| Country | Long-term testing condition in WHO's list | Zone (read from the condition) | Note |
|---|---|---|---|
| Saudi Arabia | 30 °C/65% RH | IVa | Confirmed through a regional group or by the national regulator |
| United Arab Emirates | 30 °C/65% RH | IVa | Confirmed through a regional group or by the national regulator |
| Qatar | 30 °C/65% RH | IVa | Confirmed through a regional group or by the national regulator |
| Kuwait | 30 °C/65% RH | IVa | Confirmed through a regional group or by the national regulator |
| Oman | 30 °C/65% RH | IVa | Confirmed through a regional group or by the national regulator |
| Bahrain | 30 °C/65% RH | IVa | Confirmed through a regional group or by the national regulator |
| Jordan | 30 °C/65% RH | IVa | Confirmed through a regional group or by the national regulator |
| Lebanon | 25 °C/60% RH | II | Confirmed through a regional group or by the national regulator |
| Egypt | 30 °C/65% RH | IVa | Confirmed through a regional group or by the national regulator. The Egyptian Drug Authority also names zone IVa (2022, for pharmaceutical products) |
| Libya | 25 °C/60% RH | II | Confirmed through a regional group or by the national regulator |
| Tunisia | 25 °C/60% RH | II | Confirmed through a regional group or by the national regulator |
| Morocco | 25 °C/60% RH | II | Confirmed through a regional group or by the national regulator |
| Algeria | [25 °C/60% RH] | II | IFPMA estimate, not confirmed by the regulator |
| Nigeria | 30 °C/75% RH | IVb | Reported by national regulators at the ICDRA conference, 2008 |
| Ghana | 30 °C/75% RH | IVb | Reported by national regulators at the ICDRA conference, 2008. Ghana's FDA also names zone IVb for supplements (2013) |
| Côte d'Ivoire | [30 °C/65% RH] | IVa | IFPMA estimate, not confirmed by the regulator |
| Senegal | [30 °C/65% RH] | IVa | IFPMA estimate, not confirmed by the regulator |
| Cameroon | 30 °C/75% RH | IVb | Reported by national regulators at the ICDRA conference, 2008 |
| Kenya | [30 °C/65% RH] | IVa | IFPMA estimate, not confirmed by the regulator |
| Tanzania | 30 °C/75% RH | IVb | Reported by national regulators at the ICDRA conference, 2008 |
| Uganda | 30 °C/65% RH | IVa | Confirmed through a regional group or by the national regulator |
| Ethiopia | [30 °C/65% RH] | IVa | IFPMA estimate, not confirmed by the regulator |
| South Africa | 25 °C/60% RH | II | Confirmed through a regional group or by the national regulator |
WHO's list gives conditions, not zone names; the zone is our reading of each condition against the note to Table A10.4 in WHO's TRS 1010, Annex 10. Source: WHO, Stability conditions for WHO Member States by Region, update of March 2021, written for medicines. Square brackets are WHO's mark for an estimate. Country names are shortened (Libya for Libyan Arab Jamahiriya, Tanzania for United Republic of Tanzania). Rows run by region: the Gulf and the Levant, North Africa, West and Central Africa, East Africa, southern Africa. Checked 9 October 2026.
Read against that note, 30 °C/75% RH corresponds to zone IVb, 30 °C/65% RH to zone IVa and 25 °C/60% RH to zone II. Five countries in the table have only an IFPMA estimate, not confirmed by the regulator: Kenya, Ethiopia, Senegal and Côte d'Ivoire at 30 °C/65% RH, Algeria at 25 °C/60% RH. For packaging, the condition is the heat and humidity a stability study holds the product at; how much of that humidity gets to the product depends on its pack.
What do climatic zones II, IVa and IVb mean?
Each zone stands for a long-term storage condition: the temperature and relative humidity (RH) at which a product is kept and tested over the shelf life claimed for it.
WHO's guideline on stability testing (Technical Report Series No. 1010, Annex 10, 2018) chooses the long-term condition by the climatic zone of the market where the product will be sold. Its note to Table A10.4 states the condition for three zones:
- Zone II: 25 °C/60% RH.
- Zone IVa: 30 °C/65% RH.
- Zone IVb: 30 °C/75% RH, the most humid of WHO's three long-term conditions.
During a study the temperature is held within ±2 °C and the humidity within ±5% RH. Accelerated testing, which shows early how a product reacts to stress, runs at 40 °C/75% RH for six months.
In the WHO texts we read, the long-term condition is stated by name for zones II, IVa and IVb only; zones I and III are mentioned without a condition of their own. This page covers the three zones whose conditions appear for these 23 countries. WHO warns that running stability studies at the conditions of zones I and II for products supplied to zones III and IV "could potentially lead to substandard products".
ICH Q1A(R2), the stability guideline of the International Council for Harmonisation in force on 9 October 2026, addresses climatic zones I and II. Its long-term and intermediate conditions include 30 °C/65% RH, the condition WHO gives for zone IVa. ICH left the conditions for zones III and IV to the regions and to WHO, and in a note quoted by WHO its regulators agreed that data at 30 °C/75% RH are acceptable if an applicant chooses to use them.
Which zone is my market in, and how firm is the answer?
Find the country in the table above: WHO's list gives its long-term condition, and that condition corresponds to a zone. How firm the answer is depends on where WHO took the line from, and the list marks three sources:
- Confirmed (bold type in WHO's list): obtained through regional harmonisation groups, such as the GCC, or from official communications by national medicines regulators to WHO. On this page that covers the six GCC states, Jordan, Lebanon, Egypt, Libya, Tunisia, Morocco, Uganda and South Africa, 14 countries in all.
- Reported in 2008 (normal type): collected from representatives of national regulators at the 13th International Conference of Drug Regulatory Authorities (ICDRA), held in Berne from 16 to 18 September 2008. On this page: Nigeria, Ghana, Cameroon and Tanzania. These lines are 18 years old, and a regulator may have changed its condition since.
- Estimated (italic type in square brackets): provided by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) from published climate references, among them a world map of the Köppen-Geiger climate classification. On this page: Algeria, Côte d'Ivoire, Senegal, Kenya and Ethiopia. An estimate is not a statement by the regulator.
Two readings to avoid. WHO's list does not give the GCC states the zone IVb condition: Saudi Arabia, the UAE, Qatar, Kuwait, Oman and Bahrain all have 30 °C/65% RH, which corresponds to zone IVa. And Africa is not one zone: the 15 African countries on this page fall under all three conditions, and only Nigeria, Ghana, Cameroon and Tanzania among them have 30 °C/75% RH.
The main markets of the manufacturing group behind HYPERPHARM sit under two conditions: the UAE and Saudi Arabia at 30 °C/65% RH, Lebanon at 25 °C/60% RH.
The list on who.int is the update of March 2021, and WHO's 2018 guideline calls it a living document. A search on 9 October 2026 found no newer version; that does not prove none exists.
Does WHO's list apply to food supplements?
Not as law: it was written for medicines. WHO's guideline describes it as the list of Member States that have told WHO which long-term stability testing conditions they require when a marketing authorisation is requested, that is, when a medicine is registered.
For a supplement, the rules come from the regulator in the country of sale and from what your importer has to file. Ghana's guideline for supplements carries WHO's zone IVb terms; Saudi Arabia's food guide asks for a stability study without naming a condition in the parts we read. Read the list as the starting point, then confirm with your importer what the regulator asks for.
Where does a regulator name the climate for supplements?
Among the regulators' documents we read, Ghana's names a zone for supplements, Egypt's names one for pharmaceutical products, and Saudi Arabia's food guide names no condition but asks about the packaging material for some tablet and capsule products.
- Ghana. The Food and Drugs Authority's guideline for registering food, nutritional and dietary supplements, issued in March 2013, asks for stability reports under WHO zone IVb conditions. It names accelerated testing at 40 °C ± 2 °C and 75% RH ± 5% for six months and long-term testing until the end of the shelf life, in the container closure system in which the product will be marketed in Ghana. Ask your importer whether the 2013 version is still the one in force.
- Egypt. The Egyptian Drug Authority's stability guideline (GL.CAPP.018, version 4, November 2022) states that "Egypt is categorized in climatic zone IVa", the same 30 °C/65% RH that WHO's list gives Egypt. It is written for pharmaceutical products, and we have not confirmed that it applies to supplements.
- Saudi Arabia. The SFDA's guide for food products (July 2024) asks for a stability study based on the shelf life the manufacturer proposes. For tablet and capsule products sensitive to heat, humidity or sunlight, it asks for a document that describes the packaging material and verifies its safety for use. In the parts we read, it names no testing temperature or humidity.
In the documents we read from the regulators of the UAE and Nigeria, we found no zone named for supplements. For the other countries on this page we have not checked the regulators' own supplement rules; WHO's list and your importer are the starting points there.
Filing the product in the importing country is the brand owner's or the local importer's step, not ours. What we supply for that file is the Certificate of Analysis and the product specification with each batch, and copies of the plant's certificates on request.
What does the zone mean for packaging my supplement?
The zone sets the heat and humidity a stability study puts the product through; the pack decides how much of that humidity reaches the product.
The data follow the pack. Ghana's FDA asks for the supplement stability study to be run in the container closure system in which the product will be marketed in Ghana. If you plan to change the pack, ask your importer what the regulator then expects.
Impermeable containers take humidity out of the study. WHO's guideline lists aluminium/aluminium blisters for solid dosage forms among impermeable containers, which give a permanent barrier to the passage of moisture. For products in such containers, WHO says sensitivity to moisture is not a concern, and the study can run at any controlled or ambient humidity. WHO also notes that zone IVa conditions may be acceptable in place of IVb when humidity is not an issue, for example for storage in glass containers.
A blister seals dose by dose. Each tablet or capsule sits in its own cavity under the lidding foil until it is pressed out, so taking one dose leaves the rest sealed. How much moisture passes into a cavity depends on the film; the films the machine can run are listed on the blister packing page.
A blister is not automatically the stronger pack. A 2017 modelling study of one moisture-sensitive multivitamin tablet, with 100 mg of thiamine, estimated a longer shelf life at 30 °C/75% RH for a 60 cc bottle of 30 tablets with silica gel desiccant than for an aluminium/aluminium blister. It is a calculation for one product, published in a trade journal, and the article features a desiccant supplier's product. It still makes the point that the formula and the pack are chosen together.
The label does not replace the pack. WHO's guideline says a storage statement "should not be used to compensate for inadequate or inferior packaging".
Tablets and capsules are sealed into blisters on an Uhlmann B 1240 and cartoned on an IMA IC 150.
The pack for hot markets is covered on blister packaging for hot and humid markets, and storage, shipping and remaining shelf life on shelf life and storage.
What your product decides
Before you choose a pack or a plant, your formula, your markets and your sales channel settle part of the answer. Each line shows what it costs in time or in risk.
| Your product, market or channel | What changes | What it costs you |
|---|---|---|
| A formula that takes up moisture | The market's humidity reaches the product only as far as the pack lets it, so how much moisture the pack lets through is part of the answer, and the formula and the pack are settled together | Risk: stability data are generated in one pack; if the pack changes afterwards, ask your importer whether the regulator wants new data |
| A product and pack for which humidity is not an issue | For medicines, WHO notes that zone IVa conditions may be acceptable in place of IVb when humidity is not an issue | Less risk on the humidity side; the regulator in your market still decides what it accepts |
| A market on this page at 30 °C/75% RH: Nigeria, Ghana, Cameroon or Tanzania | The most humid of WHO's long-term conditions; Ghana applies zone IVb to supplements, in the pack the product will be sold in there | Time: Ghana's guideline names six months of accelerated testing at 40 °C/75% RH and long-term testing to the end of the shelf life |
| A market on this page at 30 °C/65% RH: Saudi Arabia, the UAE, Qatar, Kuwait, Oman, Bahrain, Jordan, Egypt or Uganda | A hot condition with less humidity than 30 °C/75% RH | Risk: for medicines, WHO warns against relying on zone I and II conditions for zone IV markets; for a supplement, confirm with your importer which condition the regulator expects |
| Saudi Arabia, through the SFDA's food sector, with a tablet or capsule product sensitive to heat, humidity or sunlight | The SFDA's food guide asks for a document that describes the packaging material and verifies its safety for use | Time before filing: the document is part of the application, so it has to be ready before your importer files |
| A market on this page at 25 °C/60% RH: Lebanon, Libya, Tunisia, Morocco or South Africa | The mildest of the three conditions on this page | Risk: if the same product also goes to a hotter market, data at this condition alone do not cover it; WHO warns against using zone I and II conditions for zones III and IV |
| A market with only an IFPMA estimate: Kenya, Ethiopia, Senegal, Côte d'Ivoire or Algeria | No condition confirmed by the regulator in WHO's list | Risk: the regulator may ask for something else; confirm with your importer before you plan any data |
| Egypt, for a product registered with the Egyptian Drug Authority and sold through pharmacies | The authority's stability guideline for pharmaceutical products names zone IVa | Risk: that this guideline covers your product is not confirmed, and which Egyptian authority registers your product is for your importer to confirm; ask before you plan any data |
Questions buyers ask about climatic zones
Is the UAE a zone IVb market?
No. WHO's list gives the United Arab Emirates 30 °C/65% RH, confirmed through a regional group or by the regulator, and that condition corresponds to zone IVa. Saudi Arabia, Qatar, Kuwait, Oman and Bahrain have the same entry.
Which condition does WHO list for Nigeria and Ghana?
30 °C/75% RH, which corresponds to zone IVb. Both lines were collected from national regulators at the ICDRA conference in 2008, 18 years ago. Ghana's FDA names zone IVb in its own 2013 guideline for supplements.
Is all of Africa zone IVb?
No. Of the 15 African countries on this page, only Nigeria, Ghana, Cameroon and Tanzania have 30 °C/75% RH. Egypt and Uganda have 30 °C/65% RH, and Kenya, Ethiopia, Senegal and Côte d'Ivoire the same as an IFPMA estimate, not confirmed by the regulator. Libya, Tunisia, Morocco and South Africa have 25 °C/60% RH, and Algeria the same as an IFPMA estimate.
What do the square brackets in WHO's list mean?
They mark an estimate, not a regulator's statement. Bracketed lines come from the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and rest on published climate references. On this page that applies to Algeria, Côte d'Ivoire, Senegal, Kenya and Ethiopia.
Does WHO's list apply to food supplements?
Not as law. It was written for medicines and records the long-term conditions Member States require for a marketing authorisation. For a supplement, the regulator of the country of sale and your importer decide. Of the regulators' documents we read, Ghana's applies WHO zone IVb conditions to supplements.
How current is WHO's list?
The version on who.int is the update of March 2021. A search on 9 October 2026 found no newer one, though that does not prove none exists. Some lines are older than the update: those for Nigeria, Ghana, Cameroon and Tanzania were collected in 2008.
Does an aluminium blister make the climatic zone irrelevant?
Not entirely. WHO's guideline for medicines lists aluminium/aluminium blisters for solid dosage forms among impermeable containers and lets products in them be tested at any controlled or ambient humidity. The study is still run, and the regulator in your market may still ask for data in the pack you sell.
Is a blister always better than a bottle in a hot, humid market?
No. A blister keeps each dose sealed until it is pressed out, but its moisture barrier depends on the film. A 2017 modelling study of one vitamin tablet at 30 °C/75% RH put a 60 cc bottle with desiccant ahead of an aluminium/aluminium blister; it is a calculation for one product, in a trade-journal article that features a desiccant supplier's product. The formula and the pack are decided together.
Can a storage instruction on the label make up for a weaker pack?
No. WHO's stability guideline says a storage statement "should not be used to compensate for inadequate or inferior packaging". For supplements, Ghana's FDA asks for the stability study in the container closure system the product is marketed in.
Which zone does Egypt's regulator name?
Zone IVa. The Egyptian Drug Authority's stability guideline of November 2022 states that "Egypt is categorized in climatic zone IVa", the same 30 °C/65% RH that WHO's list gives Egypt. The guideline is written for pharmaceutical products, so check with your importer whether your supplement falls under it.
Does ICH cover hot and humid markets?
Only in part. ICH Q1A(R2) addresses climatic zones I and II, and its long-term and intermediate conditions include 30 °C/65% RH, the condition WHO gives for zone IVa. ICH left the conditions for zones III and IV to the regions and to WHO, and its regulators agreed that data at 30 °C/75% RH are acceptable if an applicant chooses to use them.
Will you register my supplement in the importing country?
No. Filing the product with the importing country's regulator is done by the brand owner or a local importer. From us come the documents such a file draws on: the Certificate of Analysis and the product specification with each batch, and copies of the plant's certificates with their numbers on request.
Read more
Blister packaging for hot and humid markets · Shelf life and storage
Ask about your product and its markets
Tell us the product, the countries you plan to sell in, the pack you have in mind and what your importer has asked for. We answer within 24 hours, Monday to Friday.
If the pack is a blister, a run starts from 2,000 cartons printed for your brand (at least 4,000 blisters), with a ready-made formula or your own, and production takes 6 to 10 weeks. Each carton holds 1 to 4 blisters, and the lidding foil is printed for your brand as well.
Sources
- World Health Organization: Stability conditions for WHO Member States by Region, update of March 2021, published as Appendix 1 to Annex 2 of WHO Technical Report Series No. 953 (Stability testing of active pharmaceutical ingredients and finished pharmaceutical products). Written for medicines. Gives long-term testing conditions, not zone names. Footnotes 1 to 3 of the list give the three sources of its entries. Page on who.int; PDF on cdn.who.int. Checked 9 October 2026.
- World Health Organization: WHO Technical Report Series No. 1010 (2018), Annex 10, Stability testing of active pharmaceutical ingredients and finished pharmaceutical products. Written for medicines. Parts used: introduction (purpose of the country list; ICH and zones III and IV), sections 2.2.7 and 2.2.7.1 (conditions by climatic zone, tolerances, accelerated testing), 2.2.7.2 and glossary (impermeable containers), 2.2.10 (storage statements), Appendix 3, Table A10.4 and its note (conditions for zones II, IVa and IVb; zone IVa in place of IVb). extranet.who.int. Checked 9 October 2026.
- International Council for Harmonisation: ICH Q1A(R2), Stability testing of new drug substances and products, Step 4 version of 6 February 2003. database.ich.org. Checked 9 October 2026.
- Food and Drugs Authority, Ghana: Guideline for Registration of Food/Nutritional/Dietary Supplements, FDA/HMD/GL-FS/2012/01, issued 1 March 2013. fdaghana.gov.gh. Checked 9 October 2026.
- Egyptian Drug Authority: Guidelines on Stability Testing of Finished Pharmaceutical Products and Active Drug Substance, EDREX: GL.CAPP.018, version 4/2022, issued 10 November 2022. edaegypt.gov.eg. Checked 9 October 2026.
- Egyptian Drug Authority: Decree 572/2022 of the Chairman of the Egyptian Drug Authority. edaegypt.gov.eg. Checked 9 October 2026.
- Saudi Food and Drug Authority, Food Sector: Guide to Pre-registration Evaluation for Food Products (file of July 2024). sfda.gov.sa. Checked 9 October 2026.
- Logel and co-authors: Why bottles with desiccant outperform foil-foil blister packaging. Pharmaceutical Technology, September 2017. Trade-journal article: a modelling study of one product (a 60 cc bottle of 30 tablets at 30 °C/75% RH); the article features a desiccant supplier's product. pharmtech.com. Checked 9 October 2026.
