must be waited for the MINSA evaluator to grant an approval for the presentation of the procedure at MINSA or a rejection, which must also be completed online and a time must be waited for the evaluator rechecks.
For the registrar, it is a challenge to match the use and load in the Karplus system with the submissions that are made physically in the MINSA, which were not eradicated.
Therefore, a double effort must be made, one online in the system as a form of "pre-review" of the procedures and then the normal and usual procedure must be carried out, presenting all the physical documents at the MINSA window, whether for registration , renewal or post registration changes.
Additionally, the Karplus system contains response times for the requirements both to complete rejections and time for once the "pre-review" has been authorized, the paperwork is submitted in person at the Pharmacy Office window. If this is not fulfilled, the paperwork is cancelled. and must be generated from scratch.
The most delicate and cumbersome procedure of all is the upload of new records. Since all the information must be digitized after it has been enumerated. The loading of the information is done in parts, so significant time must be invested to complete the online submission of each new record.
As a firm representing very important pharmaceutical houses worldwide, we have been highly proactive and efficient, generating new management systems that allow us to be at the forefront of migrations to online systems that are managed in Nicaragua and in the rest of the Central American region, to continue managing with quality each of the efforts that our clients entrust to us.
Our more than 25 years of experience at the international forefront of Central America have allowed us to become the number one firm in Life Sciences – Regulatory Affairs in the region.
If you have any questions about the karplus system, do not hesitate to contact us and we will gladly assist you.
For more information write to: otorres@latinalliance.co