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ELECTRONIC SINGLE-SHOP

USER GUIDE

ECONOMIC OPERATORS

IMPORT AUTHORIZATION
ABREMA

June 2021

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List of acronyms

- OBR: Burundian Revenue Office;

- ABREMA: Burundian Authority for the Regulation of Medicines for human use and
Food;
- GUE: Electronic Single Window;
- NIF: Tax Identification Number;
- MOH : Ministry Of Health

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List of images
Image 1: Access to the “ABREMA Authorizations” Module

Image 2: Document Access Options

Image 3: Import Authorization Request entry screen

Image 4: Search option for products in class 1

Image 5: Class 1 product search screen

Image 6: Search result for products in class 1

Figure 7: Generation and entry of data for the item to be imported (class 1)

Image 8: Adding the line relating to the item to be imported (class 1)

Image 9: Search option for products in class 2

Image 10: Class 2 product search screen

Image 11: Search result for products in class 2

Figure 12: Generation and entry of data for the item to be imported (class 2)

Image 13: Adding the line relating to the item to be imported (class 2)

Image 14: Box dedicated to comments

Image 15: Attaching scanned documents

Image 16: Downloading Scanned Documents

Figure 17: Viewing and Deleting Scanned Documents

Image 18 – Payment Notice Printout

Figure 19 – Retrieving the Import Authorization Request

Figure 20 – Cancellation of Import Authorization Request

Figure 21 – Entering payment details for the Application study fee

Figure 22 – Submission of the Import Authorization Application

Figure 23 – Request Submission Notification Message

Image 24: Message notifying the request for additional information

Figure 25: Accessing the Import Authorization Request from the Finder

Image 26: Consultation of the requested additional information

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Image 27: Message notifying the Transmission of the Authorization Request

Image 28: Message notifying the “Rejection” of the Authorization Request

Image 29: Message notifying the “Validation” of the Authorization Request

Image 30: Import Authorization Printout

Image 31: Display of the “ABREMA Authorization” tab

Figure 32: Data entry screen of the “ABREMA Authorization” tab

Image 33: Adding the article in the “ABREMA Authorization” tab

Image 34 – Pop-Up displaying the two selectivity circuits

Image 35: Notification of “Non-Compliant” control results

Image 36: Consultation of the reason for “Non-Compliant”

Figure 37: Notification of “Update” control results

Image 38: Consulting the Reason for “Update”

Image 39: Notification of “Compliant” control results

Image 40: Summary of Discharge of a Partially Discharged Import Authorization

Image 41: Partially cleared import authorization

Image 42: Search screen for a Cleared Authorization

Image 43: Line corresponding to a Cleared Authorization

Image 44: Summary of Discharge of a Fully Discharged Import Authorization

Image 45: Import Authorization Fully Cleared

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Table of Contents

List of acronyms................................................................................................................................. 2

List of images....................................................................................................................................... 3

Background ................................................................................................................................................. 7

1. Legal Framework................................................................................................................................. 7

1.1. Conditions for the importation of Medicines and Pharmaceutical products.................... 7

1.2. Formalities for the importation of medicines and pharmaceutical products................................. 8

2. Importer registration formalities .................................................................................. 8

2.1. Registration of the importer in the “Companies” table ............................................. 8

2.2. Registration of Approved Companies.................................................................................. 9

2.3. Registration of institutions not subject to Approval .................................................. 9

2.4. Granting of the access code to the Electronic Single Window system ..................................... 9

3. Formalities prior to the importation of products.................................................................. 10

3.1. Preparation of the import authorization application .................................................. 10

3.1.1. Entering data for the Import Authorization application ................................................ 10

3.1.2. Registration of the Import Authorization Application.................................................. 19

3.1.3. Amendment of the import authorization request .................................................. 20

3.1.4. Cancellation of the Import Authorization Application.................................................. 21

3.1.5. Payment of application processing fees.................................................................. 21

3.1.6. Submission of the application for import authorization.................................................. 22

3.2. Receipt of the follow-ups assigned to the request by the ABREMA Officer ................................ 23

3.2.1. Request for Additional Information...................................................................... 23

3.2.2. Transmission of the request.................................................................................. 25

3.3. Receipt of the follow-ups attributed to the request by the ABREMA Authority................................ 25

3.3.1. Review of the Import Authorization Application................................................................. 25

3.3.2. Rejection of the Import Authorization Application ................................................................. 26

3.3.3. Validation of the Import Authorization request .................................................. 26

4. Formalities for importing products................................................................................................. 28

4.1. Preparation of the customs declaration.................................................................................. 28

4.1.1. Data entry and declaration recording ................................................................ 28

4.1.2. Filing of the Declaration................................................................................................. 29

4.2. Physical inspection of products ................................................................................................ 30

4.2.1. “Non-compliant” control results ................................................................................ 30

4.2.2. “Update” Check Results ................................................................................. 31

4.2.3. “Compliant” control results.................................................................................. 32

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5. Discharge of the Import Authorization ................................................................................................ 33

5.1. Partial discharge of the Import Authorization.................................................................. 33

5.2. Total Clearance of the Import Authorization .................................................................. 34

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Context

As part of trade facilitation, and in order to fully ensure dematerialization

procedures and facilitate customs clearance operations for goods, the Office
Burundi Revenue Agency (OBR) has set up a Single Window environment
Electronics of Foreign Trade Operations, the objective of which is to enable
economic operators and the various partners of the OBR to establish, electronically,
all formalities required for customs clearance operations on import and
export.

This is how the formalities required for the importation of medicines and products
pharmaceuticals, laboratory inputs and reagents, consumable devices
and laboratory equipment at the level of the Burundian Regulatory Authority
Medicines for human use and Food (ABREMA) will be established via the Single Window
OBR electronics.

1. Legal Framework
Law No. 1/11 of May 8, 2020, regulating the practice of pharmacy and
medicine for human use, determines the conditions for exercising wholesale trade in
medicines and other pharmaceutical products for human use, and the formalities required for
the importation of these products into the national territory.

Decree No. 100/039 of February 26, 2021, establishing the creation, organization and operation of
the Burundian Authority for the Regulation of Medicines for Human Use and Food,
"ABREMA" in acronym, determines in detail the missions, the organization and the
operation of ABREMA.

1.1. Conditions for importing Medicines and Pharmaceutical

products

In application of the provisions of article 24, 25 and 26 of the above-mentioned law, “ No one may
import medicinal products for human use intended for use on the national territory that
when it has been expressly authorized by the minister responsible for public health after advice
of the regulatory authority. Only medicines and other pharmaceutical products
regularly approved in Burundi and meeting the specifications applicable to them
may be authorized for importation ”.

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“Establishments engaged in the wholesale trade of medicines and other products

pharmaceuticals for human use benefit from the status of approved importers, provided
that they comply with the legal provisions relating to the importation of medicines and
other pharmaceutical products”.

"Apart from legally approved establishments engaged in the wholesale trade of

medicines and other pharmaceutical products for human use, the Minister responsible for
public health, on the advice of the regulatory authority, may authorize the importation of
medicines approved in case of emergency duly noted for categories of persons"
listed by the same article.

1.2. Formalities for the importation of medicines and

pharmaceutical products

The importation of medicines and pharmaceutical products, narcotic substances and

psychotropic drugs, laboratory inputs and reagents, cosmetic and dietetic products
and Food, medical equipment and associated raw materials and inputs, is
subject to an “Import Authorization” issued by ABREMA, which must be requested
prior to the importation of these products.

2. Importer registration formalities

Formalities required prior to the importation of products subject to Authorization
ABREMA Imports must be carried out electronically, through the GUE, at the
instead of manual formalities.

The formalities described below must be carried out by the relevant departments as
indicated below.

2.1. Registration of the importer in the “Companies” table

In order to be able to electronically establish the required formalities before the actual importation
medicines and pharmaceutical products, the representative of the establishment
pharmaceutical company having obtained opening authorization from the Ministry of Health, and any other

entity which may be authorized to import medicines and pharmaceutical products, must
contact the Taxpayer Registration Service at the Internal Tax Office,
provided with the opening authorization, to obtain its Tax Identification Number
(NIF) and be registered in the “Companies” table.

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2.2. Registration of Approved Companies

In order to allow the importer with approval from the Ministry of Health to proceed
to the establishment of the formalities required for the request for Import Authorization of
products mentioned above, the relevant ABREMA department must enter the data
relating to the Approval granted at the level of the “Companies with Approval” reference table
and to inform the importer concerned of the approval number assigned to him.

2.3. Registration of institutions not subject to Approval

In application of the provisions of article 25 of the above-mentioned law, only importers

having the approval of the Ministry of Health can import medicines and
pharmaceutical products. However, some pharmacists, some organizations
international organizations such as WHO, UNICEF and UNDP, as well as some ministries may
also import medicines without being subject to Approval, but they must at least
must first be registered in the “Companies without Approval” reference table in order to
be able to request the Import Authorization.

In order to enable these institutions to establish the Import Authorization Request for
medicines and pharmaceutical products, the authorized user of ABREMA must
integrate into the “Companies without Approval” reference table.

The registration of these institutions in the relevant reference table must be done
prior to the establishment of the Import Authorization Application and must be based
on the Tax Identification Number (TIN) of the institution as the main data to be served.

2.4. Granting of the access code to the Electronic Single Window system

After registering the company in the appropriate reference tables, the representative
of the pharmaceutical establishment and the entity requesting the importation of the drugs and
pharmaceutical products, is required to contact the Programs and Monitoring Department at
Customs and Excise Office, with a request for access to the computer system
of the OBR in accordance with the current form and a copy of its NIF, in order to obtain a
access code to the system allowing it to establish the formalities necessary for obtaining
Import Authorization for Medicines and Pharmaceutical Products.

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3. Formalities prior to the importation of products

Import permits must be requested either by the importer himself or by

his representative, before the actual importation of medicines and products

pharmaceuticals, narcotic substances, laboratory inputs and reagents,

cosmetic, dietetic and food products, materials, devices and equipment

medical products as well as raw materials and associated inputs intended for the manufacture of

pharmaceutical products.

Furthermore, the required formalities will be carried out electronically, through the Counter

Single Electronics (GUE) of the OBR, instead of manual formalities and the process

following must be respected.

3.1. Preparation of the import authorization application

Pharmaceutical establishments and institutions wishing to apply for Authorization

for the import of medicines and pharmaceutical products must connect to the

Electronic Single Window system (Image 1), access the “Authorization” module

ABREMA”, in order to be able to carry out the operations described below:

Image 1- Access to the “ABREMA Authorizations” Module

3.1.1. Entering data for the Import Authorization application

Through the GUE document library, and in order to be able to access the form of

seizure of the application for Import Authorization, the economic operator or his representative

must proceed as follows:

- Click on the “ABREMA Authorization” Module;

- Right-click on the “Authorization” Document;

- Choose the “New” option and click on it, which will display the screen

of entering the Import Authorization request.

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Image 2 – Document Access Options

Once the application form is displayed, the operator can enter the data required for the Import Authorization
application.

3.1.1.1. “General Information” Segment

In the “General Information” section, in addition to the data generated automatically by the

system, the economic operator or his representative must enter the required data as

described below: (Image 3)

Image 3 – Import Authorization Request entry screen

- Type of request : This involves selecting the type of products that are the subject of the Import
Authorization request from the list that appears by clicking on the scroll bar;

- Office (1) : This involves entering, as an indication, the Customs office code on which
the products will be imported;

- Mode of transport (2) : This is the mode of transport that will be used for the importation of the
products;

- User Reference (3) : This is the reference that the user must assign to their Import Authorization
request and which must correspond to the Invoice number.
Proforma attached to the request subject to the products to be imported;

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- User Code (4) : This is the identification code of the system user who
is automatically generated from his profile;

- With Approval (5) : This is a box to be checked by the user, if the importer is subject to an Approval
code from the Ministry of Health and to be unchecked if the importer is not subject to an Approval
code;

- Approval Code (6) : This is the Approval number assigned to establishments engaged in the
wholesale trade of medicines and other pharmaceutical products for human use, and which must
be integrated by the relevant ABREMA department at the appropriate reference table level before
the Authorization application is established.
Import by the economic operator or his representative;

- Registration (7) : This is the number and date of registration of the Import Authorization request
which will be assigned by the system after registration.
of the request by the economic operator or its representative;

- Total price (8) : This is the total value of the products subject to the Import Authorization request
which will be calculated automatically and generated in the first box and the invoicing currency
code which must be entered by the economic operator or his representative;

- NIF Code (9) : This is the importer's Tax Identification Number. This code will be generated
automatically by the system for establishments engaged in the wholesale trade of medicines and
other pharmaceutical products for human use.
after entering the Approval code and must be entered by the economic operator or his
representative for institutions not subject to Approval.

- Name (10) : This is the name of the importer which is automatically generated in parallel with the
NIF code from the reference table “Companies with
Approval” after entering the Approval code or which is generated automatically upon entering
the importer’s NIF code if the Approval box is not checked;

- Address (11) : This is the importer's address which is automatically generated in parallel with the
NIF code from the reference table "Companies without
Approval” after entering the Approval code or which is generated automatically upon entering
the importer’s NIF code if the Approval box is not checked,

- Export country (12) : This involves entering or selecting from the relevant reference table the
export country code of the products to be imported;

- Name (13) : This involves entering the name or business name of the exporter of the products to be
importer ;

- Address (14) : This involves entering the full physical address of the exporter of the products to be
imported;

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- Status (15) : This involves selecting from the relevant reference table the status of the exporter
of the products to be imported.

3.1.1.2. Segment « Informations Articles »

The segment dedicated to Information relating to the articles of the Authorization request

Import tax must be served according to the category of the product selected:

If the category of the product selected at the import authorization level is of the class

1 (Classic Medicines or Psychotropic and Narcotic Medicines), the system displays

in the "Article Information" section of the columns that must be served by the user in
following the following procedure:

- The economic operator or his representative may enter the reference of the article if necessary.

has, or use the search engine by positioning the cursor on the box

“Reference” and right-click with the mouse, then select the option

"Search F3". This option is also allowed by clicking directly on the button

F3 on the keyboard: (Image 4)

Image 4 – Search option for products in class 1

- By clicking on one of the search options, the system will allow the display of a

search screen through which the user can enter the criteria available to him,

then click on the “Search” option to display the product(s) relating to it.

from the product reference table; (Image 5)

Image 5: Class 1 product search screen

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- Through the list of products that is displayed, the user must select the relative line

to the product you are looking for, then double-click on the line or click on the option

“Import”, which will import the selected line into the Article section of

the request; (Image 6)

Image 6: Search result for products in class 1

- Once the data relating to the selected product is generated in the boxes

appropriate (Image 7), namely:

ÿ Ref.: This is a reference code assigned to each product;

ÿ Int. Com. Denomination: This is the International Common Denomination

(DCI) which represents the active substance of the drug;

ÿ Form: This is the dosage form in which the product will be imported, which will be
generated automatically based on the selected line;

ÿ Dosage : This is the dosage relative to the product to be imported, which will be generated
automatically depending on the selected line;

ÿ Cdt. Unit: This is the packaging unit in the form of which the
product to be imported is presented, which will be generated automatically based on the
selection;

The user must enter the following data (Image 7):

ÿ Commercial designation : This involves entering, without fail, the commercial name of
the product to be imported;

ÿ Manufacturer: This requires entering the name of the manufacturer of the product to be
importer ;

ÿ Origin: This involves entering or selecting, obligatorily, the country code

of origin of the manufacturer of the product subject to the Request;

ÿ Quantity: This is to indicate, obligatorily, the total quantity of the products to be

Import based on selected packaging unit;

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ÿ Unit: This involves entering or selecting, obligatorily, the unit code

of calculation of the product subject to the request;

ÿ PU: This involves entering, obligatorily, the unit price of the product which will allow the
system to calculate and display the Total Price of each item in the appropriate box “PT”;

Figure 7: Generation and entry of data for the item to be imported (class 1)

- After completing all the data, the user must click on the “Add” icon.

Product" to allow the creation of a line representing the item of each

product to be imported and the automatic assignment of a sequential number to the line created.

(Image 8)

Image 8: Adding the line relating to the item to be imported (class 1)

If the category of the product subject to the import authorization is class 2 (Materials and

Medical Equipment or Cosmetic, Dietetic and Food Supplement Products or

Laboratory Reagents and Consumables or Raw Materials and Associated Inputs), the

system displays in the "Article Information" section columns that need to be served

by the user by following the following steps:

- The economic operator or his representative may enter the reference of the article if necessary.

has, or use the search engine by positioning the cursor on the box

“Reference” and right-click with the mouse, then select the option

"Search F3". This option is also allowed by clicking directly on the button

F3 on the keyboard: (Image 9)

Image 9 – Search option for products in class2

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- By clicking on one of the search options, the system will allow the display of a
search screen through which the user can enter the criteria available to him,
then click on the “Search” option to display the product(s) relating to it.
from the product reference table; (Image 10)

Image 10: Class 2 product search screen

- Through the list of products that is displayed, the user must select the relative line
to the product you are looking for, then double-click on the line or click on the option
“Import”, which will import the selected line into the Article section of
the request; (Image 11)

Image 11: Search result for products in class 2

- Once the data relating to the selected product is generated in the boxes
appropriate (Image 12), namely:

ÿ Ref.: This is a reference code assigned to each product, which will be generated
automatically depending on the selected line;

ÿ Product Name: This is the Name assigned to the product, which will be
generated automatically based on the selected line;

ÿ Cdt. Unit: This is the packaging unit in the form of which the
product to be imported is presented, which will be generated automatically
based on the selected line;

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The user must enter the following data: (Image 12)

ÿ Manufacturer: This requires entering the name of the manufacturer of the product to be
importer ;

ÿ Origin: This involves entering or selecting, obligatorily, the country code

of origin of the manufacturer of the product subject to the Request;

ÿ Quantity: This is to indicate, obligatorily, the total quantity of the products to be

Import based on selected packaging unit;

ÿ Unit: This involves entering or selecting, obligatorily, the unit code

of calculation of the product subject to the request;

ÿ PU: This involves entering, obligatorily, the unit price of the product which will allow the
system to calculate and display the Total Price of the item in the appropriate box “PT”;

Figure 12: Generation and entry of data for the item to be imported (class 2)

- After completing all the data, the user must click on the “Add” icon.

Product" to allow the creation of a line representing the item of each

product to be imported and the automatic assignment of a sequential number to the line created.

(Image 13)

Image 13: Adding the line relating to the article to be imported

NB : It should be noted that the process described for entering data from the article of the

request for authorization must be reproduced according to the number of articles in the request.

After completing the required data entry, the user can enter remarks if

necessary, in the appropriate box as shown in the following image: (Image 14)

Image 14 – Box dedicated to remarks

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3.1.1.3. Scanned Documents Tab

After completing the data entry of the Import Authorization Application,

the economic operator or his representative is required to attach the documents to his application

scanned documents required, including the Proforma Invoice, from the “Scanned Documents” tab

which includes the options to attach and view the documents to be attached to the
request.

In order to be able to attach the required documents to its application, the economic operator or its

representative must proceed as shown in the image (Image 15) and as described below.
below:

- Click on the “Scanned Documents” tab (1) ;

- Click on the “New” icon (2) which displays a search screen from

from which the document to be attached to the Authorization request must be selected (3) ;

Image 15: Attaching scanned documents

- Double-click on the selected document, or click on the “Open” button (4)

allows you to generate the document reference on a line of the “Documents” screen
digitized”.

- To identify the downloaded file, the economic operator must select the code

of the appropriate document from the list that appears in the first column

"Code" (1), then he must click on the "Download" button (2) to allow the

system to download and attach the document to the request. (Image 16)

Image 16: Downloading Scanned Documents

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- After downloading and attaching all the required documents, the economic operator

can view them before sending their request to the relevant ABREMA department,

and this by clicking on the "Show" button (2), and in case he notices that the document

downloaded is wrong or poorly scanned, the system offers the possibility to delete it by

clicking on the “Clear” button (1). (Image 17)

Figure 17: Viewing and Deleting Scanned Documents

NB : The document(s) which must be attached to the application must first be:

scanned, identified by a reference and saved in a directory on the machine

the user.

Common documents and specific documents which must be attached to the

Import Authorization request will be identified in a note which will be distributed by the
relevant ABREMA department.

3.1.2. Registration of the Import Authorization Application

Once all the required data has been entered, the operator must examine the consistency of the

data of his request through the “Check” icon accessible from the toolbar of the

document, then save your request using the “Save” icon.

Performing the “Save” operation will allow:

- To send a message to the operator for confirmation of the operation carried out;

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- Confirmation of the operation will allow:

ÿ Display a pop-up confirming the completion of the transaction and allowing you to
print the “Payment Notice” which is displayed in PDF format. (Image 18)

Image 18 – Payment Notice Printout

ÿ To assign a sequential registration number and date to the request

Import Authorization, and to assign the document the status “Registered”
(Recorded).

3.1.3. Modification of the import authorization request

After registering the Import Authorization request, the operator may modify
the request data through the “Retrieve” operation accessible from the screen of
search for the document. (Image 19)

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Figure 19 – Retrieving the Import Authorization Request

3.1.4. Cancellation of the Import Authorization application

After registering the request, the operator can cancel it through the operation
“Cancel” accessible from the document search screen. (Image 20)

Figure 20 – Cancellation of Import Authorization Request

Cancelling the request will result in the document being assigned the status “Cancelled”.
and no other operation will be permitted on this document.

3.1.5. Payment of application processing fees

Before submitting the Import Authorization Application, the operator must print
the payment notice and must contact the bank for payment of the study fees of the
requests required in accordance with current regulations.

The payment slip for the application study fees issued by the bank must
must include the reference of said application (Number and registration date)
of the request).

After obtaining the slip, the economic operator or his representative must:

- Scan it and save it in your machine;

- Access the document “Import Authorization Request” either through
the “Retrieve” operation or through the “Submit Authorization” operation
accessible from the document search screen;

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Enter the payment details (amount paid, bank name and payment number)
-

bordereau) in the appropriate boxes and attach the bordereau to your request (Image

21), then validate the operation.

Figure 21 – Entering payment details for the Application study fee

3.1.6. Submission of the import authorization application

After completing the application, the operator may submit it electronically to

ABREMA, through the “Submit Authorization Request” operation accessible from

from the document search screen. (Image 22)

Figure 22 – Submission of the Import Authorization Application

Selecting this operation will allow the user to access the request, verify

data consistency and execution of the operation from the “Submit” icon

permission” accessible from the document toolbar:

Confirmation of this operation will allow:

- To display a message indicating that the request submission operation is

successfully completed;

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- To send an electronic message via the system's mailbox to the Officer of

ABREMA informing him that an Import Authorization Request has been submitted

for study and action. (Image 23)

Figure 23 – Request Submission Notification Message

3.2. Receipt of the follow-ups assigned to the request by the ABREMA Officer

After submission of the import authorization request by the operator, a message from

notification will be sent automatically to the ABREAMA officer(s)

responsible for studying Import Authorization applications.

Following analysis of the application data by the ABREMA officer and the

attached documents, three consequences can be attributed to the said request:

3.2.1. Request for Additional Information

After studying and analyzing the data of the request for Import Authorization and the

attached documents, the ABREMA officer concerned may return the request to the operator

economic or its representative for additional information, such as production of a

original document or an additional document, clarification of certain concepts of the

request, etc.

Once this action is carried out, a notification message via the internal mailbox of the

system will be automatically addressed to the economic operator or his representative,

informing that his request is returned for additional information and including as

attached the Authorization request which he must access to consult the information

additional information requested. (Image 24)

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Image 24: Message notifying the request for additional information

In this case, the operator is required to:

- Retrieve your request, either through the mailbox containing the document in
attachment, either through the document search screen “Request for Authorization
"Import" accessible from the Document Library. (Image 25)

Figure 25: Accessing the Import Authorization Request from the Finder

- Consult the additional information requested by the ABREMA officer at

from the “Authorization” tab; (Image 26)

Image 26: Consultation of the requested additional information

- Complete the information and attach the additional documents requested, then
must resubmit the request through the “Submit Request” operation.
authorization”, which will send a notification message to the officer
ABREMA to re-examine the request.
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3.2.2. Transmission of the request

After studying and analyzing the data of the Import Authorization request and the

attached documents, the ABREMA officer will issue his opinion and the results of the study of said

request and then he must forward it to his superior for the final decision.

Once this action is carried out, a notification message via the internal mailbox of the

system will be automatically sent to the ABREMA Authority, notifying it of the transmission

of the request for its decision-making and the economic operator or its representative,

informing that his request is being studied and forwarded to the competent authority for decision.

decision, and including the request for Authorization as an attachment. (Image 27)

Image 27: Message notifying the Transmission of the Authorization Request

3.3. Receipt of the follow-ups attributed to the request by the ABREMA Authority

After transmission of the import authorization request by the ABREMA Officer to the

superior for making the final decision, a notification message will be

automatically addressed to the economic operator informing him of the follow-up given to his
request.

Three options may be assigned to the said request by the ABREMA Authority:

3.3.1. Revision of the Import Authorization application

After analyzing the data of the request and the results of the study made by the officer, the

superior responsible for deciding on the final decision to be given to the application

Import Authorization may return the application to the officer for review.

certain data or to request an additional document.

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In this case, the request will be returned to the officer who receives an internal notification message
of the system following the execution of this operation and which may:

- Either review the request and forward it to your superior;

- Or, if necessary, have it returned to the importer or his representative for

additional information before forwarding it to the superior.

3.3.2. Rejection of the Import Authorization application

After analyzing the data of the request and the results of the study made by the officer, the
superior responsible for deciding on the final decision to be given to the application

Import Authorization may reject the application.

Rejection of the request involves the automatic sending of a notification via the mailbox
to the economic operator or his representative:

- Informing him that his request is rejected. (Image 28)

Image 28: Message notifying the “Rejection” of the Authorization Request

- And allowing him to consult the reasons for rejection through access to the document which
is in Attached File.

3.3.3. Validation of the Import Authorization request

After studying and analyzing the data of the Authorization request and the attached documents, a
a favorable response may be granted to this request by the competent authority.

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In this case :

- A notification message will be sent to the economic operator or his representative,

informing him that his request is validated and including the Authorization as an attachment

Import validated. (Image 29)

Image 29: Message notifying the “Validation” of the Authorization Request

- The economic operator or his representative will be able to print the Authorization

Import through the “Print electronic authorization” option accessible at

from the document toolbar which allows the display of the printed document in format

PDF and print it. (Image 30)

NB : It should be noted that the signature of the Import Authorization remains

handwritten and that the printing of the document is not required, either by the importer or by

ABREMA staff, except for imports for which the

supplier requires receipt of the Authorization signed and stamped by

the competent authority.

Image 30: Import Authorization Printout

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4. Formalities for importing products

Once the prior authorization for import is granted by the competent authority of

ABREMA, the economic operator will be able to proceed with the effective importation of the

authorized products and to complete the formalities necessary for their customs clearance.

4.1. Preparation of the customs declaration

For the customs clearance of imported products, the economic operator or his representative is

required to establish a detailed declaration, through the OBR's electronic Single Window,

assigning the appropriate customs regime to the product.

4.1.1. Data entry and declaration recording

After entering all the data required for a declaration comprising one or more

items subject to Import Authorization, a click on the “Check” button allows

to display an “ABREMA Authorization” tab which is an integral part of the declaration and which

must be served by the appropriate data. (Image 31)

Image 31: Display of the “ABREMA Authorization” tab

In this case, the economic operator or its representative must proceed as described below:

Click on this tab to display the data entry screen;

-

- Enter the data relating to the Import Authorization (1) (Year of authorization,

registration number and number of the item to be cleared), which will allow the display

automatic of the initial quantity and the remaining quantity of the authorization as well as

the additional unit, then enter the data relating to the current declaration (2)

(Number of the article of the declaration which will clear the article of the authorization above

indicated, the quantity to be cleared, the batch number of the item and the expiry date for

items submitted on this date, including medicines. (Image 32)

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Figure 32: Data entry screen of the “ABREMA Authorization” tab

- Once all the data is served, you must click on the “Add Article” icon

(3) to allow the item to be added to the appropriate line. (Image 33)

Image 33: Adding the article in the “ABREMA Authorization” tab

NB : It should be noted that this process must be reproduced depending on the number

of articles of the authorization to be cleared by one or more articles of the declaration.

Once all the data has been entered, the economic operator checks the consistency of the data

of the declaration through the “Check” button, saves it through the “Save” button,

then he must file the declaration with the unit responsible for admissibility for electronic filing
of the declaration.

4.1.2. Filing of the Declaration

The agent responsible for the admissibility of declarations, after the necessary verifications, must

electronically file the declaration using the “Liquidate registered DAU” button

(Direct) » accessible from the declaration search screen.

Furthermore, the system:

- Assigns the statement to an OBR auditor;

- Directs the declaration to a Selectivity Circuit based on the selectivity criteria

OBR side and AAG (Other Administration) selectivity criteria

Governmental). (Image 34)

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Image 34 – Pop-Up displaying the two selectivity circuits

The Red circuit assigned to the declaration requires a documentary check and an inspection

by the Customs auditor in whose name the declaration is assigned.

The MOH Red Circuit requires, obligatorily, a physical inspection of the goods

by an ABREMA officer.

- Then, it automatically generates an Inspection Sheet.

4.2. Physical inspection of products

The “MOH CIRCUIT ROUGE” Circuit attributed to the declaration object of the products subject to

The Import Authorization requires a physical inspection of the

goods by the relevant ABREMA department prior to the liquidation of said

declaration by the Customs service.

For declarations that are directed to the Red circuits on the Customs side and the MOH side,

The physical inspection must be carried out jointly by the Customs service and the service

of ABREMA in order to facilitate and speed up the removal of goods.

Depending on the results of the physical inspection of the goods by the inspector of

ABREMA, the products may have the consequences described below.

4.2.1. “Non-compliant” control results

If the results of the physical inspection of the products are not compliant, the inspector

ABREMA may require the re-export of the goods or their destruction.

Performing the “Non-compliant” operation allows the system to send a message to the

Customs auditor concerned and the declarant informing them that the control results

are not compliant and the customs clearance process cannot continue. (Image 35)

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Image 35: Notification of “Non-Compliant” control results

Through the mailbox, the declarant and the verifier will have access to the document which can
be displayed in order to consult the reason for non-compliance: (Image 36)

Image 36: Consultation of the reason for “Non-Compliant”

In this case the declaration cannot be liquidated and the products must be re-exported or
destroyed in accordance with the applicable regulations.

4.2.2. “Update” control results

Following a physical inspection of the imported goods, the ABREMA inspector

may require the economic operator to produce an additional document for the purpose
of further verification, as it may require specific analysis of the product or
any other additional information. Also, the inspector may detect certain items not
conform to standards.

In these cases, an update of the inspection sheet is necessary and the completion of this
“Update” operation, allows the system to send a message to the declarant and the
relevant Customs auditor informing them that the control results are pending

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additional information or updating of the inspection sheet and that the process of
customs clearance cannot continue. (Image 37)

Figure 37: Notification of “Update” control results

Through the mailbox, the declarant and the verifier will have access to the document which can
be displayed in order to consult the requested update reason: (Image 38)

Image 38: Consulting the Reason for “Update”

Furthermore, the declaration can only be liquidated after the information has been completed.
requested, or modification of the declaration to update the inspection sheet, then
“Compliant” validation of the inspection sheet by the ABREMA inspector.

It should be noted that if the requested update concerns one or more articles recognized as non-
conform or the quantity declared incorrect for one or more items, in this case, it is the
auditor on whose behalf the declaration is assigned to retrieve the declaration and amend
data to enable automatic updating of the inspection sheet.

4.2.3. “Compliant” control results

If the result of the physical inspection of the products is compliant, the declaration will be released.
automatically by the system and can be liquidated by the Customs service.

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Completion of the “Compliant” operation of the inspection sheet allows notification of a

message to the relevant Customs auditor and the declarant informing them that the products

are compliant and customs formalities can be completed. (Image 39)

Image 39: Notification of “Compliant” control results

After liquidation of the declaration and payment of the required duties and taxes, the importer or his

representative may proceed with the removal of the goods.

5. Discharge of the Import Authorization

The liquidation of the declaration of importation of medicines and other health products by

the Customs inspector, after confirming the results of the physical inspection of the products

by the ABREMA inspector, allows the clearance of the attached Import Authorization
to the said declaration.

The clearance of the Authorization may be partial, as it may be total, and this depending on the

quantities imported.

5.1. Partial discharge of the Import Authorization

The clearance is considered partial when the quantity imported and declared at the tab level
“ABREMA Authorization” at the time of establishing the Declaration is lower than the

total quantity indicated at the level of the validated Import Authorization.

The system allows consultation of the settlement details through the “Settlement” tab of the

“Import Authorization” document.

In the “Clearance” tab, you can consult the reference of the declaration(s) that have been cleared.

Import Authorization (BIAER/2021/C/35/1) and quantities cleared (50)

(BIAER/2021/C/38/1) and the cleared quantities (50): (Image 40)

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Image 40: Summary of Discharge of a Partially Discharged Import Authorization

In the “Summary” tab, you can view the initial quantities of the Authorization (500) and the
remaining quantities (400): (Image 41)

Image 41: Partially cleared import authorization

5.2. Total Clearance of the Import Authorization

The clearance is considered total when the quantity imported and declared at the tab level
“ABREMA Authorization” at the time of establishing the Declaration is equal to the
total quantity indicated at the level of the validated Import Authorization.

Consultation of a fully discharged Import Authorization can be carried out at

through the document search screen and selecting Document Status as a criterion

“Cleared” search in addition to other criteria. (Image 42)

Image 42: Search screen for a Cleared Authorization

Clicking on the search button displays the documents indicating the status
“Cleared” of the Authorization subject to the search: (Image 43)

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Image 43: Line corresponding to a Cleared Authorization

After displaying the document, you can consult the settlement details:

Through the “Settlement” tab, you can consult the reference of the declaration or

declarations which have cleared the Import Authorization (BIAER/2021/C/23/1, and the quantities

cleared (1000): (Image 44)

Image 44: Summary of Discharge of a Fully Discharged Import Authorization

Through the “Remaining” tab, you can consult the initial quantities of the Authorization (1000)

and the remaining quantities (0): (Image 45)

Image 45: Import Authorization Fully Cleared

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