Requirements for importing Pharmaceutical Products, Medical Devices, and Health Products in Peru, Bolivia and Chile
1. Perú:
These are the documents required to import the following products:
Medicines
– Health Registration or Certificate of Registration and Summary Sheet (VUCE)
– Certificate of Analysis (batch)
– GMP Certificate or equivalent
– Official Import Certificate (COI) and RD Authorization for Entry (For
psychotropics and narcotics)
Biologicals and human plasma derivatives
– Health Registration or Certificate of Registration and Summary Sheet (VUCE)
– Certificate of Analysis (batch)
– GMP Certificate or equivalent
– Official Import Certificate (COI) and RD Authorization for Entry (For
psychotropics and narcotics)
– Negative Certificate for HIV, Hepatitis B, and C (For human plasma derivatives)
– Negative Certificate for Bovine Spongiform Encephalopathy (For derivatives
from bovine, sheep, or goat animals)
Dietary supplements and sweeteners
– Health Registration or Certificate of Registration and Summary Sheet (VUCE)
– Certificate of Analysis (batch)
– GMP Certificate or equivalent
Galenicals
– Health Registration or Certificate of Registration and Summary Sheet (VUCE)
– Certificate of Analysis (batch)
– GMP Certificate or equivalent
Natural products
– Health Registration or Certificate of Registration and Summary Sheet (VUCE)
– Certificate of Analysis (batch)
Medical devices
– Health Registration or Certificate of Registration and Summary Sheet (VUCE)
– Certificate of Analysis (batch)
– GMP Certificate or equivalent or ISO 13485
– IPEN Authorization (Only for controlled technology equipment that emits ionizing
radiation
2. Bolivia:
In Bolivia, Customs Clearance involves the set of customs procedures and formalities necessary
for applying to goods. This customs regime, established by law, will be documented, public,
simplified, and timely, in accordance with the principles of good faith, transparency, and trade
facilitation.
It is the national responsibility of AGEMED to regulate, control, supervise, regularize, and
oversee all aspects related to the National System of Medicine Surveillance and Control, with
the issuance of the Customs Clearance Authorization Certificate being performed by this entity.
The Customs Clearance Authorization Certificate (CADA) is a substantial element for accessing
legally recognized medicines. Therefore, it is solely the responsibility of the applicant to verify
the accuracy of the declared information and the documentation submitted to AGEMED in
compliance with the current regulatory framework.
For companies legally established with AGEMED, the necessary requirements are as follows:
It includes import authorizations for products intended for manufacturing, promotion,
registration samples, quality control standards, market research, or general commercialization.
a. Form 011 – Customs Clearance Authorization Certificate duly completed.
b. Commercial invoice or sales note according to origin standards.
c. Packing list or specific note from the importing company when the invoice does not
include the batch number and expiration date of all products.
d. Quality control certificate for each batch to be imported (technical sheets, quality
management system documents, or quality reports are not applicable; it refers to
quality report documents, supplier or manufacturer declaration, quality or conformity
certificate) for medicines or its equivalent for raw materials, medical devices,
diagnostic reagents, cosmetics, household hygiene products, and absorbents including
reference products.
e. Technical sheet with the description of the name, image, and coding if applicable for
biomedical equipment, accessories, and spare parts.
f. For vaccines, when applicable, the current Batch Release Certificate.
g. For the importation of Legally Recognized Medicines, the company must have valid
Legal Representation at the time of review, previously submitted in original and
legalized or apostilled to the Licensing Area of the Surveillance and Control
Department of AGEMED.
h. When applicable, a Prior Import License Administrative Resolution for controlled
substances (psychotropics/narcotics/precursors) must be included, whether it involves
raw materials, reference standards, medical samples, finished or bulk products,
registration samples. The type of product should declare the trade name according to
the invoice, the generic name (only the generic name of the controlled substance
indicating whether it is a base, salt, ether, or ester).
i. When applicable, it must be considered that, in the case of controlled substances, an
annual forecast must be provided; a supplementary forecast may be requested before
applying for the CADA.
j. Payment for the service of the "Certificate for Customs Clearance of Legally
Recognized Medicines" or "Certificate for Customs Clearance of Raw Materials" in
accordance with R.M. 0265 tariff rates.
3. Chile:
The documents required to import pharmaceutical products and their raw materials, including
narcotics and psychotropics, medical devices, cosmetics and their raw materials; dietary
supplements and pesticides for sanitary and domestic use in Chile follow the following process:
The ISP (Public Health Institute of Chile), by agreement with the Undersecretariat of Public
Health on behalf of the Regional Health Authorities (Seremis de Salud), is the body responsible
for issuing the Customs Destination Certificate (CDA) for products subject to health control
throughout the national territory, in accordance with Law 18.164/82 of the Ministry of Finance.
On the other hand, the National Customs Service authorizes the Declaration of Entry of goods
into the country (DIN). In this context, the ISP is the technical body responsible for evaluating
and authorizing the use, consumption, distribution, transfer, or disposal of goods subject to
health regulation that enter the country by issuing a Resolution of Authorization for Use and
Disposal.
To obtain the CDA:
– Health Registration (ISP Resolution only for products that require registration)
– Certificate of Analysis from the origin
– GMP Certificate
– Health authorization of the storage warehouse
– Transport guide (air or maritime)
– Commercial invoice
– Packing list
– Official Import Certificate (only for narcotic/psychotropic products)
– Export Authorization from the country of origin (only for narcotic/psychotropic products)
To obtain the Resolution of Authorization for Use and Disposal:
– Health Registration (ISP Resolution only for products that require registration)
– Certificate of Analysis from the origin
– GMP Certificate
– Health authorization of the storage warehouse
– Transport guide (air or maritime)
– Commercial invoice
– Packing list
– Customs Entry Declaration (DIN)
– Official Import Certificate (only for narcotic/psychotropic products)
– Export Authorization from the country of origin (only for narcotic/psychotropic products)
– National dispatch guide (only for narcotic/psychotropic products)