DRCPFA Guidance on Importation: Regulatory Overview | DRCPFA

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The Directorate of Health Regulation, Surveillance, and Control, specifically the Department of Regulation and Control of Pharmaceuticals and Related Products (DRCPFA), Guatemala’s regulating authority in healthcare products, has published a guidance document dedicated to importation requirements.

In particular, the document outlines the applicable requirements for importing pharmaceuticals and related goods.
Also, it provides a comprehensive overview of the importation processes, including documentation and procedural standards for various categories of imports.

The authority reserves the right to change the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation. 

The document describes in detail the requirements to be followed depending on the nature of the product in question. It highlights the key points to be considered by the parties involved to ensure compliance with the existing legal framework.

Import Requirements for Related Products

According to the guidance, for the importation of related products, importers must present a payment receipt for the import procedure fee alongside two sets of simple, legible photocopies of invoices.
These invoices must be signed in blue ink and initially sealed by the technical director, specifying the health registration number or mutual recognition for each product intended for import.

Non-Controlled Medications Importation

Like related products, importing non-controlled medications requires a payment receipt and two sets of simple, legible photocopies of invoices, signed and sealed as specified above, indicating the sanitary registration number for each product.

Controlled Medications Importation

As further explained by the authority, importing controlled medications includes additional requirements such as a simple photocopy of shipping documents and an original import certificate for specific substances.
All documentation must adhere to the outlined standards, including signing and sealing by the technical director.

Importation of Donations

The scope of the document also covers specific aspects related to the importation of donations.
According to the guidance, importing donated products necessitates a comprehensive set of documents, including payment receipts, invoices or product lists with detailed information, and specific forms signed by the legal representative of the receiving entity.
Further documentation is required for first-time imports or changes in the registered entity’s details.

Vaccine Importation

By the applicable regulatory requirements, for vaccine importation, an applicant is expected to submit a set of documents including, among other things, a payment receipt, invoice copies, sanitary registration numbers, and additional documents such as production protocol summaries and batch release certificates.

Special considerations are given to vaccines intended for the Ministry of Public Health and Social Assistance, with requirements for life validity and commitments for consumption before expiration.

End-User Importation

End-users importing products must provide a range of documents, from payment receipts to personal identification, product photographs, and medical documentation, if applicable.
This category includes specific requirements for patient imports and over-the-counter medications.

Importation of Samples for Sanitary Registration or Inscription

Sample importation for registration or sanitary inscription purposes requires documentation similar to other categories but includes specifics about the sample’s intended registration or inscription and a detailed description of the product.

Importation for Clinical Trials

Importing the products intended to be used in clinical trials requires a protocol authorization number and a letter from the clinical trial’s responsible party, together with the standard set of documents for importation.

Special Case Imports

Special case imports involve a letter of request detailing the case, medical certification, and other relevant documents tailored to the specifics of the importation case.

High Therapeutic Interest Medication Importation

This category requires a comprehensive set of documents, including a letter of request from the program head requesting the medications and quality certificates for the batches being imported.

Raw Material Importation

The importation of raw materials, both controlled and non-controlled, necessitates specific documentation, including technical data sheets detailing the composition and concentration of the products.

Importation of Chemicals Not Regulated by the Authority

For chemicals entering the department but not regulated by it, importers must present a letter indicating the specific use of the material or finished product, along with detailed technical sheets and, if applicable, permits from relevant ministries.

General Notes

The document also provides general notes and remarks regarding the importation process and requirements. In particular, all documentation must be accurately signed and sealed, with no corrections allowed, ensuring the authenticity and compliance of the importation process.

Conclusion

The present guidance provides a brief overview of the regulatory requirements for importing healthcare products to Guatemala.
The document clarifies the regulatory status for the specific types of products. Also, it highlights the key points to be considered by the parties involved to ensure compliance with the existing legal framework. 

Source

https://medicamentos.mspas.gob.gt/phocadownload/Formularios_Importaciones_Exportaciones/F-IP-r-01%20V%2007-2024%20REQUISITOS%20DE%20IMPORTACION%20%2009022024.pdf

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