Por: Andrea Castillo
The Department of Regulation and Control of Pharmaceutical and Related Products published the guide to request the opening of pharmaceutical and related establishments through the Integral System of Health Authorization Services -SIDEAS-, in order to facilitate users the steps to follow for the procedure.
- Some of the prerequisites to carry out this online procedure are:
- To have a registered user in the SIDEAS platform.
- Comply with the legal requirements in force to act as technical director or Responsible Technician of a Pharmaceutical Establishment or similar.
- The payment for the Certificate of Appointment of Technical Director must be made independently, attaching the corresponding receipt 63 A2.
Type of license to apply for
After selecting the Opening of Establishment procedure, the type of sanitary license to be applied for must be indicated, as applicable for new, renewals and transfers:
- L1 Sanitary License for Pharmaceutical Laboratory and Quality Control Laboratories.
- L2 Sanitary License for Laboratory or Factories of Related Products, Natural Medicinal Products, Medicinal Gases and Raw Materials, Pesticide Formulator for domestic and professional use.
- L3 Sanitary License for Pharmacies, Drugstores, Distributors, Pest Control and Disinfection Companies.
- L4 Sanitary License for Drugstore with Fractionation, Distributor with Fractionation, Raw Material Distributor and Pesticide Distributor.
- L5 Sanitary License for Sale of Drugs, Sale of Natural Products, Beauty Salons, Dental Depots, Kiosks.
Payment of fees
It is important to pay the fee in a proper way, since no refunds will be made in case of payment to another bank account or payment of a fee that does not correspond to the procedure. In addition, the payment of the fee will enable the boxes corresponding to the desired procedure in the platform.
The ticket must be generated in the system, depending on the type of license requested. This is downloaded and the payment is made only in agencies or virtual banking of Bantrab.
After the payment of the fee, the system will automatically show “Receipt 63A-2” which can be downloaded. Additionally, it is important to remember that the DRCPFA will accept applications/files with 63 A2 receipts issued within a maximum period of three months (Decree 05-2021).
Application Form
The system displays the Sanitary License application form corresponding to the establishment selected and according to the fee paid.
The form is filled out by typing or uploading the information requested in the boxes, some of the general data are:
- Complete Commercial Address (according to the trade license): The system allows the addition of several addresses, which will be reflected in the electronic health license.
- Category of the pharmaceutical or related establishment: The categories will be enabled depending on the fee paid.
- Legal representative: The system will automatically show the managers, associated legal representatives, at least one must be selected.
- The system automatically requests the requirements depending on the national legislation in force, the files must be uploaded in PDF format and not exceed the maximum size of 10 MB. In this way the file is entered, uploading the documents according to the respective requirement.
Once the form is completed, the system allows the file to be previewed. If the data entered is correct, the application is sent. It is important to consider that once the electronic file has been sent, it cannot be modified.
Follow-up
It is possible to follow up on the file in real time, where the status of the file is indicated, some of the definitions are:
- Draft: the user can edit it, complete the required information before sending it to the Department.
- Sent: indicates that your application has been sent to the Pharmaceutical and Related Establishments electronic mailbox for evaluation.
- In Evaluation: indicates that your file is in the process of evaluation by the Department.
- Pre-approved: indicates that the file is in the process of authorization with the Department Head.
- Rejected: indicates that the file has observations and must respond to a note of objection.
- Canceled: indicates that your file has been canceled.
- Approved: indicates that your request has been authorized.”
Translated with www.DeepL.com/Translator (free version)