Updated Guidelines For Licensing To Manufacture To Operate As A Wholesale and Retail Seller of Medical Products

Guidelines for Licensing to Manufacture, to Operate as Wholesale and Retail Seller of Medical
Products
GUIDELINES FOR LICENSING

TO MANUFUCTURE, TO OPERATE AS
WHOLESALE AND RETAIL SELLER OF
MEDICAL PRODUCTS
JULY, 2021
Doc. No.: DIS/GDL/031 Revision Date: 12/07/2021 Review Due Date: 20/07/2024
Revision No.: 1 Effective Date: 20/07/2021
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GUIDELINES DEVELOPMENT HISTORY
DRAFT ZERO 17th August 2020
ADOPTION BY RWANDA FDA 24th August 2020
STAKEHOLDERS CONSULTATION 26th August 2020
ADOPTION OF STAKEHOLDERS’ COMMENTS 28th August 2020
REVISION No:0 02nd September 2020
REVISION No: 1 12th July 2021
DATE FOR COMING INTO EFFECT 20th July 2021
Document Revision History
Date of revision Revision Changes made and/or reasons for revision

number
12/07/2021 1 1. Chapter II is renamed LICENSING &
INSPECTIONS instead of Licensing
Requirements
2. Application forms, Formats of operational
license, Format of notification letter for
withdrawal of operational License /
Certificate and requirements for
application for renewal of the operational
license are included
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TABLE OF CONTENTS
GUIDELINES DEVELOPMENT HISTORY ............................................................................ 2
DOCUMENT REVISION HISTORY ......................................................................................... 2
FOREWORD ................................................................................................................................. 3
TABLE OF CONTENTS .............................................................................................................. 4
ACCRONYMES AND ABBREVIATIONS................................................................................ 7
CHAPTER I: INTRODUCTION................................................................................................. 8
I.1 GLOSSARY ........................................................................................................................... 8
I.2 PURPOSE OF THESE GUIDELINES ................................................................................... 9
I.3 SCOPE .................................................................................................................................. 10
CHAPTER II: LICENSING & INSPECTIONS ....................................................................... 11
A. LICENSING ....................................................................................................................... 11
A.1 GENERAL REQUIREMENTS ........................................................................................... 11
B. INSPECTIONS .................................................................................................................. 11
C. APPROVAL OF THE PREMISES .................................................................................... 12
D. ADDITIONAL GUIDANCE ON LICENSING OF NEW PHARMACEUTICAL
PREMISES ................................................................................................................................ 12
2.1 AUTHORIZATION TO OPERATE AS A MANUFACTURE OF MEDICAL PRODUCTS
.................................................................................................................................................... 12
2.1.1 AUTHORIZATION ........................................................................................................... 13
2.1.2 INSPECTION OF PREMISES FOR SUITABILITY ....................................................... 13
2.1.3 LOCATION OF PREMISES FOR MEDICAL PRODUCTS MANUFACTURING ....... 14
2.1.4 STANDARDS OF CONSTRUCTION.............................................................................. 14
2.1.5 SUITABILITY OF PRODUCTION AREAS .................................................................... 15
2.1.6 REGULAR WATER SUPPLY.......................................................................................... 16
2.1.7 STORAGE AREAS AND ENVIRONMENTAL CONTROLS........................................ 16
2.1.8 CONTAINERS TO BE CLEANED .................................................................................. 17
2.1.9 DESCRIPTIVE MATERIALS TO BE KEPT SECURE .................................................. 17
2.1.10 DESIGN, CONSTRUCTION, LOCATION AND MAINTENANCE OF EQUIPMENT
17
2.1.11 FIRE-FIGHTING EQUIPMENT..................................................................................... 18
2.1.12 COMPLIANCE WITH THE LAW ON OCCUPATIONAL HEALTH AND SAFETY 18
2.1.13 WEIGHING, MEASURING, TESTING AND RECORDING EQUIPMENT TO BE
CHECKED.................................................................................................................................. 18
2.1.14 QUALITY CONTROL AREAS ...................................................................................... 19
2.1.15 DOCUMENTATION ...................................................................................................... 19
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2.2 AUTHORIZATION FOR SMALL SCALE MANUFACTURING ............................... 19
2.2.1 APPLICATION FOR AUTHORIZATION FOR SMALL SCALE MANUFACTURING
19
2.2.3 LOCATION OF PREMISES FOR SMALL SCALE
MANUFACTURING/COMPOUNDING .................................................................................. 20
2.2.5 REGULAR WATER SUPPLY.......................................................................................... 21
2.2.6 PRODUCTION AREAS TO BE SUITABLE ................................................................... 21
2.2.7 STORAGE AREAS AND ENVIRONMENTAL CONTROLS........................................ 22
2.2.8 CONTAINERS TO BE CLEANED .................................................................................. 22
2.2.9 DESIGN, CONSTRUCTION, LOCATION AND MAINTENANCE OF EQUIPMENT 23
2.2.10 FIRE-FIGHTING EQUIPMENT..................................................................................... 23
2.2.11 COMPLIANCE WITH THE LAW ON OCCUPATIONAL HEALTH AND SAFETY 23
CHECKED .................................................................................................................................. 24
2.3 AUTHORIZATION TO OPERATE A WHOLESALE OF MEDICAL PRODUCTS ... 24
2.3.1 APPLICATION FOR A WHOLESALE AUTHORIZATION.......................................... 24
2.3.3 LOCATION OF PREMISES FOR WHOLESALE OF MEDICAL PRODUCTS ........... 25
2.3.5 PREMISES SHALL BE IN GOOD STATE OF REPAIR, MAINTENANCE AND
SANITATION ............................................................................................................................ 25
2.3.6 STORAGE AREAS ........................................................................................................... 26
2.3.7 MINIMUM FLOOR SPACE AND HEIGHT ................................................................... 26
2.3.8 DOCUMENTATION AND RELATED CONTROLS ..................................................... 27
2.3.9 STAFFING REQUIREMENTS......................................................................................... 27
2.3.10 MANAGEMENT OF CONTROLLED SUBSTANCES ................................................ 27
2.3.11 GOOD DISTRIBUTION PRACTICE ............................................................................. 27
2.3.12 GOOD MANUFACTURING PRACTICE...................................................................... 28
2.3.13 GOOD DISPENSING PRACTICE ................................................................................. 28
2.4 AUTHORIZATION TO OPERATE A RETAIL SELL OF MEDICAL PRODUCTS ........ 28
2.4.1 APPLICATION FOR AUTHORIZATION ....................................................................... 28
2.4.2 INSPECTION OF PREMISES FOR SUITABILITY .................................................... 29
2.4.3 LOCATION OF PREMISES FOR RETAIL ESTABLISHMENT ................................ 29
2.4.4 STANDARDS OF CONSTRUCTION .......................................................................... 29
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2.4.5 PREMISES SHALL BE IN GOOD STATE OF REPAIR, MAINTENANCE, AND
SANITATION ............................................................................................................................ 29
2.4.6 STORAGE AREAS ........................................................................................................ 30
2.4.7 MINIMUM FLOOR SPACE AND HEIGHT ................................................................ 30
2.4.8 DOCUMENTATION AND RELATED CONTROLS .................................................. 31
2.4.9 OTHER SUPPORT STAFF THAT CAN WORK IN RETAIL ESTABLISHMENT
(OPTIONAL) .............................................................................................................................. 32
2.5 AUTHORIZATION TO OPERATE A VETERINARY DRUG SHOP ......................... 32
2.5.1 APPLICATION FOR AUTHORIZATION ....................................................................... 32
2.5.2 INSPECTION OF PREMISES SUITABILITY ............................................................. 32
2.5.3 LOCATION OF PREMISES FOR VETERINARY DRUG SHOP ............................... 33
2 . 5 . 4 STANDARDS OF CONSTRUCTION .......................................................................... 33
SANITATION ............................................................................................................................ 33
2.5.6 STORAGE AREAS ........................................................................................................... 34
2.5.6 MINIMUM FLOOR SPACE AND HEIGHT ................................................................ 34
2.5.7 DOCUMENTATION AND RELATED CONTROLS .................................................. 34
2.6 TRANSPORTATION REQUIREMENTS ..................................................................... 35
CHAPTER III: REFUSAL AND VALIDITY OF AN AUTHORIZATION .......................... 36
3.1 REFUSAL TO GRANT AN AUTHORIZATION ............................................................... 36
3.2 VALIDITY OF AN AUTHORIZATION ............................................................................. 36
CHAPTER IV: RENEWAL AND VARIATION OF AN AUTHORIZATION ..................... 37
4.1 RENEWAL OF AN AUTHORIZATION ...................................................................... 37
4.2 VARIATION OF AN AUTHORIZATION .................................................................... 37
4.3 NOTIFICATION OF CHANGE IN OWNERSHIP ........................................................ 37
ENDORSEMENT OF THE GUIDELINES ............................................................................. 40
ANNEXES .................................................................................................................................... 41
ANNEX I: LIST OF REQUIRMENTS FOR APPLICATION FOR VARIATION ............. 42
ANNEX II: LIST OF REQUIRMENTS FOR APPLICATION FOR RENEWAL OF THE
OPERATIONAL LICENSE....................................................................................................... 45
ANNEX III: APPLICATION FORMS ..................................................................................... 46
ANNEX IV: FORMAT OF AUTHORIZATION ISSUED ..................................................... 77
ANNEX V: LIST OF NOTIFICATION FOR USE WITH THESE GUIDELINES............. 88
ANNEX VI: FORMAT OF THE INSPECTION REPORT.................................................... 90
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ACCRONYMES AND ABBREVIATIONS
FDA Food and Drugs Authority

GDsP Good Dispensing Practice
GDP Good Distribution Practice
GMP Good Manufacturing Practice
HVAC Heating, Ventilation, and Air Conditioning
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CHAPTER I: INTRODUCTION
I.1 GLOSSARY
In these Guidelines, unless the context otherwise states:
“Sale” means sell by wholesale or retail and includes

a) advertise, label, prepare, expose, offer or possess 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
“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 No 003/2018 of 09/02/2018 establishing Rwanda FDA
and determining its mission, organization and functioning; it includes licenses, permits,
and certificates.
“Fee” means the income prescribed in the Fees Regulations in accordance with Article
9 and Article 32 of the Law No 003/2018 of 09/02/2018.
“Good Manufacturing Practice” means that part of Quality Management 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, Clinical Trial
Authorization or product specification. Good Manufacturing Practice is concerned with both
production and quality control.
“Law No 003/2018” means Law No 003/2018 of 09/02/2018 establishing Rwanda FDA

and determining its mission, organization and functioning;
“Law No. 47/2012” means Law No 47/2012 of 14/01/2013 relating to the regulations and
inspection of food and pharmaceutical products;
Inspection” means an organized examination or formal evaluation exercise. Inspection means

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also “A visit to a factory or other building 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.”
“Manufacturer” means a person or corporation, or other entity engaged in the business of

manufacturing medical products;
“Medical product” includes medicines, vaccines, diagnostics and medical devices.
“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 where 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.
“PRIMS” means Products Regulatory Information Management System platform.
“Qualified personnel”: means an individual who by possession of a recognized degree

who by extensive knowledge, training and experience, has successfully demonstrated his
ability to solve or resolve problems relating to the subject matter.
In these Guidelines, the following verbal forms are used:

“shall” indicates a requirement;
“should” indicates a recommendation;
“may” indicates a permission; and
“can” indicates a possibility or a capability.
I.2 PURPOSE OF THESE GUIDELINES
The “Guidelines for licensing to manufacture, to operate as wholesale or retail seller of

medical products” First Edition’ is a Rwanda Food and Drugs Authority publication
which sets out procedures and requirements for the licensing of premises selling regulated
products. They are issued in pursuance of Article 3 of Law No. 003/2018 of 09/02/2018
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establishing the Rwanda FDA and determining its mission, organization and functioning and
Articles 1 and 3 of Law No. 47/2012 of 14/01/2013 Relating to the regulation and inspection
of food and pharmaceutical products and in terms of the Regulations CBD/TRG/001 Rev.
No 1, Governing licensing to manufacture, to operate as wholesale or retail seller of
medical products.
The purpose of these guidelines for licensing to manufacture, to operate as wholesale or retail
seller of medical products is to give guidance on the requirements for the licensing
premises that manufacture, store, and distribute regulated products as the licensing of such
premises forms an integral part of ensuring that regulated products maintain their integrity
throughout their shelf life. Adherence to the guidelines by applicants will facilitate timely
review and processing of applications.
I.3 SCOPE
These guidelines apply to any person, institution, business company engaging in the
manufacturing and sale of medical products.
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CHAPTER II: LICENSING & INSPECTIONS
A. LICENSING
A.1 GENERAL REQUIREMENTS
1. All applicants for premise licenses for medical products shall apply for the license to
operate.
2. All pharmaceutical establishment license applications shall be submitted to Rwanda
FDA head office or via email (info@rwandafda.gov.rw) OR via Products Regulatory
Information Management System (PRIMS) platform.
3. An applicant for premise licenses for medical products shall submit the requirements as
described in Chapter 2 section 2.1 up to 2.5 of these guidelines.
4. Applicants shall pay all the prescribed fees as per the regulations at the time of
application through the bank accounts as indicated on Rwanda FDA website. Such payment
does not mean to be granted a license prior to fulfilling requirements for operational license.
5. Applicants for wholesale and retail pharmacies will be required to meet the Good
Distribution Practices (GDP) requirements.
6. All applicants for licenses shall be subject to comply to the approved guidelines.
7. Incomplete application documents for licensing a new pharmaceutical establishment
shall not be processed.
8. All applicants intending to establish new pharmaceutical manufacturing facilities are
advised to contact Rwanda FDA for guidance before embarking on any establishment.
9. Applicants wishing to deal in both human and veterinary medicines shall meet the
minimum requirements for suitability of premises and personnel for each section but shall
apply for a single license. The two sections shall be separated.
10. Applicants wishing to deal in both veterinary medicines and agricultural products shall
apply for operation licenses separately in their respective competent authorities. The
veterinary premises apply for licenses in Rwanda FDA. Applicants should meet the
minimum requirements for suitability of premises and personnel. The two sections shall be
separated.
B. INSPECTIONS
A person, company or institution who intends to;
The Authority shall inspect the premises to determine their suitability.
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1) Upon receipt of complete required documents for license to manufacture, to operate as

wholesale and retail seller of medical products and payment of mandatory fee,
inspection of the premises shall be conducted.
2) Prior to issuance of an operational license for premises for medical products, the
intended premises shall comply to the suitability stipulated in in Chapter 2 section 2.1
up to 2.5 of these guidelines. Any premise is granted a license after the findings of the
inspection of the premise meet the requirements.
C. APPROVAL OF THE PREMISES
Upon approval of findings of the inspection to manufacture, to operate a wholesale, and retail
seller of medical product, Rwanda FDA shall notify the applicant the decision based on the
findings of the inspections. In case of compliance to the premise licensing requirements, the
operational 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.
D. ADDITIONAL GUIDANCE ON LICENSING OF NEW PHARMACEUTICAL

PREMISES
A person, company or institution who intends to;
1) carry out the business of manufacturing, operate wholesale or retail of medical

products,
2) operate as an authorized seller or import or export of medical products or medical
representatives;
SHALL request for an authorization issued by the Authority in accordance with the
Law and Regulations.
2.1 AUTHORIZATION TO OPERATE AS A MANUFACTURE OF MEDICAL

PRODUCTS
The Authority shall inspect the premises to determine their suitability for manufacturing of
medical products.
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2.1.1 AUTHORIZATION
1) The applicant shall submit the following documents:
a) Letter of intent to manufacture medical products;

b) Certificate of registration of domestic company
c) Completed application for manufacture of medical products, in the standard
form (Doc. No DIS/FOM/106-Application for medical products manufacturing
authorization;
d) Architectural plan of the site; and
e) Environment impact assessment report.
f) Notarized degree of the qualified personnel
g) Notarized license of the qualified personnel issued by respective professional
council, where applicable
h) Copy of Identity card/passport of owner/managing director and qualified
personnel
i) Payment proof of the prescribed fees.
j) Professional agreement between company and qualified personnel
2) After satisfactory review of the preliminary documentation, the company is given

approval to start construction.
3) Preliminary inspections shall be carried out at various stages of construction and setting up
the site. These may include:
a) Site inspection 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.;
2.1.2 INSPECTION OF PREMISES FOR SUITABILITY
1) The Authority shall inspect the premises to determine their suitability for
manufacturing of medical products.
2) Premises that do not comply with the requirements for suitability shall not be
eligible for consideration for Manufacturing Authorization.
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2.1.3 LOCATION OF PREMISES FOR MEDICAL PRODUCTS MANUFACTURING
The premises shall be located in a place where they cannot be contaminated by the
external environment or other activities or contaminating the neighbouring environment.
2.1.4 STANDARDS OF CONSTRUCTION
The premises shall:
1) be of a permanent nature;
2) be protected against, adverse weather conditions including dust, ground water
seepage, vermin and pest infestation;
3) have sufficient space for the carrying out and supervision of the necessary
operations;
4) have air intakes, exhausts, and associated pipe work and trucking sited so as
to avoid contamination;
5) have the plumbing, electrical and other services in the manufacturing and
processing areas sited in a way that creates ease of cleaning and shall for this purpose
run outside the processing and manufacturing areas and be well sealed in place;
6) have drains that are of an adequate size and that are provided
7) with sufficient traps and proper ventilation;
8) have well marked fire exits and the access to the fire exits kept clear at all times;
9) have floors and walls made of a washable and impervious material with a flat surface
free of cracks and a ceiling covered with a non-flaking finish that allows easy
cleaning; and
10) be well lit, ventilated and have appropriate air-control facilities including
temperature, humidity, and filtration for the operations to be undertaken.
11) The premises shall have appropriate toilet facilities, soap, and hand washing
facilities with single-use towels or hand air drier. Toilets should not directly
communicate with production or storage areas.
12) Facilities for changing clothes and street shoes should be easily accessible and
appropriate for the number of users.
13) Eating and drinking areas or rooms should be separate from other areas.
14) Maintenance workshops should as far as possible be separated from production
areas.
15) Whenever parts and tools are stored in the production area, they should be kept in
rooms or lockers reserved for that use.
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16) The premises including the external surroundings shall be maintained in a clean
and tidy condition with regular and adequate clearance of waste materials.
2.1.5 SUITABILITY OF PRODUCTION AREAS
1) Premises shall be laid out in such a way as to allow the production to take place
in areas connected in a logical order corresponding to the sequence of the
operations and to the requisite cleanliness levels.
2) 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 or wrong application of
any of the manufacturing or control steps.
3) Weighing of starting materials shall be carried out in a separate weighing room
designed for that use.
4) Where starting and primary packaging materials, intermediate or bulk products are
exposed to the environment, interior surfaces (walls, floors and ceilings) should be
smooth, free from cracks and open joints, and should not shed particulate matter
and should permit easy and effective cleaning and, if necessary, disinfection.
5) Pipe work, light fittings, ventilation points and other services should be designed and
sited to avoid the creation of recesses which are difficult to clean. As far as possible,
for maintenance purposes, they should be accessible from outside the manufacturing
areas.
6) Drains should be of adequate size, and have trapped gullies. Open channels should be
avoided where possible, but if necessary, they should be shallow to facilitate cleaning
and disinfection.
7) Production areas should be effectively ventilated, with air control facilities (including
temperature and, where necessary, humidity and filtration) appropriate both to the
products handled, to the operations undertaken within them and to the external
environment.
8) In cases where dust is generated (e.g. during sampling, weighing, mixing and
processing operations, packaging of dry products), specific provisions shall be
taken to avoid cross- contamination and facilitate cleaning.
9) Premises for the packaging of medical products should be specifically designed and
laid out so as to avoid mix-ups or cross-contamination.
10) Production areas should be well lit, particularly where visual on-line controls are
carried out.
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11) Hand washing facilities with single-use towels or hand air drier; hand sanitizing
facilities; and appropriate protective garments prior to entering controlled areas
should be available.
2.1.6 REGULAR WATER SUPPLY
1) The premises shall have a regular and sufficient supply of water.

2) 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.
3) The chemical and microbiological quality of water used in production should be
specified and monitored.
4) Water for injections should be produced, stored and distributed in a manner which
prevents microbial growth, for example by constant circulation at a temperature
above 70°C.
2.1.7 STORAGE AREAS AND ENVIRONMENTAL CONTROLS
Storage areas shall:
1) be designed or adapted to ensure good storage conditions;

2) be secure and with segregated areas for the storage of rejected, recalled or returned
materials or products;
3) have access to the materials and goods restricted to authorized personnel only;
4) 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;
5) be clean, dry and maintained within acceptable temperature limits; where special
storage conditions are required (e.g. temperature, humidity) these should be
provided, checked and monitored;
6) be provided with receiving and dispatch bays to protect materials and products
from the weather;
7) be provided with receptions areas which shall be designed and equipped to allow
containers of incoming materials to be cleaned where necessary before storage;
8) 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 physical quarantine should give equivalent security;
9) have provisions where the starting materials and finished goods are stored under
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cover and off the floor;
10) 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;
11) Have provisions where highly active materials or products are stored in safe and secure
areas;
12) have safe and secure storage of printed packaging material
2.1.8 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.
2.1.9 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 issued, to avoid any mix-up.
2.1.10 DESIGN, CONSTRUCTION, LOCATION AND MAINTENANCE OF

EQUIPMENT
1) Manufacturing equipment shall be designed, located and maintained to suit its

intended purpose.
2) Repair and maintenance operations shall not present any hazard to the quality of the
products.
3) 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.
4) Washing and cleaning equipment shall be chosen and used in order not to be a
source of contamination.
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5) Equipment shall be installed in such a way as to prevent any risk of error or of
contamination.
6) 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 product
and thus present any hazard.
7) Balances and measuring equipment of an appropriate range and precision shall be
available for production and control operations.
8) Measuring, weighing, recording and control equipment shall be calibrated and
checked at defined intervals by appropriate methods. Adequate records of such
tests shall be maintained.
9) Fixed pipework shall be clearly labelled to indicate the contents and, where
applicable, the direction of flow.
10)Distilled, deionized and, where appropriate, other water pipes shall be sanitized
according to written procedures that detail the action limits for microbiological
contamination and the measures to be taken.
11)Defective equipment shall, if possible, be removed from production and quality
control areas, or at least be clearly labelled as defective.
2.1.11 FIRE-FIGHTING EQUIPMENT
The premises shall have sufficient fire-fighting equipment which shall, at all times, be in good
condition and readily accessible.
2.1.12 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 Chapter V.
2.1.13 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.
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2.1.14 QUALITY CONTROL AREAS
1) Quality Control laboratories shall be separated from production areas. This is

particularly important for laboratories for the control of biologicals, microbiological
and radioisotopes, which shall also be separated from each other.
2) 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.
3) Separate rooms may be necessary to protect sensitive instruments from vibration,
electrical interference, humidity, etc.
2.1.15 DOCUMENTATION
The manufacturing premises shall keep the following records:
i. Manufacturing records
ii. Medical examination records
iii. Distribution records
iv. Suppliers’ records
v. Recall records
vi. Compliant records
vii. Maintenance and calibration records
viii. Cleaning and disinfection records
ix. Quality Control Records
2.2 AUTHORIZATION FOR SMALL SCALE MANUFACTURING
2.2.1 APPLICATION FOR AUTHORIZATION FOR SMALL SCALE

MANUFACTURING
The small-scale manufacturing will deal with limited number of products in appropriate
designated area on small scale basis. These products will be for external use only.
An application for authorization for small scale manufacturing/compounding shall be made

using the standard form (Doc. No DIS/FOM/108-Application for medical products small
scale manufacturing authorization), and shall be accompanied by the following:
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1) Certificate of registration and a full registration information of domestic company;

2) Lease contract of the location, if applicable;
3) Evidence of payment of prescribed fees,
4) Notarized bachelor’s degree of qualified personnel
5) Notarized valid license to practice profession of the qualified personnel;
6) Professional agreement between the company and the qualified personnel in charge
where the owner is not the qualified personnel;
7) Copy of the identity card or passport of both the owner managing director and the
qualified personnel;
8) The minimum floor area acceptable is 120 square meters.
1) The Authority shall inspect the premises to determine the suitability of premises for
small scale manufacturing/compounding.
2) Premises that do not comply with the requirements for suitability shall not be eligible
for consideration for a small scale manufacturing/compounding.
2.2.3 LOCATION OF PREMISES FOR SMALL SCALE

MANUFACTURING/COMPOUNDING
external environment or other activities.
The premises shall:
1) Be of a permanent nature;
2) be protected against, adverse weather conditions including dust, ground water seepage,
vermin and pest infestation;
3) have sufficient space for the carrying out and supervision of the necessary operations;
4) have the plumbing, electrical and other services in the manufacturing and processing areas
sited in a way that creates ease of cleaning and shall for this purpose run outside the
processing and manufacturing areas and be well sealed in place;
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5) have drains that are of an adequate size and that are provided with sufficient traps and
proper ventilation;
6) have well marked fire exits and the access to the fire exists kept clear at all times;
7) have floors and walls made of a washable and impervious material with a flat surface free
of cracks and a ceiling covered with a non-flaking finish that allows easy cleaning; and
8) be well lit, ventilated and have appropriate air-control facilities including temperature,
humidity, and filtration for the operations to be undertaken.
9) The premises shall have appropriate toilet facilities, soap, hand washing facilities with
single-use towels or hand air drier. Toilets should not directly communicate with
production or storage areas.
10) Facilities for changing clothes and street shoes should be easily accessible and appropriate
for the number of users.
11) Eating and drinking areas or rooms should be separate from other areas.
12) Maintenance workshops should be as far as possible separated from production areas.
13) Whenever parts and tools are stored in the production area, they should be kept in rooms
or lockers reserved for that use.
14) The premises including the external surroundings shall be maintained in a clean and tidy
condition with regular and adequate clearance of waste materials.
2.2.5 REGULAR WATER SUPPLY
1) The premises shall have a regular and sufficient supply of water.

2) 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.
3) The chemical and microbiological quality of water used in production should be specified
and monitored.
2.2.6 PRODUCTION AREAS TO BE SUITABLE
1) 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;
2) 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 or wrong application of any of the manufacturing or
control steps.
3) Weighing of raw materials shall be carried out in a separate weighing room designed for
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that use as prescribed in the related guideline.
4) In case where dust is generated (e.g. during sampling, weighing, mixing and processing
operations, packaging of dry products), specific precautions should be taken to avoid
cross-contamination and facilitate cleaning.
5) Premises for the packaging of medicinal products should be specifically designed and laid
out so as to avoid mix-ups or cross-contamination.
6) Production areas should be well lit, particularly where visual on-line controls are carried
out.
7) Hand washing facilities should be equipped with single-use towels or hand air drier; hand
sanitizing facilities; and appropriate protective garments prior to entering controlled areas.
2.2.7 STORAGE AREAS AND ENVIRONMENTAL CONTROLS
Storage areas shall:
1) be designed or adapted to ensure good storage conditions;

2) be secure and with segregated areas for the storage of rejected, recalled or returned
materials or products;
3) have access to the materials and goods restricted to authorized personnel only;
4) have sufficient capacity to allow orderly storage of the various categories of materials and
products; raw and packaging materials, bulk and finished products, products in
quarantine, released, rejected, returned or recalled;
5) be clean and dry and maintained within acceptable temperature limits; where special
storage conditions are required (e.g. temperature, humidity) these should be provided,
checked and recorded;
6) be provided with receiving and dispatch bays to protect materials and products from the
weather
7) have quarantine area clearly marked and their access restricted to authorized personnel;
any system replacing the physical quarantine should give equivalent security; and
8) have safe and secure storage of printed packaging materials.
2.2.8 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.
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2.2.9 DESIGN, CONSTRUCTION, LOCATION AND MAINTENANCE OF
EQUIPMENT
1) Manufacturing equipment shall be designed, located and maintained to suit its

intended purpose.
2) Repair and maintenance operations shall not present any hazard to the quality
of the products.
3) 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.
4) Washing and cleaning equipment/ detergents shall be chosen and used in order not to
be a source of contamination.
5) Equipment shall be installed in such a way as to prevent any risk of error or of
contamination.
6) 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 product
and thus present any hazard.
7) Balances and measuring equipment of an appropriate range and precision shall be
available for production and control operations.
8) Measuring, weighing, recording and control equipment shall be calibrated and
checked at defined intervals by appropriate methods. Adequate records of such shall
be maintained.
9) Defective equipment shall be removed from production areas, or at least be clearly
labelled as defective.
2.2.10 FIRE-FIGHTING EQUIPMENT
The premises shall have fire-fighting equipment which shall, at all times, be in good condition
and readily accessible.
2.2.11 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 Labor in Rwanda, which elaborates the requirements for Occupational Health
and Safety in Chapter V.
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CHECKED
The equipment used for weighing, measuring, testing and recording shall to be subjected to
calibration for accuracy in accordance with a regular set schedule.
2.3 AUTHORIZATION TO OPERATE A WHOLESALE OF MEDICAL PRODUCTS
2.3.1 APPLICATION FOR A WHOLESALE AUTHORIZATION
A wholesale authorization can be granted to an establishment dealing with human

medicines, Veterinary medicines, Medical devices.
The supervising personnel of authorized wholesale establishments shall:
• for wholesale pharmacy be a pharmacist,

• for wholesale veterinary pharmacy be a veterinary doctor/pharmacist,
• for wholesale of medical devices and diagnostics be biomedical engineer/pharmacist
or any other relevant qualification,
• for wholesale of optical products be optician, or any other relevant qualification,
• for wholesale orthopedic products be orthopedist or any other relevant qualification,
Application to operate a wholesale establishment shall be accompanied by the following:
1) Dully filled application form;

2) Business registration certificate and a full registration information of domestic
company;
4) Evidence of payment of prescribed fees;
5) Notarized degree of the qualified personnel;
6) Notarized valid license to practice profession of the responsible qualified personnel
where applicable;
7) Professional agreement between the company and the qualified personnel in charge
where the Owner is not the responsible qualified personnel;
8) Copy of the identity card or passport of both the owner and the responsible qualified
personnel;
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1) The Authority shall inspect the premises to determine their suitability for wholesale
of medical products.
2) Premises that do not comply with the requirements for suitability shall not be eligible for
consideration for medical products Wholesale Authorization.
2.3.3 LOCATION OF PREMISES FOR WHOLESALE OF MEDICAL PRODUCTS
The premises shall be located in a place where they cannot be contaminated from the
The premises shall:
1) be of a permanent nature
2) being meant for commercial purposes or warehousing;
3) be protected against adverse weather conditions including dust, ground water seepage,
4) have adequate space for the carrying out and supervision of the necessary operations;
5) have floors and walls made of a washable and impervious material with a flat surface
free of cracks and a ceiling covered with a non-flaking finish that allows easy cleaning;
and
6) be well lit, ventilated and have appropriate air-control facilities including
2.3.5 PREMISES SHALL BE IN GOOD STATE OF REPAIR, MAINTENANCE AND

SANITATION
1) The process of maintenance and repair shall not, while being carried out, cause any
contamination of ingredients or products.
2) The external surroundings shall be maintained in a clean and tidy condition with regular
and adequate clearance of waste materials.
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3) The premises shall have a regular and sufficient supply of water of suitable quality.
4) The premises shall have appropriate toilet facilities and hand washing facilities with
single- use towels or hand air drier.
5) The premises shall have sufficient fire-fighting equipment which shall, at all times,
be in good condition and accessible.
2.3.6 STORAGE AREAS
The storage areas for medical products shall be well covered and off the floor in an area:
1) that is secure and has adequate space;

2) that is laid out to allow clear separation of different materials and products to
minimize the risk of mix-up;
3) Access to the materials and goods is restricted to authorized personnel only;
4) Medical Products that are temperature sensitive shall be kept in a temperature-
controlled storage facility; and
5) with separate area in the storage facility where recalled, expired or rejected drugs
shall be stored under lock and key.
2.3.7 MINIMUM FLOOR SPACE AND HEIGHT
1) For an establishment dealing with human medicines or medical devices, the sales
and administrative area shall have minimum continuous floor space of 30 square
meters. Within the 30 square meters, there shall be a separate office or administrative
area, with a full view of the sales area, for the responsible technician; and records shall
be maintained in this office or area. The storage areas shall have minimum floor area
of 60 square meters; and minimum height of 2.5 meters from the floor to the ceiling.
2) For an establishment dealing with veterinary medicines, the sales and administrative
area shall have minimum continuous floor space of 25 square meters. Within the
25 square meters, there shall be a separate office or administrative area, with a full
view of the sales area, for the responsible technician; and records shall be maintained
in this office or 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.
3) The sales and storage areas shall be orderly, have adequate space, and protected
from direct sunlight, heat and moisture.
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2.3.8 DOCUMENTATION AND RELATED CONTROLS
1) All records (including but not limited to invoices, purchase orders, import authorizations,
sales and distribution records, in the Wholesale premise, etc.) 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.
2) All entry and exit of medical products must be approved by the responsible qualified
personnel.
3) Availability of certified copy of license to practice of the qualified personnel in charge
where applicable.
4) Quarterly Reports on the distribution of controlled substances to be submitted to the
Authority.
5) A copy of the guideline on Good Distribution Practice (GDP), approved by the Authority.
6) Identify the establishment by a readable sign board with the number of authorization,
names and contacts of the qualified personnel in charge.
7) A copy of authorization, license to practice for the responsible qualified personnel shall
be conspicuously displayed in the retail establishment.
2.3.9 STAFFING REQUIREMENTS
1) Qualified personnel (must); and

2) Support Staff: Assistant Pharmacist, Pharmacy Technician, Medical Assistant, Veterinary
Technician or Nurse (optional) depending on the category of the establishment.
2.3.10 MANAGEMENT OF CONTROLLED SUBSTANCES
Controlled substances shall be kept in a secure, fixed separate and lockable storage place.
2.3.11 GOOD DISTRIBUTION PRACTICE
The medical products distributors shall have systems, facilities and operations that comply
with the Good Distribution Practice Guidelines, as adopted by the Authority.
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2.3.12 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.
2.3.13 GOOD DISPENSING PRACTICE
The medical products retail seller/dispenser shall have systems, facilities and operations that
comply with the Good Dispensing Practice Guidelines, as adopted by the Authority.
2.4 AUTHORIZATION TO OPERATE A RETAIL SELL OF MEDICAL PRODUCTS
2.4.1 APPLICATION FOR AUTHORIZATION
A retail authorization can be granted to an establishment dealing with human medicines,

Veterinary medicines, medical devices.
The supervising personnel of authorized retail establishments shall,
• for retail pharmacy be a pharmacist,

• for retail veterinary pharmacy be a veterinary doctor/pharmacist,
• for retail of medical devices and diagnostics be biomedical engineer or
pharmacist or any other relevant qualification,
• for retail of optical products be optician or any other relevant qualification,
• for retail orthopedic products be orthopedist or any other relevant qualification,
An application for an authorization to operate a retail establishment shall be accompanied

by the following:
1) Completed application form;

2) Business registration certificate and a full registration information of domestic
company;
4) Evidence of payment of prescribed fees;
5) Notarized degree of the qualified personnel;
6) Notarized valid license to practice profession of the responsible qualified
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personnel where applicable;
7) Professional agreement between the company and the qualified personnel in
charge
8) where the Owner is not the responsible qualified personnel;
9) Copy of the identity card or passport of both the owner and the responsible
1) The Authority shall inspect the premises with respect to Regulations, to determine
that they are suitable for retail of medical products.
2) Premises that do not comply with the requirements for suitability as laid down
in the Regulations shall not be eligible for consideration for a Retail Authorization.
2.4.3 LOCATION OF PREMISES FOR RETAIL ESTABLISHMENT
The premises shall:
1) be of a permanent nature;
2) be protected against adverse weather conditions including dust, ground water seepage,
3) have adequate space for the carrying out and supervision of the necessary operations;
4) have floors and walls made with impervious material with a flat surface free of cracks and
a ceiling covered with a non-flaking finish that allows easy cleaning; and
5) be well lit, ventilated and have appropriate air-control facilities including temperature,
humidity, and filtration for the operations to be undertaken.

SANITATION
1) The external surroundings shall be maintained in a clean and tidy condition with
regular and adequate clearance of waste materials.
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2) The premises shall have a regular supply of water of suitable quality.
3) The premises shall have appropriate toilet facilities and hand washing facilities with
single- use towels.
4) The premises shall have fire-fighting equipment which shall, at all times be in
good condition and accessible.
2.4.6 STORAGE AREAS
The storage areas for medical products shall:
1) be secure and have adequate space;

2) have restricted access to unauthorized personnel;
3) keep products that are temperature sensitive in a temperature-controlled storage facility;
4) keep products that are light sensitive in area protected from light; and
5) have a separate area for recalled, expired or rejected medical products
1) For an establishment dealing with human medicines, the retail pharmacy shall have
a minimum space of 40 square meters as whole that can be separated into minimum
sales area of 30 square meters and a storage room for Kigali City and secondary
cities. The minimum height shall be 2.5 meters from the floor to the ceiling.
2) For an establishment dealing with human medicines, the retail pharmacy shall have
sales area of 25 square meters and a storage room 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 magisterial preparation activities.
3) For an establishment dealing with veterinary medicines, the retail pharmacy shall have
sales area of 25 square meters and a storage room for Kigali City and secondary
cities. The minimum height shall be 2.5 meters from the floor to the ceiling.
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4) For an establishment dealing with veterinary medicines, the retail pharmacy shall have
sales area and a storage room for the rest of the country. The minimum height shall
be 2.5 meters from the floor to the ceiling.
5) For an establishment dealing with optical or orthopedic products, the retail of optical
and orthopedic shop shall have a minimum space of 30 square meters as whole that
can be separated into minimum sales area of 25 square meters and a storage room
everywhere in the country. The minimum height shall be 2.5 meters from the floor to
the ceiling.
6) The sales areas shall be orderly, have adequate space, and protected from direct
sunlight, heat and moisture.
The dispensing area shall:
1. be a separate lockable area with no access for the public;

2. have benches and working surfaces with impervious washable tops;
3. be fitted with a sink with running water, soap, single-use towels; and hand sanitizing
facility.
4. have provision for staff to put on appropriate protective garments.
2. The premises shall not be shared with any medical clinic, veterinary surgery or any
other business.
1) All records (including but not limited to invoices, purchase orders, sales and dispensing
records, in the retail establishment), 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.
2) All entries and dispensing of medical products must be approved by the responsible
qualified personnel.
3) Quarterly Report on the dispensed controlled substances (Narcotics and psychotropic
substances) to be submitted to the Authority.
4) A copy of the Good Dispensing Practice (GDP), approved by the Authority.
5) Authorized establishment shall be identified by a clearly displayed sign post containing
the name of establishment, names and telephone number of the qualified personnel.
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6) The license to practice and the license to operate shall be conspicuously displayed in the
establishment.
2.4.9 OTHER SUPPORT STAFF THAT CAN WORK IN RETAIL ESTABLISHMENT

(OPTIONAL)
Support Staff: Assistant Pharmacist, Pharmacy Technician, Medical Assistant, Nurse, or

veterinary technician (optional) depending on the category of the establishment.
2.5 AUTHORIZATION TO OPERATE A VETERINARY DRUG SHOP
2.5.1 APPLICATION FOR AUTHORIZATION
An authorization can be granted to company dealing with veterinary medicines in veterinary

drug shops. The supervising personnel shall be a veterinary technician.
An application for an authorization to operate a veterinary drug shop shall be accompanied

by the following:
1. Completed application form;

2. Business registration certificate and a full registration information of domestic
company;
3. Lease contract of the location, if applicable;
4. Evidence of payment of prescribed fees;
5. Notarized certificate/degree of the qualified personnel;
6. Notarized valid license to practice profession of the responsible qualified personnel
where applicable;
7. Professional agreement between the company and the qualified personnel in charge
where the Owner is not the responsible qualified personnel;
8. Copy of the identity card or passport of both the owner and the responsible qualified
personnel;
2.5.2 INSPECTION OF PREMISES SUITABILITY
1. The Authority shall inspect the premises with respect to Regulations, to determine
that they are suitable for veterinary drug shop.
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2. Premises that do not comply with the requirements for suitability as laid down in
the Regulations shall not be eligible for consideration for a veterinary drug shop
Authorization.
2.5.3 LOCATION OF PREMISES FOR VETERINARY DRUG SHOP
The premises shall be located in a place where they cannot be contaminated from the
2 . 5 . 4 STANDARDS OF CONSTRUCTION
The premises shall:
1. be of a permanent nature;
2. be protected against adverse weather conditions including dust, ground water seepage,
3. have adequate space for the carrying out and supervision of the necessary operations;
4. have floors and walls made with impervious material with a flat surface free of cracks
and a ceiling covered with a non-flaking finish that allows easy cleaning; and
5. be well lit, ventilated and have appropriate air-control facilities including

SANITATION
1. The external surroundings shall be maintained in a clean and tidy condition with
regular and adequate clearance of waste materials.
2. The premises shall have a regular supply of water of suitable quality.
3. The premises shall have appropriate toilet facilities and hand washing facilities with
single- use towels.
4. The premises shall have fire-fighting equipment which shall, at all times be in
good condition and accessible.
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2.5.6 STORAGE AREAS
The storage areas for medical products shall:
1. be secure and have adequate space;

2. have restricted access to unauthorized personnel;
3. keep products that are temperature sensitive in a temperature-controlled storage facility;
4. keep products that are light sensitive in area protected from light; and
5. have a separate area for recalled, expired or rejected veterinary drugs
For an establishment dealing with veterinary medicines, the veterinary drug shop shall
have a minimum space of 20 square meters as whole that can be separated into minimum
sales area of 15 square meters and a storage room for Kigali City and secondary cities. The
minimum height shall be 2.5 meters from the floor to the ceiling.
For an establishment dealing with veterinary medicines, the veterinary drug shop shall
have a minimum space of 15 square meters as whole that can be separated into minimum
sales area and a storage room for the rest of the country. The minimum height shall be 2.5
meters from the floor to the ceiling.
The dispensing area 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 towels; and hand
sanitizing facility.
iv. have provision for staff to put on appropriate protective garments.
1. All records (including but not limited to invoices, purchase orders, sales and
dispensing records, in the veterinary drug shop), for all veterinary medicines and
administrative records of the staff shall be properly kept in the establishment and be
readily available to the inspection service when requested for or needed.
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2. All entries and dispensing of veterinary medicines must be approved by the
responsible qualified personnel.
3. Authorized establishment shall be identified by a clearly displayed sign post
containing the name of establishment, names and telephone number of the qualified
personnel.
4. The license to practice and the license to operate shall be conspicuously displayed in
the establishment.
2.6 TRANSPORTATION REQUIREMENTS
Vehicles used to transport medical products should be properly designed and equipped to
ensure protection from different environmental and weather conditions in which it operates.
The use of vehicles with defects that could affect the quality of the medical products should
be avoided.
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CHAPTER III: REFUSAL AND VALIDITY OF AN AUTHORIZATION
3.1 REFUSAL TO GRANT AN AUTHORIZATION
An authorization to manufacture medical products, or to operate a wholesale establishment;

or to operate a retail establishment or to perform small scale manufacturing of any medical
product, operate veterinary drug shop; shall not be granted where the Authority finds the
applicant not complying with the minimum requirements prescribed in these guidelines.
3.2 VALIDITY OF AN AUTHORIZATION
1) An authorization shall be valid for one-year renewable from the date it is issued, but
may be suspended or withdrawn, if any of the conditions under which it was granted, is
violated.
2) An authorization is issued to an applicant and shall not be transferable to another applicant
without approval of the Authority.
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CHAPTER IV: RENEWAL AND VARIATION OF AN AUTHORIZATION
4.1 RENEWAL OF AN AUTHORIZATION
An authorization shall be renewed after one year from the date it was issued, upon
submission of an application for renewal and after meeting all prescribed requirements.
The application for renewal of authorization shall be done one month before its expiration.
1. An authorization shall be valid for one-year renewable from the date it is issued, but
may be suspended or withdrawn, if any of the conditions under which it was
granted, is violated.
2. Application for renewal of an authorization shall be made to the Authority within
the validity period of the authorization.
3. A grace period of 6 months after expiry of the license shall be given to an establishment
that has failed to comply with renewal requirements; after the grace period the
application shall be considered as new application. The establishment shall remain
closed after the expiry of the license.
4. An authorization is issued to an applicant and shall not be transferable to another
applicant without approval of the Authority.
5. Any change to the authorization information shall be notified to the Authority through
an application.
4.2 VARIATION OF AN AUTHORIZATION
An application shall be made to the Authority for review and approval of any variation made
on the details of the issued authorization.
4.3 NOTIFICATION OF CHANGE IN OWNERSHIP
1. Where there is a change in the ownership of the business, the person to whom
an authorization was issued under these guidelines shall immediately notify to the
Authority the change.
2. The person to whom an ownership has been transferred to shall apply to the Authority
within thirty days.
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List of Forms for use with these guidelines
1) Doc. No. DIS/FOM/106-Application for medical products manufacturing

authorization;
2) Doc. No. DIS/FOM/107-Application form for Human Wholesale Pharmacy
authorization
3) Doc. No. DIS/FOM/108-Application for Small scale manufacturing
authorization
4) Doc. No. DIS/FOM/108-Application form for Authorization to operate a
human Retail pharmacy
5) Doc. No. DIS-FOM-110_Application form for Human Wholesale of medical
equipment authorization
6) Doc. No. DIS-FOM-111_Application form for Veterinary Wholesale
Pharmacy Authorization
7) Doc. No. DIS-FOM-112_Application form for Veterinary retail pharmacy
Authorization
8) Doc. No. DIS-FOM-113_Application form for veterinary drug shop
authorization
9) Doc. No. DIS-FOM-114_Application form for an Optical shop authorization
10) Doc. No. DIS-FOM-115_Application form for an Orthopedic Shop
Authorization
List of Format of Authorization for use with these guidelines
1) Doc. No. DIS-FORM-079_Authorization to Manufacture medical products

2) Doc. No. DIS-FORM-080_Authorization to operate a Human Wholesale of
medical equipment
3) Doc. No. DIS-FORM-081_Authorization to operate a _Human Wholesale
Pharmacy
4) Doc. No. DIS-FORM-082_Authorization to operate a Human Retail Pharmacy
5) Doc. No. DIS-FORM-083_Authorization to operate a Veterinary Wholesale
pharmacy
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6) Doc. No. DIS-FORM-084_Authorization to operate a Veterinary Retail

Pharmacy
7) Doc. No. DIS-FORM-085_Authorization for Small Scale Manufacturing
8) Doc. No. DIS-FORM-086_Authorization to operate a Veterinary Drug Shop
9) Doc. No. DIS-FORM-087_Authorization to operate an Optical shop
10) Doc. No. DIS-FORM-088_Authorization to operate an Orthopedic Shop
List of Notifications for use with these guidelines
1) Doc. No. DIS-FORM-089_Notification of revocation of a Licence_or_Certificate
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ANNEXES
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ANNEX I: LIST OF REQUIRMENTS FOR APPLICATION FOR VARIATION
VARIATION CONDITION DOCUMENTS

REQUIRED
Change of If there is change of 1) Application letter
ownership ownership of the 2) Original authorization of the
facility licensed establishment
3) Notarized sales agreement
4) New Business registration

certificate and a full registration
information of domestic
company;
5) Evidence of payment of
prescribed fees;
6) Notarized degree of the qualified

personnel;
7) Notarized valid license to

practice profession of the
responsible qualified personnel
where applicable;
8) Professional agreement between

the company and the qualified
personnel in charge where the
Owner is not the responsible
9) Copy of the identity card or
passport of both the owner and
the responsible qualified
personnel;
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Change of If the location 1) Application letter
Location or of the facility
additional has been 2) Original authorization of the
warehouse physically establishment
transferred
with changes 3) New Business registration
in previously certificate and a full registration
approved information of domestic company;
address
prescribed fees;

personnel;

where applicable;

Change of If the entity 1. Application letter
qualified Engages in additional 2. Original authorization of the
personnel activities. establishment
It also refers to a 3. Business registration certificate;
change in the initial 4. Evidence of payment of
license activity prescribed fees;
5. Notarized degree of the qualified
personnel;
6. Notarized valid license to
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where applicable;
7. Professional agreement between
8. Copy of the identity card or
passport of the responsible
Change of Change of 1) Application letter
company name company name 2) Original authorization of the
without changes in establishment
location of company 3) New Business registration
owner certificate and a full registration
information of domestic company;
prescribed fees;
personnel;
where applicable;
Closure of Closure of any 1. Application letter
activity approved/added 2. Original authorization of the
activity establishment
3. Copy of signed agreement with

another related establishment for
acceptance of remaining products if
any.
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ANNEX II: LIST OF REQUIRMENTS FOR APPLICATION FOR RENEWAL OF THE
OPERATIONAL LICENSE
Renewal of the CONDITION DOCUMENTS REQUIRED

operational license
Renewal of the One month before 1) Motivation letter addressed to
operational license the expiration of Director General
the operational
2) Original license of the establishment
issued by Rwanda
license, the
FDA
applicant shall 3) Notarized Valid License to Practice
apply for the its Pharmacy Profession issued by
renewal Recognized Professional Councils in
Rwanda
4) Notarized copy of Degree (and
equivalent if applicable) of
Responsible technician
5) One recent photo passport of the
responsible technician
6) Written commitment of the
technician not practice the cumulative
function in the establishment
7) Payment of the prescribed fees
8) Copy Contract between
responsible technician and owner
9) Copy of RDB certificate of the
Company
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ANNEX III: APPLICATION FORMS
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Rwanda Food and Drugs Authority

Rue. KG 9 Avenue, Nyarutarama Plaza
P.O. Box 1948, Kigali, Rwanda. QMS No: DIS/FOM/106
email: info@rwandafda.gov.rw Revision No: 0
website: www.rwandafda.gov.rw Effective Date: 20 Jul 2021
Tel: +250 789 193 529
Application Form for an Authorization To Manufacture Medical Products
In accordance with Regulations No DIS/TRG/001 Rev. No 0 governing authorization to operate as manufacturer or

wholesaler or small scale manufacturing / compounding or retail seller of pharmaceutical products.
1. Particulars of the Applicant
Name
Designation
Plot No
Street Name
Telephone Number(s)
E-mail number
2. Particulars of Pharmaceutical Manufacturing Premises
Name of premises
Plot No
Street Name
(if different from 1 above)
Global Positioning System
(GPS) Coordinates
Telephone Number(s)
E-mail number
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3. Contact Person on the premises
Name
Designation
Telephone Number(s)
E-mail number
4. Particulars of Key Personnel
a) Name and registration number of the pharmacist in

charge of the manufacturing
b) Name and registration number of pharmacist or
name of the chemist to be in charge of quality
control
c) Name and registration number of pharmacist or
name of the chemist to be in charge of quality
assurance
d) Names and registration number of other
pharmacists employed
e) Names of other chemists employed
5. Dosage form of pharmaceutical products to be manufactured at the premises

Check applicable box by double clicking on it:
Tablets Capsules Oral Liquids Oral Powders

Creams/Ointments/Lotions Eye drops Parenteral Products
Other (specify) …………………………………………………………………………
6. Documents submitted along with the application
a) Letter of intent to manufacture a pharmaceutical product;

b) certified copies of the Memorandum and Articles of Association;
c) Architectural plan of the site;
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d) Environment impact assessment report;
e) Proof of payment of the appropriate fee;
f) Site master file;
g) List of products to be manufactured;
h) Notarized copy of the valid license to practise pharmacy profession of the pharmacist to be in
charge of the manufacturing process;
i) Notarized degrees of the key personnel to be involved in the manufacturing process, quality control
and quality assurance; and
j) Proof of payment of the prescribed fees.
7. Declaration
I certify that the above information is correct and hereby apply for a Pharmaceutical Manufacturing
Authorization for the above-named premises.
Signature of applicant Date

Name Designation
Page 49 of 92
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Rue. KG 9 Avenue, Nyarutarama Plaza QMS No: DIS/FOM/107
P.O. Box 1948, Kigali, Rwanda. Revision No: 0
email: info@rwandafda.gov.rw Effective Date: 20 Jul 2021
website: www.rwandafda.gov.rw
Tel: +250 789 193 529
Application form for Human Wholesale Pharmacy authorization

Name
Designation
Plot No
Street Name
Telephone Number(s)
E-mail number
2. Particulars of Human Wholesale Pharmacy Premises
Name of premises
Plot No
Street Name

(GPS) Coordinates
Telephone Number(s)
E-mail number
Page 50 of 92
Products
Name
Designation
Telephone Number(s)
E-mail number

1) Name and registration number of the
pharmacist
2) Name and registration number of support staff:

Assistant Pharmacist, Pharmacy Technician,
Medical Assistant or Nurse. (optional)

a) Application letter;
b) Business registration certificate and a full registration information of domestic company;
c) Lease contract of the location;
d) Evidence of payment of prescribed fees;
e) Notarized Valid license to practice pharmacy profession;
f) Commitment letter from the pharmacist to respect the laws and regulations relating to the
pharmacy practices;
g) Valid contract between the owner and the pharmacist in charge (where the Owner is not
the responsible pharmacist);
h) The professional agreement;
i) Notarized Degree and curriculum vitae of the pharmacist;
k) Copy of the identity card or passport of both the owner and the pharmacist; and
l) One recent passport-size photographs of the owner and the pharmacist; and
m) Resignation letter or contract termination of responsible technician if applicable
Page 51 of 92
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6. Declaration
I certify that the above information is correct and hereby apply for a Pharmaceutical Wholesale

Name Designation
Page 52 of 92
Products

Tel: +250 789 193 529
Application form for Small scale manufacturing authorization

Name
Designation
Plot No
Street Name
Telephone Number(s)
E-mail number
2. Particulars of Small Scale Manufacturing Premises
Name of premises
Plot No
Street Name
Page 53 of 92
Products
(GPS) Coordinates
Telephone Number(s)
E-mail number
Name
Designation
Telephone Number(s)
E-mail number

a) Name and registration number of the
pharmacist in charge of the manufacturing
b) Name and registration number of pharmacist
or name of the chemist to be in charge of
quality control
c) Name and registration number of pharmacist
or name of the chemist to be in charge of
quality assurance
d) Names and registration number of other
pharmacists employed
e) Names of other chemists employed
Page 54 of 92
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5. Dosage form of pharmaceutical products to be manufactured at the premises
Check applicable box by double clicking on it:
Oral Liquids Oral Powders . Creams/Ointments/Lotions

Other (specify) ………………………………………………………………………

a) Company profile;
b) Letter of intent to manufacture a pharmaceutical product;
c) certified copies of the Memorandum and Articles of Association;
d) Architectural plan of the site;
e) Site master file;
f) List of products to be manufactured;
g) Certified copy of the certificate of registration of the pharmacist to be in charge of the
manufacturing process;
h) Copies of certificates of the qualification of the key personnel to be involved in the
manufacturing process, quality control and quality assurance; and
i) Proof of payment of the prescribed fees.
7. Declaration
I certify that the above information is correct and hereby apply for a Small Scale Manufacturing
Name Designation
Page 55 of 92
Products

Tel: +250 789 193 529
Application form for Authorization to operate a human Retail pharmacy

Name
Designation
Plot No
Street Name
Telephone Number(s)
E-mail number
2. Particulars of human Retail Pharmacy Premises
Name of premises
Plot No
Street Name
(GPS) Coordinates
Telephone Number(s)
Page 56 of 92
Products
E-mail number
Name
Designation
Telephone Number(s)
E-mail number

a) Name and registration number of the pharmacist
b) Name and registration number of support staff:


e) Notarized Valid license to practice pharmacy profession;
pharmacy practices;
the responsible pharmacist);
i) Notarized Degree and curriculum vitae of the pharmacist;
j) Copy of the identity card or passport of both the owner and the pharmacist; and
Page 57 of 92
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k) One recent passport-size photographs of the owner and the pharmacist; and
l) Resignation letter or contract termination of responsible technician if applicable
6. Declaration
I certify that the above information is correct and hereby apply for a human Retail Pharmacy

Name Designation
Page 58 of 92
Products

Tel: +250 789 193 529
Application form for Human Wholesale of medical equipment authorization

Name
Designation
Plot No
Street Name
Telephone Number(s)
E-mail number
2. Particulars of Human Wholesale of medical equipment Premises
Name of premises
Plot No
Street Name
(GPS) Coordinates
Page 59 of 92
Products
Telephone Number(s)
E-mail number
Name
Designation
Telephone Number(s)
E-mail number

a) Name and registration number of the
responsible technician

Biomedical engineer, Medical Assistant or
Nurse. (optional)

n) Application letter;
o) Business registration certificate and a full registration information of domestic company;
p) Lease contract of the location;
q) Evidence of payment of prescribed fees;
r) Notarized Valid license to practice profession issued by the professional body
s) Commitment letter from the responsible technician to respect the laws and regulations
relating to the pharmacy practices;
t) Valid contract between the owner and the pharmacist in charge (where the Owner is not
the responsible pharmacist/biomedical engineer);
u) The professional agreement;
Page 60 of 92
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v) Notarized Degree and curriculum vitae of the pharmacist/ biomedical engineer;
w) Copy of the identity card or passport of both the owner and the pharmacist/ biomedical
engineer;
x) One recent passport-size photographs of the owner and the pharmacist/ biomedical
engineer; and
y) Resignation letter or contract termination of responsible technician if applicable
6. Declaration
I certify that the above information is correct and hereby apply for a Human Wholesale of medical
equipment Authorization for the above-named premises.

Name Designation
Page 61 of 92
Products

QMS No: DIS/FOM/111
P.O. Box 1948, Kigali, Rwanda.
Revision No: 0
email: info@rwandafda.gov.rw
Effective Date: 20 Jul 2021
Tel: +250 789 193 529
Application form for Veterinary Wholesale Pharmacy Authorization
In accordance with Regulations No DIS/TRG/001 Rev. No 0 governing authorization to operate as

manufacturer or wholesaler or small scale manufacturing / compounding or retail seller of pharmaceutical
products.
Name
Designation
Plot No
Street Name
Telephone Number(s)
E-mail number
2. Particulars of Veterinary Wholesale Pharmacy Premises
Name of premises
Plot No
Street Name
(GPS) Coordinates
Page 62 of 92
Products
Telephone Number(s)
E-mail number
Name
Designation
Telephone Number(s)
E-mail number

a) Name and registration number of the Veterinary
Doctor/ pharmacist

Assistant Pharmacist/Veterinary Doctor,
Pharmacy Technician, Medical Assistant or
Nurse. (optional)

e) Notarized Valid license to practice veterinary doctor/pharmacy profession;
pharmacy practices;
the responsible pharmacist/ veterinary doctor);
Page 63 of 92
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i) Notarized Degree and curriculum vitae of the veterinary doctor/pharmacist;
j) Copy of the identity card or passport of both the owner and the pharmacist/ veterinary
doctor
k) One recent passport-size photographs of the owner and veterinary doctor/pharmacist; and
a) Declaration
I certify that the above information is correct and hereby apply for a Veterinary Wholesale
Pharmacy Authorization for the above-named premises.

Name Designation
Page 64 of 92
Products

Tel: +250 789 193 529
Application form for Veterinary retail pharmacy Authorization

Name
Designation
Plot No
Street Name
Telephone Number(s)
E-mail number
2. Particulars of Veterinary retail pharmacy Premises
Name of premises
Plot No
Street Name
(GPS) Coordinates
Telephone Number(s)
Page 65 of 92
Products
E-mail number
Name
Designation
Telephone Number(s)
E-mail number

a) Name and registration number of the Veterinary
Doctor/ pharmacist

Assistant Pharmacist/Veterinary Doctor,
Nurse. (optional)

e) Notarized Valid license to practice veterinary doctor/pharmacy profession;
pharmacy practices;
the responsible pharmacist/ veterinary doctor);
i) Notarized Degree and curriculum vitae of the veterinary doctor/pharmacist;
Page 66 of 92
Products
j) Copy of the identity card or passport of both the owner and the pharmacist/ veterinary
doctor
k) One recent passport-size photographs of the owner and veterinary doctor/pharmacist; and
6. Declaration
I certify that the above information is correct and hereby apply for a Veterinary retail pharmacy

Name Designation
Page 67 of 92
Products

Tel: +250 789 193 529
Application form for veterinary drug shop authorization

Name
Designation
Plot No
Street Name
Telephone Number(s)
E-mail number
2. Particulars of veterinary drug shop Premises
Name of premises
Plot No
Street Name
(GPS) Coordinates
Telephone Number(s)
Page 68 of 92
Products
E-mail number
Name
Designation
Telephone Number(s)
E-mail number

a) Name and registration number of the res

Nurse. (optional)

e) Notarized Valid license to practice profession issued by the professional body;
pharmacy practices;
g) Valid contract between the owner and the responsible technician in charge (where the
Owner is not the responsible technician);
i) Notarized Degree and curriculum vitae of the responsible technician;
j) Copy of the identity card or passport of both the owner and the responsible technician
Page 69 of 92
Products
k) One recent passport-size photographs of the owner and responsible technician; and
6. Declaration
I certify that the above information is correct and hereby apply for a Veterinary Drug Shop

Name Designation
Page 70 of 92
Products

QMS No: DIS/FOM/114
P.O. Box 1948, Kigali, Rwanda.
Revision No: 0
email: info@rwandafda.gov.rw
Tel: +250 789 193 529
Application form for an Optical shop authorization

Name
Designation
Plot No
Street Name
Telephone Number(s)
E-mail number
2. Particulars of Optical Shop Premises
Name of premises
Plot No
Street Name
(GPS) Coordinates
Telephone Number(s)
Page 71 of 92
Products
E-mail number
Name
Designation
Telephone Number(s)
E-mail number

a) Name and registration number of responsible
technician


pharmacy practices;
j) Copy of the identity card or passport of both the owner and the responsible technician; and
Page 72 of 92
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k) One recent passport-size photographs of the owner and the pharmacist; and
6. Declaration
I certify that the above information is correct and hereby apply for an Optical Shop Authorization
for the above-named premises.

Name Designation
Page 73 of 92
Products

Tel: +250 789 193 529
Application form for an Orthopaedic shop Authorization
In accordance with Regulations No DIS/TRG/001 Rev. No 0 governing authorization to operate

as manufacturer or wholesaler or small scale manufacturing / compounding or retail seller of
pharmaceutical products.
Name
Designation
Plot No
Street Name
Telephone Number(s)
E-mail number
2. Particulars of Orthopaedic Shop Premises
Name of premises
Plot No
Street Name
(GPS) Coordinates
Page 74 of 92
Products
Telephone Number(s)
E-mail number
Name
Designation
Telephone Number(s)
E-mail number

a) Name and registration number of responsible
technician


pharmacy practices;
Page 75 of 92
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j) Copy of the identity card or passport of both the owner and the responsible technician; and
k) One recent passport-size photographs of the owner and the responsible technician; and
6. Declaration
I certify that the above information is correct and hereby apply for an Orthopedic Shop

Name Designation
Page 76 of 92
Products
ANNEX IV: FORMAT OF AUTHORIZATION ISSUED
Page 77 of 92
Products
QMS No: DIS/FOM/079

Revision No: 0
AUTHORIZATION
TO MANUFACTURE MEDICAL PRODUCTS
Issued under Article 9 of the Law Nº 003/2018 of 09/02/2018 Establishing Rwanda Food and Drugs
Authority and Determining its Mission, Organization and Functioning, and articles 3 &4 of the Law Nº
47/2012 of 14/01/2013 relating to the regulation and inspection of food and pharmaceutical products.
This is to certify that
Authorization No: DIS/ /FDA/2021
Issued on: / /2021 Valid up to: / /2022
was granted to:
Name of the Company: Names of premises

Company Code: Tin number
Location of premises: Province District,
Sector, Cell
Name of the Managing Director: Mr (Mrs/Ms)
Telephone Number: +2507
Head of Production Department: Mr (Mrs/Ms)
to carry out the following manufacturing activities:

Product Product type Dosage form (if applicable) Manufacturing activities
category
Pharmaceutical e.g.: Tablet, syrup, capsules Production, packaging,

products storage, labeling and
distribution
This authorization may be suspended or withdrawn if the conditions under which it was granted are violated.
The product is put on market after its assessment and registration by Rwanda FDA. The application for renewal
of license shall be done one month before its expiration.
Name and signature of Director General

+ Stamp of the institution
Page 78 of 92
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QMS N0: DIS/FOM/080

Revision No: 0
P.O. Box 1948 Kigali

info@rwandafda.gov.rw
www.rwandafda.gov.rw
Ref N°: DIS/ /FDA/20__
LICENSE TO OPERATE A HUMAN WHOLESALE OF MEDICAL EQUIPMENT
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 functioning especially in its article 3; and
considering the provisions of the Law No 47/2012 of 14/01/2013 relating to the regulation and
inspection of food and pharmaceutical products especially in its article 3 & 4;
This is to certify that NAMES OF ESTABLISHMENT, registered under company code TIN
NUMBER is licensed to operate as a human wholesale of medical equipment on the following
locations;
Sales room: Province, District, Sector, Cell.

Store room: Province, District, Sector, Cell.
Names of the Managing Director: Mr(s)/Ms NAMES OF MANAGING DIRECTOR

Names of responsible technician: Mr(s) /Ms NAMES OF RESPONSIBLE TECHNICIAN

Professional bodies Registration No: COUNCIL REGISTRATION NUMBER
Validity: This license is valid for one (1) year renewable from the date of its issuance.
NB:
1. This 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 technician shall be notified and approved by Rwanda FDA.
3. This license is not transferrable and its misuse will result into suspension or revocation.
4. The application for renewal of license shall be done one month before its expiration.
Done at Kigali on,

Page 79 of 92
Products
QMS N0: DIS/FOM/081

Revision No: 0
Effective Date:20 Jul 2021

LICENSE TO OPERATE A HUMAN WHOLESALE PHARMACY
inspection of food and pharmaceutical products especially in its article 32;
This is to certify that NAMES OF ESTABLISHMENT , registered under company code TIN
NUMBER is licensed to operate as a human wholesale Pharmacy on the following locations;


Names of responsible technician: Mr(s) /Ms NAMES OF RESPONSIBLE PHARMACIST
National Pharmacy Council Registration No: COUNCIL REGISTRATION NUMBER
NB:
Done at Kigali on,

Page 80 of 92
Products
QMS N0: DIS/FOM/082

Revision No: 0

Ref No: DIS/ /FDA/20__
LICENSE TO OPERATE A HUMAN RETAIL PHARMACY
considering the provisions of the Law Nº 47/2012 of 14/01/2013 relating to the regulation and
This is to certify that NAMES OF PREMISES, registered under company code Tin number is
licensed to operate as a human retail pharmacy located in ……………….. Province, ………..
District, …… …………..Sector, …………….cell;
Names of the Managing Director: Mr(s)/ Ms NAMES OF MANAGING DIRECTOR)

Names of responsible pharmacist: Mr (s)/ Ms NAMES OF RESPONSIBLE PHARMACIST

National Pharmacy Council Registration No: REGISTRATION NUMBER
Validity: This license is valid for one year (1) renewable from the date of its issuance.
NB:
responsible pharmacist shall be notified and approved by Rwanda FDA.
Done at Kigali on ……………………………

Page 81 of 92
Products
QMS N0: DIS/FOM/083

Revision No: 0

LICENSE TO OPERATE A VETERINARY WHOLESALE PHARMACY
This is to certify that NAMES OF ESTABLISHMENT , registered under company code TIN
NUMBER is licensed to operate as a veterinary wholesale Pharmacy on the following locations;


Names of responsible technician: Mr(s) /Ms NAMES OF RESPONSIBLE TECHNICIAN

Rwanda Council of Veterinary Doctors Registration No: REGISTRATION NUMBER
NB:
3) Any change made on details of the company name, physical location, management or
4) This license is not transferrable and its misuse will result into suspension or revocation.
5) The application for renewal of license shall be done one month before its expiration.
Done at Kigali on,

Page 82 of 92
Products
QMS N0: DIS/FOM/084

Revision No: 0

Ref No: DIS/ /FDA/_
LICENSE TO OPERATE A VETERINARY RETAIL PHARMACY
inspection of food and pharmaceutical products especially in its article 3 &4;
licensed to operate as a veterinary retail pharmacy located in ……………… . Province, …………..
District, …… …………. Sector, …………….cell;

Names of responsible technician: Mr(s)/Ms NAMES OF RESPONSIBLE TECHNICIAN

Rwanda Council of Veterinary Doctors Registration Nº: REGISTRATION NUMBER
NB:

Page 83 of 92
Products
QMS No: DIS/FOM/085
Revision No: 0
AUTHORIZATION
FOR SMALL SCALE MANUFACTURING
Issued under Article 9 of the Law Nº 003/2018 of 09/02/2018 Establishing Rwanda Food and Drugs
Authority and Determining its Mission, Organization and Functioning, and articles 3 &4 of the Law Nº
47/2012 of 14/01/2013 relating to the regulation and inspection of food and pharmaceutical products.
This is to certify that
Authorization No: DIS/ /FDA/20__
Issued on: / 20__ Valid up to: / /20__
was granted to:
Name of the Company: Names of premises

Company Code: Tin number
Location of premises: Province District,
Sector, Cell
Name of the Managing Director: Mr (Mrs/Ms)
Head of Production Department: Mr (Mrs/Ms)
to carry out the following Small Scale manufacturing activities:

Product Product type Dosage form (if applicable) Manufacturing activities
category
Pharmaceutical Pharmaceutical e.g. : Tablets, syrup, Production, packaging,

products preparations for capsules storage, labeling and
external use distribution
This authorization may be suspended or withdrawn if the conditions under which it was granted are violated.
The product is put on market after its assessment and registration by Rwanda FDA. The application for renewal
of license shall be done one month before its expiration.

Page 84 of 92
Products
QMS No: DIS/FOM/086

Revision No: 0

LICENSE TO OPERATE A VETERINARY DRUG SHOP
inspection of food and pharmaceutical products especially in its article 3 &4;
licensed to operate as a veterinary drug shop located in ……………….. Province, …………..
District, …… …………. Sector, …………….cell;


Rwanda Council of Veterinary Doctors Registration Nº: REGISTRATION NUMBER
NB:

Page 85 of 92
Products
QMS No: DIS/FOM/087

Revision No: 0

LICENSE TO OPERATE AN OPTICAL SHOP
licensed to operate as an optical shop located in ……………….. Province, ………….. District, ……
…………. Sector, …………….cell;


Rwanda Allied Health Professional Council Registration Nº: REGISTRATION NUMBER
NB:

Page 86 of 92
Products
QMS No: DIS/FOM/088

Revision No: 0

LICENSE TO OPERATE AN ORTHOPEDIC SHOP
licensed to operate as an orthopedic shop located in ……………….. Province, ………….. District,
…… …………. Sector, …………….cell;


Rwanda Allied Health Professional Council Registration Nº: REGISTRATION NUMBER
NB:

Page 87 of 92
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ANNEX V: LIST OF NOTIFICATION FOR USE WITH THESE GUIDELINES
Page 88 of 92
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QMS No: DIS/FOM/089

Revision No: 0


Attention: (Insert contact name, if available)
Company name
Address of License Holder
Dear Sir/Madam
Re: Notification of Withdraw of operational License/Certificate (delete whichever is not

applicable)
Authority and determining its mission, organization and functioning especially in its article 9.2; and
Reference is also made to the inspection that was conducted at your premise dated ………………
where it was found that you violated the conditions under which the operational license was granted
for;
Rwanda FDA would like to inform you that in exercise of the powers conferred upon Rwanda Food
and Drugs Authority by Article 9.2 of the Law Nº 003/2018 of 09/02/2018 establishing Rwanda
Food and Drugs Authority and determining its mission, organization and functioning, your
license, certificate (delete whichever is not applicable) for ……………(enter name of license,
certificate or authorization) issued by Rwanda FDA on ……… (insert date) vide license number
…….(insert number) is hereby WITHDRAWN from the date of this notice.
CONSEQUENTLY, you are directed to return the license, certificate, or authorization (delete
whichever is not applicable) above mentioned to Rwanda FDA office.

Page 89 of 92
ANNEX VI: FORMAT OF THE INSPECTION REPORT
Page 90 of 92
QMS N0: DIS/FOM/092
Revision No: 0
P. O. Box 1948 Kigali

PREMISE INSPECTION REPORT CONDUCTED AT

X INDUSTRIES
I. INTRODUCTION:
II. OBJECTIVES:
III. BUILDING
IV. EQUIPMENT
V. PERSONNEL
VI. FINDINGS
VII. RECOMMENDATION (S)
Prepared by : Reviewed by:
Name, signature, date Name, signature, date

Position Division Manager of FDIC
Approved by:
Name, signature, date

Head of Department of FDISM
Page 91 of 92
End of Document
Page 92 of 92

Updated Guidelines For Licensing To Manufacture To Operate As A Wholesale and Retail Seller of Medical Products

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Updated Guidelines For Licensing To Manufacture To Operate As A Wholesale and Retail Seller of Medical Products

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Guidelines for Licensing to Manufacture, to Operate as Wholesale and Retail Seller of Medical

GUIDELINES FOR LICENSING

GUIDELINES DEVELOPMENT HISTORY

DRAFT ZERO 17th August 2020

ADOPTION BY RWANDA FDA 24th August 2020

STAKEHOLDERS CONSULTATION 26th August 2020

ADOPTION OF STAKEHOLDERS’ COMMENTS 28th August 2020

REVISION No:0 02nd September 2020

REVISION No: 1 12th July 2021

DATE FOR COMING INTO EFFECT 20th July 2021

Document Revision History

Date of revision Revision Changes made and/or reasons for revision

FDA Food and Drugs Authority

In these Guidelines, unless the context otherwise states:

“Sale” means sell by wholesale or retail and includes

“Law No 003/2018” means Law No 003/2018 of 09/02/2018 establishing Rwanda FDA

Inspection” means an organized examination or formal evaluation exercise. Inspection means

“Manufacturer” means a person or corporation, or other entity engaged in the business of

“Medical product” includes medicines, vaccines, diagnostics and medical devices.

“Pharmaceutical product” means any substance capable of preventing, treating human or

“PRIMS” means Products Regulatory Information Management System platform.

“Qualified personnel”: means an individual who by possession of a recognized degree

In these Guidelines, the following verbal forms are used:

I.2 PURPOSE OF THESE GUIDELINES

The “Guidelines for licensing to manufacture, to operate as wholesale or retail seller of

A.1 GENERAL REQUIREMENTS

A person, company or institution who intends to;

The Authority shall inspect the premises to determine their suitability.

1) Upon receipt of complete required documents for license to manufacture, to operate as

C. APPROVAL OF THE PREMISES

D. ADDITIONAL GUIDANCE ON LICENSING OF NEW PHARMACEUTICAL

A person, company or institution who intends to;

1) carry out the business of manufacturing, operate wholesale or retail of medical

2.1 AUTHORIZATION TO OPERATE AS A MANUFACTURE OF MEDICAL

1) The applicant shall submit the following documents:

a) Letter of intent to manufacture medical products;

2) After satisfactory review of the preliminary documentation, the company is given

2.1.2 INSPECTION OF PREMISES FOR SUITABILITY

2.1.4 STANDARDS OF CONSTRUCTION

The premises shall:

2.1.5 SUITABILITY OF PRODUCTION AREAS

2.1.6 REGULAR WATER SUPPLY

1) The premises shall have a regular and sufficient supply of water.

2.1.7 STORAGE AREAS AND ENVIRONMENTAL CONTROLS

Storage areas shall:

1) be designed or adapted to ensure good storage conditions;

2.1.8 CONTAINERS TO BE CLEANED

2.1.9 DESCRIPTIVE MATERIALS TO BE KEPT SECURE

1) All product labels, printed packaging and descriptive materials shall:

(a) Be stored in a secure manner; and

2.1.10 DESIGN, CONSTRUCTION, LOCATION AND MAINTENANCE OF

1) Manufacturing equipment shall be designed, located and maintained to suit its

2.1.11 FIRE-FIGHTING EQUIPMENT

2.1.12 COMPLIANCE WITH THE LAW ON OCCUPATIONAL HEALTH AND

2.1.13 WEIGHING, MEASURING, TESTING AND RECORDING EQUIPMENT TO

1) Quality Control laboratories shall be separated from production areas. This is

The manufacturing premises shall keep the following records:

2.2 AUTHORIZATION FOR SMALL SCALE MANUFACTURING

2.2.1 APPLICATION FOR AUTHORIZATION FOR SMALL SCALE

An application for authorization for small scale manufacturing/compounding shall be made

1) Certificate of registration and a full registration information of domestic company;

2.2.2 INSPECTION OF PREMISES FOR SUITABILITY