|The New Emergency Health Kit 10.000 (WHO)|
1. The quality of the drugs must comply with internationally recognized pharmacopoeia! standards.
2. At the time of shipment the product shall have at least two thirds of its shelf life.
3. Tablets should preferably be divisible and carry characteristic symbols for easy identification.
4. Drugs should be procured only from those manufacturers able to produce documents meeting the regulations of the WHO Certification Scheme on the Quality of Pharmaceutical Products moving in International Commerce.
1. Labelling should be in English and preferably one other official language of WHO.
2. All labels should display at least the following information:
· International nonproprietary name (INN) of the active ingredient(s).
· Dosage form.
· Quantity of active ingredient(s) in the dosage form (e.g. tablet, ampoule) and the number of units per package.
· Batch number.
· Date of manufacture.
· Expiry date (in clear language, not in code).
· Pharmacopoeial standard (e.g. BP, USP...)
· Instructions for storage.
· Name and address of the manufacturer.
3. A printed label on each ampoule should contain the following:
· INN of the active ingredient(s).
· Quantity of the active ingredient.
· Batch number.
· Name of the manufacturer.
· Expiry date.
The full label should again appear on the collective package.
4. Directions for use, warnings and precautions may be given in leaflets (package inserts). However, such leaflets should be considered as a supplement to labelling and not as an alternative.
5. For articles requiring reconstitution prior to use (e.g. powders for injection) a suitable beyond-use time for the constituted product should be indicated.
Example of label:
1. Tablets and capsules should be packed in sealed waterproof containers with replaceable lid, protecting the contents against light and humidity.
2. Liquids should be packed in unbreakable leak-proof bottles or containers.
3. Containers for all pharmaceutical preparations must conform to the latest edition of internationally recognized pharmacopoeia! standards.
4. Ampoules must either have break-off necks, or sufficient files must be provided.
5. Each Basic Unit should be packed in one carton. The Supplementary Unit must be packed in cartons of mast 50 kg. The cartons should preferably have two handles attached. Drugs, renewable supplies, infusions and equipment should all be packed in separate cartons, with corresponding labels.
6. Each carton must be marked with a green label (the international colour code for medical supplies in emergency situations). The word "BASIC" must be printed on each green label for the basic unit.
Each consignment must be accompanied by a list of contents, stating the number of cartons and the type and quantity of drugs and other supplies in each carton.