Type of the Document: Guideline Document Code: NMRA/GL/MRD/03/2019 Effective Date: 2019
Guidelines on Labeling and Information Leaflets of
Medicines
Version 1.0
2019
Medicines Regulatory Division
National Medicines Regulatory Authority
Sri Lanka
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Type of the Document: Guideline Document Code: NMRA/GL/MRD/03/2019 Effective Date: 2019
1) Introduction:
Labeling includes any printed, stenciled marked, embossed or impressed text or graphic matter on
the immediate container, on the outer pack, and any other printed material supplied together with
the medicinal product. These labeling guidelines need to be applied in conjunction with medicines
regulations ‘Part VIII’
2) Purpose:
To describe and identify the product
To avoid medication errors
To contribute towards optimal therapeutic outcome
To achieve proper handling and storage of the product
To allow the product to be traced in the event of a concern such as a quality issue
3) Scope:
The document will serve as a guide to establish minimum requirements for content in labels with
reference to specific dosage forms and requirements for product and patient information leaflets
according to schedule of the medicine.
4) Definitions:
Primary label – label upon the immediate container, i.e. container in direct contact with the
product
Secondary label – label on the outer pack immediate to the container holding the product
Product information leaflet/Package insert (PI) – a leaflet accompanied with the medicinal
product containing specific information for the healthcare professional
Patient information leaflet (PIL) – a leaflet accompanied with the medicinal product containing
specific information in lay language, for the patient
Summary of Product Characteristics (SmPC) – a document approved as part of the marketing
authorisation of each medicine and aimed at healthcare professionals. It contains more
information than the product information leaflet
Dispensing label – a label giving specific instructions to the patient and attached to the
packaging of medicine at the point of dispensing.
5) Requirements:
LABEL
The container of every medicine imported, manufactured, processed or packed locally or sold or
exposed for sale shall have a label bearing the following information in English language.
(a) The official or generic name1 of the medicinal product followed by its pharmaceutical form2
and strength3. If applicable, abbreviations for the official pharmacopoeia or formulary4 in
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Type of the Document: Guideline Document Code: NMRA/GL/MRD/03/2019 Effective Date: 2019
which specifications of the drug product are described in a monograph shall be included
prior to the strength; e.g. Metformin1 Tablets2 B.P.4 500mg3
If appropriate, whether it is intended exclusively for paediatric or adult patients shall be
included.
Where the product contains up to three active substances, the international non-
proprietary name (INN) or any other commonly used official name such United States
Approved Name (USAN) or British Approved Name (BAN) shall be included. If there are
more than one official name for an active substance, the name that has been used most
commonly in Sri Lanka (e.g. paracetamol over acetaminophen) shall be preferred.
For products containing more than three active substances, name descriptive of the true
nature of the medicinal product shall be used. (E.g. Multivitamin Tablets)
(b) If conformity with a pharmacopoeial monograph is claimed for a product, relevant labeling
requirements given in both general and specific monographs shall be adhered to.
(c) The brand/proprietary name (if any)
The brand name should not be already registered for another product. Also, NMRA reserves
the right to refuse a brand name which is partially similar to an existing product and could
lead to mix up with another medicine, or a brand name deemed inappropriate due to
reasons such as exaggeration of its action or of immoral nature.
(d) A statement of the active substance(s) showing quantitative particulars:
(i) The quantity of each active ingredient, identified by its appropriate non-proprietary
name, in each dosage unit of the medicinal product expressed in terms of weight,
volume, capacity or units of activity; or
(ii) where there is no dosage unit, the quantity of each active ingredient identified by its
appropriate non-proprietary name, in the container of the medicinal product expressed
in terms of weight, volume, capacity or units of activity or percentage by weight or
volume of the total quantity;
For active substances present as salts, they should be clearly indicated.
E.g. each capsule contains Amoxicillin trihydrate equivalent to Amoxicillin 250mg
(e) Pack size: the number of doses, weight, or volume contained in the pack
(f) Excipient(s) known to have undesirable effects and any other ingredients specified by the
Authority. Particularly, presence of the following ingredients should be indicated:
(i) Colourant(s) contained in the formulation of any medicinal product
(ii) Sweeteners used as inactive ingredients (quantity in milligram per dosage unit)
(iii) Alcohol content in oral liquids (as a percentage)
(iv) Presence of benzyl alcohol in parenteral preparations.
(v) Preservatives contained in ophthalmic products. (as a percentage)
(vi) Any added microbial preservatives in parenteral preparations. (as a percentage)
(g) The dosage form
(h) The route of administration for injectable products
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Type of the Document: Guideline Document Code: NMRA/GL/MRD/03/2019 Effective Date: 2019
(i) Storage temperature and, other special storage precautions if any
(j) A special warning that the product must be stored out of reach of children.
(k) Specific instructions if the product needs to be reconstituted, diluted, or prepared by any
other means prior to its use
(l) Where applicable, the product is sterile.
(m) Where applicable, the product is free from bacterial endotoxins or that the product is
apyrogenic.
(n) For injectable solutions, not to use if visible particles are present.
(o) Any other special warnings and precautions that may be necessary for the particular
medicinal product.
(p) The date of manufacture in clear terms (month/year)
(q) The date of expiry in clear terms (month/year)
(r) The batch or lot number assigned by the manufacturer, and
(s) The period for which the medicine can be used after opening of the container or after
reconstitution of the product, if applicable.
(t) Specific precautions related to disposal of unused quantities of the product, if applicable.
(u) The name of the manufacturer and address of the manufacturing site.
The name and address of the batch releaser shall be used, if different from the drug
product manufacturer.
When the product owner is different to the manufacturer, the label shall indicate in the
following manner: ‘manufactured by (name and address of actual manufacturer) for
(name of product owner)’.
In addition, name and address of the packaging site(s) may be included [if different from
the manufacturing/release site(s)]
Directives of the National Languages Commission
In keeping with the National Languages Policy requirements, the official or generic name shall be
displayed in Sinhala and Tamil languages.
For medicines dispensed with an intact outer carton (e.g. a liquid bottle, an ointment tube),
displaying the name in local languages on the outer carton is sufficient.
If the product is taken out from the outer carton for dispensing (e.g. blister strips) or if the
product has no outer carton, the primary label should indicate the name in local languages.
The requirement is not compulsory for injections which require professional healthcare staff for
administration.
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Type of the Document: Guideline Document Code: NMRA/GL/MRD/03/2019 Effective Date: 2019
Exemptions for smaller labels
Primary labels on smaller containers such as a blister strip, an ampoule or vial with a volume of 10
ml or less shall contain the following minimum information.
(a) the generic or common name,
(b) the brand name (where applicable),
(c) the strength of the drug,
(d) lot or Batch number,
(e) the date of expiry and
(f) the name or logo of the manufacturer or the product owner.
In addition, route of administration shall be indicated for injections. This may be indicated in
abbreviations. The storage instructions shall be indicated on strips.
The information exempted on the primary label should be included on the outer carton and/or the
leaflets.
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.
General
Information provided in the labels should be consistent with the information submitted in the
application dossier.
If any other foreign language text is included in the label, the applicant must provide an official
statement to declare that the foreign text is complete, accurate, contains unbiased information and
is consistent with the English text.
All information required to be indicated on the label shall be displayed prominently, legibly and
distinctly. Information that is required should be printed on the labels and use of over-stickers is
generally not allowed. Over-stickers may be allowed to indicate the name of the medicine in
National languages and the price. In such instances, the sticker should not obstruct the view of
other required information.
In circumstances where over-stickers cannot be avoided, the applicant should consult the NMRA
with appropriate justifications.
Pictures with the exception of company logos are generally not allowed on medicine labels.
The outer carton labels for products with different strengths, dosage forms, or formulations of the
same manufacturer should be adequately differentiated (e.g. by using different colour schemes) to
minimise confusion and medication errors.
The draft artworks, specimens or mock-ups of outer cartons and primary labels submitted in the
dossier should be consistent with the formats, designs and colours of the original labels that would
be used on commercial packs to be marketed. Handwritten information on the artworks,
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Type of the Document: Guideline Document Code: NMRA/GL/MRD/03/2019 Effective Date: 2019
specimens, or mockups are not acceptable, with the exception of statements such as “batch
number and expiry dates will be printed”.
QR codes or 2D barcodes on the product’s labelling which are intended for logistics control are
allowed. However, the inclusion of QR codes or 2D barcodes with links to promotional internet
websites or other information sources is not allowed. Generally, indication of website addresses is
not allowed.
PRODUCT INFORMATION LEAFLET (PIL)
The container of every medicine classified under Schedules II and III of the NMRA regulations shall
be accompanied by a printed insert containing information drawn up in accordance the summary of
product characteristics.
It shall contain the particulars specified below:
(a) Generic or official name of the drug product, the dosage form, and the strength.
(b) Net content of the active substance(s).
When an active substance is present as a salt, this should be clearly indicated.
(c) Brand or proprietary name, if any.
(d) Product Description – a description of the relevant physical and chemical characteristics of the
drug product and a description of the appearance of the product (colour, markings etc.) should
be given.
(e) For products to be reconstituted before use, the appearance before reconstitution should be
stated. If a diluent/ solvent is accompanied with product, a physical description of
diluent/solvent should be stated.
(f) If applicable, information on pH and osmolarity should be provided.
(g) For tablets designed with a score line, information on the purpose of the score-line should be
given, e.g. ‘the score line only serves to facilitate breaking for ease of swallowing and does not
divide the tablet into equal half-doses’, or ‘the tablet can be divided into equal halves. ‘
(h) Excipients contained in the product, of which the knowledge of presence is important for the
safe and effective use of the medicinal product. (e.g. preservatives, colourants, antioxidants
etc.)
(i) Pharmacodynamics/Pharmacokinetics – information to be mentioned in this section include:
The pharmaco-therapeutic group and if available, the ATC code
Mechanism of action of each drug substance
Pharmacokinetic properties of each drug substance
Clinical trial information relating to clinical efficacy and safety; and
Relevant pharmacogenetic information from clinical studies with data showing a difference
in benefit or risk to a particular genotype or phenotype.
(j) Indication and usage – the therapeutic indication(s) of the product.
Information shall include a concise statement of each of the medicine’s approved indications,
briefly noting any major limitations of use for any or all of its indications. If multiple indications
exist, the information be presented in a bulleted format.
(k) Dosage and administration – the information required include, as appropriate:
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Type of the Document: Guideline Document Code: NMRA/GL/MRD/03/2019 Effective Date: 2019
A concise summary of the recommended dosage regimen (e.g., starting dose, dose range,
titration regimens, route of administration)
Critical differences among population subsets
Information on dose adjustments in special populations, e.g. elderly, children, renal
insufficiency, hepatic insufficiency and other concomitant diseases and therapies
Maximum recommended/tolerated daily dose and the maximum dose for an entire course
of therapy;
Monitoring requirements: advices relevant for dosage adjustment from monitoring of
clinical symptoms and signs and/or laboratory investigations, when appropriate.
Other pertinent information, such as relationship to meals and compatibility with other
drugs and fluids
Reference to a dosing regimen for an unapproved indication is not acceptable
(l) Method/Route of Administration – only standard abbreviations should be used. Non-standard
or complicated routes of administration should be carefully explained to avoid confusion.
(m) Contraindications – situations where patients should never or generally not be treated with the
medicine.
(n) Warnings and Precautions – circumstances where caution is required to ensure the safe and
efficacious use of the product.
Mention if appropriate, possible effects on the ability to drive vehicles or operate machinery.
(o) Interactions – forms of interactions with other medicines and other forms of interaction (e.g.
with alcohol, food varieties) with clinical significance.
(p) Use during Pregnancy/Lactation
(q) Adverse Effects/Undesirable Effects – a description of the adverse reactions under normal use
of the medicine and, if necessary, action to be taken by the patient. Provide an indication of
severity, clinical importance and frequency, whenever possible.
(r) Overdose and Treatment – symptoms, signs and recommended treatment of overdose or
accidental poisoning.
(s) Method of preparation – if applicable, the complete method of reconstitution or dilution should
be stated. If not accompanied with the product, the names of suitable diluents or solvents to be
indicated.
The appearance of the product after reconstitution should be stated. As appropriate, the
information on in-use shelf-life after dilution or reconstitution or first opening should be
provided in this section or the section “Shelf life”.
(t) Incompatibilities (for injections only)
(u) Storage Condition – the storage condition must be consistent with the conclusion of the
stability testing and the conditions stated on the product label and/or outer carton.
(v) Shelf Life – the shelf life must be based on stability data furnished in the dossier and consistent
with that stated on the product label and/or outer carton.
The information on in-use shelf-life after dilution or reconstitution or first opening should be
provided (if applicable).
(w) Available pack size(s) - All pack sizes intended to be marketed should be listed. Reference
should be made to the primary container closure system (e.g. glass vials, PVC/Aluminium blister,
Alu/Alu blister, HDPE bottle, ampoule, etc.).
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Type of the Document: Guideline Document Code: NMRA/GL/MRD/03/2019 Effective Date: 2019
(x) Any other components accompanying the product should be indicated (e.g. solvent, syringe,
measuring cup, needles, etc.). The primary container closure system of the diluent/solvent
provided with the drug product should also be described.
(y) The name and address of the manufacturer, batch releaser or product owner. The site address
should be compatible with the address indicated in the COPP and labels.
(z) The date on which the leaflet was last revised.
PATIENT INFORMATION LEAFLET
Every medicine specified in Schedule I or Group A of Schedule II of the NMRA regulations shall be
accompanied by a patient information leaflet. In addition, patient information leaflets shall be
required for any other medicine specified by the Authority from time to time.
The patient information leaflets shall be in English, Sinhala and Tamil languages giving specific
information on the safe and effective use of the relevant medicine, and shall accompany in each
package or container of medicine.
It should be presented in a legible format and in simple language readily comprehensible to the
consumers.
Pictorials may be used to demonstrate the correct usage of certain dosage forms such as
inhalers, ophthalmic products and suppositories
The information provided in the patient information leaflet should be scientifically accurate and
consistent with the product information leaflet and labels of the relevant medicine.
The patient information leaflet shall contain the following particulars:
(a) Name of the medicine (generic and brand if applicable), dosage form, strength, net content of
active ingredient(s), details of certain excipients such as preservatives and colourants as
decided by the Authority, and a description of the appearance of the product
(b) Any specific age groups for which the medicine is intended to, if applicable
(c) What is this medicine used for?
(d) How much and how often should the medicine be taken, and how long the course of treatment
will last?
(e) Any other specific directions about how to use the medicine
(f) Symptoms of serious or frequent possible adverse effects/undesirable effects and what to do if
such effect is experienced
(g) When this medicine should not be used?
(h) What other medicines or food should be avoided while taking this medicine
(i) What should be done, if a dose is missed?
(j) Any risks to the mother and the fetus or the infant from the use of the medicine during
pregnancy or breast-feeding.
(k) Information for any other special groups of patients, if applicable
(l) Any other precautions that should be taken while taking this medicine
(m) Signs and symptoms of overdose and what to do if more than the recommended dose has been
taken
(n) How should the medicine be stored?
(o) Information on in-use shelf-life after dilution, reconstitution, or first opening, if applicable
(p) General advices e.g. ‘keep away from children’, as decided by the Authority
(q) The name and address of the manufacturing site
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Type of the Document: Guideline Document Code: NMRA/GL/MRD/03/2019 Effective Date: 2019
(r) The name and address of the marketing authorization holder
If the product is sold without a separate leaflet, the information that is required in the PIL must be
stated on the outer carton or the primary label.
DISPENSING LABELS
When a prescription medicine or an over the counter medicine is dispensed to the patient, a
dispensing label giving specific instructions on its usage shall be fixed to the packaging of the
medicine.
If the dispensing label is fixed to the original commercial pack, it should not obscure important
information on the original label. When a medicine has to be prepared or taken out of the original
pack, the dispensing label shall be fixed on an envelope or on a suitable container used for
packaging the medicine.
The medium of instructions on the dispensing label shall be Sinhala, Tamil, or English, as for the
preference of the patient. The text should be clear and legible.
The following particulars shall be included on the dispensing label.
(a) Name of the patient
(b) Name of the medicine (generic and brand)
(c) The dose, frequency of administration
(d) Other specific directions for use, if any (e.g. before or after meals)
(e) Quantity of the medicine dispensed
(f) The name/address of the pharmacy, hospital or clinic
(g) Name and signature of the pharmacist, the medical practitioner or the dentist
(h) Medicines for external application should be labeled: “FOR EXTERNAL USE ONLY”
References:
1. Guidance for Industry, Labeling for Human Prescription Drug and Biological Products, USFDA
2. Medicines (labelling) regulations, HSA Singapore
3. Points to consider for Singapore labelling, HSA Singapore
4. FIP guidelines for the labels of prescribed medicines, FIP
