labelling of pharmaceutical drug products and cosmetics, with special emphasis on font size, type, and other recommendations such as particulars to be mentioned and legal framework for labelling

1. Labeling requirements in EU
Submitted By: BINDU
Department of Pharmaceutical Sciences,
MDU,Rohtak

2. Labeling
➢ Display of information about a product on its container , packaging, or the
product itself.
➢ In Europe , Labeling of drug for human controlled by CHMP under EMA.
➢ All the requirements and items are listed in Title V of Directive 2001/83/EC.
➢ In USA , Labeling of OTC drug are controlled by FTC and prescription drugs
are controlled by FDA.

3. Labelling covers both outer packaging and inner packaging.
Labelling ensures that the critical information is legible, easily
accessible.
The recommendations given in the package leaflet (section A) may be applicable
to labelling .
The particulars appearing on the label of all medicinal products should be
printed in characters of at least 7 points, leaving a space between lines of at least
3 mm.
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RECOMMENDATIONS FOR THE LABELLING

4. ➢These items are : :
➢ Name of the medicine;
➢Strength and, where relevant,
➢Total content;
➢Route of administration.
Where possible, these should be brought together using a
sufficiently large type size on the labelling.
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5. Legal Framework
➢ According to Article 54, Article 55 and Article 59 of Directive
2001/83/EC of the European Parliament, medicinal products for human
use medicinal products must be accompanied by outer and/or
immediate packaging information (labelling) and a package leaflet.
➢Article 58 of Directive 2001/83/EC allows for the omission of a
package leaflet where all the required information can be directly
conveyed on the packaging.
➢ Article 56 of Directive 2001/83/EC requires that the particulars to be
included in the labelling shall be easily legible, clearly comprehensible
and indelible.

6. According to Article 57 of Directive 2001/83/EC, additional labelling
requirements may apply in particular Member States in respect of price,
legal status for supply and identification and authenticity.
Labelling must contain all elements required by Article 54 of Directive
2001/83/EC or a lesser set of elements where the provisions of Article 55
of the same Directive apply.
Nevertheless, of the information items listed in Article 54 of Directive
2001/83/EC, certain items are deemed critical for the safe use of the
medicine.

7. NAME OF THE
MEDICINE
Article 54(a) of Directive 2001/83/EC requirements
related to full name of the medicinal product, with its
strength and its pharmaceutical form, and, if
appropriate, whether it is intended for babies, children
or adults, should appear on the outer packaging and
on the immediate packaging to aid accurate
identification of the medicinal product.
Where the medicinal product contains up to three active
ingredients, the INN/common name(s) of these
active ingredient(s) should be stated after the full
name, on the outer packaging and the immediate
packaging, unless the INN/common name(s) is part of
the name.

8. STRENGTH
AND TOTAL
QUANTITY
In some cases the packaging may need to contain
information on both the quantity per unit volume and
on the total quantity per total volume. The total
quantity per total volume can be particularly important
for safety reasons for injectable products and other
medicines available in solution or suspension.
Different strengths of the same medicinal product
should be expressed in the same manner: for example
250 mg, 500 mg, 750 mg, 1000 mg and NOT 1 g.
Trailing zeros should not appear (2.5 mg and NOT 2.50
mg).The use of decimal points (or comma) should be
avoided where these can be removed (i.e. 250 mg is
acceptable whereas 0.25 g is not).

9. ROUTE OF
ADMINISTRATION
— This should be as registered in the summary of
product characteristics (SPC) only according
to the standard terms.
— Negative statements should not be used: for
example “Not for intravenous use”. In
principle only standard abbreviations may be
acceptable (i.v., i.m., s.c.).
— In addition, a list of other, non-standard
abbreviations which can be used in SPC and
labelling is published on the EMEA website
(http://www.emea.europa.eu/htms/human/qr
d/docs/listnonstandard.pdf).
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10. 10
Some routes of administration will be unfamiliar to patients and may
need to be explained within the package leaflet. This is particularly
important when medicinal products are made available for self-
medication.

11. DESIGN AND
LAYOUT
● Applicants and marketing authorisation holders
should make best use of the space available to ensure
that the important information is clearly mentioned
on spaces on the outer and immediate packaging,
presented in a sufficiently large type size.
● Company logos and pictograms (if accepted in
accordance with Article 62) may be presented,
where space permits, on the outer packaging and on
immediate packaging, provided they do not interfere
with the legibility of the mandatory information.
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12. ● Use of a large type size will be appropriate, although other factors
may also be important in making the information legible.
Consideration should be given to the line-spacing and use of white
space to enhance the legibility of the information provided. For some
small packs it may not be possible to present all the critical
information in the same field of view.
● Colours should be chosen to ensure a good contrast between the text
and the background to assure maximum legibility and accessibility of
the information. Highly glossy, metallic or reflective packaging
should be avoided, as this affects the legibility of the information.
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13. TEMPLATES
FOR LABELING
The templates provided in all EEA languages on
the EMEA Website: http://www.emea.eu.int
/htms/human/qrd/qrdtemplate.htm reflect the
particulars which must appear on the labelling
and package leaflet of medicinal products
according to Directive 2001/83/EC. They will
help to ensure that the information appears as
intended by the Directive, and to ensure
consistency in the information.
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14. OTHER INFORMATION
—
Member State may ask for additional information
(Article 57 of Directive 2001/83/EC) to appear on the
packaging concerning identification and authenticity
of product, the legal category for supply and the price.
National rules will apply in these circumstances and
details on the requirements for the “blue box” in
mutual recognition and decentralized procedures are
given in the Notice to Applicants, Volume 2A, chapter
7. The “blue box” requirements in the centralised
procedure are set out in the Notice to Applicants
Volume 2C, “Guideline on the packaging information
of medicinal products for human use authorised by the
Community”.
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15. WARNING
—Keep out of the reach and sight
of children .
—Other special warning , if
necessary.
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16. EXPIRY DATE
— The expiry date printed on medicinal products
stating only month and year should be taken to
mean the last day of that month. Expiry dates
should be expressed with the month given as 2
digits or at least 3 characters and the year as 4
digits.
— E.g.: February 2007, Feb 2007, 02-2007.
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17. Name and
Address of
MAH
— Including town, postal code (if available) and
country name of the MAH in the language of the
text (Telephone, fax numbers or e-mail
addresses) may be included.
— Local representatives of the MAH, if mentioned
in the leaflet, may be included in the ‘Blue Box’
on the outer packaging.
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18. LANGUAGE
— Article 63(1), 1st and 2nd sub-paragraph of the
Directive provides that
— "The particulars for labelling listed in Articles 54, 59
and 62 shall appear in an official language or official
languages of the Member State where the medicinal
— product is placed on the market, as specified, for the
purposes of this Directive, by that Member State.
The first subparagraph shall not prevent these
particulars from being indicated in several
languages, provided that the same particulars appear
in all the languages used".
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19. Marketing
Authorisation
Number
— This is the marketing authorisation number
consisting of "EU" followed by a nine digit
number (e.g. "EU/1/96/000/000"). This number
must appear on the package, whilst the (national)
identification number, if any, can only appear
(once) in the ‘blue box’ .
— e.g.
— EU/0/00/000/001 28 tablets
— EU/0/00/000/002 56 tablets
— EU/0/00/000/003 100 tablets
— Manufacturing Lic. No. is not required to be
placed on label as in India.
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20. Blind and partially-
sighted patients
—Article 56a of the Directive
requires the name of the medicinal
product to be expressed in Braille
format on the packaging.
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21. Control of the
conformity of the
labelling with the
Directive
— Article 12(1), 2nd sub-paragraph of the
Regulation provides that "Authorisation
shall […] be refused if […] the labelling
[…] proposed by the applicant are not in
accordance with Title V of Directive
2001/83/EC".
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22. Changes to the
Labeling
— Article 61(3) of the Directive provides that:
"All proposed changes to an aspect of the
labelling or the package leaflet covered by
this Title and not connected with the
summary of product characteristics shall be
submitted to the authorities competent for
authorizing marketing. If the competent
authorities have not opposed a proposed
change within 90 days following the
introduction of the request, the applicant
may put the change into effect".
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23. SMALL
CONTAINER
● Where the labelling particulars set out in article 54 of
Directive 2001/83/EC cannot be applied in full to the
labelling of small containers, as a minimum the particulars
set out in Article 55(3) of the directive should be applied.
Other information required in Article 54 may be added as
appropriate, where space permits. The criteria for small
container status would normally apply to containers of
nominal capacity of 10ml or less. However, other factors
may need to be taken into account such as the amount of
information which has to be included and the font size
necessary to ensure the legibility of the information.
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24. Dangerous
Substances
The labeling of dangerous substances must indicate the
following:
➢The name of the substance
➢The origin of the substance (the name and address of the
manufacturer or distributor)
➢The danger symbol and an indication of danger involved
in the use of the substance
➢A reference to the special risks arising from such
dangers.
● The dimensions of the label must not be less than a
standard A8 sheet (52 x 74mm), and each symbol must
cover at least one-tenth of the label’s surface area.
Member States may require their national language(s) to
be used in the labeling of dangerous substances.24

25. Dangerous
substances
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Strength
(total and in
one ml)

27. Minimum particulars
required for Blister
/Strips Package
● Name of medicinal
product
● Name of MAH
● Expiry date
● Batch number
● Other information
● Name of product
● Route of administration
● Method of administration
(directions)
● Expiry date
● Batch number
● Contents by weight, by volume, by
unit
● Other information
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Minimum particulars for
small immediate package units

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