Remaining shelf-life requirements in international medicine supply

A medicine can be genuine, correctly stored and fully documented and still be refused at the border because it expires too soon. Many regulators set a minimum remaining shelf life for imported medicines, so that products are not dumped close to expiry and there is time to distribute and use them. The rules differ from country to country, and they matter most for orphan, specialty and biological products made in small batches with short shelf lives.

This guide explains the terms, compares the rules in several destination countries, sets out how India's own export rule differs, and gives a step-by-step check for buyers.

Key terms

• Total shelf life. The period from manufacture to expiry that the manufacturer assigned, based on stability data, under the labelled storage conditions.
• Remaining shelf life. The time left until the expiry date, measured from a reference date such as arrival or dispatch.
• Percentage remaining. Remaining shelf life divided by total shelf life, multiplied by 100. A product with a 24-month shelf life and 18 months left has 75 percent remaining.
• On arrival or at dispatch. Most destination rules apply on arrival or clearance, so transit time and permit time reduce the margin.

Shelf life assumes the product stays within its labelled storage conditions. A temperature excursion can make a product unusable long before its expiry date, which the temperature excursion guide covers.

Destination rules compared

The table summarises rules researched for the import guides on this site. Rules change, and some have exemptions or apply only to certain import routes, so confirm the current position with the regulator or the local importer before dispatch.

The sources behind each row are in the country guides: Qatar, Egypt, Ethiopia, Ghana, Tanzania, Vietnam and the United Arab Emirates. Qatar's rule comes from an April 2026 circular and its exemption guideline. Ethiopia's thresholds are in the EFDA port clearance guideline, Ghana's in the FDA Ghana import guideline and Vietnam's in a Tilleke and Gibbins summary of Decree 163.

Two patterns stand out. Percentage rules hit short-dated products hardest, because a product with a 12-month shelf life loses its margin within weeks. Fixed-month rules, as in Ethiopia, scale with the total shelf life and are easier to plan around.

A worked example

Take a product with a total shelf life of 24 months going to a country with a two-thirds rule. Two thirds of 24 months is 16 months, so at least 16 months must remain when the goods arrive. If the destination permit, export formalities and transit together take about 6 weeks after the batch is reserved, the batch needs roughly 17 and a half months left at the time it is reserved, and more if any step might slip.

The same product going to Ethiopia falls in the band of 24 months or less, so it needs 12 months left on arrival. Going to Ghana or Tanzania, the 80 percent rule for shorter-dated products applies, which means about 19 months on arrival. One batch can therefore be acceptable for one destination and not for another, which is why the destination should be named before a batch is reserved.

India's 60 percent rule for NOC stock

India has its own shelf-life rule, but it works differently. Under CDSCO's guidance for export NOCs, applied from May 2025, a formulation made under an export NOC for a drug that is unapproved in India or a new drug may be reused for a later export order only while it keeps 60 percent of its residual shelf life. Below that, the unexported stock must be destroyed in the presence of the state licensing authority. For active ingredients the threshold is 3 months.

This rule controls what a manufacturer may do with stock left over from a cancelled or reduced order. It is not a minimum shelf life on arrival, and it does not apply to products approved in India. Its practical effect for buyers is that short-dated NOC stock of an unapproved product is unlikely to be offered at all. The Indian export rules guide explains the NOC system in full.

Why named-patient and orphan supply is different

Orphan and specialty medicines are often made in small campaigns months apart, and biologicals can have short total shelf lives. When a patient needs a product now, the only available batch may sit close to a destination's threshold. Three points help in that situation.

• Ask about exemptions early. Where a regulator offers one, as Qatar and Ethiopia do, it usually has to be approved before shipment.
• Size the order to the need. Whether a quantity can be used before expiry is a decision for the prescriber and the hospital, not the supplier, but it determines whether a short-dated batch is acceptable.
• Check the route's own rules. Some special access approvals set conditions that differ from routine import rules. The guides on named-patient supply and orphan drug access routes cover those routes.

How to set and check the requirement

1. Find the destination rule. Start with the country guide, then confirm with the regulator or the local importer, including any rule specific to the import route.
2. State it in the request. Give the minimum remaining shelf life required on arrival, in months or as a percentage, in the first message. The sourcing request guide shows where it fits.
3. Allow for time before arrival. Subtract permit time, export formalities and transit from the shelf life at dispatch. The lead time estimator gives a working range.
4. Ask for the batch details before confirming. The supplier should give the batch number, manufacturing date and expiry date, backed by the manufacturer's certificate of analysis.
5. Request any exemption before dispatch. If the only available batch falls short, apply for the exemption first and ship only after approval.
6. Write it into the contract. Put the requirement in the purchase order and, where a letter of credit is used, state which document shows the expiry date. The payment guide covers credit terms.
7. Check on arrival. Record the expiry dates of the packs received and compare them with the documents.

Shelf life and cold chain

Remaining shelf life and storage are linked. A refrigerated biological that arrives on time but outside its range may be unusable whatever its expiry date says. For temperature-controlled products, match the shipper's validated hours to the route with the cold chain transit checker and read the cold chain guide before choosing a lane.