4.2.1 WHO Certification Scheme

The WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce (4), when used, will provide valuable data required for pharmaceutical quality assessment of imported drugs.

The scheme permits the control authorities of importing countries to obtain information on imported drugs. In this context, it is desirable to acquire knowledge of the quality and manufacturing conditions of imported drugs similar to that which could be obtained if the product were manufactured locally. The scope of the information required may vary according to the category of the drug and the control procedure adopted in the importing country.

4.2.2 Procedures at ports of entry

At the port of entry, consignments of drugs must be stored under suitable conditions, and for as short a time as possible, to prevent deterioration. If prolonged storage is to be avoided, the proper administrative procedures must be worked out and the type of information which should accompany each shipment will have to be designated. The effective involvement of pharmaceutical officers at customs would facilitate this task.

Batch control is sometimes carried out in respect of some imported drugs and considerations similar to those mentioned in section 4.1 are pertinent here.