ICS 11.120.01  
 
Reference number
DRS 91: 2020
© RSB 2020
  
 RWANDA 
STANDARD  DRS
91
Second  edition
2020 -mm-dd
Labelling and marking of pharmaceutical 
products  — Specification  
   
DRS 91: 2020  
©RSB 2020  - All rights reserved                  ii 
 In order to match with technological development and to keep continuous progress in industries, 
standards are subject to periodic review. Users shall ascertain that they are in possession of the latest 
edition  
 
 
 
 
 
 
 
 
© RSB 2020  
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized 
in any form or by any means, electronic or mechanical, including photocopying and microfilm, without  
prior written permission from R SB. 
Requests for permission to reprodu ce this document should be addressed to : 
Rwanda Standards  Board  
P.O Box 7099 Kigali -Rwanda  
KK 15 Rd, 49  
Tel. +250 788303492  
Toll Free: 3250  
E-mail: info@rsb.gov.rw  
Website: www.rsb.gov.rw  
ePortal: www.portal.rsb.gov.rw   DRS 91: 2020  
iii                ©RSB 2020  - All rights reserved  
 Contents  Page 
1 Scope  ................................ ................................ ................................ ................................ ................ 1 
2 Normative references  ................................ ................................ ................................ ....................... 1 
3 Terms and defi nitions  ................................ ................................ ................................ ...................... 1 
4 Symbols (and abbreviated terms)  ................................ ................................ ................................ ....3 
5 Requirements of a label  ................................ ................................ ................................ ................... 3 
6 Labelling  ................................ ................................ ................................ ................................ ........... 3 
6.1 General requirements ................................ ................................ ................................ ....................... 3 
6.2 Specific r equirements for information presentation  ................................ ................................ .......4 
Annex  A (normative)  Format for writing/printing package inserts  ................................ ............................ 6 
 DRS 91: 2020  
©RSB 2020  - All rights reserved                  iv 
 Foreword   
Rwanda Standard s are prepared  by Technical Committees and approved by Rwanda Standards Board (RSB) 
Board  of Directors in  accordance with the procedures of RSB, in compliance with Annex 3 of the WTO/TBT 
agreement on the preparation, adoption and application of standards.  
The main task of technical committees is to prepare national standards.  Final Draft Rwanda S tandards 
adopted by Technical committ ees are ratifie d by me mbers of RSB Board of Director s for publication and 
gazettment as Rwanda Standards.  
DRS 91 was prepared by Technical Committee RSB/TC 15, Pharmaceutical Products . 
In the preparation of this standard, reference was made to the following standard  (s): 
TZS 773: Labelling and marking of pharmaceutical products — Specification  
The assistance de rived from the above source is hereby acknowledged with thanks.  
This second edition cancels and replaces the first edition (RS  91: 2015 ), of which has been technically 
revised.  
Committee membership  
The following organizations were represented on the Technical Committee on Pharmaceutical products  
(RSB/TC 015) in the preparation of this standard.  
Rwanda Food and Drug Authority (RFDA)  
Rwanda Social security Boar d (RSSB)  
KIPHARMA  
Rwanda Inspectorate and Competition and Consumer protection Authority (RICA)  
Rwanda Forensic Laboratory (RFL)  
University of Rwanda – College of Sciences and Technology (UR -CST)  
INES Ruhengeri  
Rwanda  Standards Board  (RSB) – Secretariat  
 DRS 91: 2020  
v                ©RSB 2020  - All rights reserved  
  DRS 91: 2020  
1                ©RSB 2020  - All rights reserved  
 Labelling and marking of pharmaceutical products  — Specification  
1 Scope   
This Draft Rwanda Standard specifies requirements of a label for pharmaceutical products. It also gives 
special labelling and marking requirements for some preparations  such as  biological, sterile products and 
aerosols.  
2 Normative references   
The following documents are referred to in the text  in such a way that some or all of  their content constitutes 
requirements of this document.  For dated references, only the edition  cited applies. For undated references, 
the latest edition of the referenced document (including any amendments) applies.  
ISO/TS 16791:2014 , Aerosol drug delivery device design verification — Requirements and test methods  
RS ISO 780 , Packaging — Pictorial marking for handling of goods  
ISO/TS 16791:2014 , Health informatics — Requirements for international machine -readable coding of 
medicinal product package identifiers  
3 Terms and definitions   
For the purposes of this standard, the follow ing terms and definitions apply.  
3.1 
label  
legal display of written, printed or graphic matter upon the immediate container or the outside cont ainer or 
wrapper of a medicine  package  
3.2 
labeling  
all labels and other written, printed or graphic matter upon an immediate container of preparation or upon, or 
in any package or wrapper in which it is enclosed except any outer shipping container  
3.3 
pharmaceutical product  
any medicine , substance or other article manufa ctured or prepared in any way and intended for use by man 
as a medicine or as a remedy used for the purpose of medical, dental or veterinary treatment   
©RSB 2020  - All rights reserved                  2 
 3.4 
package  
package holds, restrains or encloses an article/articles or commodity/commodities to be store d or transported, 
and is defined as in any of the following definitions:  
a) one unit of a product uniformly processed, wrapped or scaled in a stream or container;  
b) a quantity of items boxed or wrapped for storage or transportation; and  
c) a container in which a product is packed;  
3.5 
package system  
two groups of components, the immediate container and the protective package  
3.5.1  
immediate container (primary package)  
container, which includes the closure and any device such as a dropper, which is in direct contact with the  
product during storage and transportation; it should perform the functions of preservation and prote ction of the  
content for required shelf and use life, identification of contents, quantity, quality, manufacturer , facilitates  
dispensing a nd use  
3.5.2  
protective package  
package component which encompasses items which are not intended to be in contact with the product e .g. 
cartons labels, wrapping, cushioning etc; it should safeguard the contents from deterioration damage  or loss  
between the  time the package is closed and the ultimate time the user opens the package  
3.6 
marking  
numbers, nomenclature, or symbols affixed to items or containers for identification, handling, shipm ent and 
storage.  
3.7 
pictorial markings  
graphic symbols used for co nveying the consignor’s intentions regarding the handling instructions – this 
overcomes differences in languages or illiteracy which instructions in language of country of origin  of little value  DRS 91: 2020  
3                ©RSB 2020  - All rights reserved  
 4 Symbols (and abbreviated terms)   
For the purpose of this stan dard, symbols and pictorial marking given in ISO 780 shall be used and the 
following abbreviations shall apply . 
a) µcg for microgram (s);  
b) mg for milligram (s);  
c) g for gram; and  
d) mL for millilitre (s).  
5 Requirements of a label  
5.1 A label shall be legible, neat and well balanced. The style of the label shall be appropriate to the 
preparation, and the size of the label shall match the container.  
5.2 The label shall remain permanently attached to the containers under all storage conditions and an area of 
the contai ner shall be left uncovered to allow inspection of the contents. If the final container is not suita ble for 
labeling (e.g.: capillary tube), it shall be in a labelled package.  
5.3 The label for internal medicines shall be in black or blue print and those f or external use, shall be in red 
print or against a red background . 
6 Labelling  
6.1 General requirements  
6.1.1  The name of the medicine . The name shall be as defined according to the international 
pharmacopeia.  
6.1.2  List of ingredients and expients   
A list of active ingredients showing the amount of each present. The unit shall be in percentage or metric 
units. 1 mg in a capsule, tablet, or other unit dosage form shall be labelled to express the quantit y of each 
therapeutically active ingredient contained in ea ch such a unit. Oral liquid may, alternatively, be labelled in 
terms of mililitres or drop portions. Distribution category – the words “Prescription Only Medicine”, “General 
Sales Medicine”, “DDA – Narcotic”, “Pharmacy Only” shall be indicated.  
6.1.3  A sta tement of the dosage form , strength  and net contents.  
6.1.4  A batch number assigned by the manufacturer.  
This is capable of yielding the complete manufacturing history of the specific package, including al l 
manufacturing, filling, sterilizing and labellin g operations.   
©RSB 2020  - All rights reserved                  4 
 6.1.5  The date of manufacture and the expiry date , (dd/mm/yyyy) . 
6.1.6  The name and physical address of manufacturer.  
6.1.7  Any special storage conditions or handling shall be specified as required by  law 12/99 . 
6.1.8  Indication and direction s for use and any warnings that may be necessary:  
a) shall be on the label for medicine  sold or dispensed directly to the consumer ; and  
b) each package insert either as a separate entity or as an integral part of the package on which are p rinted 
in readable lett ers under the headings and in the format specified in annex A. 
6.1.9   Directions for use shall be given in Kinyarwanda, English and/or French languages, in addition to an y 
other language  (s). 
6.1.10  A statement “KEEP OUT OF REACH OF CHILDREN ’’ in capital letters.  
6.1.11 The label shall contain  at least one of the official languages (Kinyarwanda, English or French)  
6.2 Specific requirements for information presentation  
6.2.1  The name of medicine and strength shall be prominent. If proprietary name is used, letter of generic 
name should be at least half as large as letters for the proprietary name.  
6.2.2  The strength shall be in percentage metric system and expressed in the smallest whole number. Mass 
in micrograms should be through to 999 milligrams through 999 then grams. The abbreviations used shall be 
as given in 4.2.  
6.2.3  “For external use only’’, for all liquids, semi -solids and solid preparations for external use.  
6.2.4  “Not to be taken ”, for the following:  
c) liquid preparations that are not admi nistered by mouth;  
d) liquid preparations that might worry the patient because the product  appears to be us ed internally , e.g. 
nasal drops, enemas, eye and ear drops;  
e) unit – dose forms not intended for oral use e.g. suppositories, pessaries, inhalation capsul es; and  
f) solution tablets used to prepare disinfectants and antiseptic solutions.  
6.2.5  “Shake the bottle  before use ’’, for liquid preparations which are disperse systems.  
6.2.6  For biological preparations:  DRS 91: 2020  
5                ©RSB 2020  - All rights reserved  
 6.2.6.1  The recommended human dose and route of ad ministration;  
6.2.6.2  The nature and amount of any preservative or added substance present in the product or any 
other inactive substances ; 
6.2.6.3  The statement “ WARNING : discard if the container is damaged or contents show presence of 
particles or signs of deterioration”; and  
6.2.6.4  For sterile surgical dressings the statement “ WARNING ” Sterile only if wrapper or seals 
unbroken, discard any unused pieces”.  
6.2.7 For aerosols, the statement “ WARNING ”: this container is pressurized, keep away from heat including the 
sun. Do not puncture or incinerate even when empty”.  
6.2.8 Any information or pictorial device including proprietary name or registered trade mark (logo) may b e 
displayed on the label provided that it is not in conflict with the requirements nor would mislead or deceive the 
consumer in any way whatsoever in respect of the medicine.  
  
©RSB 2020  - All rights reserved                  6 
 Annex  A 
(normative)  
 
Format for writing/printing package inserts  
Writing /printing shall be as follows:  
g) name (both proprietary & international non -proprietary names and do sage form of the product  
h) identification (description of the product & package)  
i) content and quantity of active ingredient in a dosage unit or suitable mass or volume or unit of the  product  
j) pharmacology  
k) therapeutic class  
l) indications  
m) side effects and adverse reactions (and interactions)  
n) precautions and warning  
o) Dosage regimen and directions for use  
p) symptoms and treatment of overdose  
q) presentation (Packing and pack size)  
r) storage instructions and shelf life  
s) name and address of registrant  
t) name and address of manufa cturer and country of origin  
u) date of publication of the insert   
 
  DRS 91: 2020  
7                ©RSB 2020  - All rights reserved  
 Bibliography  
[1] ISO/IEC Directives, Part  2, Rules for the structure and drafting of International Standards , 2016  
 
 DRS 91: 2020  
 
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