Annex 8

Points to consider for setting the remaining shelf-life of

medical products upon delivery

1. Introduction 190
2. Scope 191
3. Glossary 191
4. The need for recommendations 193
5. Remaining shelf-life 194
References 196
Further reading 197
Appendix 1 Example of minimum remaining shelf-life of medical products 199

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1. Introduction
Following discussions relating to establishing a document for the remaining shelf-
life of medical products upon delivery, and considering the discussion between
the Interagency Pharmaceutical Coordination group (IPC) representatives, it was
decided to initiate a project to establish a document on remaining shelf-life for
procurement and supply of medical products.
The concept and project to establish such a document was also discussed
during the meeting of the Fifty-third Expert Committee on Specifications for
Pharmaceutical Products (ECSPP) in October 2018. It was noted that some
guidance documents were available from different procurement agencies. It was
agreed that the World Health Organization (WHO) would initiate the discussion
and preparation of a document, while following the WHO process for the
establishment of such a paper.
Information and policy on remaining shelf-life was collected from
different agencies and interested parties and a first draft document was prepared
after an informal discussion meeting in Geneva, Switzerland, in January 2019.
It was then agreed that the document should not cover only finished
pharmaceutical products but should be extended to also cover other products,
including, but not limited to, medical devices, vaccines and in vitro diagnostics
(IVD) products. (These products are collectively referred to as “medical products”
hereafter.)
A draft document was prepared and circulated to IPC members, as well
as other interested parties, inviting comments. The comments received were
reviewed during an informal discussion meeting in June 2019 and the draft
document was updated.
The aims of this document are:
■■ to facilitate the national authorization of importation of medical
WHO Technical Report Series, No. 1025, 2020

products where applicable;

■■ to promote and support the efficient processing of medical products
in the supply chain at all levels and thus prevent wastage because of
delays;
■■ to assist in ensuring that there is sufficient stock of medical products,
with acceptable remaining shelf life, in-country;
■■ to prevent dumping of medical products;
■■ to ensure that barriers to access and supply of medical products are
addressed;
■■ to prevent out-of-stock situations;
■■ to prevent receipt of donations of medical products that are not in
accordance with this guideline; and
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■■ to prevent having expired stock of medical products.

The document is intended to provide guidance on setting the remaining
shelf-life of medical products upon delivery and should be considered by all
stakeholders in the supply chain of medical products. It is also recommended that
the recommendations herein should be considered for inclusion in the national
policy of countries.

2. Scope
The principles contained in this document should be applied to medical products
in the supply chain. This includes donated products (1).
This document focuses on remaining shelf-life and does not address
details contained in other guidelines, guides and agreements between different
parties in the supply chain.
As “kits” are made up of different products, and owing to certain
specifics related to the shelf-life of kits, these are not included in the scope of
this guideline. The principles contained in this guideline may, however, be used
in considering the remaining shelf-life of items in a kit, as the expiry date of the
kit can be short because of a specific product in the kit.
All stakeholders, including national regulatory authorities, manufacturers,
suppliers, donors and recipients, should consider the recommendations on
remaining shelf-life contained in this document.

3. Glossary
The definitions given below are taken from existing WHO guidelines, where
available, or alternatively from other recognized guidelines.
batch. A defined quantity of starting material, packaging material or product,
processed in a single process or series of processes, so that it is expected to be
homogeneous. It may sometimes be necessary to divide a batch into a number of
sub-batches, which are later brought together to form a final homogeneous batch.
In the case of terminal sterilization, the batch size is determined by the capacity
of the autoclave. In continuous manufacture, the batch must correspond to a
defined fraction of the production, characterized by its intended homogeneity.
The batch size can be defined either as a fixed quantity or as the amount produced
in a fixed time interval.
consignment (or delivery). The quantity of a medical product(s), made by one
manufacturer and supplied at one time in response to a particular request or
order. A consignment may comprise one or more packages or containers and
may include material belonging to more than one batch.
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expiry date (or expiration date). The date placed on the container or labels of
a medical product designating the time during which it is expected to remain
within established shelf-life specifications if stored under defined conditions, and
after which it should not be used.

finished pharmaceutical product (FPP). A product that has undergone all

stages of production, including packaging in its final container and labelling. An
FPP may contain one or more active pharmaceutical ingredients.

install by date. The date by which an instrument, device or other has to be

installed.

manufacture. All operations of purchase of materials and products, production,

quality control, release, storage and distribution of medical products, and the
related controls.

manufacturer. A company that carries out operations such as production,

packaging, repackaging, labelling and relabelling of medical products.

marketing authorization (product licence, registration certificate). A legal

document issued by the competent medicines regulatory authority that
establishes the detailed composition and formulation of the product and the
pharmacopoeial or other recognized specifications of its ingredients and of the
final product itself, and includes details of packaging, labelling and shelf-life.

manufacturer (IVD). Any natural or legal person with responsibility for design
and/or manufacture of an IVD product with the intention of making it available
for use, under his or her name, whether or not such an IVD product is designed
and/or manufactured by that person him- or herself or on his or her behalf by
(an)other person(s).
WHO Technical Report Series, No. 1025, 2020

manufacturing date. The date of production of a batch is defined as the date

that the first step is performed involving combination of the active ingredient
with other ingredients. Where there are no other ingredients than an active
ingredient, the date of the start of the processing or filling operation is considered
as the date of production.

medical product. Products including, but not limited to, finished pharmaceutical
products, medical devices, vaccines and IVD products.

pharmaceutical product. Any material or product intended for human or

veterinary use presented in its finished dosage form, or as a starting material for
use in such a dosage form, that is subject to control by pharmaceutical legislation
in the exporting state and/or the importing state.
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production. All operations involved in the preparation of a product, from receipt

of materials, through processing, packaging and repackaging, labelling and
relabelling, to completion of the finished product.

remaining shelf-life. Defined as the period remaining, from the date upon
delivery, to the expiry date, retest date, install by date or other use before date
established by the manufacturer.

retest date. The date when a material should be re-examined to ensure that it is
still suitable for use.

shelf-life. The period of time, from the date of manufacture, that a product is
expected to remain within its approved product specification while handled and
stored under defined conditions.

upon delivery. The date the medical product is delivered as specified, e.g. at the
port, at the point in country after customs clearance, or at the end-user – and as
defined in the agreement between relevant parties.

4. The need for recommendations

As there was no harmonized approach on remaining shelf-life for medical
products amongst procurers, donors and recipient countries, it was agreed
that it will be beneficial to have a harmonized approach when considering
remaining shelf-life. This will assist national regulatory authorities (NRAs),
suppliers, donors, procurers, importers and distributors to manage medical
products throughout the supply chain, thus ensuring the availability of quality
medical products within their remaining shelf-life reaching the end-user. The
authorization of importation of medical products by NRAs sometimes delays
access to medical products. A harmonized approach among countries may
facilitate authorization and release of medical products in the supply chain in a
timely manner.
This is not a standalone document. It should be read with other
documents, guides and guidelines, including, but not limited to, WHO
guidelines such as Stability testing of active pharmaceutical ingredients and
finished pharmaceutical products (2), Good storage and distribution practices
(3), Guidelines for medicines donations (1), Model quality assurance system for
procurement agencies (4), The International Pharmacopoeia (5) and guidelines
of the International Council for Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use (6).

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5. Remaining shelf-life
Note: The manufacturing date of a medical product should be defined by the
manufacturer and be provided, if requested.

5.1 Principles
Decisions on remaining shelf-life for medical products should be defined
realistically, contextualized and adapted to each importer, following a thorough
risk assessment taking into account the criteria on page 195. It should be defined
and be based on relevant factors, including but not limited to the category and
type of product; inventory level; manufacturing and transit lead time; local
release lead time; storage condition; delivery chain; and resources in the recipient
country or region.
There should be agreements between suppliers, purchasers and recipients
covering the relevant responsibilities of each party, including remaining shelf-
life or expiry date.
Products should be transported, received, stored and distributed in
accordance with WHO Good storage and distribution practices (3). Special
attention should be given to temperature-, light- and moisture-sensitive products.
Products supplied by the manufacturer or supplier should meet the
policy of national government and the recommendations in terms of remaining
shelf-life prescribed in this document.
Products should be appropriately labelled. The label should include the
expiry, retest or install by date, as appropriate. Products with an “install by” date
should be installed prior to the date specified by the supplier.
Products received should be scrutinized in an attempt to identify possible
substandard and falsified products. It should be ensured that, for example, the
expiry date is not falsified (7).
WHO Technical Report Series, No. 1025, 2020

Where different periods for remaining shelf-life have been defined for
products, recipients should ensure that the products meet the remaining shelf-
life requirement for the intended destination, e.g. central warehouse, regional
warehouse, testing site or user point.
National authorization for importation, where required, should be
obtained based on the available information, including the expiry date of the
product, to allow for calculation of the remaining shelf-life and to assist in
expediting approval.
Where so justified, suppliers, recipients and national authorities may
negotiate deviations from the policy for remaining shelf-life, provided that:
■■ where the remaining shelf-life is shorter than stipulated in the policy,
it is ensured that the stock will be consumed prior to expiry; and
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■■ the medical product reaches end-users with adequate remaining

shelf-life to permit confidence on the time to consume it before
expiry.
Risk assessment to ensure that the parameters listed above are met
should be done, taking into account the following considerations:
■■ assessment of need;
■■ type of product: different criticality for the safety of the patient
between pharmaceutical products, vaccines, medical devices and
IVD products;
■■ expiry date: with this the remaining shelf-life at delivery time can
be estimated;
■■ compliance with WHO guidelines on Good storage and distribution
practices (3);
■■ delivery time to storage facility;
■■ storage conditions;
■■ stock rotation;
■■ delivery time from storage to end-user;
■■ frequency of stock replenishment – order frequency (based on
consumption): recipients and end-users should regularly verify that
medical products in stock are rotated or used within their remaining
shelf-life, and adjust the quantities ordered to make sure that the
medical products will be used during their remaining shelf-life;
■■ assessment of the real needs, to ensure that the medical products
can be used within their shelf-life;
■■ emergencies: during an emergency situation, the remaining shelf-
life policy should be well balanced to ensure that life-saving medical
products will be received on time; and that the needs will be covered
if there is an increased demand.;
■■ the logistic setup: the location of the premises, the number of
means/types of transportation and the number of e.g. vehicles, and
its adaptability will have an impact on the speed of the delivery and,
hence, on the confidence that products will be used before their
expiry date;
■■ the activity specificities: similarly, whether the medical products will
be used by the national programme, or are managed directly by the
importer, outside of a national programme, will make a difference in
terms of speed of delivery to the end-user; and
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■■ the point of delivery: national warehouses, or importer or end-user

facilities will also have an impact on the speed of delivery.

5.2 Expiry date

Products, such as pharmaceutical products, should have an expiry date allocated
by the manufacturer. The expiry date should be established based on the results
of stability testing obtained in the relevant packaging (primary and secondary
packaging, where appropriate) and required stability conditions (2).

5.3 Retesting
Where a manufacturer or supplier has obtained approval from an NRA for a new
or extended shelf-life, this may be applied.
Products with an expiry date should not be subjected to retesting
by the purchaser or recipient for the purpose of extension of shelf-life. Only
in exceptional cases, such as product shortages, should a recipient consider
extending the expiry date of received batches, subject to certain conditions, such
as availability of scientific data, the application of risk management principles,
and NRA approval. The new expiry date should be reflected on the packaging.
Products with a retest date allocated by a manufacturer, e.g. chemicals
and reagents, may be retested and used if the quality parameters are met.
An illustrative example of recommended remaining shelf-life of products
is given in Appendix 1.

References
1. Interagency guidelines. Guidelines for medicines donations, 3rd ed. Geneva: World Health
Organization; 2011 (https://apps.who.int/iris/bitstream/handle/10665/44647/9789241501989_
eng.pdf?sequence=1, accessed 18 November 2019).
WHO Technical Report Series, No. 1025, 2020

2. Stability testing of active pharmaceutical ingredients and finished pharmaceutical products. In:
WHO Expert Committee on Specifications for Pharmaceutical Preparations: fifty-second report.
Geneva: World Health Organization; 2018: Annex 10 (WHO Technical Report Series, No. 1010;
http://apps.who.int/medicinedocs/documents/s23498en/s23498en.pdf, accessed 18 November
2019).
3. Good storage and distribution practices for medical products. In: WHO Expert Committee
on Specifications for Pharmaceutical Preparations: fifty-fourth report. Geneva: World Health
Organization; 2020: Annex 7 (WHO Technical Report Series, No. 1025).
4. Model quality assurance system for procurement agencies. In: WHO Expert Committee on
Specifications for Pharmaceutical Preparations: forty-eighth report. Geneva: World Health
Organization; 2014: Annex 3 (WHO Technical Report Series, No. 986; http://apps.who.int/
medicinedocs/documents/s21492en/s21492en.pdf, accessed 18 November 2019).
5. The International Pharmacopoeia, 9th ed. Geneva: World Health Organization; 2019 (https://
apps.who.int/phint/en/p/docf/, accessed 4 November 2019).
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6. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for
Human Use (https://www.ich.org/, accessed 18 November 2019).
7. WHO guidance on testing of “suspect” falsified medicines. In: WHO Expert Committee on
Specifications for Pharmaceutical Preparations: fifty-second report. Geneva: World Health
Organization; 2018: Annex 5 (WHO Technical Report Series, No. 1010; http://apps.who.int/
medicinedocs/documents/s23452en/s23452en.pdf, accessed 18 November 2019).

Further reading
■■ WHO good manufacturing practices for pharmaceutical products: main principles. In: WHO
Expert Committee on Specifications for Pharmaceutical Preparations: forty-eighth report.
Geneva: World Health Organization; 2014: Annex 2 (WHO Technical Report Series, No. 986;
https://www.who.int/medicines/areas/quality_safety/quality_assurance/TRS986annex2.pdf,
accessed 15 November 2019).
■■ WHO guidelines for sampling of pharmaceutical products and related materials. In: WHO Expert
Committee on Specifications for Pharmaceutical Preparations: thirty-ninth report. Geneva: World
Health Organization; 2005: Annex 4 (WHO Technical Report Series, No. 929; https://apps.who.
int/medicinedocs/documents/s21440en/s21440en.pdf, accessed 18 November 2019).
■■ Guidance on good practices for pharmaceutical quality control laboratories. In: WHO Expert
Committee on Specifications for Pharmaceutical Preparations: forty-fourth report. Geneva: World
Health Organization; 2010: Annex 1 (WHO Technical Report Series, No. 957; https://www.who.
int/medicines/areas/quality_safety/quality_assurance/GoodpracticesPharmaceuticalQuality
ControlLaboratoriesTRS957Annex1.pdf, accessed 17 November 2019).
■■ Model guidance for the storage and transport of time-and temperature-sensitive pharmaceutical
products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations: forty-fifth
report. Geneva: World Health Organization; 2011: Annex 9 (WHO Technical Report Series, No. 961;
http://apps.who.int/medicinedocs/documents/s18683en/s18683en.pdf, accessed 18 November
2019).
■■ WHO guidelines on quality risk management. In: WHO Expert Committee on Specifications for
Pharmaceutical Preparations: forty-seventh report. Geneva: World Health Organization; 2013:
Annex 2 (WHO Technical Report Series, No. 981; https://www.who.int/medicines/areas/quality_
safety/quality_assurance/Annex2TRS-981.pdf, accessed 18 November 2019).
■■ Technical supplements to Model guidance for storage and transport of time- and temperature-
sensitive pharmaceutical products. (WHO Technical Report Series, No. 961, 2011), Annex 9. In:
WHO Expert Committee on Specifications for Pharmaceutical Preparations: forty-ninth report.
Geneva: World Health Organization; 2015: Annex 5 (WHO Technical Report Series, No. 992; https://
apps.who.int/medicinedocs/documents/s21896en/s21896en.pdf, accessed 18 November 2019).
■■ WHO Good manufacturing practices for biological products. In: WHO Expert Committee on
Specifications for Pharmaceutical Preparations: fiftieth report. Geneva: World Health Organization;
2016: Annex 3 (WHO Technical Report Series, No. 996; https://apps.who.int/medicinedocs/
documents/s22400en/s22400en.pdf, accessed 18 November 2019).
■■ Guidance for procurement of in vitro diagnostics and related laboratory items and equipment.
Geneva: World Health Organization; 2017 (https://apps.who.int/iris/bitstream/handle/10665/
255577/9789241512558-eng.pdf?sequence=1, accessed 18 November 2019).

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■■ Technical Guidance Series (TGS) for WHO Prequalification Diagnostic Assessment. TGS2:
Establishing stability of in vitro diagnostic medical devices. In: WHO Expert Committee on
Biological Standardization: sixty-eighth report. Geneva: World Health Organization; 2018: Annex
5 (WHO/BS/2017.2304 Rev. 1; WHO Technical Report Series, No. 1011; https://apps.who.int/iris/
bitstream/handle/10665/259742/WHO-BS-2017.2304-eng.pdf?ua=1, accessed 18 November
2019).
■■ Technical Guidance Series (TGS) for WHO Prequalification Diagnostic Assessment. Annex
to TGS2: Establishing component stability for in vitro diagnostic medical devices. Geneva:
World Health Organization; 2019 (WHO/MVP/EMP/RHT/PQT/2019.03; https://apps.who.int/iris/
bitstream/handle/10665/311345/WHO-MVP-EMP-RHT-PQT-2019.03-eng.pdf?ua=1, accessed 18
November 2019).
■■ ISO 23640:2011(en). In vitro diagnostic medical devices – evaluation of stability of in vitro
diagnostic reagents (https://www.iso.org/obp/ui/#iso:std:iso:23640:ed-1:v1:en, accessed 18
November 2019).
■■ EP25-A: Evaluation of stability of in vitro diagnostic reagents; approved guideline. Wayne (PA):
Clinical and Laboratory Standards Institute; 2009 (https://clsi.org/media/1424/ep25a_sample.
pdf, accessed 18 November 2019).
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Appendix 1
Example of minimum remaining shelf-life of medical
products
Note: The total shelf-life of a product is based on results from testing during
stability (and, where relevant, sterility) studies under specified conditions. The
storage and transport conditions stipulated by the manufacturer should be
followed, to ensure the product quality is maintained.

Table A8.1
Example of the minimum remaining shelf-life (RSL; at the time of dispatch and upon
delivery) of medical products, based on the outcome of risk assessment

RSL at time of RSL at time RSL at time

dispatch from of delivery at of delivery at
manufacturer’s port of entry end-user
Total shelf-life (TSL) premises of country level
48 months < TSL ≤ 60 months 40 months 30 months 12 months
36 months < TSL ≤ 48 months 30 months 24 months 12 months
24 months < TSL ≤ 36 months 20 months 15 months 6 months
12 < TSL ≤ 24 months 9 months 7 months 3 months
TSL ≤ 12 months Special arrangements and conditions apply

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