Guidelines on control of importation and exportation of cosmetic products  
Doc. No.: FDISM/FDIEC/GDL/005  Revision Date: 13/12/2022  Review Due Date: 26 /12/2025  
Revision No.: 0  Approval date: 21 /12/2022   Effective Date: 27 /12/2022  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
GUIDELINES ON CONTROL OF IMPORTATION AND 
EXPORTATION OF COSMETIC PRODUCTS  
 
 
 
 
DECEMBER , 2022
Guidelines on  control of importation and exportation of cosmetic products  
Doc. No.: FDISM/FDIEC/GDL/005  Revision Date: 13/12/2022  Review Due Date: 26 /12/2025  
Revision No.: 0  Approval date: 21 /12/2022   Effective Date: 27 /12/2022  
                                                                                                                                                                Page 2 of 17  
FOREWORD  
 
 
 
 
 
 
 
 
Guidelines on  control of importation and exportation of cosmetic products  
Doc. No.: FDISM/FDIEC/GDL/005  Revision Date: 13/12/2022  Review Due Date: 26 /12/2025  
Revision No.: 0  Approval date: 21 /12/2022   Effective Date: 27 /12/2022  
                                                                                                                                                                Page 3 of 17  
GUIDELINES DEVELOPMENT HISTORY  
  
DRAFT ZERO  15/09/2022  
ADOPTION BY RWANDA FDA  20/10 /2022  
STAKEHOLDERS CONSULTATION  11/11/2022  
ADOPTION OF STAKEHOLDERS’ COMMENTS  18/11 /2022  
DATE FOR COMING INTO EFFECT  27/12/2022  
 
Document Revision History  
 
Date of re vision  Revision number  Changes made and/or reasons for revision  
13/12 /2022  0 First issue  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  Guidelines on  control of importation and exportation of cosmetic products  
Doc. No.: FDISM/FDIEC/GDL/005  Revision Date: 13/12/2022  Review Due Date: 26 /12/2025  
Revision No.: 0  Approval date: 21 /12/2022   Effective Date: 27 /12/2022  
                                                                                                                                                                Page 4 of 17  TABLE OF CONTENTS  
 
FOREWORD  ................................ ................................ ................................ ................................ ............  2 
GUIDELINES DEVELOPMENT HISTORY  ................................ ................................ ..........................  3 
Document Revision History  ................................ ................................ ................................ .....................  3 
ACRONYMS AND ABBREVIATIONS  ................................ ................................ ................................ . 5 
DEFINITIONS  ................................ ................................ ................................ ................................ .........  6 
INTRODUCTION  ................................ ................................ ................................ ................................ .... 8 
SCOPE  ................................ ................................ ................................ ................................ ......................  8 
CHAPTER I: IMPORTATION OF MEDICATED COSMETIC PRODUCTS  ................................ ...... 9 
I.1. REQUIREMENTS  ................................ ................................ ................................ .........................  9 
I.1.1. General requirements  ................................ ................................ ................................ ...............  9 
I.1.2. Eligibility for Importation  ................................ ................................ ................................ ........  9 
I.1.3. Specific requirements  ................................ ................................ ................................ .............  10 
I.1.4. Processing app lications  ................................ ................................ ................................ ..........  12 
I.1.5. Validity of an Authorization  ................................ ................................ ................................ .. 12 
I.1.6. Inspection of imported consignments at ports of entry  ................................ ..........................  13 
I.1.7. Sampling of imported products  ................................ ................................ ..............................  14 
I.1.8. Release of consignments  ................................ ................................ ................................ ........  14 
I.1.9. Release underseal  ................................ ................................ ................................ ...................  14 
I.1.10. Rejection of consignments  ................................ ................................ ................................ ... 14 
CHAPTER II: EXPORTATION OF COSMETIC PRODUCTS  ................................ ...........................  15 
II.1. General requirements  ................................ ................................ ................................ ..................  15 
II.2. Eligibility for Export  ................................ ................................ ................................ ...................  15 
II.3. Requirement for Exporta tion of cosmetic products  ................................ ................................ .... 16 
ENDORSEMENT OF THE GUIDELINES  ................................ ................................ ...........................  17 
 
 
 
 
  Guidelines on  control of importation and exportation of cosmetic products  
Doc. No.: FDISM/FDIEC/GDL/005  Revision Date: 13/12/2022  Review Due Date: 26 /12/2025  
Revision No.: 0  Approval date: 21 /12/2022   Effective Date: 27 /12/2022  
                                                                                                                                                                Page 5 of 17  
ACRONYMS AND ABBREVIATIONS  
 
Rwanda FDA :   Rwanda Food and Drugs Authority  
NGOs:     Non-Gover nment Organizations  
COA :    Certificate of Analysis  
PoE:     Port of Entry  
GDL :    Guideline  
MoU :    Memorandum of Understanding  
PRIMS :   Pharmaceutical Regulatory information system /ILMS  
GMP :   Good Manufacture practices  
ISO:   International Organization f or Standardization  
CE    :   Conformité Européenne  
IP : Investigation Product  
 
  
 
 
 
 
 
 
 
 
  
  Guidelines on  control of importation and exportation of cosmetic products  
Doc. No.: FDISM/FDIEC/GDL/005  Revision Date: 13/12/2022  Review Due Date: 26 /12/2025  
Revision No.: 0  Approval date: 21 /12/2022   Effective Date: 27 /12/2022  
                                                                                                                                                                Page 6 of 17  
DEFINITIONS  
 
In these guidelines, unless the context otherwise states:  
Authority  means Rwanda Food and Drugs Authority, or its acronym “Rwanda FDA” established u nder 
article 2 of the law No 003/2018 of 09/02/2018;  
Authorization  means a legal document granted by Rwanda Food and Drugs Authority to the applicant 
under the law No 003/2018 of 09/02/2018 determining its mission, organization, and functioning, it 
include s licenses, permits, and certificates;  
Consignment means a quantity of goods that are sent to a person or place to be sold;  
Donation  means an act or instance of presenting Medicated cosmetic, medical products, processed foods 
and other; Products regulated  to recipients in emergency or as a part of development aid in non -
emergency situations;  
Exporter  means a person, country, or organization that sends goods or services to another country for 
sale;  
Importer  means a person or organization that brings goods  or services into a country from abroad for 
sale; 
“Manufacturer ” means a person who is involved in the production, processing, compounding, 
formulating, filling, refining, transforming, packaging, repackaging and labelling of cosmetics.  
“Cosmetic ” means a ny substance or preparation intended to be placed in contact with the various 
external parts of the human body (including epidermis, hair system, nails, lips and external genital 
organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly 
to cleaning them, perfuming them, changing their appearance or correcting body odours, protecting them 
or keeping them in good conditions.  
“Medicated cosmetics “or “cosmeceuticals”  are products that have both cosmetic and therape utic 
effects, and are intended to have a beneficial effect on skin health and beauty. Like medicated cosmetics, 
they are applied topically but contain active ingredients that have an effect on skin cell function. In some 
cases, their action is limited to t he skin surface (such as exfoliants), while others can penetrate to deeper 
levels, either enhancing or limiting normal skin function.  
 “Batch number or Lot”  means the number or a combination of numbers and letters specifically given 
to a medicated cosmetic s product which is linked to the manufacturing history of the product;  
“Label”:  Means any tag, brand, mark, pictorial or other descriptive matter, wri tten, printed, stencilled , 
marked, embossed or impressed on or attached to a container of any cosmeti c product or raw material.  
Import Visa  means an authorization/permit issued to the importer after confirmation by the Authority 
that manufacturer(s)/suppliers of cosmetics or their raw materials to be imported comply with 
international and national standar ds. The Import visa gives the right to the importer to confirm an 
order/purchase order of the products and to apply for import license.  Guidelines on  control of importation and exportation of cosmetic products  
Doc. No.: FDISM/FDIEC/GDL/005  Revision Date: 13/12/2022  Review Due Date: 26 /12/2025  
Revision No.: 0  Approval date: 21 /12/2022   Effective Date: 27 /12/2022  
                                                                                                                                                                Page 7 of 17  Import License  means an authorization/permit issued to the importer by the Authority, authorizing 
him/her to import cosm etics or their raw materials into the country after complying with the documentary 
importation requirements;  
Export Permit  means a permit issued to an exporter by the Authority, authorizing him/her to export 
cosmetic products from the country;  
“Approve” or  “approval ” means official consent by the Authority as an acceptance of an importation 
or exportation of the cosmetics to be used in the Rwandan market;  
“Fee” means the regulatory service charge prescribed in the Fees Regulations in accordance with Article  
9 and Article 32 of the Law No 003/2018 of 09/02/2018.  
“Prohibited Ingredient”  refers to a substance which is forbidden to be a component of a cosmetic  due 
to its toxicity or poisonous  effects to human health ;  
“Ingredients”  means any substance that is o ne of the components of a medicated cosmetic and includes 
colouring      agents, botanicals, fragrance, and flavour, but does not include substances that are used in 
the preparation of the medicated cosmetic.      that are not present in the final product as a result of the 
chemical process.  
“Leaflet of a medicated cosmetic”  refers to a printed paper and includes any written information related 
to a medicated cosmetic.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 Guidelines on  control of importation and exportation of cosmetic products  
Doc. No.: FDISM/FDIEC/GDL/005  Revision Date: 13/12/2022  Review Due Date: 26 /12/2025  
Revision No.: 0  Approval date: 21 /12/2022   Effective Date: 27 /12/2022  
                                                                                                                                                                Page 8 of 17  
INTRODUCTION  
 
The quality, efficacy, and safety of Medicated Cosmetic produ cts can be highly affected by the lack of 
adequate control on importation and exportation. It is therefore imperative that the manufactu re, 
importation and exportation of Medicated Cosmetic products, both nationally and internationally 
conforms to certain set standards.  
 
The Authority has developed these guidelines to strengthen the control of importation and exportation 
of these products and to assist those in the field to adhere to the legal framework during importation and 
exportation activities.  
 
The m ain objective of these guidelines is to provide importers and exporters of cosmetics and their raw 
materials with the necessary information to enable them to comply with the law and regulations 
governing the control of importation and exportation of these products.  
 
These guidelines are organized into two Chapters. The first chapter provides the requirements and 
procedures to be followed up during the importation of Cosmetics while the second one outlines the 
requirements and procedures for the exportation of these products.  
 
SCOPE  
 
These guidelines apply to cosmetic products as specified in the law No 47/2012 of 14/01/2013 relating 
to the regulation and inspection of food and pharmaceutical products ,   Law nº 003/2018 of 09/02/2018 
establishing Rwanda Food and Drugs Authority and determining its mission, Organisation, and 
functioning ,  Ministerial Order Nº20/38 of 26/02/2016 determining the list of cosmetics whose use is 
prohibited in Rwanda  and  Regulations No CBD/TRG/011 governing control of medicated cos metics in 
Rwanda. The guideline outlines requirements for the importation and exportation of cosmetic products 
and their raw materials . 
 
 
 
 
 
 
 
 
 
 Guidelines on  control of importation and exportation of cosmetic products  
Doc. No.: FDISM/FDIEC/GDL/005  Revision Date: 13/12/2022  Review Due Date: 26 /12/2025  
Revision No.: 0  Approval date: 21 /12/2022   Effective Date: 27 /12/2022  
                                                                                                                                                                Page 9 of 17  
CHAPTER I: IMPORTATION OF MEDICATED COSMETIC PRODUCTS                             
 
I.1. REQUIREMENTS  
 
I.1.1.  General requirements  
 
All cosmetic products must be imported by importers whose premises are licensed by Rwanda FDA or 
who fall within the eligible importer category.  
Cosmetic products to be imported shall not be banned or contain prohibited substances incl uding but not 
limited to skin bleaching/whitening ingredients     or    containing ingredients      which have      been 
banned in the country of origin or in Rwanda for quality or safe ty purpose.  
All imported cosmetic products must have at least two -third s (2/3) of their shelf life remaining when 
they arrive at the port of entry. Cosmetic  products to be imported shall comply with labelling 
requirements according to related Standards.      
A cosmetic product registered by Rwanda FDA shall be imported by the  marketing authorization holder’ 
Local Technical Representative or by any other company authorized by the marketing authorization 
holder or by the manufacturer in case he/she is the marketing authorization holder.  
All consignments of cosmetic products shal l pass through the gazetted ports of entry and shall be 
subjected to physical inspection at the port of entry or at importer’s premise for the consignments 
released under seal before being used to ensure they comp ly with claimed specifications.  
Apart from the specific requirements for importation/exportation, the Authority reserves the right , when 
deemed necessary and for justified reasons, to request the importer to provide any other 
document/information for further analysis.  
 
 
I.1.2.  Eligibility for Impor tation      
 
1. Only the following shall be eligible/allowed to import cosmetic products and their raw materials:  
2. A manufacturer of cosmetic products holding operational license issued by the Authority;  
3. A wholesaler or retailer of cosmetic products holding o perational license issued by the Authority;  
4. Researchers or research institutions authorized by competent institutions to conduct research or 
clinical  trial in the country.                
5. Company importing sample for laboratory testing;      
6. Persons import ing cosmetic products for personal use ;      
7. Government institutions;  
8. Non-government institutions authorized by competent institution;  
9. A beneficiary of cosmetic products donation upon presentation of the donation  certificate;  
10. A company or individual attend ing exhibition upon presentation of the invitation and a commitment 
letter stipulating that the remaining products will be re -exported after the exhibition;   Guidelines on  control of importation and exportation of cosmetic products  
Doc. No.: FDISM/FDIEC/GDL/005  Revision Date: 13/12/2022  Review Due Date: 26 /12/2025  
Revision No.: 0  Approval date: 21 /12/2022   Effective Date: 27 /12/2022  
                                                                                                                                                                Page 10 of 17  11. A tourist, a visitor in the country or any other person for justified reasons after getting author ization 
from the Authority . 
 I.1.3.  Specific requirements  
 
 I.1.3.1.  Requirements to apply for Import Visa  
 
The following are requirements to apply for an import visa:  
a. Application letter where applicable  
b. A proforma invoice showing :  
i. Invoice number and date ,  
ii. Name of the manufacturer  
iii. Name and full address of exporter and importer,  
iv. Country of origin of the product,  
v. A clear description of each product including brand and common names,  
vi. Quantity, value for each product and the currency.  
c. The operational license  of the importer where applicable  
d. Certificate of compliance of th e manufacturer or the supplier;  
 
The certificate of compliance  include s but not limited to the followings: ISO Certificate, Good 
Manufacturing Practices certificate (GMP), Good Distribution P ractices certificate (GDP), Operational 
License from respective Regulatory body, or Health certificate, permit to use standardization mark (Ex: 
TBS, KEBS…), etc.  
 
Note:  
 Certificate of compliance may not be a mandatory requirement only for a justifiable r eason 
approved by the Authority.  Ex: If the manufacturer is located in a country with Stringent 
Regulatory Authority.  
 Products imported from countries with Stringent Regulatory Authorities will be exempted from 
providing the above quality documents.  
 Produ cts imported from countries where quality documents can’t be provided, will be allowed to 
be imported if and only if the embassy of the countries of origin endorse the application. The 
endorsement confirms that products are imported from reliable sources.      
 
I.1.3.2. Requirements to apply for Import License  
 
After getting an Import Visa, the second step is to apply for an Import License. It is an authorization that 
permits the applicant to import the approved cosmetic products and is granted for a single  consignment.  
The following are requirements to apply for an import license : 
a. Import Visa  
b. Commercial invoice having the following information:  
i. Invoice number and date,  
ii. Name of the manufacturer,  Guidelines on  control of importation and exportation of cosmetic products  
Doc. No.: FDISM/FDIEC/GDL/005  Revision Date: 13/12/2022  Review Due Date: 26 /12/2025  
Revision No.: 0  Approval date: 21 /12/2022   Effective Date: 27 /12/2022  
                                                                                                                                                                Page 11 of 17  iii. Name and full address of exporter and importer,  
iv. Country of  origin of the product,  
v. Clear description of each product including brand and common names,  
vi. Quantity, value for each product and the currency.  
c. A packing list (if applicable) with the following information: Imported products and their 
quantities, Batch/lot  number, Manufacturing and expiry date.  
d. Certificate of analysis issued by the manufacturer or a designated laboratory, for each batch 
number, indicating the following information:  
i. Name and address of the manufacture  
ii. Brand and common name of the cosmetic pr oduct,  
iii. Product description,  
iv. Batch/lot number  
v. Manufacturing and expiry date (or Best before date),  
vi. Tested Parameters and their results (specification and qualitative/quantitative results)  
vii. Specification limit  
viii. Document traceability references (e.g. document  number, revision, etc.)  
ix. Signed by authorized personnel.  
e. A Proof of Payment of verification fees as specified in the Regulations CBD/TRG/004 related to 
regulatory service tariff/fees and fines.  
 
Note:  
 Certificate of Analysis may not be a mandatory requir ement only for a justifiable reason approved 
by the Authority.  Ex: Products manufactured in EAC member states, or if the manufacturer is 
located in a country with stringent regulatory Authority.   
 Products imported from countries with Stringent Regulatory Authorities will be exempted from 
providing the above quality document.  
 Products imported from countries where quality documents can’t be provided, will be allowed to 
be imported if and only if the embassy of the countries of origin endorse  the application . The 
endorsement confirms that products are imported from reliable sources.  
 In case of donation, Certificate of donation and Donation acceptance letter will be required.  
 
I.1.3.3. Requirements to apply for importation of registered Cosmetic products  
 
To import cosmetic products registered by Rwanda FDA, the applicant shall submit the following 
requirements:  
a. Commercial invoice,  
b. Operational license,  
c. Certificate of analysis for each batch except  for products originating from EAC countries and 
countries und er Mutual Recognition with Rwanda FDA).  
d. Proof of payment of verification fees as specified in the Regulations CBD/TRG/004 related to 
regulatory service tariff/fees and fines.  
 Guidelines on  control of importation and exportation of cosmetic products  
Doc. No.: FDISM/FDIEC/GDL/005  Revision Date: 13/12/2022  Review Due Date: 26 /12/2025  
Revision No.: 0  Approval date: 21 /12/2022   Effective Date: 27 /12/2022  
                                                                                                                                                                Page 12 of 17  
I.1.3.4. Authorization to import cosmetic products for special cases  
 
a. Requireme nts to apply for importation of cosmetic products for research purpose:  
i. Application letter addressed to the Director General of the Authority,  
ii. Authorization to conduct research issued by competent institution,  
iii. Invoice with description of the products.  
b. Requirements to apply for importation of cosmetic products for sample registration:  
i. Application letter addressed to the Director General of the Authority,  
ii. Invoice with description of the products.   
c. Requirements to apply importation of cosmetic products for e xhibition  
i. Application letter addressed to the Director General of the Authority,  
ii. Commercial Invoice,  
iii. Certificate of compliance of the manufacturer,  
iv. Certificate of analysis for each batch number of the products to be exhibited  
v. Commitment letter agreeing to re-export the remaining products after exhibition.  
d. Requirements to apply for importation of Cosmetic products declared as personal effects: a 
tourist, a visitor in the country or any other person who wants to import Cosmetic products for 
personal use, not for sale, shall request for an authorization by providing informat ion described 
in the Guidelines No: FDISM/FDIEC/GDL/003 related to importation and exportation of 
regulated products declared as personal effects.  
 
I.1.4 . Processing applications  
 
An applica tion for import visa or for import license, fulfilling all requirements, will be processed in 3 
working days. The applicant will be notified by the Authority, in writing, about the decision either 
approval or rejection. An  authorization is issued to an app licant, for a particular consignment, and shall 
not be transferable.   
 
 I.1.5 . Validity of an  Authorization    
 
The import visa shall be valid for six (6) months from the date of issuance .  
The import license shall be valid for six (6) months from the dat e of issue.6. Renewal of an import license  
In case an import license is expired before being used, the applicant shall apply for renewal by submitting 
the following documents:  
- Application letter addressed to Director General of Rwanda FDA,  
- Operational lic ense of the importer,  
- Expired import license,  
- Commercial invoice, and  
- Payment proof of inspection fees for the previous application.  
 
 Guidelines on  control of importation and exportation of cosmetic products  
Doc. No.: FDISM/FDIEC/GDL/005  Revision Date: 13/12/2022  Review Due Date: 26 /12/2025  
Revision No.: 0  Approval date: 21 /12/2022   Effective Date: 27 /12/2022  
                                                                                                                                                                Page 13 of 17  
I.1.6. Inspection of imported consignments at ports of entry  
 
Each consignment of cosmetic products must be inspected by the Authority at the port of entry or at 
importer’s premise for the consignments released under seal , before being used to ensure they comply 
with applicable regulati ons and claimed specifications.  
The consignment must be accompanied by the following r equirements:  
a) A valid import license issued by the Authority,  
b) A corresponding commercial invoice,  
c) A certificate of analysis for each  batch,  except for products originating from EAC countries and 
countries under Mutual Recognition with Rwanda FDA).  The impor ted cosmetic products must 
have at least two -thirds (2/3) of their shelf life remaining when they arrive at the port of entry.  
 
The appearance of the imported cosmetic product shall reflect its true nature for example, free from 
foreign matters, damaged pa ckaging, discoloured, etc.  
The primary packaging of cosmetic products must be clearly labelled in officially recognized languages 
in Rwanda with the following information:  
i. Trade name or brand name;  
ii. Intended use of cosmetic products;  
iii. Instructions for use     
iv. Country of origin   
v. Net content(weight/volume);  
vi. Name and physical address of the manufacturer site;  
vii. List of ingredients (International Nomenclature Cosmetic Ingredients name);  
viii. Manufacturing dates;  
ix. Expiry dates  
x. The batch or lot number;  
xi. Storage conditions       
xii. Precautions and warnings;                                                                       
 
The primary packaging of imported cosmetic shall be clearly labelled in at least one of the official 
languages used in Rwanda and the labelling shall comply with the relevant cosmetic labelling standa rd.  
If any message on the label is not in one of the official languages, a supplementary label translated in 
one of the official languages shall be used and available to consumers. The translated information shall 
fully and accurately reflect the one on the original label.  
The translation shall be signed and stamped by the manufacturer or the Embassy of the country having 
the original language on the label as their official language or stamped by a Notary who knows that 
language.  
 
Cosmetic products with labels which show eviden ce of alteration, will be regarded as substandard. Such 
alterations include:  
Entire label or parts with details such as batch number, dates of manufacturer and expiry cut off,  
Evidence of labels being removed or new ones attached or new labels being pasted  over old ones,  
 Guidelines on  control of importation and exportation of cosmetic products  
Doc. No.: FDISM/FDIEC/GDL/005  Revision Date: 13/12/2022  Review Due Date: 26 /12/2025  
Revision No.: 0  Approval date: 21 /12/2022   Effective Date: 27 /12/2022  
                                                                                                                                                                Page 14 of 17  Details of being erased or painted out and replaced with new details,  
 
Counterfeiting. The  primary package shall be sealed in such a way that the product cannot be reached or 
tempered without damaging the seal.  
 
 I.1.7. Sampling of importe d products  
 
During physical inspection, if any cosmetic product is suspected for poor quality or whenever deemed 
necessary, the inspector may take samples for further investigation and the consignment shall not be 
released until the laboratory results are available for decision -making. The inspector shall fill out the 
Report of findings (PV de constat ). In case of routine sampling, the consignment from which the samples 
have been taken shall be released to the importer for distribution.  
 
I.1.8 . Release of co nsignments  
 
Once satisfied that all importation conditions have been fulfilled as required, the Inspector shall release 
the consignment  with approved stamp . For the partial shipment, the importer will write "PARTIAL 
SHIPMENT" on the import license and invo ice, alon g with the quantities imported.  
 
I.1.9 . Release underseal  
 
When a consignment is not physically inspected at port of entry or needs further inspection, for instance 
intra-region consignments, consignments that require special storage conditions, c onsignments that 
cannot be offloaded at the port of entry, or any other reason as may be decided by the Authority shall be 
released under seal and inspected at owner's premise before being used.  
 
I.1.10 . Rejection of consignments  
 
If the physical inspecti on finds out that the consignment doesn’t comply with related cosmetic      
standards, the products shall be rejected. The importer shall implement the decisions taken and incur the 
cost.  
 
The following shall apply for such consignments:  
a. The inspector sha ll not release the consignment and rejection shall be applied.  
b. Cosmetics that contains prohibited ingredients  
c. Cosmetic products not meeting labelling specifications  
Cosmetic products rejected because of safety and quality reasons shall be disposed. The ap plication for 
safe disposal shall be done by the owner within one month. For protection of public health,  the Authority 
has power to destroy, by its own discretion, the  substandard rejected product at the  products owners cost 
he Rejected product will get a  full release in the Rwanda electronic single window (Resw) after the 
submission of the destruction/disposal certificate.  Guidelines on  control of importation and exportation of cosmetic products  
Doc. No.: FDISM/FDIEC/GDL/005  Revision Date: 13/12/2022  Review Due Date: 26 /12/2025  
Revision No.: 0  Approval date: 21 /12/2022   Effective Date: 27 /12/2022  
                                                                                                                                                                Page 15 of 17  Where the consignment is quarantined, the inspector shall issue a report of findings (PV de constat                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
) clearly stating the quara ntined products and the reason.  Cosmetic  products rejected for reasons other 
than their composition safety and quality shall be rejected and follow the procedure for re -export.  
 
The following are the reasons for re -export of a consignment:  
a. Cosmetic products which  are not allowed or withdrawn from the Rwanda market.  
b. Medicated cosmetics that contains ingredients prohibited in Rwanda.           
c. Any other reason the authority may deem necessary.  
 
The importer shall re -export them in the country of origin or to a third  country within a period of three 
months from the date of rejection and incur the cost. Copies  of export documents stamped at the exit 
port shall be submitted to Rwanda FDA as evidence of re-exportation exercise.  
 
CHAPTER II: EXPORTATION OF COSMETIC PRODUC TS 
 
II.1. General requirements  
 
Exporters of cosmetic products should have a valid Export License issued by the Authority  
All cosmetic products must be exported by exporters whose premises are licensed by Rwanda FDA or 
who fall within the eligible export er category. On  pre-packaged  cosmetic products to be exported shall 
comply with specifications and/or requirements prescribed by the Authority.  
 
Cosmetic products to be exported shall comply with relevant cosmetic standards.  
All consignments of cosmetics p roducts to be exported must exit through gazetted ports of exit and shall 
be subjected to physical inspection at the port of exit or at exporter’s premise to ensure they comply with 
claimed specifications.  
 
II.2. Eligibility for Export  
 
Only the following shall be allowed to export cosmetic products;      
a) A manufacturer of cosmetic products holding operational license issued by the Authority;  
b) A wholesaler or retailer of cosmetic products holding operational license issued by the Authority;  
c) Researchers or research institutions authorized by competent institution to conduct researches;  
d) An individual or company exporting a sample for laboratory testing;  
e) Government institutions;  
f) Non-government institutions authorized by competent institution;  
g) A company or ind ividual attending exhibition  
h) A tourist, a visitor in the country or any other person for justified reasons after getting 
authorization from the Authority  
 Guidelines on  control of importation and exportation of cosmetic products  
Doc. No.: FDISM/FDIEC/GDL/005  Revision Date: 13/12/2022  Review Due Date: 26 /12/2025  
Revision No.: 0  Approval date: 21 /12/2022   Effective Date: 27 /12/2022  
                                                                                                                                                                Page 16 of 17  
II.3. Requirement for Exportation of cosmetic products  
 
All applications for an export license shall  be accompanied by the following documents:  
a) Operational authorization of the exporter;      
b) Invoice of the product to be exported including the following information:  
i. Invoice number and date,  
ii. Manufacturer name  
iii. Name and full address of exporter and import er,  
iv. Country of origin of the product,  
v. Clear description of each product including brand and common names,  
vi. Quantity, value for each product, and the currency.  
c) A packing list (if applicable) with the following information:  
i. Exported products name and their  quantities   
ii. Batch/lot number,  
iii. manufacturing  
iv. and expiry date.  
d) Certificate of analysis issued by the manufacturer or a designated laboratory, for each batch 
number, indicating the following information:  
i. Name and address of the manufacturer,  
ii. Brand and co mmon name of the cosmetic product,  
iii. Product description,  
iv. Batch/lot number,  
v. Manufacturing and expiry date (or Best before date),  
vi. Tested parameters and their results (qualitative/quantitative) results and specifications,  
vii. Specifications limit,  
viii. Document tracea bility references (e.g. document number, revision, etc.)  
ix. Signed by authorized personnel.  
e) A Proof of Payment of verification fees as specified in the Regulations CBD/TRG/004 related 
to regulatory ser vice tariff/fees and fines.  
 
An export license is issued to an applicant, for a particular consignment, and shall not be transferable.    
The export license will be valid for three (3) months from the date of issuance.  
Applications for export license, fulfilling all requirements, will be processed within 3 worki ng days.  
 
 
 
 
 
 
 
 Guidelines on  control of importation and exportation of cosmetic products  
Doc. No.: FDISM/FDIEC/GDL/005  Revision Date: 13/12/2022  Review Due Date: 26 /12/2025  
Revision No.: 0  Approval date: 21 /12/2022   Effective Date: 27 /12/2022  
                                                                                                                                                                Page 17 of 17  
ENDORSEMENT OF THE GUIDELINES