Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Produ cts 
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
GUIDELINES FOR  LICENSING OF PUBLIC AND PRIVATE 
MANUFACTURERS, DISTRIBUTORS, WHOLESALERS AND 
RETAILERS OF MEDICAL PRODUCTS  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
SEPTEMBER , 2022  
Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 2 of 71  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
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GUIDELINES DEVELOPME NT HISTORY  
 
DRAFT ZERO   17/08/ 2020  
ADOPTION BY RWANDA FDA  24/08/ 2020  
STAKEHOLDERS CONSULTATION  26/08/ 2020  
ADOPTION OF STAKEHOLDERS’ COMMENTS  28/08/2020  
DATE FOR COMING INTO EFFECT  26/09/2022  
 
Document Revision History  
 
Date of 
revision  Revision 
number  Changes made and/or reasons for revision  
12/07/2021  1 1. Chapter II is renamed LICENSING & INSPECTIONS instead of 
Licensing Requirements  
2. Application forms, Formats of w license, Format of notification 
letter for withdrawal of premise license  / Certificate and 
requirements for application for renewal of the premise license  are 
included  
28/12/2021  2 1. The timeline for standards of service delivery has been added . 
2. Description of different sections of the inspection report has been 
added.  
3. Revisi on of requirements to obtain a premise license . 
4. The title is renamed as Guidelines Governing Licensing of public 
and private Manufacturers, Distributors, Wholesalers and Ret ailers 
of Medical Products instead of Guidelines for Licensing to 
Manufacture, to Operate as Wholesale and Retail Seller of Medical 
Products.  
5. Categorization of inspection findings has been added  
6. The application form was revised to be used for all categori es of 
premises to replace the former application forms by category  
24/08/2022  3 1. Amendment of space requirements of premises of medical 
products: Private and public Wholesalers, Retailers, 
Orthopedic  and optical shops, health Centre  and health posts  
2. Clari fication on the validity of the premise license  for renewal 
and other variations  
3. The Annex I: Process flow chart was revised  
4. The Annex III: Premise registration certificate was added  
5. The Annex VI: was revised  
6. Editorial changes to align with the new forma t 
  Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 4 of 71  
TABLE OF CONTENTS  
 
FOREWORD  ................................ ................................ .....................  Error! Bookmark not defined.  
GUIDELINES DEVELOPMENT HISTORY  ................................ ................................ .....................  2 
DOCUMENT REVISION HISTORY  ................................ ................................ ................................ . 3 
TABLE OF CONTENTS  ................................ ................................ ................................ ....................  4 
ACRONYMS AND ABBREVIATIONS  ................................ ................................ ............................  7 
GLOSSARY / Definitions  ................................ ................................ ................................ ...................  8 
1. INTRODUCTION  ................................ ................................ ................................ ..................  11 
1.1 Scope  ................................ ................................ ................................ ................................ ............  11 
2. LICENSING AND INSPECTIONS  ................................ ................................ .......................  11 
2.2 Inspections  ................................ ................................ ................................ ................................ ... 12 
2.2.1 Types of inspections  ................................ ................................ ................................ .................  12 
2.2.2 Approval of the premises  ................................ ................................ ................................ ..........  13 
3. MEDICAL PRODUCTS MANUFACTURING FACILITY  ................................ ........................  14 
3.1 Location of premises for medical products manufacturing  ................................ .........................  15 
3.2 Standards of construction  ................................ ................................ ................................ ............  15 
3.3 Suitability of production area s ................................ ................................ ................................ ..... 16 
3.4 Regular water supply  ................................ ................................ ................................ ...................  17 
3.5 Storage areas and environmental controls  ................................ ................................ ...................  17 
3.6 Containers to be cleaned  ................................ ................................ ................................ ..............  18 
3.7 Descriptive materials to be kept secure  ................................ ................................ .......................  18 
3.8 Design, construction, location an d maintenance of equipment  ................................ ...................  18 
3.9 Fire -fighting equipment  ................................ ................................ ................................ ...............  19 
3.10 Compliance with the law on occupational health and safety  ................................ .....................  19 
3.11 Weighing, measuring, testing and recording equipment to be checked  ................................ .... 19 
3.12 Quality control areas  ................................ ................................ ................................ ..................  19 
3.13 Minimum floor space and height  ................................ ................................ ...............................  20 
3.14 Documentation  ................................ ................................ ................................ ...........................  20 
4. PREMISES OF DISTRIBUTORS, WHOLE SALERS AND RETAILERS OF MEDICAL 
PRODUCTS  ................................ ................................ ................................ ................................ ...... 20 
4.1 Location of premises for distributors, wholesalers and retailers of medical products  ................  20 
4.2 Standards of construction  ................................ ................................ ................................ ............  21 
4.3 Premises shall be in good state of repair, maintenance and sanitation  ................................ ........  21 
4.4 Storage ar eas ................................ ................................ ................................ ................................  21 
4.4 Minimum floor space and height  ................................ ................................ ................................ . 22 
4.5 Documentation and related controls  ................................ ................................ ............................  23 
5. PERSONNEL  ................................ ................................ ................................ .........................  23 
5.1 Personnel for the medical products manufacturing facility  ................................ ....................  23 
5.1.1  Training  ................................ ................................ ................................ ...............................  27 
6. REQUIREMENTS FOR PREMISE REGISTRATION AND LICENSING  ................................  28 
6.2 Requirements to open a human wholesale pharmacy  ................................ ................................ .. 29 
6.3. Requirements to open a huma n wholesale of medical device  ................................ ....................  30 
6.4. Requirements to open a veterinary wholesale pharmacy  ................................ ...........................  31 
6.5 Requirements to open a veterinary retail pharmacy  ................................ ................................ .... 31 Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
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6.6 Requirements to open a veterinary drug shop  ................................ ................................ .............  32 
6.7 Requirements to open a human retail pharmacy  ................................ ................................ ..........  33 
6.8 Requirements to open an orthopedic shop  ................................ ................................ ...................  34 
6.9 Requirements to op en an optical shop  ................................ ................................ .........................  34 
6.10 Requirements for assistant technician  ................................ ................................ .......................  35 
7.REQUIREMENTS TO RE -GRANT A LICENSE OR APPROVAL OF A SUBSTANT IAL 
MODIFICATION  ................................ ................................ ................................ ..............................  35 
7.1 Requirements for relocation or additional storage space of the licensed premise  .......................  36 
7.2 Requirements to cha nge the authorized personnel of the licensed premise  ................................  36 
7.3 Requirements to change the name of establishment  ................................ ................................ .... 37 
7.4 Requirements t o change the ownership of the licensed premise  ................................ .................  37 
7.5 Requirements to close the licensed establishment  ................................ ................................ ....... 38 
7.6 Requirements for ren ewal of the premise license  ................................ ................................ ........  38 
8. LICENSING OF PUBLIC AND PRIVATE HOSPITAL PHARMACIES  ................................ .. 38 
8.1 Personnel  ................................ ................................ ................................ ................................ ...... 39 
8.2 Premises  ................................ ................................ ................................ ................................ ....... 39 
8.3 Equipment  ................................ ................................ ................................ ................................ .... 40 
8.4 Requirements for licensing hospital pharmacies (referr al, districts hospitals for public institutions 
and all private hospital pharmacies)  ................................ ................................ ................................ .. 40 
8.5 Documentation and related controls  ................................ ................................ ............................  41 
9.LICENSING OF CENTRAL MEDICAL STORE AND THE BRANCHES  ................................  41 
9.1 Personnel  ................................ ................................ ................................ ................................ ...... 42 
9.2 Premises  ................................ ................................ ................................ ................................ ....... 42 
9.3 Equipment  ................................ ................................ ................................ ................................ .... 42 
9.4 Requirements for licensing the central medical store and the branches  ................................ ...... 43 
9.5 Documenta tion and related controls  ................................ ................................ ............................  43 
10.1 Personnel  ................................ ................................ ................................ ................................ .... 44 
10.2 Premises  ................................ ................................ ................................ ................................ ..... 44 
10.3 Equipment  ................................ ................................ ................................ ................................ .. 45 
10.4 Requirements for licensing the health center and health post pharmacies  ................................  45 
10.5 Documentation and related cont rols ................................ ................................ ..........................  46 
10.6 Management of controlled substances  ................................ ................................ .......................  46 
11. GOOD PRACTICES  ................................ ................................ ................................ ...................  46 
11.1 Good Distribution Practice  ................................ ................................ ................................ ........  46 
11.1.1. Transport and delivery Validation  ................................ ................................ .........................  46 
11.2 Good Manufacturing Practice  ................................ ................................ ................................ .... 47 
11.3 Good Dispensing Practice  ................................ ................................ ................................ ..........  47 
12. ESTABLISHMENT OF LICENSING AND INSPECTION TECHNICAL AND ADVISORY 
COMMITTEE  ................................ ................................ ................................ ................................ .... 47 
13. VALIDITY OF AN APPLICATION AND AUTHORIZATION ................................ ...............  47 
13.1 Validity of an application  ................................ ................................ ................................ ..........  47 
13.2 Validity of an authorization  ................................ ................................ ................................ ....... 47 
13.3 Display of the authorization  ................................ ................................ ................................ ....... 47 
13.4 Display of sign post  ................................ ................................ ................................ ...................  48 
14. CATEGORIZATION OF INSPECTION FINDINGS  ................................ ................................  48 Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
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14.1 Manufacturing facilities  ................................ ................................ ................................ .............  49 
14.1.1 Critical no n-compliances  ................................ ................................ ................................ ........  49 
14.1.2 Major non -compliances  ................................ ................................ ................................ ..........  50 
14.1.3 Minor (other) non -compliances  ................................ ................................ ..............................  51 
14.2 Public and private distributors/wholesalers of medical products  ................................ ..............  52 
14.2.1 Critical non -compliances  ................................ ................................ ................................ ........  52 
14.2.2 Major non -compliances  ................................ ................................ ................................ ..........  53 
14.2.3 Minor (other) non -compliances  ................................ ................................ ..............................  54 
14.3 Public and private retailers of medical products  ................................ ................................ ........  54 
14.3.1 Critical non -compliances  ................................ ................................ ................................ ........  54 
14.3.2 Major non -compliances  ................................ ................................ ................................ ..........  55 
14.3.3 Minor (other) non -compliances  ................................ ................................ ..............................  56 
15. WARNING, SUSPENSION AND REVOCATION  ................................ ................................ ... 56 
16. APPEALS AND REVIEW  ................................ ................................ ................................ ..........  58 
17. COMMENCEMENT  ................................ ................................ ................................ ...................  58 
ENDORSEMENT OF THE GUIDELINES  ................................ ...... Error! Bookmark not defined.  
ANNEX I: PROCESS FLOW CHART  ................................ ................................ .............................  62 
ANNEX II: APPLICATION FORM  ................................ ................................ ................................ . 63 
ANNEX III: PREMISE REGISTRATION CERTIFICATE  ................................ .............................  68 
ANNEX IV: FORMAT OF AUTHORIZATION ISSUED  ................................ ..............................  68 
ANNEX V: LIST OF NOTIFICATION FOR USE WITH THESE GUIDELINES  .........................  71 
  Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
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ACRONYMS AND ABBREVIATIONS  
 
FDA              Food and Drugs Authority  
GDP             Good Distribution Practice s 
GMP              Good Manufacturing Practice s 
GSP                      Good Storage Practices  
HVAC             Heating, Ventilation, and Air Conditioning  
RDB                    Rwanda Developmen t Board  
 
 
  Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 8 of 71  
GLOSSARY  / DEFINITIONS  
 
In these Guidelines, unless the context otherwise states:  
 
"Applicant " means any legal or natural person, established within or outside Rwanda, seeking to 
obtain or having obtained the license to manufacture medical pro ducts;  
 
“Authority ” means Rwanda Food and Drugs Authority  or its acronym “Rwanda FDA”, established 
under Article 2 of the Law;  
 
“Authorization ” means a legal document granted by Rwanda Food and Drug Authority to an 
applicant under the Law N 003/2018 of 09/ 02/2018 establishing Rwanda FDA and determining its 
mission, organization and functioning; it includes licenses, permits, and certificates.  
 
“Authorized personnel”  means an individual who possesses a recognized  academic  degree, has 
extensive knowledg e, tra ining and experience, and successfully demonstrated his /her ability to solve 
or resolve problems relating to the subject matter.  
 
“Critical Non-compliance ” When the deviation affects a quality attribute, a critical process 
parameter, an equipment or instru ment critical for process or control, of which the impact to patients 
(personnel or environment) is highly probable, including life threatening situation, the deviation is 
categorized as Critical requiring immediate action, investigated and documented. A “ Critical” non-
compliance  may consist of several related non-compliances , none of which on its own may be 
“Critical”, but which may together represent a” Critical” non-compliance , or systems’ failure where 
a risk of harm was identified and should be explain ed and reported as such.  
 
“Critical equipment” means any piece of the  equipment, instrument , or systems, whose malfunction 
or failure may cause variation in the quality and safety of the medical products.  
 
“Distributor”  means a person or organization who  receives, stores, warehouses, handles, holds, 
offers, markets or displays medical products. A distributor 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, supplier s, retailers.  
 
“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 numerous 
activities which occur during the distribution proce ss as well as providing a tool to secure the 
distribution system from falsified, unapproved, illegally imported, stolen, substandard, adulterated 
or misbranded products.  
 
“Good manufacturing practices or its acronym  “GMP” means that part of quality assuran ce 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.  Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
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“Good storage practices  or its acronym “GSP” means that part of quality assu rance that ensures that 
the quality of products is maintained by means of adequate control throughout the storage thereof.  
 
“Inspection ” means an organized examination or formal evaluation exercise. Inspection means also 
“A visit to a factory or other buil ding to check that everything is satisfactory and all rules are being 
obeyed. An official check done on something to see that it is of the right standard or quality, or 
whether it is safe to use.  
 
“Inspector”  means a person  appointed, authorized and design ated by the Authority in accordance 
with laws  tasked wit h performing inspection -related duties.  
  
“Magistral preparation”  means medicines  prepared in a pharmacy for an individual patient in 
accordance to a prescription  from a doctor . 
 
“Manufacturer”  means  a person or corporation, or other entity engaged in the business of 
manufacturing medical products;  
 
“Minister”  means the Minister responsible for health  
 
“Medical product”  includes human and veterinary drugs; human and animal vaccines and other 
biologic al products, poisonous substances, herbal medicines, medicated cosmetics, human and 
veterinary medical devices, laboratory and cleaning chemicals and pesticides  
 
“Minor/Other Non-compliance  A non-compliance  that is not classified as either “Critical” or 
“Major”, but indicates failure to meet the standards of premises suitability. A non-compliance  may 
be judged as “Minor”  because there is insufficient information to classify it as “Critical” or “Major”.  
 
“Major Non-compliance ” A non-compliance  that is not a “Critical” non-compliance , but could have 
major effects on the overall safety, efficacy and quality of the medical products. This consists of 
several  
“Minor/Other”  related non-compliances , none of which on its own may be “Major”, but which may 
together rep resent a “Major” non-compliance  or systems failure and should be explained and reported 
as such.  
 
“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 functions. It also 
means products used in disinfecting premises in which food and drugs are manufactured, prepared 
or stored, cleaning  hospitals, equipment and farm houses  
“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.  
 Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
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“Quality Risk Management”  means  a systematic process for the assessment, control, 
communication and review of risks to the quality of products in the supply chain  
 
“Retailer”  is an entity that is authorized to carry on the busine ss of dispensing or providing medical 
products directly to a patient.   
“Sale” means sell by wholesaler or retailer and includes  
a) advertise, label, prepare, expose, offer for sale;  
b) smuggle, administer, hawk, supply, barter, or dispose of to any person;  
c) distribute, deliver or transmit, by way of gift or sample or in any other way whatsoever  
 
“Tariff/Fees”  includes any charge made or levied in connections with the services rendered by the 
Authority.   
 
“Wholesaler”  is an entity that is authorized to carry on th e 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 Guidelines, the following verbal forms are used:  
“shall ” indicates a r equirement;  
“should ” indicates a recommendation;  
“may” indicates a permission; and  
“can” indicates a possibility or a capability.  
 
  Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
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1. INTRODUCTION  
 
The “ Guidelines for Licensing of Public and Private Manufacturers, Distributors, Wholesalers and 
Retailers o f Medical Products  “Revision 3” is a Rwanda Food and Drugs Authority publication which 
sets out procedures and requirements for the registration and licensing of premises selling regulated 
produc ts. They are issued pursuant to  of Article 3 of Law N° 003/20 18 of 09/02/2018 establishing 
the Rwanda FDA and determining its mission, organization and functioning , and Article 1 and 3 of 
Law N° 47/2012 of 14/01/2013 relating to the regulation and inspection of food  and pharmaceutical 
products as well as registratio n of activities and premises  in terms of the Regulations 
FDISM/FDIC/TRG/001 , Governing Licensing of Public and Private Manufacturers, Distributors, 
Wholesalers and Retailers of Medical Products.  
 
The purpose of these g uidelines for licensing of public and private manufacturers, distributors, 
wholesalers and r etailers of medical p roducts  is to give guidance on the requirements for the  
registration and  licensing of premises that manufacture, store, and distribute regulated products as 
the licensing of such pr emises forms an integral part of ensuring that regulated products maintain 
their integrity throughout their shelf life  and supply chain . Adherence to the guidelines by applicants 
will facilitate timely review and processing of applications.  
 
1.1 Scope  
 
These guidelines  should  apply to domestic, public, and private manufacturers, distributers, 
wholesalers and retailers of medical products involved in the manufacture, storage, sale, distribution, 
and dispensing of medical products as stipulated in Article 3 o f Law No 003/2018 of 09/02/2018 
establishing Rwanda Food and Drugs Authority and determining its mission, organization and 
functioning.  
 
2. LICENSING AND INSPEC TIONS  
2.1. General requirements for application of registration certificate and premise license  
a) All applications shall be submitted to Rwanda FDA head office or via email addressed to the 
Director General at (info@rwandafda.gov.rw ) or via  integrated  management information 
system ; 
 
b) An applicant for premise  registration and  licensing of medical  products shall submit the 
requirements as described in these guidelines ; 
 
c) Applicants shall pay all the prescribed fees as per the  relevant  regulations at the time of 
application through the bank accounts as indicated on R wanda FDA website. Such payment 
does not mean to be granted a license prior to fulfilling requirements for registration and 
licensing ; 
 
d) Applicants for manufacturing facility of medical products will be required to meet the Good 
Manufacturing Practices (GMP ) requirements   Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
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e) Applicants for wholesale rs and retail ers of medical products  will be required to meet the Good 
Distribution Practices (GDP) and Good Storage Practices (GSP) requirements as detailed in 
the guidelines for Good Storage and Good Distribution p ractices.  
 
f) For outsourced GDP and GSP activities: A written and approved contract or formal agreement 
between the contract giver and contract acceptor  
 
g) All applicants intending to establish new manufacturing facilities of medical products are 
advised to c ontact Rwanda FDA for guidance before embarking on any establishment;  
 
h) Incomplete application for registration and licensing a new premise shall not be processed ; 
 
i) Applicants wishing to deal in both veterinary medicines and agricultural products shall appl y 
for premise registration and premise license separately in their respective competent 
authorities. The veterinary premises shall apply for registration and licens ing in Rwanda 
FDA. Applicants should meet the minimum requirements for suitability of premis es and 
personnel. The two sections shall be separated.  
 
2.2 Inspections  
 
The Authority shall conduct an inspection for confirmation of the compliance requirements in order 
to grant or re -grant a premise license  or approval of a substantial modification.  
 
Premises that do not comply with the requirements for suitability shall not be eligible for 
consideration for an authorization.  
 
2.2.1 Types of inspections  
 
There are four types of licensing inspection s divided into the following categories:  
 
a) Pre-approval  inspection ; 
 
b) Concise  inspection ; 
 
c) Follow -up inspection;  
 
d) Special inspection; and  
 
e) Any other types as the Authority may designate.  
 
The inspection should  be conducted  as follows:  
 
a) the pre-approval  inspection is a full inspection of all applicable component s of licensing 
provisions  for manufacturer, wholesaler, distributor and retailers. It may be indicated when 
the premise  is: Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
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i.Newly established  
 
ii.Requests for renewal of a premise license  
 
iii.Has a history on non -compliance with GMP;  GDP and GSP  
 
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 not been inspect ed during the last 3 to 5 years;  
 
b) Concise  inspections  are the evaluation of limited aspects relating to licensing compliance 
within a premise . The premise  with a consistent record of compliance with licensing 
requirements  through previous routine inspections are eligible for concise inspections. The 
focus of a con cise inspectio n is on a limited number of licensing requirements, plus the 
identification of any significant changes that could have been introduced since the last 
inspection. Evidence of non-compliances observed during a concise inspection should trigger 
a more comprehensive inspection;  
 
c) Follow -up inspections  (re-inspection) are made to monitor the result of corrective measures. 
They are normally carried out from 6 weeks to 6 months after the initial inspection, depending 
on the nature of the defects and t he work to be undertaken. They are limited to specific 
licensing  requirements that have not been observed or that hav e been inadequately 
implemented;  
 
d) Special  inspections  may be necessary to undertake spot checks following complaints, recalls 
related to su spected quality defects in products or reports of adverse drug reactions. Such 
inspections may be focused on one product, a group of related products, or specific operations 
such as mixing, sterilization, or labeling. Special visits may be also made to est ablish how a 
specific product is manufactured as a prerequisite for marketing approval or issuance of an 
export certificate . 
 
2.2.2 Approval of the premises  
 
Upon approval of findings of the inspection to manufacture, distribute, to operate as wholesalers or 
retailers of medical product s, Rwanda FDA shall notify the applicant the decision based on the 
findings of the inspections.  
 
In case of compliance to the premise registration and licensing requirements, the registration 
certificate and  premise license  shall be granted to the applicant. In case of non -compliances to the 
premise licensing requirements, a feedback letter with corrective actions shall be issued to the 
applicant.  
 Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
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3. MEDICAL PRODUCTS MA NUFACTURING FACILITY  
 
The Authority shall inspect the pr emises to determine their suitability for manufacturing of medical 
products . Applicants should fulfill the prerequisites as detailed below prior to premise licensing. 
Premises that do not comply with the requirements for suitability shall not be eligible f or 
consideration of an authorization.  
 
Applicants should apply for:  
 
1) Location approval for medical product manufacturers:  
 
The Authority shall approve the site location for the medical product manufacturers after satisfactory 
review of preliminary documen ts: 
 
a) Letter of intent ; 
 
b) Land master plan indicating the location and the surrounding activities . 
 
2) Approval of the factory design and layout to comply with the Good Manufacturing Practices 
before the start of site construction , this covers:  
 
a) Environmental impact assessment  
 
b) Production process flow chart, sanitation facilities (Clean water and waste water treatment 
system),  
 
c) Mechanical ventilation /Air handling unit /Heat, Ventilation and Air Conditioning (HVAC).  
 
d) Construction and process materials such as p harmaceutical grade material,  
 
e) Finishing materials for production floor, ceiling and walls should be seamless, easy to clean.  
 
Preliminary inspections shall be carried out at various stages of construction and setting up the site.  
These include:  
 
a) Site insp ection before construction  
 
b) Site inspection at completion of construction of the premises;  
 
c) Site inspection at the completion of installation of equipment and utilities, e.g., HVAC, water, 
compressed gases, etc.;  
 
Upon receipt of complete required document s for registration and license to manufacture, Distribute, 
to operate as Wholesalers or Retailers and payment of prescribed fee, inspection of the premises shall 
be conducted.  Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 15 of 71  
 
Prior to issuance of registration certificate and license  for premises dealing with medical products, 
the intended premises shall comply to the  following  premise suitability requirements.   
 
3.1 Location of premises for medical products manufacturing  
 
The premises shall be located in a place where they cannot be contaminated by the ex ternal 
environment or other activities or contaminating the neighboring  environment.  
 
3.2 Standards of construction  
 
The premises shall:  
 
a) Be of a permanent nature;  
 
b) Be protected against, adverse weather conditions including dust, ground w ater seepage;  
verm in and pest infestation;  
 
c) Have sufficient space for the carrying out and supervision of the necessary operations;  
 
d) Have air intakes, exhausts, and associated pipe work and trucking sited so as to avoid 
contamination;  
 
e) Have the plumbing, electrical and othe r 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;  
 
f) Have drains that are of an adequate size and that are provided ; 
 
g) With sufficient traps and proper ventilation;  
 
h) Have well marked fire exits and the access to the fire exits kept clear at all times;  
 
i) Have floors and walls made of a washable and impervious material with a flat surface free of 
cracks and a c eiling covered with a non -flaking finis h that allows easy cleaning;  
 
j) Proper lighting , ventilated and have appropriate air -control facilities including temperature, 
humidity, and filtration for the operations to be undertaken;  
 
k) The premises shall have appr opriate toilet facilities, soap, and hand washing facilities with 
single -use towels or hand air drier. Toilets should not directly communicate w ith production 
or storage areas;  
 
l) Facilities for changing clothes and street shoes should be easily accessible a nd appr opriate 
for the number of users;  Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
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m) Eating and drinking areas or rooms shou ld be separate from other areas;  
 
n) Maintenance workshops should as far as possible is separated from production  areas;  
 
o) Whenever parts and tools are stored in the production area , they should be kept in rooms o r 
lockers reserved for that use;  
 
p) The premises including the external surroundings shall be maintained in a clean and tidy 
condition with regular and adequate clearance of waste materials.  
 
3.3 Suitability of production area s 
 
a) 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 cle anliness levels;  
 
b) 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 medicinal products or their components, to avoid cross -contamination and 
to minimize the risk of omission o r wrong application of any of the  manufacturing or control 
steps;  
 
c) Weighing of starting materials shall be carried out in a separate weig hing room designed for 
that use;  
 
d) Where starting and primary packaging materials, intermediate or bulk products are exp osed 
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 necessary, disinfection;  
 
e) Pipe work, li ght 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;  
 
f) 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 facil itate cleaning and 
disinfection;  
 
g) Production areas should be effectively ventilated, with air con trol 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;  
 
h) In cases where dust is generated (e.g., during sampli ng, weighing, mixing and processing 
operations, packaging of dry products), specific provisions shall be taken to avoid cross - 
contam ination and facilitate cleaning;  Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 17 of 71  
i) Premises for the packaging of medical products should be specifically designed and laid ou t 
so as to avoid  mix-ups or cross -contamination;  
 
j) Production areas should be well lit, particularly where visual on -line controls are carried out.  
 
k) Hand washing facilities with single -use towels or hand air dri er; hand sanitizing facilities and 
appropriate  protective garments prior to entering controlled areas should be available.  
 
3.4 Regular water supply  
 
a) The premises shall have a regular  and sufficient supply of water;  
 
b) Water treatment plants and distribution systems should be designed, constructed and 
maintained so as to ensure a reliable source of water of an appropriate quality;  
 
c) The chemical and microbiological quality of water used in production sh ould be specified 
and monitored;  
 
d) Water for injections should be produced, stored and distributed in a m anner which prevents 
microbial growth, for example by constant circulation at a temperature above 70°C.  
 
3.5 Storage areas and environmental controls  
 
a) Be designed or adapted to ensure good storage conditions;  
 
b) Be secure and with segregated areas for the st orage of rejected, recalled or returned materials 
or products;  
 
c) Have access to the materials and goods restricted to authorized personnel only;  
 
d) 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 recalled;  
 
e) Be clean, dry and maintained within acceptable temperature limits; where special storage 
conditions are required (e.g., t emperature, humidity) these should be provided, checked and 
monitored;  
 
f) Be provided with receiving and dispatch bays to protect materials and products from the 
weather;  
 
g) Be provided with receptions areas which shall be designed and equipped to allow contai ners 
of incoming materials to be cleaned where necessary before storage;  Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 18 of 71  
h) Where quarantine status is ensured by storage in separate areas, these areas shall be clearly 
marked and their access restricted to authorized personnel; any system replacing the phys ical 
quarantine should give equivalent security;  
 
i) Have provisions where the starting materials and finished goods are stored under cover and 
off the floor;  
 
j) 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;  
 
k) Have provisions where highly active materials or products are stored in safe and secure areas;  
 
l) Have safe and secure storage of printed packaging material . 
 
3.6 Containers to be cleaned  
 
All processing containers, vessels 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.  
 
 3.7 Descriptive materials to be  kept secure  
 
1) All product labels, printed packaging and descriptive materials shall:  
 
a) Be stored in a secure manner; and  
 
b) Be accessed by only authorized personnel.  
 
2) Proper records shall be kept for the labels, printed packaging and descriptive materials iss ued, to 
avoid any mix -up. 
 
 3.8 D esign, construction, location and maintenance of equipment  
 
a) Manufacturing equipment shall be designed, located and maintain ed to suit its intended 
purpose;  
 
b) Repair and maintenance operations shall not present any hazard to the quality of the products.  
 
c) Manufacturing equipment shall be designed so that it can be easily and thoroughly cleaned. 
It shall be cleaned according to detailed and written procedures and stored only in a clean and 
dry condition;  
 
d) Washing and cleaning eq uipment shall be chosen and used in order not to be a source of 
contamination;  
 Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 19 of 71  
e) Equipment shall be installed in such a way as to prevent any ri sk of error or of contamination;  
 
f) 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 the quality of the prod uct and thus present any hazard;  
 
g) Balances and measuring equipment of an appropriate  range and precision shall be available 
for pr oduction and control operations;  
 
h) Measuring, weighing, recording and control equipment shall be calibrated and checked at 
defined intervals by appropriate methods. Adequate records of such tests shall be mainta ined.  
 
i) Fixed pipework shall be clearly labelled to indicate the contents and, where ap plicable, the 
direction of flow;  
 
j) Distilled, deionized and, where appropriate, other water pipes shall be sanitized according to 
written procedures that detail the action  limits for microbiological contaminati on and the 
measures to be taken;  
 
k) Defective equipment shall, if possible, be removed from production and quality control areas, 
or at least be clearly labelled as defective.  
 
3.9 Fire-fighting equipment  
 
The premises shall have sufficient fire -fighting equipment which shall, at all times, be in good 
condition and readily accessible.  
 
3.10 Compliance with the law on occupational health and safety  
 
The premises shall comply with the requirements of the Law N° 66/2018 of 30/08/2018 Regulating 
Labour in Rwanda, which elaborates the requirements for Occupational Health and Safety in its 
Chapter 5.  
 
3.11 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.  
 
 3.12 Quality control areas  
 
a) Quality Control laboratories shall be separated from production areas. This is particularly 
important for laboratories fo r the control of biologicals, microbiological and radioisotopes, 
which shall also be separated from each other.  Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 20 of 71  
b) 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.  
 
c) Separate rooms may be necessary to protect sensitive instruments from vibration, electrical 
interference, humidity, etc.  
 
 3.13 Minimum floor space and hei ght  
 
The manufacturing facility of medical products shall have up to a height of  2.5 meters  from the floor, 
be smooth and capable of being kept clean. The minimum floor shall have adequate space to 
accommodate all manufacturing activities carried out.   
 
3.14 Documentation  
 
The manufacturing premises shall keep the following records:  
 
a) Manufacturing records  
 
b) Medical examination records  
 
c) Distribution records  
 
d) Suppliers’ records  
 
e) Recall records  
 
f) Compliant records  
 
g) Maintenance and calibration records  
 
h) Cleaning  and disinfection records  
 
i) Quality Control Records  
 
4. PREMISES OF DISTRIBU TORS, WHOLESALERS AN D RETAILERS OF MEDIC AL 
PRODUCTS  
 
4.1 Location of premises for distributors, wholesalers and retailers of medical products  
 
The premises shall be located in a pla ce where they cannot be contaminated from the external 
environment or other activities.  
 
 Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 21 of 71  
4.2 Standards of construction  
 
The premises shall:  
 
a) Be of a permanent nature ; 
 
b) Being meant for commercial purposes or warehousing;  
 
c) Be protected against adverse weath er conditions including dust, ground water seepage, 
vermin and pest infestation;  
 
d) Have adequate space for the carrying out and supervision of the necessary operations;  
 
e) Have floors and walls made of a washable and impervious material with a flat surface fr ee of 
cracks and a ceiling covered with a non -flaking finish that allows easy cleani ng;  
 
f) Be well lit, ventilated and have appropriate air -control facilities including temperature and 
humidity.  
 
4.3 Premises shall be in good state of repair, maintenance an d sanitation  
 
a) The process of maintenance and repair shall not, while being carried out, cause any 
contamina tion of ingredients or products;  
 
b) The external surroundings shall be maintained in a clean and tidy condition with regular and 
adequa te clearance of waste materials;  
 
c) The premises shall have a regular and sufficient supply of water of su itable quality;  
 
d) The premises shall have appropriate toilet facilities and hand washing facilities with singl e- 
use towels or hand air drier;  
 
e) The premises shall have s ufficient fire -fighting equipment which shall, at all times, be in good 
condition and acce ssible;  
4.4 Storage areas  
 
The storage areas for medical products shall be well covered and off the floor in an area:  
 
a) That is secure and has adequate space;  
 
b) That is  laid out to allow clear separation of different materials and products to minimize the 
risk of mix -up; 
 
c) Access to the materials and goods is restricted to authorized personnel only;  Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 22 of 71  
d) Medical Products that are temperature sensitive shall be kept in a temper ature -controlled 
storage facility;  
 
e) With separate area in the storage facility where recalled, expired or rejected drugs shall be 
stored under lock and key.  
 
 4.4 Minimum floor space and height  
 
a) For a distributor or wholesaler dealing with the human medic ines or medical devices, the total 
floor space shall have a minimum space of 90 square meters. The sales area shall have 
minimum floor space of 30 square meters, 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 
meter s from the floor to the ceiling;  
 
b) For distributor or wholesaler dealing with veterinary medicines, total floor space shall have a 
minimum space of 70 square meters. The sales area shall have minimum floor  space of 25 
square meters, and records shall be maintained in this area. The storage areas shall have 
minimum floor area of 45 square meters; and minimum height of 2.5 meters from the floor to 
the ceiling;  
 
c) For a retailer dealing with human medicines, the  retail pharmacy shall have a layout of one 
room with a minimum space of 40 square meters for Kigali City and secondary cities. The 
minimum height shall be 2.5 meters  from the floor to the ceiling;  
 
d) For a retailer dealing with human medicines, the retail p harmacy shall have a layout of one 
room with a minimum space of 30 square meters for the rest of the country. The minimum 
height shall be 2.5 meters from the floor to the ceiling.  
 
Note: For human retail pharmacy that shall apply for magistral preparation,  the minimum 
additional space of 10 square meters in the same establishment shall be dedicated to 
accommodate magistral preparation activities.  
 
e) For an establishment dealing with veterinary medicines, the retail pharmacy shall have a 
layout of one room wit h a minimum space of 30 square meters  for Kigali City and secondary 
cities. The minimum height shall be 2.5 meter s from the floor to the ceiling;  
 
f) For an establishment dealing with veterinary medicines, the retail pharmacy shall have a 
layout of one room w ith a minimum space of 20 square meters  for the rest of the country. The 
minimum height shall be 2.5 meter s from the floor to the ceiling;  
 
g) For an establishment dealing with optical or orthopedic products, the retail of optical and 
orthopedic shop shall ha ve a layout of one room with a minimum space of 30 square meters. 
The minimum height shall be  2.5 meter s from the floor to the ceiling;  
 Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
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h) The sales and storage areas shall be orderly, have adequate space, and protected from dir ect 
sunlight, heat and moistur e; 
 
i) The dispensing area of the retailers of medical products shall:  
 
i.be a separate lockable area with no access for the public;  
 
ii.have benches and working surfaces with impervious washable tops;  
 
iii. Be fitted with a sink with running water, soap, single -use to wels; and hand sanitizing 
facility;  
 
iv.Have provision for staff to put on appropriate protective garments;  
 
v.The premises shall not be shared with any medical clinic, veterinary surgery or any other 
business.  
 
4.5 Documentation and related controls  
 
a) All recor ds (including but not limited to invoices, purchase orders, import authorizations, 
sales and distribution records, in the distributor, wholesale premise and retailer’s premises) 
for all medical products and administrative records of the staff shall be prop erly kept in the 
medical products establishment and be readily available to the inspection service when 
request ed for or needed;  
 
b) All entry and exit of medical products must be approved by the responsible authorized 
personnel ; 
 
c) Availability of copy of lice nse to practice of the authorized personnel  in charge where 
applicable;  
 
d) Quarterly reports on the distribution of controlled substances t o be submitted to the Authority;  
 
e) Identify the establishment by a readable sign board with the number of authorizations , names 
and contacts of the authorized personnel  in charge;  
 
f) A copy of  the premise  license and license to practice profession for the responsible authorized 
personnel  shall be conspicuously displayed in the establishment.  
 
5. PERSONNEL  
 
5.1 Personnel for the medi cal products manufacturing facility  
 
a) There are shall be sufficient authorized personnel  to carry out all manufacturing activities and the 
responsibility for every individual has to be clearly understood and recorded;  Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
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b) The manufacturer s hall have an organiza tion chart;  
 
c) All responsible staff shall have their duties recorded in written descriptions and adequate 
authority to c arry out their responsibilities;  
 
d) Duties for authorized person nel may be delegated to designated deputies of s atisfactory 
qualification l evel;  
 
e) There are shall be no gaps or unexplained overlaps in responsibilities of personnel concerned ; 
 
f) Unauthorized personnel shall not enter production, storage and quality control areas or use them 
as passage.  
 
A manufacturing facility shall have the fol lowing key personnel:  
 
i) Head of production ; 
 
ii) Head of quality unit ; 
 
iii) Head of quality assurance ; 
 
iv) Head of quality control ; 
 
v) Authorized personnel.  
 
Key personnel responsible for supervising the manufacture and quality unit including quality 
assurance and quali ty control for manufacture of medical products shall possess the qualification 
with scientific education and practical experience.  
 
g) The head of production should have bachelor education in Pharmacy but if not, available options 
should be of a bachelor hold er in the following:  
 
i)  Pharmac eutical sciences and technology ; 
 
ii) Biological Sciences ;  
 
iii) Chemistry (analytical or organic) or  biochemistry ; 
 
iv) Chemical engineering ; 
 
v) Veterinary medicine ; 
 
vi) Any other relevant qualification . 
 
 Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
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8) The head of quality unit shall ha ve bachelor education in any of the following:  
i) Pharmac eutical sciences and technology ; 
 
ii) Biological Sciences;  
 
iii) Chemistry (analyti cal or organic) or biochemistry ; 
 
iv) Chemical engineering ; 
 
v) Veterinary medicine ; 
 
vi) Any other relevant qualification . 
 
9) The head of  quality control shall have bachelor education in any of the following:  
 
i) Pharmac eutical sciences and technology ; 
 
ii) Biological Sciences ; 
 
iii) Chemistry (analyti cal or organic) or biochemistry ; 
 
iv) Chemical engineering ; 
 
v) Veterinary medicine ; 
 
vi) Any other relevant qual ification . 
 
10) 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 materials and products;  
 Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 26 of 71  
ix) The performance and evaluation in process controls;  
 
x) The retention of records;  
 
xi) The monitoring of complian ce with good manufacturing practice requirements;  
 
xii) The inspection, investigation, and taking of samples, in order to monitor factors that may 
affect product quality.  
 
 11) 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 imple mentation;  
 
iii) To ensure that the production records are evaluated and signed by a designated person before 
they are made available to the quality control department;  
 
iv) To check the maintenance of the department, premises and equipment;  
 
v) To ensure that the app ropriate process validations and calibrations of control equipment are 
performed and recorded, and the reports made available;  
 
vi) To ensure that the required initial and continuing training of production personnel is carried 
out and adapted according to need . 
 
12) The head of the quality unit including quality assurance and quality control department generally 
shall have the following responsibilities:  
 
i) To approve or reject starting 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 chec k the maintenance of the department, premises and equipment;  Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 27 of 71  
vii) To ensure that, appropriate validations, including those of analytical procedures, and 
calibrations of control equipment 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 pro gramme.  
 
5.1.1 Training  
 
It is a requirement to provide on job training for all staff. The following must be undertaken:  
 
1) A manufacturer shall provide training as per written program for all the personnel whose duties 
take them into production areas or into cont rol laboratories including the technical, maintenance, 
and cleaning personnel, and any other personnel whose activities could af fect the quality of the 
product;  
 
2) Recruited personnel shall receive training appropriate to the duties assigned to them in addit ion 
to basic training on theory and practice of good manufacturing practice.  
 
3) All personnel shall receive continuing training, evaluated and records be retrieved a s per 
approved training program;  
 
4) Personnel working in areas where contamination is a hazardo us such as clean areas or Areas 
where  highly  active,  toxic,  infectious, sensitizing materials are handled s hall be given 
specific training;  
 
5) Visitors or untrained personnel shall not enter production and quality control areas, if necessary, 
they shall be c losely supervised and practice personnel hygiene includ ing wearing protective 
clothing;  
 
6) Consultants and contract staff shall be qualified for their service and their training records kept.  
5.2  Personnel for distributors, wholesalers and retailers of medical products  
The supervising personnel of authorized medical products establishments shall:  
 
1) For a distributor of medical products, be a pharmacist or a ny other relevant qualification;  
 
2) For a human wholesale pharm acy, be a registered pharmacist;  Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 28 of 71  
 
3) For a wholesa le veterinary pharmacy, be  a veterinary doctor/pharmacist;  
 
4) For wholesale of optical products be optician or a ny other relevant qualification;  
 
5) For a wholesale of medical devices and diagnostics be a biomedical 
engineer/pharmacist/laboratory technician or any other re levant qualification;  
 
6) For wholesale of orthopedic products be an orthopedist / orthopedic technician or a ny other 
relevant qualification;  
 
7) For a human retail pharm acy, be a registered pharmacist;  
 
8) For a retail veterinary pharmacy, be a registe red veterinary doctor/pharmacist;  
 
9) For a veterinary drug shop, be a registered veterinary technician (A 2 Level) or pharmacy 
technician;  
 
10) For a retail of medical devices and diagnostics be registered biomedical engineer or registered 
pharmacist or any other  relevant qualifi cation;  
 
11) For a retail of optical products be an optician or a ny other relevant qualification;  
 
12) For a retail orthopedic product, be an orthopedist or a ny other relevant qualification;  
 
13) Public hospital pharmacies (referral, provincial and di strict hospitals) be  a registered 
pharmacist;  
 
14) Public health center pharmacies be a pharmacist or any other relevant qualification as required  
by the Supervising Institution;  
 
15) Private hosp ital pharmacies be a pharmacist;  
 
16) Supporting staffing requirements ( optional): Assistant Pharmacist, Pharmacy Technician, 
Medical Assistant, Veterinary Technician or Nurse depending on the c ategory of the 
establishment with minimum 3  years of experience in that domain . Assistant staff must be 
recognized officially by the A uthority.   
 
6. REQUIREMENTS FOR PRE MISE REGISTRATION AN D LICENSING  
6.1 R equirements to operate as a manufacturer of medical product  
1) Duly filled application form:  Application form for premise licensing of medical products ; 
 
 
 Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
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2) RDB registration certificate o f the domestic company ; 
 
3) Architectural plan of the site ; 
 
4) Environment impact assessment report ; 
 
5) Proof of payment of the prescribed fees ; 
 
6) List of products to be manufactured ; 
 
7) Lease/rent contract of the premise/house  or any other relevant document ;  
 
8) Nota rized copy of Degree and equivalence if applicable of authorized personnel , with 2 years’  
minimum experience for a Bachelor degree holder; or 6 months’  minimum experience for a 
Master degree holder in the relevant field with working experience in a company  that has 
been approved as manufacturer of medical products ; 
 
9) Notarized Valid License of the authorized personnel  to Practice Profession issued by 
Recognized Professional Councils in Rwanda ; 
 
10) Notarized degrees of the key personnel to be involved in the man ufacturing process, quality 
control and quality assurance ; 
 
11) Professional agreement between the Managing Director of the manufacturing plant and the 
authorized personnel  in case the Managing Director is not the authorized personnel ; 
 
12) Copy of the identity ca rd or passport of both the Managing Director and the authorized 
personnel ; 
 
13) Written commitment of the technician, to respect the laws and regulations relating to the 
pharmacy practices and oversight the quality of products being manufactured;  
 
14) Signed resig nation letter/proof of service delivered issued by the last employer of authorized 
personnel , if applicable;  
 
15) Copy of Valid contract between authorized personnel  and Managing Director of the 
manufacturing facility ; 
 
16) Curriculum vitae of the authorized perso nnel. 
 
 
6.2 R equirements to open a human wholesale pharmacy  
 
1) Duly filled application form: Application form for premise licensing of medical products ; 
 Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 30 of 71  
2) RDB registration certificate of the domestic company ;       
 
3) Lease/rent contract of the premise/house  or any other relevant document;    
 
4) Evidence of payment of prescribed fees to Rwanda FDA Accounts Notarized copy of Degree 
(and Equivalence if applicable) of Authorized personnel , with minimum of 2 months’  
experi ence in supply chain management;  
 
5) Notarized Val id License to Practice Pharmacy Profession is sued National Pharmacy Council;  
 
6) Curriculum vitae of the authorized personnel  ;  
 
7) Professional agreement between the Managing Director of the pharmacy and the authorized 
personnel  in case the Managing Director i s not the authorized personnel ; 
 
8) Copy of the identity card or passport of both the Managing Director and the authorized 
personnel ;   
 
9) Written commitment of the technician to respect the laws and regulations relating to the 
pharmacy practices ;   
 
10) Signed res ignation letter/proof of service delivered issued by the last employer of authorized 
personnel , if applicable ;      
 
11) Copy of valid contract between authorized personnel  and Managing Director of the pharmacy . 
 
6.3. Requirements to open a human wholesale of medical device  
 
1) Duly filled application form: Application form for premise licensing of medical products ; 
 
2) RDB registration cert ificate of the domestic company;  
 
3) Lease/rent contract of the premise/house  or any other relevant document;  
 
4) Evidence of payment of prescribed fees to Rwanda FDA Accounts ;  
 
5) Notarized copy of Degree (and equivalence if applicable) of Authorized personnel ; 
 
6) Notarized Valid License to Practice Profession issued by Recognized Professional Councils 
in Rwanda ; 
 
7) Curriculum vitae of the authorized personnel ; 
 
8) Copy of the identity card or passport of both the Managing Director and the authorized 
personnel ; Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 31 of 71  
9) Written commitment of the technician, to respect the laws and regulations relating to the 
pharmacy practices ; 
 
10) Signed resignation letter/ proof of service delivered issued by the last employer of authorized 
personnel , if applicable ; 
 
11) Copy of valid contract between authorized personnel  and Managing Director of the 
wholesale . 
 
6.4. Requirements to open a veterinary wholesale pharmacy  
 
1) Duly fil led application form: Application form for premise licensing of medical products ;  
 
2) RDB registration cert ificate of the domestic company;   
 
3) Lease/rent contract of the premise/house  or other relevant document;  
 
4) Evidence of payment of prescribed fees to Rwan da FDA Accounts ; 
 
5) Notarized copy of Degree (and equivalence if applicable) of Authorized personnel ; 
 
6) Notarized Valid License to Practice Profession issued by Recognized Professional Councils 
in Rwanda ;  
 
7) Curriculum vitae of the authorized personnel  ; 
 
8) Professional agreement between the Managing Director of the wholesale and the authorized 
personnel  in case the Managing Director is not the authorized personnel ; 
 
9) Copy of the identity card or passport of both the Managing Director and the authorized 
personnel ; 
 
10) Written commitment of the technician to respect the laws and regulations relating to the 
pharmacy practices ; 
 
11) Signed resignation letter/proof of service delivered issued by the last employer of authorized 
personnel , if applicable ; 
 
12) Copy of valid contract  between authorized personnel  and Managing Director of the veterinary 
wholesale pharmacy . 
 
6.5 Requirements to open a veterinary retail pharmacy  
 
1) Duly filled application form: Application form for premise licensing of medical products ; 
 Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 32 of 71  
2) RDB registration ce rtificate of the domestic company;  
 
3) Lease/rent contract of the premise/house  or any other relevant document;  
 
4) Evidence of payment of prescribed fees to Rwanda FDA Accounts ; 
 
5) Notarized copy of Degree (and Equivalence if applicable) of authorized personnel ; 
 
6) Notarized Valid License to Practice Profession issued by Recognized Professional Councils 
in Rwanda ; 
 
7) Curriculum vitae of the new authorized personnel ; 
 
8) Professional agreement between the Managing Director of the wholesale and the authorized 
personnel  in case the Managing Director is not the authorized personnel ; 
 
9) Copy of the identity card or passport of both the Managing Director and the authorized 
personnel ; 
 
10) Written commitment of the technician, to respect the laws and regulations relating to the 
pharma cy practices ; 
 
11) Signed resignation letter/proof of service delivered issued by the last employer of authorized 
personnel , if applicable ;    
 
12) Copy of valid contract between authorized personnel  and Managing Director of the veterinary 
retail pharmacy .  
 
6.6 Requirements to open a veterinary drug shop  
 
1) Duly filled application form: Application form for premise licensing of medical products ; 
 
2) RDB registration certificate of the domestic company ; 
 
3) Lease/rent contract of the premise/house  or any other relevant doc ument;   
 
4) Evidence of payment of prescribed fees to Rwanda FDA Accounts ; 
 
5) Notarized copy of Degree (and equivalence if applicable) of Authorized personnel  (A2 
Level) ; 
 
6) Notarized Valid License to Practice Profession issued by Recognized Professional Councils  
in Rwanda ;  
 
7) Curriculum vitae of the authorized personnel ; Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 33 of 71  
8) Professional agreement between the Managing Director of the wholesale and the authorized 
personnel  in case the Managing Director is not the authorized personnel ; 
 
9) Copy of the identity card or pass port of both the Managing Director and the authorized 
personnel ; 
 
10) Written commitment of the technician to respect the laws and regulations relating to the 
pharmacy practices ; 
 
11) Signed resignation letter/proof of service delivered issued by the last employer  of authorized 
personnel , if applicable ; 
 
12) Copy of valid contract between authorized personnel  and Managing Director of the veterinary 
drug shop .   
 
NB: The veterinary drug shops shall not be located in Kigali City and Secondary cities but shall 
be located in the rest of the country.  
 
6.7 Requirements to open a human retail pharmacy  
 
1) Duly filled application form: Application form for premis e licensing of medical products;  
 
2) RDB registration certificate of the domestic company ; 
 
3) Lease/rent contract of the prem ise/house  or any other relevant document;  
 
4) Evidence of payment of prescribed fees to Rwanda FDA Accounts ; 
 
5) Notarized copy of Degree (and equivalence if applicable) of Authorized personnel , with 
minimum of 2 months experience in community pharmacy ; 
 
6) Notariz ed Valid License to Practice Pharmacy Profession issued National Pharmacy Council   
 
7) Curriculum vitae of the authorized personnel  ; 
 
8) Professional agreement between the Managing Director of the pharmacy and the authorized 
personnel  in case the Managing Dire ctor is not the authorized personnel ; 
 
9) Copy of the identity card or passport of both the managing director and the authorized 
personnel ; 
 
10) Written commitment of the technician, to respect the laws and regulations relating to the 
pharmacy practices ;  
 Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 34 of 71  
11) Signed  resignation letter/proof of service delivered issued by the last employer of authorized 
personnel , if applicable ; 
 
12) Copy of valid contract between authorized personnel  and Managing Director of the pharmacy . 
 
6.8 Requirements to open an orthopedic shop  
  
1) Duly filled application form: Application form for premise licensing of medical products ; 
 
2) RDB registration cert ificate of the domestic company;  
 
3) Lease/rent contract of the premise/house  or any other relevant document;  
 
4) Evidence of payment of prescribed fees  to Rwanda FDA Accounts ;  
 
5) Notarized copy of Degree (and equivalence if applicable) of Authorized personnel ; 
6) Notarized Valid License to Practice Profession issued by Recognized Professional Councils 
in Rwanda ; 
 
7) Curriculum vitae of the authorized personnel ; 
 
8) Professional agreement between the Managing Director of the wholesale and the authorized 
personnel  in case the Managing Director is not the authorized personnel ; 
 
9) Copy of the identity card or passport of both the Managing Director and the authorized 
personnel ; 
 
10) Written commitment of the technician, to respect the laws and regulations relating to the 
pharmacy practices ; 
 
11) Signed resignation letter/proof of service delivered issued by the last employer of authorized 
personnel , if applicable ; 
 
12) Copy of valid c ontract between authorized personnel  and Managing Director of the 
Orthopedic shop . 
 
6.9 Requirements to open an optical shop  
 
1) Duly filled application form: Application form for premis e licensing of medical products;  
 
2) RDB registration cert ificate of the dom estic company;  
 
3) Lease/rent contract of the premise/house  or any other relevant document;  
 
4) Evidence of payment of prescri bed fees to Rwanda FDA Accounts;  Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 35 of 71  
5) Notarized copy of Degree (and equivalence if applicable) of Authorized personnel ; 
 
6) Notarized Valid Lice nse to Practice Profession issued by Recognized Professional Councils 
in Rwanda ; 
 
7) Curriculum vitae of the authorized personnel ; 
 
8) Professional agreement between the Managing Director of the wholesale and the authorized 
personnel  in case the Managing Directo r is not the authorized personnel ; 
 
9) Copy of the identity card or passport of both the Managing Director and the authorized 
personnel ; 
 
10) Written commitment of the technician to respect the laws and regulations relating to the 
pharmacy practices ; 
 
11) Signed resi gnation letter/proof of service delivered issued by the last employer of authorized 
personnel , if applicable ; 
 
12) Copy of valid contract between authorized personnel  and Managing Director of the optical 
shop . 
 
6.10 Requirements for assistant technician  
 
1) Appli cation letter addressed to Director General of Rwanda FDA  
 
2) Original premise license issued by Rwanda FDA   
 
3) Notarized degree (and equivalence if applicable) of the assistant technician  
 
4) Notarized valid license to practice profession of the assistant techn ician where applicable  
 
5) Copy of valid contract between assistant technician and managing director  
 
6) Copy of the identity card or passport of assistant technician  
 
7.REQUIREMENTS TO RE-GRANT A LICENSE OR APPROVAL OF A SUB STANTIAL 
MODIFICATION  
 
The following  classes of substa ntial modifications are allowed . Clients are advised to contact the 
Rwanda FDA for any g uidance in this respect. These include : 
 
1) Major substantial modification  includes , but not limited to:  
 
a) Relocation or additional storag e space of the l icensed premise;  Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 36 of 71  
 
b) Change of the authorized personnel ; 
 
c) Additional production line;  
 
d) Expansion of establishment;  
 
e) Change of critical equipment in the  manufacturing facility;  
 
f) Addition of critical equipmen t in the manufacturing facility;  
 
g) Removal of equipmen t in the manufacturing facility;  
 
h) Change of activity.  
 
2) Minor substantial modification  include s, but not limited to:  
 
a) Change of the name of the establis hment;  
 
b) Closure of the licensed premise;  
 
c) Notif ication of assistant technician;  
 
d) Change of ownership of t he licensed premise: The person to whom an ownership has been 
transferred to shall apply to the Authority within thirty days . 
 
For major substantial modification, the applicant shall wait for the written approval of the Authority 
before the implementation of the requested variation.  
 
7.1 Requirements for relocation or additional storage space of the licensed premise  
 
a) Duly filled application form: Application form for premise licensing of medical products ; 
 
b) Recent copy premise license issued by Rwanda FDA;  
 
c) New RDB registration certificate of domestic company;  
 
d) Evidenc e of payment of prescribed fees;  
 
e) Lease contract for the pharmaceutical establishment . 
 
7.2 R equirements to change the authorized personnel  of the licensed premise  
 
a) Duly filled application form:  Application form for premise licensing of medical products ;  
 Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 37 of 71  
b) Recent copy premise  license issued by Rwanda FDA;  
c) RDB registration certificate of the domestic company ; 
 
d) Evidenc e of payment of prescribed fees;  
 
e) Notarized degree of the authorized personnel ; 
 
f) Notarized valid license to practice profession of the responsible authorized personnel  where 
applicable;  
 
g) Professional agreement between the establishment and the authorized personnel  in charge 
where the managing director is not the responsible authorized personnel ; 
 
h) Curriculum vitae of the new authorized personnel ; 
 
i) Copy of valid contract between authorized personnel  and Managing Director ; 
 
j) Resignation letter of the former authorized personnel  addressed to Director General of 
Rwanda FDA a nd acknowledged by  the employer;  
 
k) Written commitment of the technician not practice the cumulative function in the 
establishment ; 
 
l) Resignation letter with acknowledgement of the employer and addressed to the Director 
General of Rwanda FDA of the incoming authorized personne l (if he/she has been working) ; 
 
m) Copy of the identity card or passport of both the managing Director and the responsible 
authorized personnel . 
 
7.3 R equirements to change the name of establishment  
 
a) Duly filled application form: Application form for premis e licensing of medical products;  
 
b) Recent premise license  issued by Rwanda FDA;  
 
c) RDB registration certificate of the domestic company . 
 
7.4 Requirements to change the ownership of the licensed premise  
 
a) Dully completed application form for premise licensing o f medical products to close the 
business ; 
 
b) Recent premise license  issued by Rwanda FD A; 
 
c) Notarized sales agreement between former and new owner ; Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 38 of 71  
 
d) RDB registration certificate of the domestic company ; 
 
e) Notarized degree of the authorized personnel ; 
 
f) Notarize d valid license to practice profession of the responsible authorized personnel  where 
applicable ; 
 
g) Copy of the identity card or passport of both the managing director and the responsible 
authorized personnel . 
 
7.5 Requirements to close the licensed establis hment  
 
a) Dully completed application form for premise licensing of medical products to close the 
business ; 
 
b) Recent premise license  issued by Rwanda FDA;  
 
c) Provide a list of closing stock of medical products and its intended use.  
 
7.6 Requirements for renewal of the premise license  
 
a) Duly filled application form: Application form for premise licensing of medical products  
 
b) Recent premise license  issued by Rwanda FDA,   
 
c) Written commitment of the technician not to practice the cumulative function in the 
establishm ent 
 
d) RDB registration certificate of the domestic company  
 
e) Evidence of payment of prescribed fees  
 
f) Notarized valid license to practice profession of the authorized personnel  where applicable  
 
g) Copy Contract between authorized personnel  and managing direct or 
 
h) Copy of the identity card or passport of both the managing director and the responsible 
authorized personnel  
 
8. LICENSING OF PUBLIC  AND PRIVATE HOSPITA L PHARMACIES  
 
The Hospital Pharmacy shall be licensed in accordance with these guidelines. The pharm acy shall be 
managed by a licensed pharmacist.  
 Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 39 of 71  
8.1 Personnel  
 
a) The pharmacy service shall ensure the professional and technical staffing levels are 
commensurate with the workload volume and patient care requirements to safely and 
competently provide medic al products distribution  and clinical pharmacy services;  
 
b) Pharmacy technicians or other authorized personnel  shall be utilized to reduce the 
pharmacist’s time committed to the mechanism of drug distribution without reducing 
professional and legal responsib ility in accordance wi th the pharmacist to technician;  
 
c) There shall be written job descriptions for all pharmacy personnel clearly delineating 
professional and technical       functions.  
 
8.2 Premises  
 
a) The hospital pharmacy shall have the premise of suffic ient size to stor e and dispense medical 
products;  
 
b) Within the hospital pharmacy there shall be a separate st orage area and dispensing area;  
 
c) The hospital pharmacy shall have a minimum floor space of 40 square meters that can be 
divided into the dispensing area and a storage area for Kigali City and secondary cities. The 
minimum height shall be 2.5 meter s from the floor to the ceiling;  
 
d) The hospital pharmacy shall have a minimum floor space of 30 square meters that can be 
divided into the dispensing area of and a storage area for rest of the country. The minimum 
height shall be 2.5 meters from the floor to the ceiling. The premise shall allow safe and 
proper storage of medical products;  
 
The premise shall allow:  
 
i)  Safe and proper storage of medical products ; 
 
ii)  A safe working environment for pharmacy staff (e.g., consideration for the handling 
of antibiotic, cytotoxic, biological, and hazardous products) ; 
 
iii) The provision of clinical and a dministrative pharmacy services;  
 
e) The hospital pharmacy medical products ro oms shall be well lit, ventilated, and maintaine d 
in a clean and orderly manner;  
 
f) No person shall prepare, compound, dispense, package or store any medicat ion under 
unsanitary conditions;  
 Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 40 of 71  
Note: For hospital pharmacy performing the magistral preparation, t he minimum additional 
space of 10 square meters in the same establishment shall be dedicated to accommodate 
magistral preparation activities.  
 
8.3 Equipment  
 
a) The hospital pharmacy shall be equipped with appropriate equipment to stor e and dispense 
medical p roducts;  
 
b) The hospital pharmacy shall have a sanitary sink, kept in clean condition, easily accessible to 
the prescription preparation area, not accessible to the public and supplied with clean water.  
 
c) The hospital pharmacy shall also meet the following re quirements and contain:  
 
i) computerized database and printing system with internet access to manage medical 
products ; 
 
ii) Equipment to store cold chain products with temperature monitoring devices ; 
 
iii) counting trays and spatulas ; 
 
iv) container for waste disposal ; 
 
v) Secure cupboards to keep narcotics and other controlled substances;  
 
vi) Appropriate facilities (shelves, cupboards, pallets, etc.) to store medical products and 
ensure the good storage practices.  
 
8.4 Requirements for licensing hospital pharmacies (referral, d istricts hospitals for public 
institutions and all private hospital pharmacies)  
 
a) Duly filled application form: Application Form for premis e licensing of medical products;  
 
b) RDB registration certificate of the domestic company or equivalent certificate;    
 
c) Lease/rent contract of  the premise/house or any other relevant document;   
 
d) Evidence of payment of prescribed fees as detailed in the “Regulation Related Regulatory 
Service Tariff/fees and Fines”;   
 
e) Notarized copy of Degree (and Equivalence if applicable) of  Authorized personnel , with 
minimum of 4 months ‘experience in clinical pharmacy ; 
 
f) Notarized Valid License to Practice Pharmacy Profession issue d by National Pharmacy 
Council;  Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 41 of 71  
g) Curriculum vitae of the authorized personnel  ;  
 
h) Professional agreement between Managing Director/Director General of the hospital and the 
authorized personnel ;  
 
i) Copy of the identity card or passport of both the Managing Director/ Director General of the 
hospital and the authorized personnel ;   
 
j) Written commitment of the technician t o respect the laws and regulations relating to the 
pharmacy practices ;   
 
k) Signed resignation letter/proof of service delivered issued by the last employer of authorized 
personnel , if applicable ; 
 
l) Copy of valid contract/appointment letter between authorized  personnel  and Managing 
Director/Director General of the hospital.   
 
8.5 Documentation and related controls  
 
a) All records (including but not limited to invoices, purchase orders, import authorizations if 
applicable, sales and distribution records, in public  and private hospitals for all medical 
products and administrative records of the staff shall be properly kept in the medical products 
establishment and be readily available to the inspection service when requested for or needed.  
 
b) All entry and exit of med ical products must be approved by the responsible authorized 
personnel . 
 
c) Availability of copy of license to practice of the authorized personnel  in charge where 
applicable.  
 
d) Quarterly reports on the distribution of controlled substances to be submitted to the Authority.  
 
e) Identify the establishment by a readable sign board with the number of authorizations, names 
and contacts of the authorized personnel  in charge.  
 
f) A copy of premise license  and license to practice profession for the responsible authorized 
personnel  shall be conspicuously displayed in the establishment.  
 
9.LICENSING OF CENTRAL  MEDICAL STORE AND T HE BRANCHES  
 
The central medical store and the branches shall be licensed in accordance with these guidelines. The 
pharmacy of the central medical st ore and the branches shall be managed by a licensed pharmacist.  
 
 Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 42 of 71  
9.1 Personnel  
 
The pharmacy shall ensure the professional and technical staffing levels are commensurate with the 
workload volume.  
 
There shall be written job descriptions for all pharmacy personnel clearly delineating professional 
and technical  functions.  
 
9.2 Premises  
 
a) The pharmacy shall have the premise of sufficient  size to store medical products;  
 
b) Within the pharmacy there shall be a separa te sales area and storage area;  
 
c) For central me dical store and the branches dealing with the human medicines or medical 
devices, the total floor space shall have a minimum space of 90 square meters. The sales area 
shall have minimum floor space of 30 square meters, and records shall be maintained in th is 
area. The storage areas shall have minimum floor area of 60 square meters; and minimum 
height of 2.5 meter s from the floor to the ceiling;  
 
The premise shall allow:  
 
a) Safe and proper storage of medical products ; 
 
b) A safe working environment for pharmacy s taff (e.g. consideration for the handling of 
antibiotic, cytotoxic, biological, and hazardous products) ; 
 
c) The pharmacy medical products rooms shall be well lit, ventilated, and maintained in a clean 
and orderly manner.  
 
9.3 Equipment  
 
a) The pharmacy shall be  equipped with appropriate equi pment to store medical products;  
 
b) The pharmacy shall have a sanitary sink, kept in clean condition, easily accessible to the 
prescription preparation area, not accessible to the publi c and supplied with clean water;  
 
c) The phar macy shall also meet the following requirements and contain:  
 
i) computerized database and printing system with internet access to manage medical 
products ; 
 
ii) Equipment to store cold chain products with temperature monitoring devices ; 
 
iii) container for waste dispo sal; Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 43 of 71  
iv) Secure cupboards to keep narcotics and other controlled substances;  
 
v) Appropriate equipment (shelves, cupboards, pallets, etc.) to store medical products 
and ensure the good storage practices.  
 
9.4 Requirements for licensing the central medical store a nd the branches  
 
a) Duly filled application form: Application Form for premise licensing of medical products ;  
 
b) RDB registration certificate of the domestic company or equivalent certificate ;  
 
c) Lease/rent contract of the premise/house  or any other relevant d ocument;  
 
d) Evidence of payment of prescribed fees as detailed in the “Regulation Related Regulatory 
Service Tariff/fees and Fines”;  
 
e) Notarized copy of Degree (and Equivalence if applicable) of Authorized personnel , with 
minimum of 2 months’ experience in su pply chain management ; 
 
f) Notarized Valid License to Practice Pharmacy Profession issue d by National Pharmacy 
Council;  
 
g) Curriculum vitae of the authorized personnel ; 
 
h) Professional agreement between Managing Director and the authorized personnel ; 
 
i) Copy of the  identity card or passport of both the Managing Director and the authorized 
personnel ; 
 
j) Written commitment of the technician to respect the laws and regulations relating to the 
pharmacy practices ;  
 
k) Signed resignation letter/proof of service delivered issu ed by the last employer of authorized 
personnel , if applicable ; 
 
l) Copy of valid contract/appointment letter between authorized personnel  and Managing 
Director.   
 
9.5 Documentation and related controls  
 
a) All records (including but not limited to invoices, pur chase orders, import authorizations if 
applicable, sales and distribution records, in public and private hospitals for all medical 
products and administrative records of the staff shall be properly kept in the medical products 
establishment and be readily available to the inspection servi ce when requested for or needed;  Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 44 of 71  
b) All entry and exit of medical products must be approved by the responsible authorized 
personnel ; 
 
c) Availability of copy of license to practice of the authorized personnel  in charge where 
applicable;  
 
d) Quarterly reports on the distribution of controlled substances to be submitted to the Authority.  
 
e) Identify the establishment by a readable sign board with the number of authorizations, names 
and contacts of the authorized personnel  in charge;  
 
f) A copy of premise license  and license to practice profession for the responsible authorized 
personnel  shall be conspicuously displayed in the establishment.  
 
10. LICENSING OF HEALTH  POSTS AND HEALTH CE NTERS PHARMACIES  
 
a) The health posts and health centers  pharmacies shall be licensed in accordance with these 
guidelines. The pharmacy shall be managed by licensed authorized personnel  having the 
educational background in pharmacy, nursing an d other relevant qualification;  
 
b) Health posts and health centers shall onl y manage medical products that are authorized at 
each level of the health system as detailed in current national list of essential medicines.  
 
10.1 Personnel  
 
Health posts and health centers shall ensure the professional and technical staffing levels are 
commensurate with the workload volume and patient care requirements to safely and competently 
provide medical products distribution.  
 
10.2 Premises  
 
a) The health posts and health centers shall have the premise of sufficient size to stor e and 
dispense medical products;  
 
b) The health center pharmacy shall have a minimum floor space of 15 square meters whereas 
the health post pharmacy shall have a minimum floor space of 10 square meters that can be 
divided into storage area and the dispensing area to allow:  
 
i) Safe a nd proper storage of medical products ; 
 
ii) A safe working environment for pharmac y staff;  
 
iii) The provision of clinical and administrative pharmacy services.  
 Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 45 of 71  
c) The pharmacy medical products rooms shall be well lit, ventilated, and maintained in a clean 
and orderl y manner.  
 
10.3 Equipment  
 
a)  The pharmacy shall be equipped with appropriate equipment to stor e and dispense medical 
products;  
 
b) Secure cupboards to keep narcotics and controlled substances.  
 
10.4 Requirements for licensing the health center and health post pharmacies  
 
a) Duly filled application form:  Application Form for premise licensing o f medical products;  
 
b) RDB registration certificate of the domestic company or equivalent certificate 
/recom mendation from local government;       
 
c) Lease/rent  contract of the p remise/house or any other relevant document;   
 
d) For licensing of health centers and health posts, the Authority may exempt regulatory service 
fees; 
 
e) Notarized copy of Degree (and Equivalence if applicable) of authorized personnel ; 
 
f) Notarized Valid License t o Practice Profession issued by Recognized Professional Councils 
in Rwanda;  
 
g) Curriculum vitae of the authorized personnel ;   
 
h) Professional agreement between Managing Director/Head of health center/health post and the 
authorized personnel ;   
 
i) Copy of the id entity card or passport of both the Managing Director/ Head of health 
center/health post and the authorized personnel ;   
 
j) Written commitment of the authorized personnel  to respect the laws and regulations relating 
to the pharmacy practices ;   
 
k) Signed resig nation letter/proof of service delivered issued by the last employer of authorized 
personnel , if applicable ; 
 
l) Copy of valid contract/ appointed letter between authorized personnel  and Head of health 
center/health post . 
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10.5 Documentation and related cont rols 
 
a) All records (including but not limited to invoices, purchase orders, sales records, in health 
centers and health posts for all medical products and administrative records of the staff shall 
be properly kept in the medical products establishment and b e readily available to the 
inspection servi ce when requested for or needed;  
 
b) Quarterly reports on the distribution of controlled substances to be submitted to the Authority ; 
 
c) Identify the establishment by a readable sign board with the number of authorizat ions, names 
and contacts of the authorized personnel  in charge;  
 
d) A copy of premise license  and license to practice profession for the responsible authorized 
personnel  shall be conspicuously displayed in the establishment.  
 
10.6 Management of controlled sub stances  
 
a) Controlled substances shall be kept in a secure, fixed separate and lockable storage place.  
 
b) Quarterly reports on the distribution of controlled substances shall be submitted to the 
Authority.  
 
11. GOOD PRACTICES  
 
11.1 Good Distribution Practice  
 
The medical products manufacturers/distributors or wholesalers shall have systems, facilities and 
operations that comply with the Good Distribution Practice Guidelines, as adopted by the Authority.  
 
11.1.1. Transport and delivery Validation  
 
a) The applicant should keep the transport validation data available and should submit the m to 
the Authority upon request;  
b) The distributor shall be responsible for reviewing the transport route for suitability by means 
of assessment of environmental conditions (temperature  and relative humidity) on the 
product including pro duct integrity during transport;  
c) The distributor shall ensure that the products can be safely transported within the temperature 
profile defined for each product and that compliance can b e demonstrated to  the Authority;  
d) Storage, distribution and transport validation shall be conducted in line with the World 
Health Organization (WHO) guidance for the storage and transport of time - and temperature –
sensitive medical products. The latest version of these guide lines as revised by the WHO 
shall be applicable in each case.  
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retailers of medical Products   
 
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11.2 Good Manufacturing Practice  
 
The medical products Manufacturer shall have systems, facilities and operations that comply with 
the Good Manufacturing Practice Guidelines, as adopted by the  Authority.  
 
11.3 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.  
 
12. ESTAB LISHMENT OF LICENSIN G AND INSPECTION TEC HNICAL AND 
ADVISORY COMMITTEE  
 
The Authority shall establish a technical and/or advisory committee comprising of internal and/or 
external experts from different fields and scientific research to advise the Authority on Licensing and 
inspection regulatory matters with clear terms of reference.  
 
13. VALIDITY OF AN APPL ICATION AND AUTHORIZ ATION  
 
13.1 Validity of an application  
 
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 Medical Products . The complete application is processed within a period of t hirty ( 30) 
working days from the date of submission.  
 
An in complete application shall be rejected until all requirements are fulfilled as described in section 
(4) of these guidelines . 
 
13.2 Validity of an authorization  
 
An authorization shall be valid for twelve (12) months  of the fiscal year  renewable. All author ization 
issued shall expiry by 30th June of the fiscal year.  
 
Any change(s) to the information contained in the authorization shall be notified to the Authority 
within a period of five (5) working days.  
 
13.3 Display of the authorization  
 
The license to p ractice , the premise registration certificate and premise license shall be conspicuously 
displayed in the establishment.  
 
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retailers of medical Products   
 
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13.4 Display of sign post  
  
Authorized establishment shall be identified by a clearly displayed sign post containing the name of 
establishment, premise registration number, names and telephone number of the authorized 
personnel . 
 
14. CATEGORIZATION OF I NSPECTION FINDINGS  
 
The following section provides the classification of compliance based on risk factors that shall guide 
the Authorit y on decision -making after conducting premise inspection.  
 
The regulatory actions shall be classified as in the following non -compliance categories:  
 
a) Minor/Other Non-compliance : A non-compliance  that is not classified as either “Critical” 
or “Major”, but  indicates a departure from premises suitability. A non-compliance  may be 
judged as “Minor”  because there is insufficient information to classify it as “Critical” or 
“Major”.  
 
b) Major Non-compliance : A non-compliance  that is not a “Critical” non-compliance , but 
which:  
 
i) has produced or may produce a product which does not comply with its Marketing 
Authorization, Clinical Trial Authorization, product specification; pharmacopoeia 
requirements, facility and equipment safety, quality control laboratory, authorized  
personnel . 
 
ii) does not ensure effective implementation of the required premises control measures;  
 
iii) indicates a major deviation from the terms of the manufacturing authorization;  
 
iv) indicates a failure to carry out satisfactory procedures for release of batc hes or failure 
of the authorized person to fulfill his/her duties;  
 
v) consists of several “Minor/Other”  related non-compliances , none of which on its own 
may be “Major”, but which may together represent a “Major” non-compliance  or 
systems failure and should  be explained and reported as such.  
 
c) Critical Non-compliance : 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 
patients (or personnel or enviro nment) is highly probable, including life threatening situation, 
the deviation is categorized as Critical requiring immediate action, investigated and 
documented.  
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retailers of medical Products   
 
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i) A non-compliance  which has produced, or leads to a significant risk of producing 
either a pr oduct which is harmful to the human or veterinary patient or a product which 
could result in a harmful residue in a food producing animal.  
 
ii) A “Critical” non-compliance  also occurs when it is observed that the manufacturer 
has engaged in fraud, misrepresent ation or falsification of products or data.  
 
iii) A “Critical” non-compliance  may consist of several related non-compliances , none of 
which on its own may be “Critical”, but which may together represent a” Critical” 
non-compliance , or systems’ failure where a r isk of harm was identified and should 
be explained and reported as such.  
 
14.1 Manufacturing facilities  
 
14.1.1 Critical non -compliance s 
 
1) Premises:  
a) Site Location which does not comply with environmental requirement to manufacture 
medical products.  
 
b) No air filtration system to eliminate airborne contaminants that are likely to be generated 
during manufacture or packaging (i.e: HVAC/ air handling unit)  
 
c) Generalized malfunctioning of the ventilation system(s) with evidence of widespread cross -
contamination.  
 
d) 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.  
 
e) Lack of pharmaceutical water system, clean water, an d waste water treatment system  
 
f) Finishing materials: production floor area, ceiling and walls that are not seamless and easy to 
clean  
 
2) Equipment  
 
a) Equipment used for manufacturing operations of critical products not qualified with      
evidence of malfuncti oning.  
 
b) Evidence of contamination of products by foreign materials such as grease, oil, rust particles 
from the  equipment.  
 
 
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retailers of medical Products   
 
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3) Personnel  
 
Staff in charge of Quality Control or production does not hold a university degree in a science related 
to the work bei ng conducted, and does not have sufficient practical experience in their area of 
responsibility.  
 
4) Sanitation  
 
a)  Evidence  of widespread accumulation of residues/extraneous matter indicative of inadequate 
cleaning,  
 
b) Evidence  of gross infestation  
 
14.1.2 Major non -compliances  
 
1) Premises  
 
a) Malfunctioning of the ventilation system that could result in possible localized or occasional 
cross -contamination.  
 
b) Accessory supplies (steam, air, nitrogen, dust collection etc) not qualified.  
 
c) Heating Ventilation Air Conditi oning (HVAC) and purified water (PW) system not 
qualified.  
 
d) Absence of temperature and humidity gadgets or monitoring records at the time of the 
premise license  renewal.  
 
e) Damages to walls/ceilings immediately adjacent or above manufacturing areas or equip ment 
where the product is exposed.  
 
f) Un-cleanable surfaces created by pipes, fixtures or ducts directly above products or 
manufacturing equipment.  
 
g) Surface finish (floors, walls, ceilings) that do not permit effective cleaning.  
 
h) Unsealed porous finish in ma nufacturing areas with evidence of contamination (mould, 
powder from previous productions etc)  
 
i) Insufficient manufacturing space that could lead to mix ups.  
 
2)  Equipment  
 
a) Equipment does not operate within its specifications.  
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retailers of medical Products   
 
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b) Tanks for manufacturing of liqu ids and ointments not equipped with sanitary clamps.  
 
c) Stored equipment not protected from contaminations.  
 
d) Inappropriate equipment for production: surfaces porous and non -cleanable/material to shed 
particles  
 
e) No covers for tanks, hoppers or similar manufac turing equipment.  
 
f) Equipment location does not prevent cross -contamination or possible mix ups for operations 
performed in common area.  
 
g) Purified water not maintained or operated to provide water of adequate quality.  
 
h) Leaking gaskets.  
 
i) No calibration progr am for measuring equipment /no records maintained.  
 
j) No equipment usage logs.  
 
k) No fire -fighting equipment/Fire alarm systems, emergency doors . 
 
3) Personnel  
 
a) Delegation of responsibilities of key personnel for Quality Control and production to 
insufficiently q ualified persons.  
 
b) Insufficient personnel in Quality Control and production resulting in a high possibility of 
error.  
 
4) Health and Sanitation  
 
a) Sanitation program not in writing but premises in acceptable state of cleanliness.  
 
b) Absence of Medical emergency k its. 
 
c) Absence of Emergency shower . 
 
14.1.3 Minor (other) non -compliances  
 
1) Premises  
 
a) Doors giving direct access to exterior from manufacturing and packaging areas used by 
personnel.  
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retailers of medical Products   
 
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b) Un-screened/un -trapped floor drains.  
 
c) Outlets for liquids and gases not id entified.  
 
d) Damages to surfaces not directly adjacent or above exposed products.  
 
e) Inadequate rest, change, wash -up and toilet facilities.  
 
2) Equipment  
 
a) Insufficient space between equipment and walls to permit cleaning.  
 
b) Base of immovable equipment not adequa tely sealed at points of contact.  
 
c) Use of temporary means or devices for repair.  
 
d) Defective or unused equipment used for non -critical products not qualified.  
 
3) Sanitation  
 
a) Incomplete written sanitation program  
 
b) Sanitation or Health and hygiene programs not  properly implemented or followed by 
employees.  
 
14.2 Public and private distributors/wholesalers of medical products  
 
14.2.1 C ritical non -compliances  
 
1) Premises:  
 
a) Insufficient floor space and height requirements  
 
b) Surrounding area that can cause contaminati on from the external environment or other 
activities.  
 
c) Floor, ceiling and walls that are not well maintained.  
 
d) Lack of Proper ventilation/  Air handling unit /Heat, Ventilation and Air Conditioning 
(HVAC).  
 
e) Lack of Temperature and humidity monitoring system s 
 
f) Storage of products requiring refrigeration at  ambient temperatures.  
 
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retailers of medical Products   
 
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g) Rejected or recalled products found in sellable stock.  
 
2) Equipment/Furniture  
a) Lack of storage furniture.  
 
b) Lack of secure and lockable storage place for controlled medical products  
 
c) Lack of equipment to store related temperature sensitive medical products  
 
d) Lack of appropriate vehicle for transportation of medical products  
 
3) Personnel  
 
Operating without a n authorized personnel   
 
4) Documentation  
 
a) Absence of controlled medical products distr ibution report . 
 
b) Falsification of documentation and related controls . 
 
c) Purchase from or supply of medicinal products to a non -authorized person.   
 
14.2.2 Major non -compliances  
 
1) Premises:  
 
a) Damage of walls, ceilings, roof, doors and windows.  
 
b) Surface finish (floors, walls, ceilings) that do not permit effective cleaning.  
 
c) Inappropriate  ventilation /Air handling unit /Heat, Ventilation and Air Conditioning (HVAC).  
 
d) Inappropriate temperature and humidity monitoring systems and lack of monitoring records 
at the time of the routine inspection.  
 
e) Inappropriate  sanitation facilities (toilets, washing station, etc ) 
 
2) Equipment/Furniture  
 
a) Lack of Fire-fighting equipment.  
 
b) Inappropriate storage furniture.  
 
c) Inappropriate secure and lockable storage place for controlled me dical products.  
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retailers of medical Products   
 
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d) Inappropriate equipment to store related temperature sensitive medical products.  
 
3) Personnel  
 
Absence of the authorized personnel  during working hours  
 
4) Documentation  
 
Lack of premise license , import & export documents, distribution records,  records of 
expired/damaged products  
 
14.2.3 Minor (other) non -compliances  
 
a) Lack of appropriate lighting systems  
 
b) Premise license  issued by Rwanda FDA not displayed  
 
c) License to practice profession issued by professional bodies of the authorized personnel  not 
displayed  
 
d) Absence of Filing systems of documents  
 
14.3 P ublic and private retailers of medical products  
 
14.3.1 Critical non -compliances  
 
1) Premises:  
 
a) Insufficient floor space and height requirements  
 
b) Surrounding area that can cause contamination from t he external environment or other 
activities.  
 
c) Lack of proper ventilation  
 
d) Lack of temperature and humidity monitoring systems  
 
e) Storage of products requiring refrigeration at ambient temperatures;  
 
f) Rejected or recalled products found in sellable stock.  
 
2) Equipment/ Furniture  
 
a) Lack of secure and lockable storage place for controlled medical products  
 
b) Lack of equipment to store related temperature sensitive medical products  Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
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3) Personnel  
 
Operating without an authorized personnel   
 
4) Documentation  
 
a) Lack of Prescr iption of controlled medical products  
 
b) Falsification of documentation and related controls  
 
  14.3.2 Major non -compliances  
 
1) Premises:  
 
a) Damage of walls, ceilings, roof, doors and windows  
 
b) Surface finish (floors, walls, ceilings) that do not permit effective  cleaning.  
 
c) Inappropriate natural ventilation/Mechanical ventilation  
 
d) Inappropriate temperature and humidity monitoring systems and lack of monitoring records 
at the time of the routine inspection.  
 
e) Inappropriate sanitation facilities (toilets, washing st ation, etc)  
 
2) Equipment/Furniture  
 
a) Lack of Fire-fighting equipment.  
 
b) Lack of appropriate storage furniture.  
 
c) Inappropriate secure and lockable storage place for controlled medical products.  
 
d) Inappropriate equipment to store related temperature sensitive me dical products.  
 
3) Personnel  
 
Absence of the authorized personnel  during working hours.  
 
4) Documentation  
 
Lack of premise license , import & export documents, distribution records, records of 
expired/damaged products.  Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
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14.3.3 Minor (other) non -compliances  
 
a) Lack of appropriate lighting systems  
 
b) Premise license  issued by Rwanda FDA not displayed  
 
c) License to practice profession issued by professional bodies of the authorized personnel  not 
displayed  
 
d) Absence of Filing systems of documents  
 
e) Lack of Water filter/wate r dispenser with drinking water and cups  
 
f) Lack of appropriate technician overall coat  
 
g) Failure to put on technician overall coat  
 
h) Lack of waiting and counselling area with suitable furniture  
 
N.B: Note that the listed non -compliances may not be exhausted  enough to cover all possible non -
compliances. Non -compliances shall be classified upon discretion of the Authority.  
 
15. WARNING, SUSPENSION  AND REVOCATION  
 
A warning letter may be issued to the applicant or the authorization be suspended or revoked wher e 
the Authority finds the applicant not complying with any of the requirements or conditions in these 
Regulations; or has ceased to be fit to carry on the business.  
 
The Authority shall cancel, suspend or withdraw a license of a facility if the facility co ntravenes 
following licensing requirements:  
 
1) Any of the conditions under which the license was issued no longer exist,  
 
2) The information on which the approval was given is later found to be false,  
 
3) The circumstances under which the approval was given no lon ger exist,  
 
4) Repeated violation of the regulatory administrative sanction or decision.  
 
Where the license is suspended, withdrawn or cancelled, the Authority shall issue a notice to the 
management of the facility.  
 
The Authority shall take steps including c losure to ensure that the manufacturing, wholesale or 
distribution activity is stopped until otherwise decided by the Authority.  
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retailers of medical Products   
 
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Measures towards enforcing this article may include the publication of the Rwanda FDA’s action on 
its website and other releva nt media. An authorization holder or applicant may notify Authority his 
or her grounds when he or she:  
 
1) Objects to any suspension or revocation of authorization, or to any notice served,  
 
2) Objects to the refusal of authorization or the imposition of any con dition, may notify the 
Director General of its desire to make written representations to, or be or appear before and 
be heard by, a person appointed by the Director General for that purpose.  
 
Any notification of an objection pursuant to provisions of parag raph 3 of this Article, shall be made 
within fourteen days of service on the notice to which the notification pursuant to paragraph 3 of this 
Article, relates.  
 
Where the Authority receives a notification pursuant to provisions of paragraph 3 of this Artic le, he 
or she shall appoint a person to consider the matter.  
 
The person appointed shall determine the procedure to be followed with respect to the consideration 
of any objection  
The person appointed pursuant to provisions of paragraph 5 of this Article,  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 made pursuant to provisions of paragraph 7 of this Article, shall be made i n 
writing to the Authority, 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 pursuant to provisions of paragraph 
7 of this Article,  
 
Within fou rteen days of receipt of any recommendation made pursuant to provisions of paragraph 7 
of this Article, the Director General shall inform the complainant whether he/she accepts the 
recommendation and, if he/she does not accept it, of the reasons for his/he r decision.  
 
Where the Director General is notified of an objection pursuant to provisions of paragraph 3 (1) of 
this Article, before the date upon which the suspension or revocation or the notice is due to take 
effect, the suspension or revocation of a n otice in respect of which the objection is made shall not 
take effect until  
 
1) The person appointed pursuant to provisions of paragraph 5 of this Article, has considered 
the matter in accordance with the provisions of this regulation and made a recommendatio n; 
and 
 
2) The Director General has informed the complainant concerned of his decision with regard to 
the recommendation pursuant to provisions of paragraph 11 of this Article.  Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
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Subject to the provisions of paragraph 12 of this Article, where the Director Gen eral is notified of an 
objection pursuant to subject to the provisions of paragraph 3 (1) of this Article, within the period 
specified provisions of paragraph 4 of this Article, to a suspension, revocation or other notice which 
has already taken effect on the date the notification was made, the suspension, revocation or notice 
in respect of which the objection is made shall cease to have effect until;  
 
1) The person appointed pursuant to provisions of paragraph 5 of this Article has considered the 
matter in ac cordance with the provisions of paragraph (13) shall not apply:  
 
2) In relation to a suspension or revocation, or a notice served, which takes immediate effect in 
accordance with these guidelines; or  
 
In any other case, where the director general determines t hat it is necessary in the interests of public 
safety for the suspension, revocation or notice to take effect on the date originally specified, and 
serves a notice in writing to that effect on the establishment concerned.  
 
16. APPEALS AND REVIEW  
 
The manuf acturer, distributor, wholesaler and retailer of medical products or any other person 
responsible for the regulated premises, if not satisfied with the decision of the Authority, may submit 
his/her appeal to the management of the Authority for the review w ithin thirty ( 30) working days 
from the date of the reception of the decision.  
 
The Authority shall within thirty ( 30) working days from the date of appeal application review, vary 
or reject its decision.  
 
If the appellant is not satisfied with the decisi on of the supervising Authority, he/she may appeal to 
the Supervising Authority of Rwanda FDA or the Minister of Health in his or her attributions whose 
decision shall be final.  
 
17. COMMENCEMENT  
 
These guidelines shall enter into force on the date of si gnature and publication. All prior provisions 
contrary to these guidelines are hereby repealed.  
 
LIST OF FORM FOR USE WITH THESE GUIDELINES  
 
1) Doc. FDISMFDIC/FOM/002 - Application form for premise licensing of medical products  
 
2) Doc. FDISM/ FDIC /FOM /010_premise  licensing inspection  for medical gas production plant 
report  form 
 
3) Doc. FDISM/FDIC /FOM/009 _ Premise licensing inspection  for medical manufacturing facility  
report form  Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
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4) Doc. FDISM/ FDIC/FOM/008  Premise licensing, GSP&GDP inspection for wholesaler, 
distribut or and retailer of medical products report Form  
 
LIST OF FORMAT OF PREMISE REGISTRATION CERTIFICATE  
 
1) Doc FDISM/FDIC/FMT/180 _Premse registration certificate  
 
LIST OF FORMAT OF AUTHORIZATION FOR USE WITH THESE GUIDELINES  
 
1) Doc. N⁰. FDISM/FDIC/FMT/003 _Premise license for manufacturer of medical products  
 
2) Doc N⁰. FDISM/FDIC/FMT/005 _ Premise license  
 
LIST OF NOTIFICATIONS FOR USE WITH THESE GUIDELINES  
 
1) Withdrawal/suspension of premise license  
 
 
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retailers of medical Products   
 
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Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
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ANNEXES  
 
  Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
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ANNE X I: PROCES S FLOW CHART   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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ANNE X II: APPLICATION FOR M 
   
 
 Department/Division  Food and Drugs Inspection and Safety 
Monitoring/Food and Drugs Inspection & 
Compliance  
Document Type:  Form  Doc. No  : 
FDISM/FDIC/FOM/00 2 
  
Title: Application Form for 
Premise Licensing of medical 
products  
 Revision Number  : 1 
Revision Date:  :  24/08/2022  
Effective Date  : 22/09/2022  
Review Due Date  : 21/09/2025  
Ref Doc.  : 
FDISM/FDIC/GDL/005  
                                                 
Name of Premise:  
 
 Application date:           /         /         
                               DD / MM/ YYYY  
Domestic Company Registration code:   Registration date in Rwanda FDA:         /         /  
                                                          DD/ MM/ YYYY  
Physical location:  
(Province, District, Sector, Cell)  Registered Address :  
 
 
 
Global Positioning System (GPS) Coordinates  Name of responsible technician:  
(If applicable)  
 
 
Company e -mail:  
 
 
Company Telephone:  
 
 Qualification:  
Name of Managing Director:  
 Email of responsible technician:  
(if applicable)  
 
 
Email of Managing Director  
 
 
Telephone No:  
 Tel of responsible technician:  
TYPE OF PREMISE:  
(Please tick below)  
 
  Retailer  
  Wholesaler  
  Distributor  
  Manufacturer  
  Hospital Pharmacy  
  Central Medical Stores  
  Health Centres  
  Healt h Posts  
  Other MAIN ACTIVITY  
(Please tick below)  
 
 Human retail pharmacy  
 Human wholesale pharmacy  
 Human wholesale of medical device  
 Small scale manufacturer  
 Manufacturer of medical products  
 Veterinary Drug shop  
 Veterinary r etail pharmacy  
 Veterinary wholesale pharmacy  
 Veterinary manufacturing facility  TYPE OF APPLICATIONS  
(Please tick below)  
   
 Site location approval  
 New Application  
 Renewal  
  Variation  
      Change of ownership  
      Change of 
locatio n&Additional line  
      Change authorized 
personnel  
Format: QMS/FMT/002  
Revision No: 1  
Effective Date: 20 June 2022  Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 64 of 71  
…….………………………….  
 
 
  Vaccine manufacturing facility  
  Herbal drugs wholesaler  
  Herbal drugs retailer  
  Herbal drugs manufacturer  
 Hospital pharmacies  
 Central Medical stores  
 Health pos ts & Health Centers  
 Orthopedic shop  
 Optical shop  
  Other specify ………………..  
……………………………………        Change of name of the    
Establishment  
       Closure of the business 
activities  
 Re-inspection  
  Other specify 
……………….…  
AFFIDAVIT  
I hereby  affirm  that the  statement  in this application  is true and correct.   
 
 
  
Applicant’s  Name  and Signature  Date  (dd/mm/yyyy)  
 
 
 
FOR OFFICIAL USE ONLY:  
 
Date Received :  ……./……./……  
Inspection date: … …/……../……..   
Approved/ Denial:  A  /  D .   
Approval date :  …../……./……  
 
  I. REQUIREMENTS  FOR  PREMISE LICENSING  OF 
MEDICAL PRODUCTS  
New application  
Renewal  
Change ownership  
Change technician  
Change location  
Additional line  
Additional branch  
Change of name  
Closure of business  
 
Premise name:  Date:  
……../…../...….  
 
Documents  YES   NO 
1 A dully  filled  application  form  for 
premises  licensing of Medical Products - 
FDISM/FDIC/FOM/00 2    x x x x x x x x x 
2 RDB registration certificate of the 
domestic company or equivalent 
certificate  /recommendation from local 
government    x x x  x  x x  
3 Architectural plan of the site applicable 
for manufacturing facility    x    x x x   
4 Environment impact assessment report 
applicable for manufacturing facility    x    x x x   
5 Proof  of Payment  of the prescribed  fees 
(referred to regulation related to 
Regulatory service Tariff/fees and Fines)  
   x x  x x x x   Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 65 of 71  
6   List of products to be manufactured  
applicable for manufacturing facility    x         
7 Lease/rent contract of the 
premise/house  
   x    x  x   
  8 Notarized copy of Degree (and 
equivalence if applicable) of 
Responsible Technician  
NB: 
i.Human Retail Pharmacy: minimum 
of 2 months experience in 
community pharmacy  
ii.Human Wholesale Pharmacy:  
minimum of 2 months’ 
experience in supply chain 
management  
iii.Central medical store and the 
branches:  minimum of 2 
months’ experience in supply 
chain management  
Hospital pharmacy:  minimum of 4 
months’ experience in clinical pharmacy    x  x x   x   
  9 Notarized Valid License of the 
responsible technician to Practice 
Profession issued by Recognized 
Professional Councils in Rwanda (if 
applicable)  
   x x  x x   x   
 10 Notarized degre es of the key personnel 
to be involved in the manufacturing 
process, quality control and quality 
assurance  
NB: 2 years minimum experience for a 
Bachelor degree holder; or 6 months 
minimum experience for a Master 
degree holder in the relevant field with 
working exper ience in a company that 
has been approved as manufacturer of 
medical products    x   x   x   
 11 Professional agreement between the 
Managing Director/  Director General/ 
Chief Executive Officer  and the 
responsible technician in case the 
Managing Director is not the responsible 
technician    x x x x   x   Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 66 of 71  
 12 The copy  of Identity  Card/Passport of  
the managing  Director / Director 
General/ Chief Executive Officer and 
the Responsible technician    x x x x   x   
 13 Written commitment of the 
responsible technician, to respect the 
laws and regulations relating to the 
profession and ethics    x x  x  x x   
 14 Signed resignation letter/proof of 
service delivered issued by the last 
employer of responsible technician, if 
applicable    x   x   x   
 15 Copy of Valid contract between responsible 
technician and Managing Director/  Director 
General/ Chief Executive Officer    x x x x   x   
 16 A Detailed  curriculum vitae  of the  
responsible technician    x   x   x   
 17  Original authorization of the 
establishment issued by Rwanda FDA     x x x x x x x x 
 18 Notarized sales agreement between former 
and new owner      x       
 19 Provide a list of closing stock of medical 
products and its intended use            x 
 
 
II. RE – INSPECTION  
 
Premise name:  Date:  
……./…../...….  
 
Documents  YES   
NO 
1  Re-inspection application letter addressed to the Director General of 
Rwanda FDA, mentioning the proposed dates.  
   
2 The proof of payment of prescribed re -inspection fees    
3 A Corrective Actions and Preventive Actions (CAPA) repo rt, detailing what 
has been implemented with respective visual proof and timelines for non -
implemented recommendations.  
   
 
III. SITE LOCATION APPROVAL  
 
Premise name:  Date:  
……./…../...….  
 
Documents  YES  NO 
1 Letter of intent    Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 67 of 71  
2 Site master plan (indicatin g the location /plan of the premise and the 
surroundings activities)    
3 Environmental impact assessment    
 
VI. ARCHITECTAL PLAN APPROVAL  
 Premise name:  Date:  
……./…../...….  
 
Documents  YES  NO 
1    Approval letter for site location from the Authority    
 
 
 
 
2   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) Finishing materials (Production floor and walls shall be seamless, 
ceiling, doors and windows shall be easy to clean).    
 
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  WILL  NOT  be accepted.  
3. Application  processes will  take 30 working days upon receipt of fully complete documents 
required .  Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 68 of 71  
ANNEX III:  PREMISE REGISTRATION  CERTIFICATE  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                                                                                      
ANNEX IV: FORMAT OF AUTHORIZ ATION ISSUED  
 
 
Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 69 of 71  
 
        Rwanda Food and Drugs Authority    
          Nyarutarama Plaza , KG 9 Avenue   
          P.O. Box: 1948 Kigali - Rwanda     
          Email: info@rwandafda.g ov.rw     
          website: www. rwandafda.gov.rw  
 
 
 
PREMISE LICENSE FOR MANUFACTURER OF 
MEDICAL PRODUCTS  
 
Referring to the Law Nº 003/2018 of 09/02/2018 and law Nº 47/2012 of 14/01/2013  
 
This is to certify that  
Premise license  No:     FDISM/FDIC /  /FDA/YYYY  
 
Issued on:       /      /YYYY    Valid up to :       /      /YYYY  
was granted to:  
 
Name of the Company:   
Company code:             
Location of the premises:                                    Province, District, Sector, Cell,  Village  
Name of the Managing Director:   Mr (Mrs/Ms)     
Telephone Number:   Telephone number:                                             +2507      
Head of Production Department:   Mr (Mrs/Ms)     
 
to carry out the following manufacturing activities:  
Product category  Product 
type Dosage form 
(if applicable ) Manufacturing activities  
i.e 
Pharmaceutical 
products   e.g.: Tablet, 
syrup, 
capsules  Production, packaging, 
storage, labeling and 
distribution  
This premise license  may be suspended or withdrawn if the cond itions under which it was 
granted are violated. The product is put on market after its assessment and registration by 
Rwanda FDA.   
Name and signature of Director General  
+ Stamp of the institution  
QMS No: FDISM/FDIC/FMT/003  
Revision No: 1  
Effective Date: 22 Sep 2022  
 
Premise registration certificate N°:  RWA -FDA -PPP-IIII-DDDD  
 Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 70 of 71  
                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  
                                           
 
Ref N°:FDISM/FDIC/………/FDA/YYYY  
 
 
 
PREMISE LICENSE   
 
Referring to the Law Nº 003/2018 of 09/02/2018 and law Nº 47/2012 of 14/01/2013  
 
This is to certify that…. Insert the name of the company….  with premise  license  number RWA -
FDA -MM-YYYY -SN…………… under company code………… is licensed to store and operate 
as ….  INSERT THE CATEGORY OF THE PREMISE  on the following location: Sales room: 
Province/District/Sector/Village and store room: Province/District/Sector/Village.  
 
This premise is GSP&GDP c ompliant  (where applicable)  
 
Storage conditions  of medical products : 
…………………………  
Names of the Managing Director: ………….  
Telephone Number: …………………………  
 
Names of authorized personnel : …………  
National Council Registration Nº: …………  
 
This license is valid until ………  
 
  N.B 
1. This premise license must be prominently displayed in the premises to which it refers to.  
2. Any change made on details of the company name, physical location, management or 
responsible pharmacist shall be notified and approved by Rwanda  FDA.  
3. This prem ise license is not transferrable and its misuse will result into suspension or  
revocation.  
Done at Kigali on ……………………………  
Name and signature of Director General  
+ Stamp of the institution  
  
QMS No: FDISM/FDIC/FMT/005  
Revision No:1  
Effective Date:22 Sep 2022  
 
Premise registration certificate N°:  RWA -FDA -PPP-IIII-DDDD  
 Guidelines for  licensing of public and private manufacturers, distributors, wholesalers and 
retailers of medical Products   
 
Doc. No.: FDISM/FDIC/GDL/005  Revision Date: 24/08 /2022  Review Due Date: 23/08/2025  
Revision No.: 3  Approval date: 22 /09/2022   Effective Date: 26/09/2022  
 
Page 71 of 71  
ANNEX V: LIST OF NOTIFICATION FOR USE  WITH THESE GUIDELIN ES 
P.O.  Box 1948 Kigali  
info@rwandafda.gov.rw    
www.rwandafda.gov.rw   
 
(Insert contact name, if available ) 
Company name   
Telephone  
Address of License Holder  
 
Dear Sir/Madam  
 
Re: Withdraw al of premise license  
 
Reference is made to the Law Nº 003/2018 of 09/02/2018  establishing Rwanda Food and Drugs 
Authority and determining its mission, organization and function ing especially in its article (9) 2 to 
grant or withdraw authorizat ion relating to matters regulated under that Law ;  
 
Reference is also made to the Law Nº 047 /2018 of 14 /01/2013 relating to the regulation and 
inspection of food and pharmaceutical products especially in its article 37 (5) to close down premises 
considered in violation of that Law ;  
 
Reference is also made to article 4 of the Law referred to in the preceding paragraph which states 
that the licensee may have his or her license revoked if he or she contravenes the provisions of this 
Law; 
 
Further reference is made to the inspection that was conducted at your premise dated……….., where 
it was found that NAME OF THE PREMISE   …mention the violation s……  
 
It is against this background that  we notify you that operational license  License Ref Nº: …..of NAME 
OF THE PREMIS E is hereby revoked for reason stated above . You are stopped from …. state the 
relevant (i.e: pharmaceutical)  activities in NAME OF THE PREMISE  with immediate effects  
 
Sincerely,  
 
Name and signature of Director General  
+Stamp of the institution   
End of Doc ument  
Kigali on   ……. /……. / 2022  
Ref. No: FDISM/FDIC/             /FDA/YYYY