Islamic Republic of Iran
Ministry of Health and Medical Education
Food and Drug Organization
Title: Guideline for labeling of biological products.
Type:
Finalized
√ Draft
No.:
Date of Issue:
Document No.: BP-ST-18-03
Name of Office: Biologic,Deputy for Drug
In order to Labeling and packaging the biological products, all mentioned items in “General guidelines of
labeling and leaflet ” and contained items about drug dosages must be considered. It is also necessary to
observe these items as follow:
1- Outer package: the following information must be written on the package in a clear and legible
form:
- Brand or brand-generic name (according to the approved IRC form)
- Generic name (according to the official list of Iran drugs)
- Pharmaceutical potency (according to the official list of drugs of Iran)
- The package Size
- Ingredients (the proportion of the active and excepiant ingredients)
- Method of administration and use
- Storage conditions
- Drug registration code number in Iran
- Expire date
- Batch number
- Special warning and special precautions for use (according to the qualified authorities, clinical trial
results, or Iranian drug council approval)
- Necessary cautions for remaining materials and disposal method (for vaccines and other products
if it is necessary)
- Iranian representative name
Reconstitution method.
Drug usability period of time after Reconstitution.
- Physician’s prescription by considering a proper place on the package for inserting the prescription
- Price for consumer
- Name, address and logo of marketing authorization, country of origin or city name (if there is
dissimilarity between the place of production, it would be better to mention the name, logo, and
city-country of origin)
- Inserting these phrases “prescription medicine only”.“ Before usae Read carefully the internal
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leaflet” and “keep drug out of reach of children”, & “any unused product and waste material
should be disposed of in accordance with food and drug organization requirements.
- Package contents
- It is recommended to insert the barcode on label and package.
It is important to note that the writings on the packages must be in two languages English and Persian. If
there is not enough space, it is necessary inserting the followings in Persian:
Specific or generic-specific name (according to the approved IRC form)
- Generic name (according to the Iran drugs official list)
- Drug strength (according to Iran drugs official list)
- Method of administration and use
- Storage conditions
- Reconstitution method
- Drug usability period of time after Reconstitution
- Special cautions and necessary warnings.
2- Container (vial, ampoule, cartridge, pen, bag, syringe, bottle, and etc.)Small immediate package:
The written information on the container and the outer package should be the same except the
condition that the product container is so small and there is not enough space to write the entire
information on its outer package. Labels must be written in two languages unless there is not
enough space; in these cases labels in English language are permitted but other languages except
English and Persian should not be used. The following information should be clear and legible on
the label.
-Specific or generic-brand name (according to the Iran IRC confirmed form )
-Generic name (according to the Iran drugs official list)
-Drug Strength(according to the official list of Iran drugs)
-Route of administration
-Expire date
-Batch number
-The amount of active ingredients
-Storage condition
-Specific cautions and necessary warnings License holder ,s name or logo
-Iran drug registration number
- Drug usability period of time after Reconstitution
-Size of package
-License holder ,s name or logo, city or country holding license ,s name (if the place of ---production is in different place, it’d better to mention the name, logo, and the name of the city,
country of the origin)
Note: in case of lacking enough space on the package, the following items must be written on it:
-Specific or generic-brand name (according to the official list of drugs of Iran)
-Generic name (according to the official list of the Iran drugs )
-Drug strength (according to the official list of)
- Method of administration and use
-Expire date
-Batch number
-Name or logo of the license holder
-The cards which are at the behind of the PVC (in the case of pre-filled syringes) would also follow
the above measurements.
3- Details:
Drug strength and the amount of the active ingredients
-Because of the safety reasons, the microgram units must be written in full name and all forms of
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abbreviations must be avoided.
-In Persian part ,abbreviations such as mg. or ml. must not be used.
-Strength of products which divided among several dosages must be mentioned in dosage forms
and the strength of soluble products which do not contain several dosages must be mentioned as
an active ingredient in one milliliter.
-It is recommended that the active ingredients of the small package products which are provided in
ampoule or syringes, should be mentioned in package unit.
- If the amount of active ingredient is one gram or more than one gram it should be mentioned in
gram and if it is less than one tenth of a milligram it should be mentioned by microgram unit .
- If the active ingredient is offered in lyophilized powder form, this phrase “ CX gram active
ingredient in milliliter will be gotten after being dissolved based on the mentioned method” must
be stated unless the cases that there are several methods of dissolving which resulted in different
concentrations.
Drug dosage
The following phrases are suggested to be written in Persian section:
Inject able/edible solution
Solution for intravenous infusion
Lyophilized powder and solvent for preparing inject able solution
Inject able /edible suspension
Nasal/oral inhalation solution
Box Contents:
It is necessary to point to the box contents on the box like :
Box contains : one vial lyophilized powder, X gr.
One vial solvent of 10 milliliter water for injection
The package Size :
The size of the package must be mentioned on the drug package and on the label, both of them.
In the case of soluble products, the size of the package must be mentioned in millimeter, and for
multi doses products by number of dosages.
Excipient
It is necessary to mention all of the excipients used in drug formulation on the drug box. In
addition, for vaccines, the applied ‫ سویه‬and cell cultures through their production processes
should be pointed on the box of products. Like:
Every inject able syringe (0.5 millimeter) contains: …
Specific cautions and necessary warnings
Some specific cautions and necessary warnings must be mentioned on the drug packages and also on the
product, commensurate with the kind of the biologic product. It is suggested to use the following
expressions in their places:
-Each syringe is a single use product.
-Avoid shaking the drug/”shake completely before using .”
- Persons with egg allergy should be cautious using this product .
-Avoid using is opacity or particles.
-Avoid using the product in case of having allergy against any ingredients of the formulation.
-Keep product from being freezed.
Batch number and Expire Date
It is suggested to write the expire date” and “batch number” phrases on the printed package and jet print
numbers in case of production series.
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If the maximum stability of the product is changing with type and amount of solvent, “for more information
on stability period of the product after dissolution read the leaflet inside the package carefully” must be
inserted on the package.
In case some products, like some of type of vaccines, stability period after reconstitution must be expressed
in hours, days, months, or years.
Storage Condition
It is necessary to write expire date and storage condition of multi dosages products after its first time using
or after solution preparing time of lyophilized products on the main box of the drug or its container . For
example: The vial which is being used can be stored in refrigerator temperature 2 – 8 degree centigrade
through 24 hours.
- Method of administration and use
Method of administration and use should be written in Bold and by a different color. It is suggested to
translate Subcutaneous/SC as and avoid mentioning it like “avoid using intravenously”.
The Name and Logo of the Manufacturing Country
While there are two drug manufacturing companies, first one the license holder and second one the partner
company, it is not necessary the logo of the partner company be inserted.
Agency in Iran
It is suggested to insert Iranian agency name on the imported drug package to facilitate follow up.
It is necessary to insert the following cases especially on the vaccine packages.
1- Adjuvant
2- Variants and cell cultures used in the production process
3- Number and volume of the dosage
4- In case of using adjuvant
5- The word “vaccine” must be mentioned on the package of human vaccine.
“The Leaflet of the Biological Products
A leaflet or manual must be provided for every biological products. Information mentioned in this leaflet must
be according with “the leaflet preparation guidelines of the Food and Drug Organization .The products which
have leaflet special guidelines or have European Union SPC, this guideline must be considered in the leaflet.
The final leaflet of the biologic products must be prepared based on the mentioned products clinical studies
results and the proved facts of these studies must be taken into account.
It should be noted that the Persian version of the leaflet must be provided along with the product by the
first importation of products. If there is drug two drug leaflets, one for the patient and the other for the
physician, only the patient’s leaflet must be translated into Persian language Otherwise it is necessary to
translate leaflet completely and it must be provided in both Persian and English languages. All the pages
must be provided with the confirmation of technical director and a related faculty member ( seal &
signature).
- It is necessary to insert some specific warnings in leaflet, like “any unused product and waste
material should be disposed of in accordance with food and drug organization requirements.
”.
Or, about plasma-derived products:
Standard measures to prevent infections resulting from the use of medicinal products prepared from human
blood or plasma include selection of donors, screening of individual donations and plasma pools for specific
markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility
of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses
and other pathogens.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV, and for the
non-enveloped virus HAV. The measures taken may be of limited value against non-enveloped viruses such
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as parvovirus B19.
Parvovirus B19 infection may be serious for pregnant women (fetal infection) and for individuals with
immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia).
Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of
human plasma-derived products.
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