Regulations governing licensing of public and private manufacturers, 
distributors, wholesalers and retailers of medical Products  
 
Doc Ref No.: FDISM/FDIC/TRG/001 Rev_3 
     
 
 
 
 
 
 
 
 
 
 
  
 
 
 
REGULATIONS  GOVERNING LICENSING OF PUBLIC 
AND PRIVATE MANUFACTURERS, DISTRIBUTORS, 
WHOLESALERS AND RETAILERS OF MEDICAL 
PRODUCTS  
(Rwanda FDA L aw No 003/2018 of 09/02/2018, Article 9) 
 
 
  
 Regulations governing licensing of public and private manufacturers, 
distributors, wholesalers and retailers of medical Products  
 
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REGULATION DEVELOPMENT HISTORY  
 
DRAFT ZERO  05/11/ 2019  
ADOPTION BY RWANDA FDA  14/12/2019  
STAKEHOLDERS CONSULTATION  29/12/ 2019  
ADOPTION OF STAKEHOLDERS’ COMMENTS  02/12/ 2020  
DATE FOR COMING INTO EFFECT  28/09/2022  
 
Document Revision History  
 
Date of revision  Revision number  Changes made and/or reasons for revision  
10/01/2020  0 First Issue  
02/10/2020  1 The title of the Regulations  was renamed as 
“Regulations  Governing Licensing to 
Manufacture, to Operate as Wholesale and 
Retail Seller of Medical Products ” instead of 
“Regulations  governing licensing to manufacture 
pharmaceutical products or to operate as 
wholesale or a retail seller of pharmaceutical 
products”  
 
26/01/2022  2 1. The title of the Regulations  was renamed 
as Regulations  Governing Licensing of 
Public and Private Manufacturers, 
Distributors, Wholesalers and Retailers of 
Medical Products instead of “ Regulations  
Governing Licensing to Manufacture, to 
Operate as Wholesale and Retail Seller of 
Medical Products”.  
2. Requirements f or licensing of public and 
private institutions have been included.  
  
  
 
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24/08/2022  3 1. Article 6: Application for premise 
registration and license to operate was 
revised for rejection of incomplete 
application   
2. Article 7: Conditions for registration of a 
premise, Article 9: Appointment of 
inspectors, Article 10: Conflict of interest, 
Article 11: Powers of inspectors, were 
added in CHAPTER II of these 
Regulations  
3. Article 17: Requirements to re -grant, 
renew a licen se to operate or approval of 
a substantial modification for submission 
of all  applications for renewal by 30th 
April of the fiscal year.  
4. Article 18: Validity of an authorization. 
The validity for all license to operate shall 
follow the fiscal year of starting from 1st 
July to 30th June 
5. Article 25: Transport and delivery 
validation, was added in CHAPTER III of 
these Regulations  
6. Article 28: Annex A was generated from 
these Regulations  
7. Article 33: Closure of business activity, 
was added in CHAPTER V  
8. Edito rial changes have been made for 
adoption of the new Regulations  format  
   
  
 
Regulations governing licensing of public and private manufacturers, 
distributors, wholesalers and retailers of medical Products  
 
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TABLE OF CONTENTS  
 
REGULATION DEVELOPMENT HISTORY  ................................ ................................ ...................  2 
Document Revision History  ................................ ................................ ................................ ................  2 
ADOPTION AND APPROVAL OF THE REGULATIONS  ................................ .............................  4 
TABLE OF CONTENTS  ................................ ................................ ................................ ....................  5 
CHAPTER ONE: GENERAL PROVISIONS ................................ ................................ .....................  7 
Article One: Purpose of these Regulations  ................................ ................................ ..........................  7 
Article 2: Citation  ................................ ................................ ................................ ................................  7 
Article 3: Scope  ................................ ................................ ................................ ................................ ... 7 
Article 4: Definitions  ................................ ................................ ................................ ...........................  7 
CHAPTER II: LICENSING AND INSPECTIONS  ................................ ................................ ............  9 
Article 5: Obligation to obtain premise registration certificate and license to operate  .......................  9 
Article 6: Application for premise registration and license to operate  ................................ ..............  10 
Article 7: Conditions for registration of a premise  ................................ ................................ ............  10 
Article 8: Inspection of premises for suitability  ................................ ................................ ................  11 
Article 9: Appointment of inspectors  ................................ ................................ ................................  11 
Article 10: Conflict of Interest  ................................ ................................ ................................ ...........  11 
Article 11: Powers of inspectors  ................................ ................................ ................................ ........  11 
CHAPTER III: PERSONNEL  ................................ ................................ ................................ ...........  12 
Article 12: Key Personnel for the medical products manufacturing facility  ................................ ..... 12 
Article 13: Academic qualifications of key personnel  ................................ ................................ ...... 12 
Article 14: Training  ................................ ................................ ................................ ...........................  12 
Article 15: Authorized Personnel for distributors, wholesalers and retailers of medical products  ... 12 
Article 16: Requirements to be granted  registration certificate and a license to operate  ..................  13 
Article 17: Requirements to re -grant, renew a license to operate or approval  of a substantial 
modification  ................................ ................................ ................................ ................................ ....... 13 
CHAPTER IV: VALIDITY OF AN AUTHORIZATION  ................................ ................................  13 
Article 18: Validity of an Authorization  ................................ ................................ ............................  13 
Article 19: Establishment of Licensing and Inspection technical and advisory Committee  .............  14 
Article 20: Publication of inspected, registered and licensed premises  ................................ .............  14 
Article 21: Display of an Authorization  ................................ ................................ ............................  14 
Article 22: Display of a sign post  ................................ ................................ ................................ ...... 14 
Article 23: Good Distribution Practice  ................................ ................................ ..............................  14 
Article 24: Transport and delivery validation  ................................ ................................ ....................  14 
Article 25: Good Manufacturing Practice  ................................ ................................ ..........................  14 
Article 26: Good Dispensing Practice  ................................ ................................ ...............................  14 
Article 27: Documentation and related controls  ................................ ................................ ................  15 
CHAPTER V: FINAL PROVISIONS  ................................ ................................ ...............................  15 
Article 28: Administrative sanctions  ................................ ................................ ................................ . 15 
Article 29: Other Regulatory Actions  ................................ ................................ ................................  16 
Article 30: Warning  ................................ ................................ ................................ ...........................  16 
Article 31: Suspension of the license  ................................ ................................ ................................ . 16 
Article 32: Revocation of license/certificate  ................................ ................................ .....................  17 
Article 33: Reinstatement  ................................ ................................ ................................ ..................  17  
  
 
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Article 34: Appeals and Review  ................................ ................................ ................................ ........  17 
Article 35: Closure of business activity  ................................ ................................ .............................  18 
Article 36: Commencement  ................................ ................................ ................................ ...............  18 
 
   
  
 
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CHAPTER ONE:  GENERAL PROVISIONS  
Article One : Purpose of these Regulations  
 
These Regulations  enforce the legal framework for application, inspection , storage, distribution, and 
licensing of public and private manufacturers, distributors, wholesalers and retailers of Medical 
Products.  
Article 2:  Citation  
 
These Regulations  are cited as the “ Regulations  FDISM/FDIC/TRG/001 Rev_  3, governing licensing 
of public and private manufacturers, distributors, wholesalers and retailers of medical p roducts.”  
Article 3:  Scope  
 
These Regulations  apply to  public, and p rivate manufacturers, distributo rs, wholesalers and retailers 
of medical products involved in the manufacture, storage, s ale, distribution, and  dispensing of 
medical products.  
Article 4:  Definitions  
 
In these Regulations , unless the context otherwise requires , the  following terms have meaning 
ascribed to them : 
 
“Authority”  means the Rwanda Food and Drugs Authority or its 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 th e Law No 003/2018 of 09/02/2018, it includes licenses, permits, and certificates.  
  
“Authorized personnel”  means an individual who possesses a recognized  academic  degree, has 
extensive knowledg e, training and experience, and successfully demonstrated his /her ability to solve 
or resolve probl ems relating to the subject matter.  
 
“Conflict of interest”  means any interest in any business related to medicines declared by the 
inspector that may affect or reasonably perceived to affect the quality or the re sult of his work or 
remediation.  
 
“Critical  observation”  means an observation describing a situation that will most likely result in a 
non-compliant product or a situation that may result in immediate or latent health risk and any 
observation that involves fraud, misrepresentation, or fa lsification  of products or data.  
  
“Critical equipment” means any piece of equipment, instrumentation, or systems, whose 
malfunction or failure may cause variation in the quality and safety of the medical products.  
  
  
 
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“Distribution” means the procuring, purchasing, hol ding, storing, selling, supplying, importing, 
expo rting, or movement of products regulated by the Authority . 
 
“Distributor” means a person or organization who receives, stores, warehouses, handles, holds, 
offers, markets or displays medical products. A dis tributor shall be an entity that is appropriately 
authorized by the competent authority to perform the intended function as prescribed in these 
Regulations , and which can be held accountable for its activities. These include but not limited to 
governments at all levels, public and private health and storage facilities, manufacturers of finished 
products, importers, exporters, distributors, wholesalers, suppliers, retailers.   
 
“Fiscal year”  means an accounting period that begins on July 1 and ends on June 30.  
 
“Good distribution practices or its acronym  “GDP” means that part of quality assurance that 
ensures that the quality of a product is maintained by means of adequate control of the nume rous 
activities which occur during the distribution process  as well as providing a tool to secure the 
distribution system from falsified, unapproved, illegally imported, stolen, substandard, adu lterated 
or misbranded products.  
 
“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.  
 
“Good manufacturing practices or its acronym  “GMP” means that part of quality assurance which 
ensures that products are consistently produced and controlled to the quality standards appropriate to 
their intended use and as required  by the marketing authorization.  
 
“Good storage practices  or its acro nym “GSP” means that part of quality assurance that ensures that 
the quality of products is maintained by means of adequate control  throughout the storage thereof.  
  
“Herbal medicine ” means a medical product with a label identifying it’s  dosage that contains one 
or more substances of natural origin that are derived from plants.  
 
“Inspector”  means a  person  appointed, authori zed and designated  by the Authority in accordance 
with laws tasked with performing inspection -related duties.  
  
“Ma nufacturer”  means a company that carries out at least one step of manufac ture. 
 
“Medical product”  includes human and veterinary drug, human and animal vaccines and other 
biological pro ducts used in clinical as drug, herbal medicines and human and veterinary medical 
devices . 
 
“Minister”  Means the M inister responsible for health . 
 
“Owner of premises ” means a person authorized to deal in the business of storage, transport and 
distribution of medical products.  
  
  
 
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“Pharmaceutical product”  means any substance capable of preventing, treating human or animal 
diseases and any other substance intended for administration to a human being or an animal in order 
to diagnose diseases, restore, correct or carry out modification of organic or mental f unctions. It also 
means products used in disinfecting premises where food and drugs are manufactured, prepared or 
stored, cleaning hosp itals, equipment and farmhouses.  
 
“Premises”  means any plot of land, buildings or boats, aircrafts, vehicles, a part of a  building, 
channels, yards, a place of storage, annexed to a building, or part of that building, carriage or 
receptacle of any kind, whether open or closed.  
 
“Raw material”  means any substance, reagent, or solvent which is intended for use in the productio n 
of an active substance and from which the active substance is not directly manufactured or extracted.  
 
“Registration certificate”  means an authorization issued to the  registered  company for indefinite  
period . 
 
“Retailer ” is an entity that is authorized to carry on the business of dispensing or providing medical 
products directly to a patient.   
 
“Tariff/Fees”  Includes any charge made or levied in connections with ser vices rendered by the 
Authority.  
 
“Wholesaler”  is an en tity that is authorized to carry on the business of selling medical products in 
large quantities to other authorized sellers with the exception of dispensing or providing medical 
products directly to a patient . 
 
In these Regulations , the following verbal forms are used:  
“Shall”  indicates a requirement;  
“Should”  indicates a recommendation;  
“May”  indicates a permission; and  
“Can”  indicates a possibility or a capability  
 
CHAPTER II:  LICENSING AND INSPECTIONS  
 
Article 5:  Obligation to obtain premise registration certificate and premise license  
 
Any activity related to the manufacture, storage, import, export, sale, packaging, distribution, supply 
and transport of pharmaceutical products, human and animal vaccines and other biological p roducts 
used in clinical as drugs, medical devices, poisonous product, medicated cosmetics, herbal medicines 
and any other health commodities must be registered and licensed.  
 
All premises, facilities, establishments and companies throughout the supply chain must be registered 
and possess a valid premise license issued by the Authority. No person or entity shall manufacture, 
distribute, wholesale or retail medical products witho ut prior authorization from the Authority.  
  
  
 
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The premise  registration certificate and license for premises used for carrying out activities under 
Paragraph 1 this article  of this Regulation is granted by Rwanda FDA. The requirements to obtain a 
registration  certificate and license to operate are detailed in the relevant guidelines  on licensing of 
public and private manufacturers, distributors, wholesalers and retailers of m edical Products . 
 
No pharmacy importing pharmaceutical products and medical devices shall sell them on a wholesale 
basis to other pharmacies in the same category.  The Authority shall conduct an inspection for 
confirmation of the compliance to the licensing requirements in order to grant or re -grant a premise 
license or approval of a substantial modification.  
 
A premise license  to operate  as public and private manufacturers , distributors, wholesalers and 
retailers of medical products shall not be granted where the Authority finds the applicant not 
complying with the requirements prescr ibed in these Regulations  and relevant regulatory documents.   
The premise  license may  be suspended or withdrawn if any of the conditions under which it was 
granted, is violated . 
Article 6 : Application for premise registration and premise license  
 
An application shall be made to the Au thority addressed to the Director General of Rwanda FDA , 
accompanied by all required documents as described in the relevant  guidelines  for licensing of public 
and private manufacturers, distributors, wholesalers and retailers of m edical Products . 
 
An application  is considered to be complete on submission of all required documents provided in the 
relevant guidelines  on licensing of public and private manufacturers, distributors, wholesalers and 
retailers of m edical Pro ducts . An incomplete application shall be rejected until all requirements are 
fulfilled.  
Article 7: Conditions for registration  and licensing  of a premise  
 
Every premise  dealing with me dical products shall be made of permanent building materials, durable  
and located away from sites or activities that would comprise the safety, quality and efficacy of 
medical products . 
 
Premises shall be designed, constructed, adapted, and maintained to suit the operations carried out 
and to facilitate cleaning and mainten ance, provide maximum protection against the entry of insects, 
birds, or animals , minimize the risk of errors and contamination having regard to the type and stage 
of manufacturing which the buildings and facilities are used for.  
 
All manufacturing facilities for medical products , shall comply with GMP requirements  according to 
the Regulation s governing Good Manufacturing  Practices of medical products.  
 
Premises involved in storing, distribution and retailing of medical products shall comply with  the 
GSP & GDP principles, pharmacovigilance system and have minimum space and height 
requirements as detailed in the guidelines  for Good Storage and Good Distribution Practices of 
medical products , guidelines on safety and vigilance of medical products and health technology  and  
  
 
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guidelines  for licensing of public and private manufacturers, distributors, wholesalers and retailers 
of medical p roducts  respectively  
Article 8: Inspection of premises for suitability  
 
The Authority shall inspect the premises to determine the ir suitability, for  public and private 
manufacturers, distributors, wholesalers and retailers of medical products upon receipt of a complete 
application.  
 
Premises that do not comply with the requirements for licensing shall not be eligible for consideration 
of a premise license. The  site location approval shall be undertaken  prior to construction for  medical 
products manufacturers . 
Article 9: Appointment of inspectors  
 
The Authority shall appoint inspectors to inspect public and private manufacturers, wholesalers, 
distributors and retailers of medical products. The inspectors shall have the relevant qualification in 
terms of academic education, training, and experience to effectively take part in the inspection . 
Article 10: Conflict of Interest  
 
To avoid any conflict of interest, all inspectors declare any conflict of interest upon appointment.  
Article 11: Powers of inspectors  
 
To enforce compliance for conducting inspections, an inspector appointed following thes e 
Regulations  shall, upon production of evidenc e that he/she is so authorized : 
1⁰ At any reasonable time to enter any premises, other than premises used only as a private 
dwelling house, where he/she has reason to believe it is necessary to visit, including a ny 
premises of any person who carries out any of the a ctivities referred to in these Regulations ; 
 
2⁰ To carry ou t at those premises during the visit, inspections, examinations, tests, and analyses 
as he/she considers necessary;  
 
3⁰ To require the production of,  inspect and take copies of extracts from  any book, document, 
data or record in whatever form it is held at, or in the case of computer data or records 
accessible at the premises;  
 
4⁰ To take possession of any samples for examination and analysis and any othe r article, 
substance, book, document, data or record in whatever form they are held at, or in the case of 
computer data or records accessible at, the premises;  
 
5⁰ To question any person whom, he/she finds at the premises and has reasonable cause to 
believe c an give relevant information;  
  
  
 
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6⁰ To require any person to afford he/she such assistance as considered necessary concerning 
any matter within that person's control, to which that person has responsibilities; and  
 
7⁰ To require, as considered necessary, any person to afford he/she such facilities as may 
reasonably require that person to afford. Nothing in this paragraph shall be taken to compel 
the production by any person of a document of which he/she would on grounds  of legal 
professional privilege be entitled to withhold production  
 
8⁰ To perform his or her duties with respect, confidentiality, humility and with integrity . 
 
CHAPTER III:  PERSONNEL  
Article 12: Key Personnel for the medical products manufacturing facility  
 
A manufacturing facility shall at least have the following key personnel:  
 
1⁰ Head of production;  
2⁰ Head of quality assurance;  
3⁰ Head of quality control; and  
4⁰ Authorized person nel. 
 
A manufacturer shall formally notify the Authority of the name of authorized personnel  appointed 
by the manufacturer and the specific functions which have been delegated to such persons  for the 
purpose of approval . Key posts shall be  occupied by full -time personnel.  
Article 13: Academic qualifications of key personnel  
 
The necessary qualificati ons of the key personnel are  detailed  by the Authority  in the relevant 
guidelines on licensing of public and private manufacturers, distributors, wholesalers and retailers of 
medical Products . 
 
Article 14: Training  
 
A manufactur er shall provide training s according to  written program for all the personnel whose 
duties take them into production areas or into control laboratories including the technical, 
maintenance and cleaning personnel, and any other personnel whose activities could  affect the 
quality of the product.  
Article  15: Authorized personnel for distributors, wholesalers and retailers of medical products  
  
The necessary qu alifications of the authorized personnel  will be detailed by the Authority in the 
relevant guidelines  on licensing of public and private manufacturers, distributors, w holesalers and 
retailers of medical p roducts.  
  
  
 
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Article 16: Requirements to be granted  registration certificate and premise license   
 
The requirements for the applicants before they are granted a premise  license  based on type of 
activity, are provided for in the relevant guidelines  on licensing of public and private manufacturers, 
distributors, wholesalers and retailers of medical p roducts  issued by the Authority.  
 
The applicant is required to  fulfill all the requirements as per the guidelines and comply with the 
premise standard before the  registration certificate and premise license  is granted  
Article 1 7: Requirements to re -grant, renew a premise license  or approval of a substantial 
modification  
 
The applicant shall inform the Authority of any substantial modification carried out for the purpose 
of its approval.  For critical  substantial modification, the applicant shall wait for the written approval 
of the Authority  before the implementation of the requested substantial modification . The types of 
substantial modification are  detailed in the relevant guidelines  on licensing of public and private 
manufacturers, distributors, wholesalers and retailers of medical product s,  
 
The Authority shall conduct inspection for confirmation of the compliance requirements in order to 
re-grant a premise license or approval of a major substantial modification.  The requirements for 
renewal and substantial modification  are detailed in the relevant guidelines  on licensing of public 
and private manufacturers, distributors, wholesalers and retailers of medical products . 
 
All applications for renewal of the premise license  shall be submitted by 30th April of the same year. 
Any premise with expired  premise  license shall be closed until the license is renewed.  
 
An incomplete application for renewal shall be rejected until all requirements are fulfilled . The 
applicant is subjected to fines on s ubmission of the completed dossier after the expired premise  
license  for operating without a valid premise license .  
 
Operating without a valid  premise license  for a period of six months , the application shall be 
submitted as a new application in accordance with requirements for new application provided in the 
relevant guidelines for licensing  of public and private manufacturers, distributors, wholesalers and 
retailers of medical products and the administrative fines for operating without a valid premise license  
shall be applicable pursuant to article 28  of this Regulations.  
 
CHAPTER I V: VALIDITY OF AN AUTHORIZATION  
Article 1 8: Validity of an authorization  
 
A premise licens e shall be valid for  a period of  twelve (12) months  of the fiscal year  renewable . All 
premise licenses issued by the Authority shall expire  by 30th June of the  same year .  
 
A premise license  is issued to an applicant and shall not be transferred to another applicant or premis e 
without prior written approval of the Authority.  Any change(s) to the information contained on the 
premise  license  shall be notified to the Authority within a period of five (5) working days.    
  
 
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Article 19: Establishment of Licensing and Inspection technical and advisory Committee  
 
The Authority shall establish technical and/or advisory committee s comprising of internal and/or 
external experts from different fields and scientific research to advise the Autho rity on licensing and 
inspection regulatory matters with clear terms of reference.  
Article 20: Publication of inspected, registered and licensed premises  
 
Inspected, registered, licensed, and un -functional premises as well as premises with revoked, 
suspended premise licenses  shall be published monthly on the Rwanda FDA website, and on any 
other media, as the Authority may decide from time to time.  
 
The list of retail pharmacies  on duty r oster shall be published quarterly on the Rwanda FDA website, 
and on any other media, as the Authority may decide from time to time.  
Article 21: Display of the authorization  certificate  
 
The registration certificate, premise license and license to practice  profession  shall be conspicuously 
displayed in the authorized premise . 
Article 22: Display of a sign post  
 
An authorized premise  shall be identified by a clearly displayed sign post containing the registration 
certificate number, name of the premise , names and telephone number of the authorized  personnel.  
Article 23: Good Distribution Practice  
 
The medical products  manufacturers , distributors or wholesalers shall have systems, facilities and 
operations that comply with the Good Distribution Practice Regulations  and Guidelines, as adopted 
by the Authority.  
Article 2 4: Transport and delivery validation   
 
The distributor  shall be responsible for qualification  of all transportation or vehicles used in the 
transportation of medical products to ensure medical product safety and quality. The requirements 
for transport and delivery qualification are described in the relevant g uidelines . 
Article 25: Good Manufacturing Practice  
 
The manufacturer of a medical product shall have systems, facilities and operations that comply with 
the Good Manufacturing Practice Regulations  and Guidelines, as adopted by the Authority.  
Article 26: Good Dispensing Practice  
 
The medical products retail seller/dispenser and hospital pharmacies shall have systems, facilities and 
operations that comply with the Good Dispensing Practice Guidelines, as adopted by the Authority.   
  
 
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Article 27 : Documentation a nd related controls  
 
All records including but not limited to invoices, purchase orders, import authorizations, sales and 
distribution records, throughout the supply chain ; for all medical products and administrative records 
of the staff shall be properly kept and be readily available to the inspection service when requested for 
or needed.  
 
All entry and exit of medical products must be approved by the authorized personnel.  Reports on the 
distribution of controlled substances  shall be submitted to the Authority  on Quarterly basis . 
 
CHAPTER V : FINAL PROVISIONS  
Article 2 8: Administrative sanctions  
 
Any person who contravenes the  provisions of  these  Regulations , shall be liable to  the 
administrative measures and sanctions  under Annex A ; which  comprises of administrative fines 
for: 
 
1° Manufacturing, importation, sale, storage and distribution of substandard, unapproved, 
counterfeit/falsified, expired and fraudulent regulated products .   
 
2° Illegal opening of premises closed by the Rwanda FDA .  
 
3° Absence of a n authorized personnel in an authorized premise  dealing with regulated 
products . 
 
4° Operating without operational license . 
 
5° Operating without valid operational license .  
 
6° Closure of the pharmacy which is officially on duty .  
 
7° Production without production manager or/ quality control manager . 
 
8° Transport of regulated products in unacceptable conditions . 
 
9° Failing to ensure that narcotics and other controlled substances are kept in a secured 
cupboard . 
 
10° Failure to provide prescriptions/reports for dis tribution of narcotics and controlled 
products at the time of inspection . 
 
11° Any change to the authorization without notifying the Authority within the prescribed 
timelines  
  
  
 
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12° Relocation without notifying the Authority . 
 
13° Obstruction of inspectors from Rwanda Food and Drugs Authority  
 
Article 29: Other Regulatory Actions  
 
The Authority shall take other  regulatory actions based on Minor, Major and Critical non -
compliances as recommended by the inspectors when making decisions on the outcome of 
inspections : 
 
1⁰ Minor non -compliances imply :  
 
a. Corrective action within a given time frame  
b. Request for compliance report  
 
2⁰ Major non -compliances  imply : 
 
a. Issue warning letter  
b. Temporary withdrawal or suspension of the license  to operate . 
 
3⁰ Critical  non-compliances  imply : 
 
a. Temporarily closure of the premise , 
b.  Revocation of the license to operate  
c. Not granting  the license to operate . 
 
Article 30: Warning  
 
The Authority may issue a warning letter to the licensed premise under the following conditions:  
 
1° If non -related and non -licensed activities are found to be performed in the licensed premise.  
 
2° Minor malpractices or non -conformances that may not affect the quality and safety of the 
products manufactured, stored, or distributed.  
Article 31 : Suspension o f the  premise  license  
 
The Authority may suspend a licensed premise if it is satisfied that:  
1° Repeated violations of the conditions that triggered a warning letter as stated in article 30.  
 
2° The licensed premise made a false or misleading statement or misrepresentation in the 
application;  
 
3° Alteration or modification of the premises and/or equipment after approval by the Authority.  
  
  
 
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4° The premises in which the product or part thereof is manufact ured, packaged or stored are 
unsuitable for the manufacturing, packaging or storing of the product;  
 
5° Performing activities that are not in the scope of the premise license  
 
6° Any of the conditions under which the premise lic ense was issued no longer exist  
The suspension of the license shall set out the reason for the proposed suspension, any corrective 
action required to be taken and the time within which it shall be taken. The suspension of the license 
shall not exceed six (6) months.  
Article 3 2: Revocatio n of premise licens e 
 
The Authority may revoke the premise license  if: 
1° Repeated violations of the conditions that triggered a suspension as  stated in article 20 of 
this R egulations.  
 
2° The suspended premise fails to provide the corrective actions within the timeline stated during 
the suspension of the premise license.  
 
3° Premise l icense has been suspended for a period of more than 12 months.  
 
4° It is necessary to do so in order to prevent in jury to the health or safety of patients, users or 
other persons.  
 
5° Abandonment of the licensed activities  
6° Bankruptcy or liquidation of the licensee  
Article 33 : Reinstatement  
 
A licensee whose license/certificate is revoked may be reinstated in registered/ licensed premises after 
three (3) years from the day his or her revocation was issued. However, in the interests of the service, 
a licensee whose revocation has been issued may be reinstated in registered/licensed premises before 
the expiration of three (3 ) years.  
Article 34: Appeals and Review  
 
An authorization holder or applicant may notify the Authority of his or her grounds when he/she:  
1⁰ Objects to any suspension or revocation of the authorization, or any notice served;  
 
2⁰ Objects to the refusal of authorization or the imposition of any condition may notify the 
Authority of his desire to make written representations to, or be or appear before and be heard 
by, a person appointed by the Authority for that purpose.  
 
  
  
 
Regulations governing licensing of public and private manufacturers, 
distributors, wholesalers and retailers of medical Products  
 
Doc Ref No.: FDISM/FDIC/TRG/001 Rev_3   Page 18 of 18 
 
Any person aggrieved by a decision of  the Authority may appeal to the Authority for review of a 
decision within thirty ( 30) working days from the date of the notice. The Authority shall within thirty 
(30) working days from the date of receiving the written notification  and make its own decisi on 
whether to vary, reject or uphold the  decision.  
 
Where the Authority receives notification pursuant to provisions of paragraph 1 of this Article, the 
Authority shall appoint a person to consider the matter. The person appointed shall determine the 
proce dure to be followed concerning the consideration of any objection.  
 
The person appointed by the Authority, shall consider any written or oral objections made by the 
objector or complainant in support of its objection, and shall make a recommendation to the 
Authority.  
 
A recommendation shall be made in writing to the Autho rity, and a copy of it shall be sent to the 
complainant concerned, or to its nominated representative. The Authority shall take into account any 
recommendation made within fourteen days of receipt of such recommendation.  
 
The Authority shall inform the com plainant whether it accepts the recommendation and, if not, the 
reasons for its decision.  
 
If a person is dissatisfied with a decision after review, he/she may appeal to the supervising Authority 
of Authority  or the Minister whose decision shall be final.  
Article 35 : Closure  of business activity   
 
Where the owner  of the premise plans to close down the business, he/she shall formally notify the 
Authority and inform the appropriate management of the medical products  within the timelines 
specified in the relevant guidelines  on Licensing of public and private Manufacturers, Distributors, 
Wholesalers and Retailers of Medical Products . 
Article 36: Commencement  
 
These Regulations  shall enter into force on the date of signature and publication. All prior provisions 
contrary to these Regulations  are hereby repealed.  
 
END OF DOCUMENT  
  
ANNEX -A: FAULTS AND ADMINISTRATIVE SANCTIONS  
 
Fault  Administrative sanction  
1. Manufacturing, importation, sale, 
storage and distribution of 
substandard, unapproved, 
counterfeit/falsified, expired and 
fraudulent regulated products   25% to 50% of the product  value  found in 
violation . 
2. Illegal opening of premises closed 
by the Rwanda FDA   500,000 Frw  
 
3. Absence of an authorized personnel 
in an authorized premise dealing 
with regulated products   500,000 Frw  
 
4. Operating without operational 
license  1,000,000 FRW   
5. Operating without valid operational 
license   100,000 Frw  
Note that for each delay, a 25% increment, 
on the original fine will be applied monthly 
from the second month after expiry of the 
license. This charge of 25% increment shall 
not go beyond 6 months after expiry of the 
license  
6. Closure of the pharmacy which is 
officially on duty  100,000 Frw  
7. Production without production 
manager or/ quality control manager  500,000 Frw  
 
8. Transport of regulated products in 
unacceptable conditions   200,000 Frw  
 
9. Failing to ensure that narcotics and 
other controlled substances are kept 
in a secured cupboard   100,000 Frw  
10. Failure to provide 
prescriptions/reports for distribution 
of narcotics and controlled products 
at the time of inspection   100,000 Frw  
11. Any change to the authorization 
without notifying the Authority 
within the prescribed timelines  100,000 Frw  
12. Relocation without notifying the 
Authority  100,000 Frw  
13. Obstruction of inspector  from Rwanda 
Food and Drugs Authority   100,000 Frw  for each day of obstructions