TNAG-1710-FCO40-2386-Royal-visits-from-the-UK-to-Hong-Kong-1987 — Page 136

3) Non-compliance with drug standards in

aspects.

any other

Article 35 Personnel of drug manufacturing enterprises, drug handling enterprises and medical units in direct contact with drugs must undergo a medical examination annually. People suffering from communicable diseases or any other diseases, which may cause the contamination of drugs should not be engaged in any work that cannot avoid direct contact with drugs.

CHAPTER W

THE PACKAGING AND

REPACKAGING OF DRUGS

Article 36 Drugs should be packaged in a way to meet the requirements raised by the nature of individual drug, to facilitate their storage, transportation and medical usage. A date of expiration should be put on the package whenever such a date has been fixed.

Herbal drugs must be packaged in the course of transpor- tation, each package should give the identity and origin of the consignment, date of dispatch, name of the consignor, and bear a sign showing that the quality of the consignment is acceptable.

Article 37 All the packages of a drug should be labelled

-38-

and a package insert should be attached to each package. The label or package insert should give the name and strength of the product, name of the manufacturer, the serial number of the approval document, the lot number, principal ingredients, indications, usage, dosage, contra-indications, adverse reactions and precautions.

The label of narcotic drugs, psychotropic substanees, poisons, radioactive pharmaceuticals and drugs for external use only should bear a sign of special device.

Article 38 A drug handling enterprise engaged in the re- packaging of drugs should be equipped with the requisite facilities adaptable to the scale of its business, and the hygienic requirements should also be observed. Pharmaceu- tical technicians should be put in charge of the operation and the data of repackaging should be recorded completely and accurately.

A package insert should be attached to each package of the repackaged product. The label of the new package should give the name and strength of the product, name of the manufacturer, the lot number of the original package, name of the repackaging unit and the lot number of the repac- kaged product, and a date of expiration should also be put on the new package if the original package bears such a date.

-39-