XN000022-1987-03-25 — Page 17

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WEDNESDAY, MARCH 25, 1987

SHE SAID THAT THE GROUP UNDERSTOOD THAT SUCH AMENDMENTS MIGHT REQUIRE CONSULTATION AND MEMBERS DID NOT WISH TO DELAY THE PASSING OF THESE REGULATIONS WHICH CONTAINED MORE IMPORTANT PROVISIONS. THE GROUP, HOWEVER AGREED TO LET THE PHARMACY AND POISONS REGISTRATION COMMITTEE TO UNDERTAKE THE MONITORING ROLE FOR THE TIME BEING.

+THE ADMINISTRATION ASSURES US THAT IN FUTURE DURING THE PROCESS OF REGISTRATION, STEPS WILL BE TAKEN TO REQUIRE INFORMATION REGARDING POSSIBLE CONTRA-INDICATIONS AND SIDE-EFFECT TO BE SPECIFIED ON THE LABEL OR LEAFLET ATTACHED TO A MEDICINE.

+MEMBERS OF THE AD HOC GROUP TEND TO FEEL THAT A DIRECT LEGAL REQUIREMENT TO INCLUDE SUCH INFORMATION IS A BETTER SAFEGUARD THAN INDIRECT ADMINISTRATIVE ENFORCEMENT.

+1 WOULD THEREFORE URGE THE ADMINISTRATION TO MONITOR THIS PROPOSED MEASURE CLOSELY. SHOULD IT BE FOUND NOT TO BE WORK ING SATISFACTORILY, FURTHER AMENDMENTS TO THE REGULATIONS MUST THEN BE MADE, DR IP SAID.

TURNING TO THE PROPOSED REGULATION 6, SHE SAID THAT THE EFFECT OF THIS NEW AMENDMENT WAS THAT NOT ONLY WAS THE SALE AND DISTRIBUTION OF UNREGISTERED OR DEREGISTERED PHARMACEUTICAL PRODUCTS PROHIBITED, BUT POSSESSION OF THEM WAS ALSO AN OFFENCE.

DR IP SAID UNSCRUPULOUS TRADERS WOULD NOW BE PREVENTED FROM TAKING ADVANTAGE OF THE LOOPHOLE BY STORING SUCH PRODUCTS OUTSIDE THEIR NORMAL BUSINESS PREMISES.

SHE ALSO CALLED ON THE GENERAL PUBLIC TO USE DISPENSARIES WHICH HAD A QUALIFIED PHARMACIST IN ATTENDANCE.

DR THE HON CHIU HIN-KWONG ALSO SPOKE ON THE REGULATIONS.

HE CONSIDERED THAT CLEAR, ACCURATE AND IMPORTANT INFORMATION ON DOSAGE, ROUTE AND FREQUENCY OF ADMINISTRATION WERE ESSENTIAL BUT DETAILS ON CONTRA-INDICATIONS, SIDE-EFFECTS, PRECAUTIONS AND WARNINGS WERE ALSO INDISPENSABLE.

+IT WILL BE IMPRACTICABLE, IF NOT IMPOSSIBLE, TO REQUEST PHARMACEUTICAL MANUFACTURERS TO PROVIDE EVERY SINGLE DETAIL OF THE DRUGS CONCERNED.

+ HOWEVER, IT IS IMPERATIVE TO ENSURE THAT KEY INFORMATION IS NOT OMITTED.

+THEREFORE, THE REGISTRATION COMMITTEE IS URGED TO TAKE UP THE RESPONSIBILITY TO CHECK ALL ESSENTIAL DETAILS DURING THE REGISTRATION PROCESS,+ HE SAID,

/DR CHIU