CRITERIA FOR THE LABELLING OF PHARMACEUTICAL SPECIALITIES
The following list gives the maximum information which, from the public health point of view, should be shown on the outside of a package containing a pharmaceutical speciality or on the container (bottle, tube, etc.) containing the speciality.
This list should not be considered to preclude the insertion on labels of other information (such as price data) which national regulation require to be shown, insofar as this additional data is called for on grounds other than those of public health.
It is recognised that the information to be included on ampoules and other small containers must be left to the discretion of the authorities.
1. Name of speciality;
2. Composition (formula):
b) Quantitative of active principles;
3. Reference number for identifying production (batch number);
4. The number of the marketing authorisation;
5. Name and address of:
a) Manufacturer, or
b) Responsible vendor;
6. Restricted distribution, where applicable
7. Pharmaceutical form and contents;
8. Methods of use;
9. Date of expiry (if necessary);
10. Special conservation precautions (if necessary);
11. Special distinctive marks under legislation relating to poisons and narcotics.
NOTE. The information required under Items 8, 9 and 10 should be given in the language or languages of the country in which the pharmaceutical speciality is being sold.