Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
                                                                                     
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
GUIDELINES FOR LICENSING OF MEDICATED 
COSMETICS, PESTICIDES, LABORATORY AND 
HOUSEHOLD CHEMICALS PREMISES  
  
 
 
 
 
SEPTEMBER, 2022  
  
Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 2 of 43 
FOREWORD  
 
Rwanda Food and  Drugs Authority is a regulatory body established by the Law No 003/2018 of 
09/02/2018. One of the functions of Rwanda FDA is to formulate regulations and guidelines and to 
regulate matters related to quality, safety and efficacy of medicated cosmetics, pe sticides, laboratory and 
household chemicals on the Rwandan market.  
 
Considering the provision of the Regulations No. FDISM/FDIC/TRG/004 Rev _0 Governing  licensing of 
pesticides, laboratory and household chemicals  premises  and Regulations No . CBD/TRG/011 Rev_0 
Governing Control of Medicated Cosmetics especially in its articles 29,30,31,32,33 and 34 ; the Authority 
Issues Guidelines No. FDISM/FDIC/GDL/009  for Licensing of Medicated Cosmetics, Pesticides, 
Laboratory and Household C hemicals Premis es. 
 
These guidelines provide guidance to applicants to ensure that they comply with the prescribed 
requirements.  
 
Applicants are encouraged to familiarize with the guidelines and follow them when preparing and 
submitting applications for licensing of thei r premises  dealing with manufacturing, wholesaling, 
importing and retailing medicated cosmetics, pesticides, laboratory and household chemicals.  
 
Adherence to these guidelines will ensure that all relevant information is provided for licensing of 
medicated  cosmetics, pesticides, laboratory and household chemicals premises . This will facilitate 
efficient and effective analysis of the applications and speed up the approval processes.  
 
Rwanda FDA acknowledges all the efforts of key stakeholders who participat ed in the development and 
validation of these guidelines.  
 
 
 
 
Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 3 of 43 
GUIDELINES DEVELOPME NT HISTORY  
 
DRAFT ZERO   30/08/2021  
ADOPTION BY RWANDA FDA  10/09/2021  
STAKEHOLDERS CONSULTATION  15/09/2021  
ADOPTION OF STAKEHOLDERS ’ COMMENTS  20/09/2021  
DATE FOR COMING INTO EFFECT  30/09/2022  
 
Document Revision History  
 
Date of revision  Revision number  Changes made and/or reasons for revision  
25/08 /2022  0 First Issue  
 
 
  
 
 
 
  Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 4 of 43 
TABLE OF CONTENTS  
 
FOREWORD  ................................ ................................ ................................ ................................ ..........  2 
GUIDELINES  DEVELOPMENT  HISTORY  ................................ ................................ ........................  3 
DOCUMENT REVISION HISTORY ................................ ................................ ................................ ...............  3 
TABLE  OF CONTENTS  ................................ ................................ ................................ ........................  4 
ACRONYMS  AND  ABBREVIATIONS  ................................ ................................ ...............................  6 
GLOSSARY  / DEFINITIONS  ................................ ................................ ................................ ....................  7 
CHAPTER  ONE:  INTRODUCTION  ................................ ................................ ................................ .........  11 
1.1 PURPOSE  ................................ ................................ ................................ ................................ ..........  11 
1.2 SCOPE  ................................ ................................ ................................ ................................ ..............  11 
1.3 SUBMISSION OF AN APPL ICATION  ................................ ................................ ................................ ..... 11 
1.4 VALIDITY OF AN APPLIC ATION  ................................ ................................ ................................ .........  11 
1.5 REGISTRATION OF ACTIV ITIES AND PREMISES  AND LICENSE TO PRAC TICE ................................ ........  12 
1.6 VALIDITY OF A PREMISE  REGISTRATION CERTIF ICATE AND LICENSE  ................................ ................  12 
CHAPTER  2: INSPECTIONS  AND LICENSING  REQUIREMENTS  ................................ .................  13 
2.1 INSPECTIONS  ................................ ................................ ................................ ................................ .... 13 
2.2 TYPES OF  INSPECTIONS  ................................ ................................ ................................ .....................  13 
2.3 CATEGORIZATION OF INS PECTION COMPLIANCE  ................................ ................................ ...............  13 
2.3.1  MANUFACTURING FACILITIES  ................................ ................................ ................................ ....... 14 
2.3.2  WHOLESALER , IMPORTER OR RETAIL OF COSMETICS , HOUSEHOLD PESTICIDE S, HOUSEHOLD 
CHEMICALS AND LABORA TORY CHEMICALS  ................................ ................................ ...........................  16 
2.4 REQUIREMENTS TO OPERAT E AS A MANUFACTURER OF MEDICATED COSMETI CS, PESTICIDES , 
LABORATORY OR HOUSEH OLD CHEMICALS  ................................ ................................ ............................  17 
2.4.1  SITE LOCATION APPROVAL  ................................ ................................ ................................ ............  17 
THE PREMISES SHALL BE  LOCATED IN A PLACE WHERE THEY CANNOT BE  CONTAMINATED BY THE  
EXTERNAL ENVIRONMENT  OR OT HER ACTIVITIES OR CO NTAMINATING THE NEIG HBOURING ENVIRONMENT .
 ................................ ................................ ................................ ................................ ..............................  17 
2.4.2  ARCHITECTURAL PLAN APPROVAL AND LAYOUT T O COMPLY WITH THE GOOD MANUFACTURING 
PRACTICES BEFORE THE START OF SITE CONSTR UCTION ................................ ................................ .........  18 
2.4.3  PREMISE INSPECTION  ................................ ................................ ................................ ....................  18 
2.4.4  PERSONNEL FOR THE PRO DUCTS MANUFACTURING FACILITY  ................................ ........................  23 
2.4.5  DOCUMENTS REQUIRED FO R A MANUFACTURER 'S APPLICATION  ................................ ...................  26 
2.5 REQUIREMENTS TO OPERATE A WHOLESA LER, IMPORTER AND /OR RETAILER OF MEDIC ATED 
COSMETICS , PESTICIDES , LABORATORY OR HOUSE HOLD CHEMICALS  ................................ .....................  26 
2.5.1  PREMISE  ................................ ................................ ................................ ................................ ........  26 
2.5.2  DOCUMENTATION AND REL ATED CONTROLS  ................................ ................................ .................  28 
2.5.3  PERSONNEL  ................................ ................................ ................................ ................................ ... 28 
2.5.4  DOCUMENTS REQUIRED FO R A WHOLESALER , AN IMPORTER OR RETA IL OF LABORATORY CHE MICALS
 ................................ ................................ ................................ ................................ ..............................  28 
2.5.5  DOCUMENTS REQUIRED FO R WHOLESALER , IMPORTER OR RETAIL OF COSMETICS , HOUSEHOLD 
PESTICIDES AND HOUSE HOLD CHEMICALS  ................................ ................................ ..............................  29 Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 5 of 43 
2.6 APPROVAL OF THE PREMI SES ................................ ................................ ................................ ...........  29 
CHAPTER  3: LICENSE RENEWAL AND SUBSTANTIAL MODIFICAT ION ................................ ...................  30 
3.1 DOCUMENTS REQUIRED FO R OPERATIONAL LICENS E RENEWAL  ................................ .......................  30 
3.2 DOCUMENTS REQUIRED FO R RELOCATION OR ADDITI ONAL STORAGE SPACE O F THE LICENSED PREMI SE
 ................................ ................................ ................................ ................................ ..............................  30 
3.3 DOCUMENTS REQUIRED FO R THE CHANGE OF THE RESPONSIBLE TECHNICI AN OF THE LICENSED 
PREMISE  ................................ ................................ ................................ ................................ .................  30 
3.4 DOCUMENTS REQUIRED TO  CHANGE THE OWNERSHI P OF THE LICENSED PR EMISE  .......................  31 
3.5 DOCUMENTS REQUIRED TO  CHANGE THE NAME OF T HE LICENSE PREMISE  ................................ ........  31 
3.6 DOCUMENTS REQUIRED TO CLOSE TH E LICENSED PREMISE  ................................ ...............................  31 
CHAPTER  4: GOOD  PRACTICES  ................................ ................................ ................................ ..... 32 
4.1 GOOD DISTRIBUTION PRACTICES  ................................ ................................ ................................ ..... 32 
4.2 GOOD STORAGE PRACTICES  ................................ ................................ ................................ ....... 32 
4.3 GOOD MANUFACTURING PRACTICES  ................................ ................................ ...............................  32 
ENDORSEMENT  OF THE  GUIDELINES ................................ ................................ ..........................  33 
APPENDICES  ................................ ................................ ................................ ................................ ...... 34 
APPENDIX  I: APPLIC ATION  FORM  ................................ ................................ ................................  34 
LIST  OF FORMATS  USED  WITH  THESE  GUIDELINES  ................................ ................................  37 
  Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 6 of 43 
ACRONYMS  AND ABBREVIATIONS  
 
CAPA  : Corrective Action and Preventive Action  
GDP  : Good Distribution Practice  
GMP  : Good Manufacturing Practices  
GSP : Good Storage Practices  
 
 
  Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 7 of 43 
GLOSSARY  / DEFINITIONS  
 
In these guidelines , unless  the context otherwise requires:  
 
“Applicants ” means a person, company or their representative manufacturing or selling pesticides, 
laboratory and household chemicals applying for inspection for suitability of premises licensing of the 
product.  
 
“Authority ” means the Rwanda Food and Drugs Authority or the acronym “Rwanda FDA” established 
by Law N° 003/2018 of 09/02/2018.  
 
“Authorization ” means a legal document granted by Rwanda Food and Drugs Authority to an applicant 
under the Law N° 003/2018 of 09/02/201 8 establishing Rwanda FDA and determining its mission, 
organization and functioning; it includes premise registration certificate and licenses.   
 
“Chemicals ” means laboratory chemicals, industrial chemicals and cleaning chemicals.  
 
“Cosmetic”  means any sub stance 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 e xclusively or 
mainly to cleaning them, perfuming them, changing their appearance or correcting body odours, 
protecting them or keeping them in good conditions.  
“Counterfeit product”  A product which is deliberately and fraudulently mislabeled with respect to 
identity and/or source. Counterfeit products may include products with the correct ingredients, or with 
the wrong ingredients, without active ingredients, with insufficient/incorr ect active ingredients or with 
fake packaging.  
 
“Critical Deficiency”  when the deviation affects a quality attribute, a critical process parameter, an 
equipment or instrument critical for process or control, of which the impact to personnel or environment  
is highly probable, including life threatening situation, the deviation is categorized as critical requiring 
immediate action, investigated and documented. A “Critical deficiency ” may consist of several related 
deficiencies, none of which on its own may b e “Critical”, but which may together represent a” Critical” 
deficiency, or systems’ failure where a risk of harm was identified and should be explained and reported 
as such.  
 
“Critical equipment”: means any piece of the  equipment, instrumentation, or systems, whose 
malfunction or failure may cause variation in the q uality and safety of the  products.  
 
“Distribution  “The procuring, purchasing, holding, storing, selling, supplying, importing, exporting, 
or movement of products.  
 Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 8 of 43 
“Good Distribution Practi ce (GDP) ” is a part of quality assurance that ensures that the quality of a 
product is maintained by means of adequate control of the numerous activities which occur during the 
distribution process as well as providing a tool to secure the distribution sys tem from counterfeits, 
unapproved, substandard, falsified or misbranded products.  
 
“Good Manufacturing Practices (GMP) ” means that part of Quality Management which ensures that 
products are consistently produced and controlled to the quality standards app ropriate to their intended 
use and as required by the Marketing Authorisation, Clinical Trial Authorisation or product 
specification. Good Manufacturing Practice is concerned with both production and quality control.  
 
“Good Storage Practices (GSP) ” is that  part of quality assurance that ensures that the quality of a 
product is maintained by means of adequate control throughout the storage thereof.  
 
“Household Chemical Substance  “means a substance or mixture of substances packaged for use in a 
domestic or o ffice setting as a germicide, an antiseptic, disinfectant, pesticide, insecticide, vermicide, 
rodenticide, detergent or any other substance or mixture of substances declared by the competent 
Authority to be a chemical substance.  
 
“Household Pesticide”  means Any material or mixture of substances used for the control of the pests 
(e.g. flies, mosquitos, cockroaches, ants, rodents) found in places of human habitation, work and 
recreation. Products that are intended for use in domestic or commercial establishm ents for the control 
of flying, crawling and structural insect pests (e.g. termiticides, rodenticides and wood preservative).  
 
“Importer”  means a person or body corporate permitted and authorized to import under the laws and 
regulations in Rwanda pertaini ng to pesticides, laboratory and household chemicals not for sale 
purposes. e.g. Raw materials importers used in the factory, other products imported for in -house use 
(e.g.: in hotels, etc.)  
 
“Labeling”  means process of identifying a product including the following information, as appropriate: 
name of the product; active ingredient(s), type and amount; batch number; expiry date; special storage 
conditions or handling precautions; directions for use, warnings an d precautions; names and addresses 
of the manufacturer and/or the supplier.  
 
“Laboratory chemical”  refers to any chemical that is used in laboratory testing and experiments 
(research/teaching/diagnostic laboratories). Most are standard chemical reagents or simple chemicals 
that serve as basic ingredients to synthetize more complex chemicals. They can be  used for 
investigative or diagnostic propose such as in the preparation of drugs or in laboratory experiments.   
“Major Deficiency”  means a  deficiency that is not a “Critical” deficiency, but could have major 
effects on the overall safety, efficacy and qu ality of the products. This consists of several 
“Minor/Other” related deficiencies, none of which on its own may be “Major”, but which may together 
represent a “Major” deficiency or systems failure and should be explained and reported as such.  
 Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 9 of 43 
“Manufactu rer” means a person or corporation, or other entity engaged in the business of 
manufacturing Pesticides and laboratories or Household Chemicals.  
 
“Medicated cosmetics “or “cosmeceuticals”  are products that have both cosmetic and therapeutic 
(cosmetic or dr ug-like) effects, and are intended to have a beneficial effect on skin health and beauty. 
Like m edicated cosmetics, they are  topically applied as creams or lotions but contain active ingredients 
that have an effect on skin cell function. In some cases, their action is limited to the skin surface (such 
as exfoliants), while others can penetrate to deeper levels, either enhancing or limiting normal skin 
functions . 
 
“Minor/Other Deficiency ” means a  deficiency that is not classified as either “Critical” or “ Major”, 
but indicates failure to meet the standards of premises suitability. A deficiency may be judged as 
“Minor” because there is insufficient information to classify it as “Critical” or “Major”.  
 
“Online shop”  means a premise that delivers, distr ibutes,  or dispenses pesticides, laboratory and 
household chemicals by means of the i nternet . 
 
“Pesticide ” means any substance, or a mixture of substances of chemical or biological ingredients 
intended for repelling, destroying or controlling any pest, or regulat ing plant growth.  
 
“Premises”  means any plot of land, buildings or boats, aircraft, vehicles, a part of a building, a place 
of storage, manufacturers, wholesalers, importers, retailers of medicated cosmetics, pesticides, 
laboratory and household chemicals whether open or closed.  
 
“Qualified personnel ”: means an individual who by possession of a recognized degree, who by 
extensive knowledge, training and experience, has successfully demonstrated his ability to solve or 
resolve problems relating to the subject matter.  
 
“Retailer ” means a person or body corporate permitted and authorized to store and sell under the laws 
and regulations in Rwanda pertaining to pesticides, laboratory and household chemicals to the public 
in relatively small quantities for use rather than for resale.  
 
“Stora ge” The storing of products up to their point of use.  
 
“Substandard products”  refer to products that fail to meet specifications stated in recognized 
international standards or the manufacturer’s approved product dossier submitted for registration.  
 
“Substantial modification”  means a change to the premises, equipment, personnel, procedures, and 
processes that is likely to a have significant impact and affect the quality,  safety and the  
integrity of the products manufactured, stored, distributed, and used.  
 Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 10 of 43 
 “Wholesale ” means a person or body corporate permitted and authorized to import, store, and supply 
under the laws and regulations in Rwanda pertaining to pesticides, laboratory and household chemicals 
to authorized retailers.  
 
In these Regulations , the following verbal forms are used:  
“shall ” indicates a requirement;  
“should ” indicates a recommendation;  
“may” indicates permission; and  
“can” indicates a possibility or a capability.  
  Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 11 of 43 
CHAPTER ONE : INTRODUCTION  
 
1.1 Purpose  
 
The purpose of these guidelines is to give guidance on the requirements for the licensing premises that 
manufacture, import, store, exhibit, sale, dispense and distribute medicated cosmetics, pesticides, 
laboratory and household chemicals as the licensing of such premises forms an integral part of ensuring 
that products maintain their integrity throughout their distribution channels. Adherence to the guidelines 
by applicants will facilitate the timely review and processing of applications.  
 
1.2 Scope  
 
These  guidelines shall apply to premises involved in the manufacture, import, storage, exhibit, sale, 
dispensing and distribution of medicated cosmetics, pesticides, laboratory and household chemicals. 
The premises include but not limited to manufacturers, wholesalers, importers and retailers of 
pesticides, laboratory and household chemicals.  
 
1.3 Submission of an application  
 
An application for premises registration and licensing shall be made in writing via a cover letter and 
application form dated and signed by the applicant . The submitted cover letter and application form 
should be accompanied by the required documents  as described in these guidelines.  
 
When an application is made via email or hard copy, t he applicant shall submit an application to the  
Authority on the following  address:  
Director General  
Rwanda Food and Drugs Authority  
Nyarutarama Plaza, Rwanda  
KG 9 Avenue, Kigali  
P.O. Box 1948, Kigali, Rwanda.  
E-mail :  info@rwandafda.gov.rw  
 
The application for premises registration and licensing  may be made  via Integrated Regulatory 
Information Management System (IRIMS) platform.   
 
1.4 Validity of an application   
 
All applications for premise licensing shall comply with the regulatory requirements. All applications 
shall be valid for a period of ninety (90) calendar days from the date of application.  
 Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 12 of 43 
If the applicant fails to comply with premise licensing requirem ent (s) within a period of ninety (90) 
calendar days unless otherwise authorized by the Authority, the application shall be closed. If the 
applicant wishes to re -submit the application, it shall be considered as a new application and the 
prescribed fees sh all be paid.  
 
The timeline for service delivery upon receipt of complete application with all documents required is 
thirty (30) working days.  
 
1.5 Registration of activities and premises  and license to practice  
 
Any activity related to the manufacture, storing, import or export, sale, packaging, distribution of 
medicated cosmetics, pesticides, laboratory and household chemical products  shall be registered. The 
registration of activities and premises shall be prove n by a certificate issued by the Authority.  
 
The license to operate premises used for carrying out the aforementioned activities is granted according 
to the types of licenses and other condi tions as detailed in these guidelines.  
 
1.6 Validity of a premise registration certificate and license  
 
The premise registration certificate is issued once upon successful registration of premises and 
activities. It is permanent and should bear a u nique identification number of the premise.  
 
A license to operate shall be  valid for one -year renewable from the date it is issued. The validity of the 
renewed license to operate shall refer to the date of the first issuance of the operational license  of the 
premise . Application for renewal of a license to operate shall be made to the Authority one month 
before the end of the validity period of the license to operate.  
 
An authorization is issued to an applicant and shall not be transferable to another applicant without 
approval of the Authority.  
 
 
 
 
 
 
 
 
 
 
 
 Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 13 of 43 
CHAPTER 2: INSPECTIONS AND LICENSING REQUIREMEN TS  
 
2.1 Inspections  
 
The Authority shall conduct an inspection for confirmation of the compliance requirements in order to 
grant or re -grant a license or approva l of a substantial modification and to ensure that premise s are 
suitable to accommodate intended activities.  
 
Premises that do not comply with the requirements for suitability shall not be eligible for consideration 
for authorization.  
 
2.2 Types o f inspections  
 
The following type s of inspection may be conducted : 
 
a) The routine inspection:   is a full inspection of all applicable components of licensing  
requirements . It may be conducted  when the establishment:  
 
i. Newly established  
ii. Requests for renewal of an operational license  
iii. Has a history on non -compliance with legal provisions (Laws and regulations)  
iv. Has introduced new product lines or new products, or has made significant modifications to 
manufacturing methods or processes, or has made changes in key personnel, premises, 
equipment, etc.  
v. Has made any substantial modification  to registered and licensed premise information  
 
b) Follow -up inspections  (re-inspection) are made to monitor the result of corrective measures. 
They are normally carried out depending on the nature of the defects and the work to be 
undertaken. They are limited to specific licensing requirements that have not been observed or 
that have been inadequately implemented.  
 
c) Special licensing inspections  may be necessary to undertake spot checks following complaints , 
recalls related to suspected quality defects in products or reports of adverse reactions of the 
product. Such inspections may be focused on one product, a group of related products, or 
specific operations such as mixing, labelling or packaging.  
 
2.3 Categorization of inspection compliance  
 
The following section provides the classification of compliance based on risk factors that shall guide 
the Authority on decision -making after conducting premise inspection.  
 
The regulatory actions shall be classified a s in the following non -compliance categories:  Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 14 of 43 
a) Critical  
b) Major  
c) Minor  
 
2.3.1 Manufacturing Facilities  
 
2.3.1.1 Critical non -compliances  
 
a) Premises  
 
If the premise does not comply with the followings:  
 
i. Site Location which does not comply with environmental requirement to manufacture products  
ii. No air filtration system to eliminate airborne contaminants that are likely to be generated during 
manufacture or packaging.  
iii. Generalized malfunctioning of the ventilation system (s) with evidence of widespread cross -
contamination.  
iv. Inadequate segregation of manufacturing process and testing areas from other manufacturing 
areas that may pose serious health hazards and cross contamination depending on the product 
to be manufactured.  
v. Lack of clean water, and waste water tr eatment system  
vi. Finishing materials: production floor area, ceiling and walls that are not seamless and easy to 
clean  
 
b) Equipment  
 
i. Equipment used for manufacturing operations of critical products not qualified with evidence 
of malfunctioning.  
ii. Evidence of c ontamination of products by foreign materials such as grease, oil, rust particles 
from the equipment.  
 
c) Personnel  
 
Staff in charge of quality control or production does not hold a university degree in a science related to 
the work being conducted, insuffici ent practical experience i n their area of responsibility.  
 
d) Sanitation  
 
i. Evidence of widespread accumulation of residues/extraneous matter indicative of inadequate 
cleaning  
ii. Evidence of gross infestation.  Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 15 of 43 
2.3.1.2 Major non -compliances  
 
a) Premises  
 
i. Malfunctioning of the ventilation system that could result in possible localized or occasional 
cross -contamination.  
ii. Accessory supplies (steam, air, nitrogen, dust collection etc.) not qualified.  
iii. Heating Ventilation Air Conditioning (HVAC) not qualified  
iv. Temperature and humidity not controlled or monitored when necessary.  
v. Damages to walls/ceilings immediately adjacent or above manufacturing areas or equipment 
where the product is exposed.  
vi. Un-cleanable surfaces created by pipes, fixtures or ducts directly a bove products or 
manufacturing equipment.  
vii. Surface finish (floors, walls, ceilings) that do not permit effective cleaning.  
viii. Insufficient manufacturing space that could lead to mix-ups. 
ix. Quarantine areas accessible to unauthorized personnel and not well marked . 
 
b) Equipment  
 
i. Equipment does not operate within its specifications  
ii. No covers for tanks, hoppers or similar manufacturing equipment if applicable  
iii. Equipment used for manufacturing operation not qualified  
iv. Stored equipment not protected from contaminations.  
v. Inappropriate equipment for production: surfaces porous and non -cleanable/material to shed 
particles  
vi. Equipment location does not prevent cross -contamination or possible mix-ups for operations 
performed in the common area s. 
vii. No calibration program for measur ing equipment /no records maintained.  
viii. No fire -fighting equipment/Fire alarm systems, emergency doors  
 
c) Personnel  
 
i. Delegation of responsibilities of key personnel for Quality Control and production to 
insufficiently qualified persons.  
ii. Insufficient personnel in Quality Control and production resulting in a high possibility of error.  
 
d) Sanitation  
 
i. Sanitation program not in writing but premises in acceptable state of cleanliness.  
ii. Absence of m edical emergency kits.  
iii. Absence of Emergency shower.  
 Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 16 of 43 
2.3.1.3  Minor (other) non-compliances  
 
a) Premises  
 
i. Un-trapped floor drains.  
ii. Damages to surfaces not directly adjacent or above exposed products.  
iii. Inadequate rest, change, wash -up and toilet facilities.  
 
b) Equipment  
 
i. Insufficient space between equipment and walls to permit cleaning.  
ii. Base of immovable equipment not adequately sealed at points of contact.  
iii. Defective or unused equipment used for non -critical products not qualified.  
 
c) Sanitation  
 
i. Incomplete written sanitation program  
ii. Sanitation or h ealth and hygiene programs not properly implemented or followed by employees.  
 
2.3.2 Wholesaler, importer or retail of medicated cosmetics, household pesticides, household 
chemicals and laboratory chemicals  
 
2.3.2.1 Critical Non -Compliances  
 
a) Premises  
 
If the premise does not comply with the followings:  
 
i. Minimum floor space and height requirements  
ii. Natural/Mechanical ventilation/Air handling unit /Heat, Ventilation and Air Conditioning 
(HVAC).  
iii. Temperature and humidity monitoring systems  
iv. Surrounding area that can cause contamination from the external environment or other activities.  
v. Floor, ceiling and walls maintenance  
 
b) Equipment/documentation  
 
i. Lack of secure and lockable storage place for hazardous products  and related documentation  
ii. Lack of equipment to store related temperature sensitive pro ducts  and related documentation  
 
c) Personnel  
Operating without a responsible technician where applicable  Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 17 of 43 
2.3.2. 2 Major Non -Compliances  
 
a) Premises  
 
i. Damage of walls, ceilings, roof, doors and windows  
ii. Surface finish (floors, walls, ceilings) that do not permit effective cleaning.  
iii. Inappropriate Natural/Mechanical ventilation /Air handling unit /Heat, Ventilation and Air 
Conditioning (HVAC).  
iv. Inappropriate temperature and humidity monitoring systems  
 
b) Equipment/documentation  
 
i. Lack of fire-fighting equipment  
ii. Inappropriate storage furniture (Solid shelves, Pallets)  
iii. Inappropriate secure and lockable storage place for hazardous products  
iv. Inappropriate equipment to store related temperature sensitive products  
v. Lack of operational license documents (import & export d ocuments, distribution records, 
Records of expired/damaged products)  
vi. Lack of appropriate transportation means from the wholesaler store to the retailers  
vii. Inappropriate sanitation facilities (toilets, etc.)  
 
2.3.2.3 Minor (Other) Non -Compliances  
 
i. Lack of app ropriate lighting systems  
ii. Premise registration certificate and o perational License issued by Rwanda FDA not displayed  
iii. License to practice profession issued by professional bodies of the responsible technician not 
displayed where applicable  
iv. Temperature mon itoring records not updated where applicable  
v. Absence of Filing systems of documents  
 
2.4 Requirements to operate as a manufacture r of medicated cosmetics, pesticides, laboratory or 
household chemicals  
 
The Authority shall approve the site for product manufacturers. Applicants should fulfill  the 
prerequisites as detailed below prior to new application or premise licensing. Applicants should apply 
for: 
 
2.4.1 Site location approval  
 
The premises shall be located in a place where they cannot be contaminated by the external environment 
or other activities or contaminating the neighbouring environment.  
 Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 18 of 43 
The Authority shall approve the site location for manufacturers after a satisfactory review of the 
followin g preliminary documents:  
 
a) Letter of intent  
b) Site master plan (indicating the location /plan of the premise and the surroundings activities)  
c) Environmental impact assessment  
 
2.4.2 Architectural Plan Approval and layout to comply with the Good Manufacturing Practices 
before the start of site construction  
 
The applicant shall submit the following documents:  
 
a) Approval letter for site location from the Authority  
b) Architecture plan showing but not limited to the following:  
i. Production process flow chart.  
ii. Sanitation  facilities (Clean water and waste water treatment system)  
iii. Mechanical ventilation /Air handling unit /Heat, Ventilation and Air Conditioning 
(HVAC).  
iv. Construction and process materials (grade material)  
v. Finishing materials (production floor, ceiling and wal ls should be seamless, easy 
to clean).  
 
Note: Preliminary inspections shall be carried out at various stages of construction and setting 
up the site. These shall include:  
 
a) Site inspection at completion of construction of the premises;  
b) Site inspection at the completion of installation of equipment and utilities, e.g., HVAC, water, 
compressed gases, etc.;  
 
Upon receipt of complete required documents for license to manufacture, import, store, exhibit sale, 
dispensing and distribution of medicated cosmetics, pesticides, laboratory and household chemicals and 
payment of prescribed fee, inspection of the premises shall be conducted, personnel shall be  
 
2.4.3 Premise inspection  
 
The Authority shall inspect the premises to determine their suitability for manufact uring of regulated 
products. The following components during premi se inspection shall be covered:  
 
a) Standards of construction  
 
The prem ises shall:  
 Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 19 of 43 
i. Be of a permanent nature;  
ii. Be protected against, adverse weather conditions including dust, ground water seepage, vermin 
and pest infestation;  
iii. Have sufficient space for the carrying out and supervision of the necessary operations;   
iv. Have air intakes, exhausts, and associated pipe work and trucking site d so as to avoid 
contamination;  
v. Have the plumbing, electric al and other services in the manufacturing and processing areas sited 
in a way that creates ease of cleaning and shall for this purpose run outside the processing and 
manufacturing areas and be well sealed in place;  
vi. Have drains that are of an adequate size  
vii. With sufficient traps and proper ventilation;  
viii. Have well marked fire exits and the access to the fire exits  kept clear at all times;  
ix. Have floors and walls made of a washable and impervious material with a flat surface free of 
cracks and a ceiling covered with a non -flaking finish that allows easy cleaning;  
x. Be well lit, ventilated and have appropriate air -control facilities including te mperature and 
humidity.  
xi. The premises shall have appropriate toilet facilities, soap, and hand washing facilities with 
single -use towels or hand air drier. Toilets should not directly communicate with production 
or storage areas.  
xii. Facilities for changing clo thes and street shoes should be easily accessible and appropriate for 
the number of users.  
xiii. Eating and drinking areas or rooms should be separate from other areas.  
xiv. Maintenance workshops should as far as possible is separated from production areas.  
xv. Whenever parts and tools are stored in the production area, they should be kept in rooms or 
lockers reserved for that use.  
xvi. The premises including the external surroundings shall be maintained in a clean and tidy 
condition with regular and adequate clearance of wast e materials.  
 
b) Suitability of production areas  
 
i. Premises shall be laid out in such a way as to allow the production to take place in areas 
connected in a logical order corresponding to the sequence of the operations and to the requisite 
cleanliness levels.  
 
ii. The adequacy of the working and in -process storage space should permit the orderly and logical 
positioning of equipment and materials so as to minimize the risk of confusion between different 
products or their components, to avoid cross -contamination and to minimize the risk of omission 
or wrong application of any of the manufacturing or control steps.  
 
iii. Weighing of starting materials shall be carried out in a separate weighing room designed for that 
use. 
 Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 20 of 43 
iv. Where starting and primary packaging materials, int ermediate or bulk products are exposed to 
the environment, interior surfaces (walls, floors and ceilings) should be smooth, free from cracks 
and open joints, and should not shed particulate matter and should permit easy and effective 
cleaning and, if neces sary, disinfection.  
 
v. Pipe work, light fittings, ventilation points and other services should be designed and sited to 
avoid the creation of recesses which are difficult to clean. As far as possible, for maintenance 
purposes, they should be accessible from outside the manufacturing areas.  
 
vi. Drains should be of adequate size, and have trapped gullies. Open channels should be avoided 
where possible, but, if necessary, they should be shallow to facilitate cleaning and disinfection.  
 
vii. Production areas should be effectively ventilated, with air control facilities (including 
temperature and where necessary, humidity and filtration) appropriate both to the products 
handled, to the operations undertaken within them and to the external environment.  
 
viii. In cases where dus t is generated (e.g., during sampling, weighing, mixing and processing 
operations, packaging of dry products), specific provisions shall be taken to avoid cross - 
contamination and facilitate cleaning.  
 
ix. Premises for the packaging of products should be speci fically designed and laid out so as to avoid 
mix-ups or cross -contamination.  
 
x. Production areas should be well lit, particularly where visual on -line controls are carried out.  
 
xi. Hand washing facilities with single -use towels or hand air drier; hand sanitizin g facilities; and 
appropriate protective garments prior to entering controlled areas should be available.  
 
c) Regular water supply  
 
i. The premises shall have a regular and sufficient supply of water.  
ii. Water treatment plants and distribution systems should be des igned, constructed and 
maintained so as to ensure a reliable source of water of an appropriate quality.  
iii. The chemical and microbiological quality of water used in production should be specified and 
monitored.  
 
d) Storage areas and environmental controls  
 
Stora ge areas shall:  
 
i. Be designed or adapted to ensure good storage conditions;  Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 21 of 43 
ii. Be secure and with segregated areas for the storage of rejected, recalled or returned materials 
or products;  
iii. Have access to the materials and goods restricted to authorized personnel only;  
iv. Have sufficient capacity to allow orderly storage of the various categories of materials and 
products; starting and packaging materials, intermediate, bulk and finished products, products 
in quarantine, released, rejected, returned or recal led; 
v. Be clean, dry and maintained within acceptable temperature limits; where special storage 
conditions are required (e.g., temperature, humidity) these should be provided, checked and 
monitored;  
vi. Be provided with receiving and dispatch bays to protect mat erials and products from the 
weather;  
vii. Be provided with receptions areas which shall be designed and equipped to allow containers 
of incoming materials to be cleaned where necessary before storage;  
viii. Where quarantine status is ensured by storage in separate a reas, these areas shall be clearly 
marked and their access restricted to authorized personnel; any system replacing the physical 
quarantine should give equivalent security;  
ix. Have provisions where the starting materials and finished goods are stored under co ver and 
off the floor;  
x. Have a separate sampling area for starting materials; if sampling is performed in the storage 
area, it should be conducted in such a way as to prevent contamination or cross - 
contamination;  
xi. Have provisions where highly active materials or products are stored in safe and secure areas;  
xii. Have safe and secure storage of printed packaging material.  
 
e) Containers to be cleaned  
 
All processing containers and utensils shall be cleaned and labelled as such before they are stored and 
shall be rechecked for cleanliness before being issued out to the manufacturing areas.  
 
f) Descriptive materials to be kept secure  
 
All product labels, printed packaging and descriptive materials shall:  
 
i. Be stored in a secure manner; and  
ii. Be accessed by only authorized personnel.  
 
Proper records shall be kept for the labels, printed packaging and descriptive materia ls issued, to avoid 
any mix -up. 
 
g) Design, construction, location and maintenance of equipment  
 
i. Manufacturing equipment shall be designed, located an d maintained to suit its intended purpose.  Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 22 of 43 
ii. Repair and maintenance operations shall not present any hazard to the quality of the products.  
iii. Manufacturing equipment shall be designed so that it can be easily and thoroughly cleaned. It 
shall be cleaned accordi ng to detailed and written procedures and stored only in a clean and dry 
condition.  
iv. Washing and cleaning equipment shall be chosen and used in order not to be a source of 
contamination.  
v. Equipment shall be installed in such a way as to prevent any risk of error or of contamination.  
vi. Production equipment shall not present any hazard to the products. The parts of the production 
equipment that come into contact with the product must not be reactive, additive or absorptive 
to such an extent that it will affect t he quality of the product and thus present any hazard.  
vii. Balances and measuring equipment of an appropriate range and precision shall be available for 
production and control operations.  
viii. Measuring, weighing, recording and control equipment shall be calibrated  and checked at defined 
intervals by appropriate methods. Adequate records of such tests shall be maintained.  
ix. Fixed pipework shall be clearly labelled to indicate the contents and, where applicable, the 
direction of flow.  
x. Distilled, deionized and, where ap propriate, other water pipes shall be sanitized according to 
written procedures that detail the action limits for microbiological contamination and the 
measures to be taken.  
xi. Defective equipment shall, if possible, be removed from production and quality con trol areas, or 
at least be clearly labelled as defective.  
 
h)  Fire-fighting equipment  
 
The premises shall have sufficient fire -fighting equipment which shall, at all times, be in good condition 
and readily accessible.  
 
i) Weighing, measuring, testing and recording equipment to be checked  
 
The equipment used for weighing, measuring, testing and recording shall be subjected to recorded 
checks for accuracy in accordance with a regular set schedule.  
 
j) Quality control areas  
 
Quality Control laboratories shall be  designed to suit the operations to be carried out in them. Sufficient 
space shall be given to avoid mix -ups and cross - contamination. There shall be adequate suitable storage 
space for samples and records.  
 
Separate rooms may be necessary to protect sensi tive instruments from vibration, electrical 
interference, humidity, etc.  
 
 Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 23 of 43 
k) Documentation  
 
The manufacturing premises shall keep the following records:  
 
i. Manufacturing records  
ii. Medical examination records  
iii. Distribution records  
iv. Suppliers’ records  
v. Recall records  
vi. Complaint records  
vii. Maintenance and calibration records  
viii. Cleaning and disinfection records  
ix. Quality Control Records  
 
2.4.4 Personnel for the products manufacturing facility  
 
a) There are shall be sufficient qualified personnel to carry out all manufacturing activities and the 
responsibility for every individual has to be clearly understood and recorded.  
b) The manufacturer shall have an organization chart.  
c) All responsible staff shall have their duties recorded in written descriptions and adequate 
authority to carry out their responsibilities.  
d) Duties for responsible personnel may be delegated to designated deputies of satisfactory 
qualification level.  
e) There are shall be no gaps or unexplained overlaps in responsibilities of personnel concerned.  
f) Unaut horized personnel shall not enter production, storage and quality control areas or use them 
as passage.  
g) A manufacturing facility shall have the following key personnel:  
i. Head of production;  
ii. Head of quality assurance;  
iii. Head of quality control; and  
iv. Authorized personnel.  
 
Note: All manufacturing facilities shall inform the Authority about the appointed key personnel 
for the purpose of their approval.  
 
Key personnel responsible for supervising the manufacture and quality unit including quality assurance 
and quali ty control for manufacture of products shall possess the qualification with scientific educ ation 
and practical experience.  
 
The head of production shall have bachelor education in Pharmacy and/or Chemist but if not, available 
options shall be for person with at least a bachelor education in the following:  
 Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 24 of 43 
i. Pharmaceutical sciences and technology;  
ii. Chemistry (analytical or organic) or biochemistry;  
iii. Chemical engineering;  
iv. Any other relevant qualification  
 
The head of quality assurance unit shall have bachelor education in any of the following:  
i. Pharmacy;  
ii. Pharmaceutical sciences and technology;  
iii. Chemistry (analytical  or organic) or biochemistry.  
iv. Any other relevant qualification  
 
The head of quality control shall have bachelor education in any of the following:  
i. Pharmacy;  
ii.  Pharmaceutical sciences and technology;  
iii. Chemistry (analytical or organic) or biochemistry;  
iv. Microbiology;  
v. Any other relevant qualification  
 
The head of the production and quality control departments generally shall have some shared, or jointly 
exercised, responsibilities relating to quality in:  
 
i. The authorization of written procedures and other documents, including amendments;  
ii. The monitoring and control of the manufacturing environment;  
iii. Plant hygiene;  
iv. Process validation and calibration of analytical  apparatus;  
v. Training including the application and principles of quality assurance;  
vi. The approval and monitoring of suppliers of materials;  
vii. The approval and monitoring of contract manufacturers;  
viii. The designation and monitoring of storage conditions for mater ials and products;  
ix. The performance and evaluation in process controls;  
x. The retention of records;  
xi. The monitoring of compliance with good manufacturing practice requirements;  
xii. The inspection, investigation, and taking of samples, in order to monitor factors t hat may 
affect product quality.  
 
The head of the production department shall have the following responsibilities:  
 
i. To ensure products are produced and stored according to the appropriate documentation in 
order to obtain the required quality;  
ii. To approve the  instructions relating to production operations, including the in­ process 
controls and to ensure their strict implementation;  Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 25 of 43 
iii. To ensure that the production records are evaluated and signed by a designated person before 
they are made available to the quali ty control department;  
iv. To check the maintenance of the department, premises and equipment;  
v. To ensure that the appropriate process validations and calibrations of control equipment are 
performed and recorded, and the reports made available;  
vi. To ensure that t he required initial and continuing training of production personnel is carried 
out and adapted according to need.  
 
The head of the quality assurance and quality control department generally shall have the following 
responsibilities:  
 
i. To approve or reject s tarting materials, packaging materials, and intermediate, bulk, and 
finished products;  
ii. To evaluate batch records;  
iii. To ensure that all necessary testing is carried out;  
iv. To approve sampling instructions, specifications, test methods, and other quality control  
procedures;  
v. To approve and monitor analysis carried out under contract;  
vi. To check the maintenance of the department, premises and equipment;  
vii. To ensure that, appropriate validations, including those of analytical procedures, and calibrations 
of control equi pment are done;  
viii. To ensure that the required initial and continuing training of quality control personnel is carried 
out and adapted according to need;  
ix. Establish, implement and maintain the quality system;  
x. Supervision of regular internal audits or self -inspections;  
xi. Participate in external audits; and  
xii. Participate in validation programme.  
 
2.4.4.1 Training  
 
A manufacturer shall provide training as per written program for all the personnel whose duties take 
them into production areas or into control laboratori es including the technical, maintenance, and 
cleaning personnel, and any other personnel whose activities could affect the quality of the product.  
 
Recruited personnel shall receive training appropriate to the duties assigned to them in addition to basic 
training on theory and practice of good manufacturing practice.  
 
All personnel shall receive continuing training, evaluated and records be retrieved as  per approved 
training program.  
 
Personnel working in areas where contamination is a hazardous suc h as cle an areas or Areas where 
highly  active,  toxic,  infectious, sensitizing materials are handled shall be given specific training.  Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 26 of 43 
Visitors or untrained personnel shall not enter production and quality control areas, if necessary, they 
shall be closely supervis ed and practice personnel hygiene including wearing protective clothing.  
 
Consultants and contract staff shall be qualified for their service and their training records kept.  
 
2.4.5 Documents required for a manufacturer's application  
 
a) Application letter addressed to the Director General of Rwanda FDA  
b) Duly filled application form: Application form for premise licensing of cosmetics, household 
pesticides, household chemicals and laboratory chemicals  
c) Certificate of domestic company registration  issued by Rwa nda Development Board or 
equivalent  
d) Architectural plan of the site   
e) Product process flowchart (s)  
f) Environment impact assessment report   
g) Proof of payment of the prescribed fees  
h) List of products to be manufactured  
i) Lease/rent contract of the premise/house  
j) Notarized copy of Degree (and equivalence if applicable) of Responsible Technician  
k) Notarized Valid License of the responsible technician to Practice Profession issued by 
Recognized Professional Councils in Rwanda if applicable  
l) Notarized degrees of the key per sonnel to be involved in the manufacturing process, quality 
control and quality assurance  
m) Valid Contract between the Managing Director of the manufacturing plant and the responsible 
technician in case the Managing Director is not the responsible technician   
n) Copy of the identity card or passport of both the Managing Director and the responsible 
technician  
o) Written commitment of the technician, to respect the laws and regulations relating to the 
manufacturing practices performed and oversight the quality of pr oducts being manufactured.  
p) Signed resignation letter/proof of service delivered issued by the last employer of responsible 
technician, if applicable  
q) Curriculum vitae of the responsible technician  
 
2.5 Requirements to operate a wholesaler , importer  and/or retailer of medicated cosmetics, 
pesticides, laboratory or household chemicals  
 
2.5.1 Premise  
 
a) Location  
 
The premises shall be located in a place where they cannot be contaminated from the external 
environment or other activities.  Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 27 of 43 
 
The external surroundings shall be maintained in a clean and tidy condition with regular and adequat e 
clearance of waste materials.  
 
b) Standards of construction  
 
Premises shall be in good state of repair, maintenance and sanitation  and shall be:  
 
i. Be of a permanent nature  
ii. Being meant for commercial purposes or warehousing;  
iii. Be protected against adverse weather conditions including dust, ground water seepage, 
vermin and pest infestation;  
iv. Have adequate space for the carrying out and supervision of the necessary operations;  
v. Have floors and walls made of a washable and impervious material with a flat surface free 
of cracks and a ceiling covered with a non -flaking finish that allows easy cleaning; and  
vi. Be well lit, ventilated and have appropriate air -control facilities including  temperature and 
humidity.  
vii. The process of maintenance and repair shall not, while being carried out, cause any 
contamination of ingredients or products.  
viii. The premises shall have a regular and sufficient supply of water of suitable quality.  
ix. The premises shal l have appropriate toilet facilities and appropriate hand washing facilities.  
x. The premises shall have sufficient fire -fighting equipment which shall, at all times, be in 
good condition and accessible.  
 
c) Storage areas  
 
The storage areas for products shall be  well covered and off the floor in an area:  
 
i. That is secure and has adequate space;  
ii. That is laid out to allow clear separation of different materials and products to minimize the risk 
of mix -up; 
iii. Access to the materials and goods is restricted to authorized  personnel only;  
 
iv. Products that are light (photo) and temperature sensitive shall  be stored adequately  such a skin 
lighteners agents that are used  among the cosmetic body lotion,  
v. With separate area in the storage facility where recalled, expired or reject ed products shall be 
stored under lock and key.  
 
d) Minimum floor space and height  
 
i. For a wholesaler dealing with laboratory chemicals, the total floor space shall have a minimum 
space of 90 square meters. The sales area shall have a minimum floor space of 30  square meters, Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 28 of 43 
and records shall be maintained in this area. The storage areas shall have minimum floor area of 
60 square meters; and minimum height of 2.5 meters  from the floor to the ceiling.  
 
ii. For a wholesaler dealing with medicated cosmetics, household pesticides and household 
chemicals, the total floor space shall have a minimum space of 10  square meters and minimum 
height of 2.5 meters from the floor to the ceiling.  
 
iii. For a retailer dealing with laboratory chemicals, the sales and a dministrative area shall have 
minimum floor space of 30 square meters as whole. The minimum height shall be 2.5 meters 
from the floor to the ceiling.  
 
iv. For a retailer dealing with cosmetics, household pesticides and household chemicals, shall have 
a minimum  space of five (5)  square meters as whole. The minimum height shall be 2.5 meters 
from the floor to the ceiling.  
 
v. For an importer dealing with laboratory chemicals, the storage areas shall have minimum floor 
area of 40 square meters; and minimum height of 2.5 meters from the floor to the ceiling.  
 
vi. For an importer dealing with cosmetics, household pesticides and household chemicals, the 
storage areas shall have minimum floor area of 10 square meters; and minimum height of 2.5 
meters from the floor to the ceiling.  
 
2.5.2 Documentation and related controls  
 
All records (including but not limited to invoices, purchase orders, import authorizations, sales and 
distribution records in the wholesale, importer and retailer’s premises).  
 
A copy of premise registration certificate and operational license issued by the Authority and license to 
practice profession (where applicable) for the responsible qualified personnel shall be conspicuousl y 
displayed in the premis . 
 
2.5.3 Personnel  
 
For a wholesale r or a retailer of laboratory chemicals, be a  pharmacist, chemist or any other relevant 
qualification.  
 
For the wholesaler or retailer of medicated cosmetics, household pesticides and household chemicals, be 
a managing director of the establishment or her/ his delegate.  
 
2.5.4 Documents required for a wholesaler, an importer or retail of laboratory chemicals  
 
a) Application letter addressed to the Director General of Rwanda FDA  Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 29 of 43 
b) Duly filled application form: Application form for premise licensing of cosmetics, household 
pesticides, household chemicals and laboratory chemicals  
c) RDB registration certificate of the domestic company  or equivalent  
d) Lease/rent contract of the premise/house.  
e) Evidence of payment of prescribed fees to Rwanda FDA Accounts.  
f) Notarized copy of  Degree (and Equivalence if applicable) of responsible technician  
g) Notarized valid license to Practice Profession issued by Recognized Professional Councils in 
Rwanda if applicable.  
h) Contract between the managing director and the responsible technician in ca se the Managing 
Director is not the responsible technician.  
i) Copy of the identity card or passport of both the managing director and the responsible technician.  
j) Written commitment of the technician to respect the laws and regulations relating to the 
managem ent of chemicals.  
k) Signed resignation letter/proof of service delivered issued by the last employer of responsible 
technician, if applicable.  
l) A detailed curriculum vitae of the responsible technician.  
 
2.5.5 Documents required for wholesaler, importer or re tail of cosmetics, household pesticides 
and household chemicals  
 
a) Application letter addressed to the Director General of Rwanda FDA  
b) Duly filled application form: Application form for premise licensing of cosmetics, household 
pesticides, household chemicals  and laboratory chemicals.  
c) Certificate of domestic company registration  issued by Rwanda Development Board or 
equivalent  
d) Lease/rent contract of the premise/house.  
e) Evidence of payment of prescribed fees to Rwanda FDA Accounts.  
f) Copy of the identity card or passport of the Managing Director.  
g) A recent passport -size photo.  
 
2.6 Approval of the p remises  
 
Upon approval of findings of the inspection to manufacture , import , wholesale , store, exhibit, sale, 
dispense and distribute  of medicated cosmetics, pesticides, laboratory and household chemicals; the 
Authority shall notify the applicant the decision based on the findings of the inspections. In case of 
compliance with the premise licensing requirements, the premise registration  certificate and license shall 
be granted to the applicant.  
 
In case of non -compliances to the premise licensing requirements, a feedback letter with corrective 
actions may  be issued to the applicant.  
 Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 30 of 43 
CHAPTER 3: LICENSE R ENEWAL AND SUBSTANTI AL MODIFICATION  
 
The applicant shall inform the Authority any modification carried out for the purpose of its approval.  
 
The Authority may  conduct an inspection for confirmation of the compliance requirements in order to 
re-grant a license or approval of a su bstantial modification.  
 
3.1 Documents required for operational license renewal  
 
a) Application letter addressed to the Director General of Rwanda FDA  
b) Duly filled application form: Application form for premise licensing of cosmetics, household 
pesticides, household chemicals and laboratory chemicals.  
c) Notarized degree (or equivalence if applic able) of the responsible technician . 
d) Recent operational license of the establishment issued by Rwanda FDA.  
e) Written commitment of the responsible technician, to respect relevant laws and regulations and 
oversight the quality of products being handled where applicable.  
f) Certificate of the domestic company registration  
g) Evidence of payment of prescribed fees.  
h) Notarized valid license to practice profession of the responsible t echnician personnel where 
applicable.  
i) Contract between the establishment and the responsible technician in charge where the managing 
director is not the responsible technician . 
j) Copy of the identity card or passport of both the managing director and the res ponsible technician . 
 
3.2 Documents required for relocation or additional storage space of the licensed premise  
 
a) Application letter addressed to the Director General of Rwanda FDA  
b) Duly filled application form: Application form for premise licensing of cosm etics, household 
pesticides, household chemicals and laboratory chemicals.  
c) Original operational license  of the establishment issued by Rwanda FDA  
d) New certificate of domestic company registration  
e) Evidence of payment of prescribed fees  
f) Lease contract for the establishment  
 
3.3 Documents required for the change of the responsible technician of the licensed premise  
 
a) Application letter addressed to the Director General of Rwanda FDA  
b) Duly filled application form: Application form for premise licensing of cosme tics, household 
pesticides, household chemicals and laboratory chemicals.  
c) Original operational license  of the establishment issued by Rwanda FDA.  
d) Certificate of the domestic company registration  
 Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 31 of 43 
e) Evidence of payment of prescribed fees.  
f) Notarized degree (or  equivalence if applicable) of the responsible technician.  
g) Notarized valid license to practice profession of the responsible technician where applicable.  
h) Contract between the establishment and the responsible technician in charge where the 
managing director is not the responsible technician.  
i) Written commitment of the responsible technician, to respect relevant laws and regulations and 
oversight the quality of products being handled.  
j) Copy of the identity card or passport of both the managing Director and the responsible 
technician.  
k) Signed resignation lett er/proof of service delivered of  the outgoing respo nsible technician  
l) Signed resignation letter/proof of service delivered issued by t he last employer of the incoming 
responsible technician, if applicable .  
m) A Detailed curriculum vitae of the responsible technician.  
 
3.4 Documents required to change the ownership of the licensed premise  
 
a) Application letter addressed to the Director General of  Rwanda FDA  
b) Duly filled application form: Application form for premise licensing of cosmetics, household 
pesticides, household chemicals and laboratory chemicals.  
c) Original operational license  of the establishment issued by Rwanda FDA.  
d) Notarized sales agreement between former and new owner.  
e) New  and/or updated  certificate of the domestic company registration  
f) Notarized degree (or equivalence degree) of the responsible technician  where applicable.  
g) Notarized valid license to practice profession of the respo nsible technician  where applicable.  
h) Contract between the establishment and the responsible technician  in charge where the 
managing director is not the responsible technician  
i) Copy of the identity card or passport of both the new managing director and the responsible 
technician . 
 
3.5 D ocuments required to change the name of the license premise  
 
a) Application letter addressed to the Director General of Rwanda FDA  
b) Duly filled application form: Application form for premise licensing of cosmetics, household 
pesticides, household chemicals and laboratory chemicals.  
c) Original operational license  of the licensed premise issued by Rwanda FDA.  
d) New certificate of domestic co mpany registration.  
 
3.6 Documents required to close the licensed premise  
 
a) Application letter addressed to the Director General of Rwanda FDA  
b) Dully completed application form: Application form for premise licensing of cosmetics, 
household pesticides, household chemicals and laboratory chemicals.  Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 32 of 43 
c) Original of the premise registration  certificate issued by Rwanda FDA.  
d) Recent operational license issued by Rwanda FDA.  
e) A list of closing stock of products and its intended use.  
 
CHAPTER 4: GOOD PRAC TICES  
 
4.1 Good Distribution Practices  
 
Medicated cosmetics, p esticides, laboratory and household chemical products distributors shall have 
systems, facilities and operations that comply with the International Code of Conduct on Pesticide and 
Household Chemicals distribution and Guidelines  on good distribution practices as adopted by the 
Authority.  
 
Areas, where medicated cosmetics, pesticides, laboratory and household chemicals are distributed shall 
be regularly inspected to ensure that the premises and medicated  cosmetics, pesticides, laboratory and 
household chemicals are in an accep table condition.  
 
Vehicles used to transport products should be properly designed and equipped to ensure protection 
from different environmental and weather conditions in which it op erates.  
 
The use of vehicles with defects that could affect the quality of the products should be avoided.  
 
4.2 Good Storage Practices  
 
Medicated cosmetics, p esticides, laboratory and household chemicals shall be stored/displayed 
separately and away from all other materials to avoid any possibility of a source of fire, contamination 
and confusion with other materials.  
 
Areas, where medicated cosmetics, pesticides, laboratory and household chemicals are stored, shall be 
regularly inspected to ensure that the pr emises and medicated cosmetics, pesticides, laboratory and 
household chemicals are in an acceptable condition.  
 
4.3 Good Manufacturing Practices  
 
Medicated cosmetics, p esticides, laboratory and household chemical product manufacturers shall have 
systems, facilities a nd operations that comply with g uidelines  on good manufacturing practices  as 
adopted by the Authority.  
 
Areas, where medicated cosmetics, pesticides, laboratory and household chemicals are manufactured 
shall be regularly inspected to ensure that the premises and medicated cosmetics, pesticides, laboratory 
and household chemicals are in an acceptable condition.  
 Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 33 of 43 
 
ENDORSEMENT OF THE G UIDELINES   
 
  
Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 34 of 43 
APPENDICES  
 
APPENDIX  I: APPLICATION FORM  
 
   
 
 Department/Division  Food and Drugs Inspection and Safety 
Monitoring/Food and Drugs Inspection & 
Compliance  
Document Type:  Form  Doc. No  : 
FDISM/FDIC/FOM/003  
  
Title: Application Form for Premise 
Licensing of Cosmetics, Household 
Pesticides, Household Chemicals and 
Laboratory Chemicals  
 Revision Number  : 0 
Revision Date:  :  02/09/2022  
Effective Date  : 15/09/2022  
Review Due Date  : 14/09/2025  
Ref Doc.  : 
FDISM/FDIC/GDL/009  
 
Name of Premise:  
…………………………………………….  
…………………………………………….  
 Application date:            /         /         
                               DD / MM/ YYYY  
Domestic Company Registration code (TIN):   
 
…………………………………………….  
 Premise Registration Certificate Number  (Issued by 
Rwanda FDA):  
…………………………………………………………  
 
Physical location:  
(Province, District, Sector, Cell, Village)  
…………………………………………….  
…………………………………………….  
…………………………………………….  
 
Global Positioning System  (GPS) Coordinates  
…………………………………………….  
…………………………………………….  
 Company e -mail:  
 
…………………………………………………………  
 
 
 
Company Telephone:  
 
…………………………………………………………  
 
Name of responsible technician:  
(If applicable)  
…………………………………………….  
…………………………………………….  
Email of responsible te chnician:  
(if applicable)  
…………………………………………….  
…………………………………………….  Name of Managing Director:  
…………………………………………………………  
…………………………………………………………  
 
Email of Managing Director  
…………………………………………………………  
 
 
Format: QMS/FMT/ 002 
Revision No: 1  
Effective Date: 20 June 2022  Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 35 of 43 
…………………………………………….  
Telephone of responsible technician:  
……………………………………………  
……………………………………………  
 Telephone of the managing Director:  
…………………………………………………………  
…………………………………………………………  
TYPE OF PREMISE:  
(Please tick below)  
 
  Retailer  
  Wholesaler  
  Importer  
  Manufacturer  
Other (Please Specify) 
…….…………  
 
 
 MAIN ACTIVITY  
(Please tick below)  
 
 Retailer of Cosmetics  
 Retailer of Household 
Pesticides  
 Retailer of Household 
Chemicals  
 Retailer of Laboratory 
Chemicals  
Wholesaler of Cosmetics  
Wholesaler of Household 
Pesticides  
Wholesaler of Househ old 
Chemicals  
Wholesaler of Laboratory 
Chemicals  
Importer of Cosmetics  
Importer of Household 
Pesticides  
 Importer of Household 
Chemicals  
  Importer Laboratory 
Chemicals  
 Manufacturer of Cosmetics  
 Manufacturer of Household 
Pesticides  
 Manufacturer of Household 
Chemicals  
 Manufacturer  of Laboratory 
Chemicals  
  Other (specify) 
………………..  ……………  TYPE OF APPLICATIONS  
(Please tick below)  
   
 Site location approval  
 New Application (Premise 
Registration & Licensing  
 License Renewal  
  Relocation or additional 
storage space of the licensed 
premise  
 Change of the responsible 
technician  
 Change of the ownership  
 Change the name of the license 
premise  
 Closure of the business 
activities  
 Re-inspection  
Other specify 
……………….…  
AFFIDAVIT  Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 36 of 43 
I hereby affirm that the statement in this application is true and correct.  
 
 
 
 
  
Applicant’s Name and Signature                                       Date (dd/mm/yyyy)  
 
 
 
INSTRUCTION FOR APPLICANT:  
 
1. Ensure that ALL  sections of the application form are fully completed before submission. 
Send completed application form with stated requirements (see above) to the official email 
:info@rwandafda.gov.rw  
2. Incomplete application fo rm WILL NOT  be accepted.  
3. Application processes will take 30 working days upon receipt of fully complete documents 
required.  
4. All applications shall be valid for a period of ninety (90) calendar days from the date of 
application. When applicants failed to co mply with the requirement (s) within ninety (90) 
calendar days’ period, they shall re -apply and the prescribed premise licensing fees shall 
be paid.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 37 of 43 
 
LIST OF FORMATS  USED  WITH THESE GUIDELIN ES 
 
1) Format of the l icense to manufacture Cosmetics, Household Pesticides, Household 
Chemicals or Laboratory Chemicals (Doc. No.  FDISM/FDIC/FMT/004 ) 
2) Format of the license to operate a Wholesale/Retail of Laboratory Chemicals (Doc. No  
FDISM/FDIC/FMT/009 ) 
3) Format of the license to operate a Wholesale of Cosmetics/Household Pesticides/Household 
Chemicals (Doc. No.  FDISM/FDIC/FMT/010 ) 
4) Format of the license to operate as a Retail of Cosmetics, Household Pesticides or Household 
Chemicals (Doc. No.  FDISM/FDIC/FMT /011) 
5) License to operate as an Importer of Cosmetics, Household Pesticides, Household Chemicals 
or Laboratory Chemicals (Doc. No. FDISM/FDIC/FMT/012 ) 
6) Format for the premise registration certificate ( Doc. No.  FDISM/FDIC/FMT/024 ) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 38 of 43 
        Rwanda Food and Drugs Authority  
          Nyarutarama Plaza, KG 9 Avenue  
          P.O. Box: 1948 Kigali - Rwanda   
          Email: info@rwandafda.gov.rw    
          website: www. rwandafda.gov.rw  
 
 
License to manufacture Cosmetics/Household Pesticides/Household Chemicals/Laboratory 
Chemicals  
[Made under article 7(1) of the Regulations No FDISM/FDIC/TRG/004 Rev_0 ] 
 
License Number: ……….             Issue Date: dd/mm/yyyy             Valid up to: dd/mm/yyyy  
 
This is to certify that  the……. (Insert the Premise Name) with registration No …………..of dd/mm/yyyy 
located in …Province Name/Kigali City,  District Name, Sector Name, Cell Name, Village Name under the 
management of ………( insert the names of the managing director) as a managing director , 
Tel:................................................. and (insert the name of the responsible technician) a s a head of 
production department/unit;  
 
Is licensed to carry out the following manufacturing activities:  
 
Product category  Product type  Dosage form ( if 
applicable ) Manufacturing activities  
e.g. Cosmetics/Household 
Pesticides/Household 
Chemicals/Laboratory 
Chemicals    e.g. Production, packaging, 
storage, labeling and 
distribution  
 
Conditions:  
 
1. The product is put on market after its assessment and registration by Rwanda FDA.  
2. This authorization may be suspended or withdrawn if the conditions under which it was granted 
are violated.  
3. The application for renewal of license shall be done one month before its expiration.  
 
 
Done at Kigali on ...dd/mm/yyyy  
 
Signature of the Director General and Seal of the Authority  
 
 
Name of the Director General  
Director General  
 
 
QMS No: FDISM/FDIC/FMT/004  
Revision No: 0  
Effective Date: 15/09/2022  Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 39 of 43 
        Rwanda Food and Drugs Authority  
          Nyarutarama Plaza, KG 9 Avenue  
          P.O. Box: 1948 Kigali - Rwanda   
          Email: info@rwandafda.gov.rw    
          website: www. rwandafda.gov.rw  
 
 
License to operate a Wholesale/Retail of Laboratory Chemicals  
[Made under article 7(1) of the Regulations No FDISM/FDIC/TRG/004 Rev_0 ] 
 
 License Number: ……….             Issue Date: dd/mm/yyyy             Valid up to: dd/mm/yyyy  
 
 
This is to certify that  the……. (Insert the Premise Name) with registration No …………..of dd/mm/yyyy 
located in …Province Name/Kigali City, District Name, Sector Name, Cell Name, Village Name is licensed 
to operate as a Wholesale/Retail of Laboratory Chemicals . 
 
Names of the Managing Director: Names…….  
Telephone Number: ………………….  
 
Names of Responsible Technician:  Names…….  
Name of the Professional Council … and then write…  No: Registration Number  
 
 CONDITIONS  
1. This license does not authorize the holder to operate business in unregistered premises or during 
the period of suspension or revocation of the premise registration certificate in respect of which it 
was issued.  
2. This license must be prominently displayed in the premises to which it refers to.  
3. Any change made on details of the company name, physical location, management or responsible 
pharmacist shall be notified and approved by Rwanda FDA.  
4. This license is not transferrable and its misuse will result into suspension or revocation.  
5. The application for license shall be done one month before its expiration.  
 
Done at Kigali on . ..dd/mm/yyyy  
 
Signature of the Director General and Seal of the Authority  
 
 
Name of the Director General  
Director General  
 
 
 
 
QMS No: FDISM/FDIC/FMT/009  
Revision No: 0  
Effective Date: 15/09/2022  Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 40 of 43 
 
        Rwanda Food and Drugs Authority  
          Nyarutarama Plaza, KG 9 Avenue  
          P.O. Box: 1948 Kigali - Rwanda   
          Email: info@rwandafda.gov.rw    
          website: www. rwandafda.gov.rw  
 
 
License to operate a Wholesale of Cosmetics/Household Pesticides/Household Chemicals  
[Made under article 7(1) of the Regulations No FDISM/FDIC/TRG/004 Rev_0 ] 
 
 License Number: ……….             Issue Date: dd/mm/yyyy             Valid up to: dd/mm/yyyy  
 
 
This is to certify that  the……. (Insert the Premise Name) with registration No …………..of dd/mm/yyyy 
located in …Province Name/Kigali City, District Name, Sector Name, Cell Name, Village Name is licensed 
to operate as a Wholesale of Cosmetics/Household Pesticides/Household Chemicals . 
 
Names of the Managing Director: Names…….  
Telephone Number: ………………….  
 
 
 CONDITIONS  
1. This license does not authorize the holder to operate business in unregistered premises or during 
the period of suspension or revocation of the premise registration certificate in respect of which it 
was issued.  
2. This license must be prominently displayed in the premises to which it refers to.  
3. Any change made on details of the company name, physical location, management or responsible 
pharmacis t shall be notified and approved by Rwanda FDA.  
4. This license is not transferrable and its misuse will result into suspension or revocation.  
5. The application for license shall be done one month before its expiration.  
 
Done at Kigali on ...dd/mm/yyyy  
 
Signatu re of the Director General and Seal of the Authority  
 
 
Name of the Director General  
Director General  
 
 
 
 
 
QMS No: FDISM/FDIC/FMT/010  
Revision No: 0  
Effective Date: 15/09/2022  Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 41 of 43 
 
 
        Rwanda Food and Drugs Authority  
          Nyarutarama Plaza, KG 9 Avenue  
          P.O. Box: 1948 Kigali - Rwanda   
          Email: info@rwandafda.gov.rw    
          website: www. rwandafda.gov.rw  
 
 
License to operate a Retail of Cosmetics/Household Pesticides/Household Chemicals  
[Made under article 7(1) of the Regulations No FDISM/FDIC/TRG/004 Rev_0 ] 
 
 License Number: ……….             Issue Date: dd/mm/yyyy             Valid up to: dd/mm/yyyy  
 
 
This is to certify that  the……. (Insert the Premise Name) with registration No …………..of dd/mm/yyyy 
located in …Province Name/Kigali City, District Name, Sector Name, Cell Name, Village Name is licensed 
to operate as a Retail of Cosmetics/Household Pesticides/Household Chemicals . 
 
Names of the Managing Director: Names…….  
Telephone Number: ………………….  
 
 
 CONDITIONS  
1. This license does not authorize the holder to operate business in unregistered premises or during 
the period of suspension or revocation of the premise registration certificate in respect of which it 
was issued.  
2. This license must be prominently displayed in the premises to which it refers to.  
3. Any change made on details of the company name, physical location, management or responsible 
pharmacist shall be n otified and approved by Rwanda FDA.  
4. This license is not transferrable and its misuse will result into suspension or revocation.  
5. The application for license shall be done one month before its expiration.  
 
Done at Kigali on ...dd/mm/yyyy  
 
Signature of the Director General and Seal of the Authority  
 
 
Name of the Director General  
Director General  
 
 
 
 
QMS No: FDISM/FDIC/FMT/011  
Revision No: 0  
Effective Date: 15/09/2022  Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 42 of 43 
 
 
 
        Rwanda Food and Drugs Authority  
          Nyarutarama Plaza, KG 9 Avenue  
          P.O. Box: 1948 Kigali - Rwanda   
          Email: info@rwandafda.gov.rw    
          website: www. rwandafda.gov.rw  
 
 
License to operate an Importer of Cosmetics/Household Pesticides/Household Chemicals/ 
Laboratory Chemicals  
 
[Made under article 7(1) of the Regulations No FDISM/FDIC/TRG/004 Rev_0 ] 
 
 License Number: ……….             Issue Date: dd/mm/yyyy             Valid up to: dd/mm/yyyy  
 
 
This is to certify that  the……. (Insert the Premise Name) with registration No …………..of 
dd/mm/yyyy located in …Province Name/Kigali City, District Name, Sector Name, Cell Name, Village 
Name is licensed to operate as an Importer of Cosmetics/Household Pesticides/Household 
Chemicals/ Labor atory Chemicals . 
. 
 
Names of the Managing Director: Names…….  
Telephone Number: ………………….  
 
 
 CONDITIONS  
1. This license does not authorize the holder to operate business in unregistered premises or during 
the period of suspension or revocation of the premise registration certificate in respect of which it 
was issued.  
2. This license must be prominently displayed in the premises to which it refers to.  
3. Any change made on details of the company name, physical location, management or responsible 
pharmacist shall be n otified and approved by Rwanda FDA.  
4. This license is not transferrable and its misuse will result into suspension or revocation.  
5. The application for license shall be done one month before its expiration.  
 
Done at Kigali on ...dd/mm/yyyy  
 
Signature of the Director General and Seal of the Authority  
 
 
Name of the Director General  
Director General  
 
QMS No: FDISM/FDIC/FMT/012  
Revision No: 0  
Effective Date: 15/09/2022  Guidelines for Licensing of Medicated Cosmetics, Pesticides, Laboratory and Hou sehold Chemicals 
Premises  
 
Doc. No.: FDISM/FDIC/GDL/009  Revision Date: 25/08/2022  Review Due Date: 29/09/2025  
Revision No.: 0 Approval date: 20/09/2022   Effective Date: 30/09/2022  
   Page 43 of 43 
 
 
 
                                  Rwanda Food and Drugs Authority  
          Nyarutarama Plaza, KG 9 Avenue  
          P.O. Box: 1948 Kigali - Rwanda    
          Email: info@rwandafda.gov.rw    
          website: www. rwandafda.gov.rw  
 
 
PREMISE REGISTRATION CERTIFICATE  
[Made under article 3 of the Law Nº 47/2012 of 14/01/2013  relating to the regulation and 
inspection of food and pharmaceutical products. ] 
 
This is to certify that the ……  (Premise Name as written on RDB or equivalent certificate)  under the 
management of Mr/Mrs/Ms. …………………………located in Kigali City/Province Name, District 
Name, Sector Name, Cell Name, Village Name, has been registered as…… ( Type of Premise  e.g: 
Retail Pharmacy, Wholesale Pharmacy, Pharmaceutical Manufacturing Plan e tc.) 
…………………………with Registration Number …………. of dd/mm/yyyy……………….  
 
1. Subject to the following conditions: -The premises and the manner in which the business is to be 
conducted shall conform to requirements of Rwanda Food and Drugs Authority at all times.  
2. Any change in the ownership, name and location of the registered premises shall be approved by 
the Authority.  
3. This certificate is not transferable to other premises or to any other person.  
4. This certificate shall be displayed conspicuously in the registered premises.  
5. The certificate shall only be used to operate business related to products approved by Rwanda 
FDA.  
6. The certificate does not replace the operational license.  
 
Done at Kigali on ...dd/mm/yyyy  
 
Signature of the Director General and Seal of the Autho rity 
 
Name of the Director General  
Director General  
 
 
 
 
QMS No: FDISM/FDIC/FMT/024  
Revision No: 0  
Effective Date: 05/07/2022  