GUIDANCE ON THERAPEUTIC PRODUCT REGISTRATION IN SINGAPORE  APRIL 2021 
–POINTS TO CONSIDER FOR SINGAPORE LABELLING
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP        Appendix 7 - Page 1 of 6 APPENDIX 7 POINTS TO CONSIDER FOR SINGAPORE LABELLING  
Labelling refers to any printed or graphic information on the immediate container, 
outer packaging and any other form of printed material supplied together with the 
therapeutic product  (TP). This includes the outer carton, inner/blister labels and 
package insert or patient information leaflet . 
All product labelling must be in English. If non -English text is included in the 
labelling, applicants must provide an official statement to declare that the non -
English text is complete, accurate and unbiased inform ation and is consistent with 
the English text. Information provided in the labels should be consistent with the 
information submitted in the application dossier.  
1 OUTER CARTON AND  INNER/BLISTER LABELS  
The outer carton refers to the product packaging in which the immediate packaging 
is placed, e.g. the carton box containing blister strips. The inner label refers to the 
label that is fixed onto the primary container closure system, e.g. the label affixed 
to a bottle , vial or ampoule. The blister label refers to the foil backing of a blister 
strip.  
In addition to the legal labelling requirements, the following information shall be 
present on the labelling of the product:  
Parameters  Outer 
Carton  Inner 
Label  Blister Label  
1. Product Name  ✓ ✓ ✓
2. Dosage Form  ✓ ✓* NA 
3. Name of Active Substance(s) ** ✓ ✓ ✓
4. Strength of Active Substance(s)  ✓ ✓ ✓
5. Batch Number  ✓ ✓ ✓
6. Manufacturing Date  ✓ ✓* NA 
7. Expiry Date  ✓ ✓ ✓
8. Route of Administration  ✓ ✓ NA 
9. Storage Condition  ✓ ✓* NA 
10. Name & Address  (or Logo)  of 
Product Owner and/or Product 
Registrant  ✓ ✓* Name/Logo of 
Manufacturer/  
Product 
Owner /Product 
Registrant  
11. Name & Address of Manufacturer** * ✓ ✓* NA GUIDANCE ON THERAPEUTIC PRODUCT REGISTRATION IN SINGAPORE  APRIL 2021 
– POINTS TO CONSIDER FOR SINGAPORE LABELLING  
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP              Appendix 7 - Page 2 of 6 
 12.  Warnings (if applicable)  ✓ ✓* NA 
13.  Pack Sizes (unit  or volume)  ✓ ✓ NA 
14.  Special Labelling (if applicable)  ✓ ✓* NA 
15.  Name & Content of preservative(s) 
(if applicable)  ✓ ✓* NA 
NA Not applicable  
* Exempted for small labels such as an ampoule or vial with a nominal volume of 10 ml 
or less. Other factors may be considered such as the amount of information which 
needs to appear on the label and the font size necessary to achieve legibility of the 
information.  
** When the active substance is present as a salt, this should be clearly indicated, e.g. 
“each tablet co ntains 60mg active substance (as citrate) or each tablet contains 10mg 
active substance hydrochloride” etc. This statement is optional for inner label s and 
blister s. However , the name and strength of active ingredient must be indicated on the 
inner label a nd blister . 
***     The words “Batch released by” instead of “Manufactured by” may be used if the site 
named is responsible for product release. The name and address of either the 
manufacturer or the batch releaser should be present.  
  
If the product is supplied without an outer carton, the information that is required on 
the outer carton should be stated on the inner label.   
 
Information that is required should be printed on the labels and the use of 
overstickers is generally not allowed . In c ircumstances where overstickering cannot 
be avoided, the applicant should  consult  HSA via the online feedback form . 
However, r edressing (e.g. use of colour stickers) to facilitate product differentiation 
may be acceptable and the revised product labels should be submitted for 
registration.  
 
The outer carton and inner labels for products with different strengths, dosage 
forms, or  formulations should be adequately differentiated (e.g. by using different 
colour schemes) to minimise confusion and medication errors.  
 
Where practicable, the name and strength of the product should appear over each 
blister pocket or be oriented centrally  across the pack. It is important that the 
particulars remain available to the user up to the point at which the last dose is 
removed from the blister pack.  
 
The draft artwork, specimen or mock -up of the outer carton and inner/blister labels 
submitted  in the dossier  should be  consistent  with the format, design and colour 
that are to be printed.  
 
Email addresses , website addresses  and telephone numbers on the product’s 
labelling are acceptable , as long as the intent of such inclusion s is non -promotional.  
Machine readable codes (QR codes or 2D barcodes) for logistics control or directing 
the user to the e lectronic PI/PIL  of the TP  (e-labelling)  may be included.  For more 
information on e -labellin g, please refer to Appendix 7a: Guidance on Electronic 
labelling  for Therapeutic Products.