Re­call pro­ce­dure up­date

Pharmacy Daily - - NEWS -

RE­PLAC­ING the Uni­form Re­call Pro­ce­dure for Ther­a­peu­tic Goods (2004), the Ther­a­peu­tic Goods Ad­min­is­tra­tion (TGA) has re­leased an up­date of the doc­u­ment, fol­low­ing pub­lic con­sul­ta­tion.

The TGA says the pur­pose of the new doc­u­ment, which takes ef­fect 15 Jan 2018, is to “as­sist the spon­sor to con­duct re­calls and non-re­call ac­tions us­ing a stan­dard­ised sys­tem­atic pro­ce­dure”.

Spon­sors can fol­low the process to “re­spond ef­fi­ciently and ef­fec­tively to is­sues with a ther­a­peu­tic good” where they be­lieve the prod­uct may pose a risk to pub­lic health and safety.

Manda­tory re­calls or­dered by the TGA will also need to fol­low the pro­ce­dures out­lined in the doc­u­ment, with civil and crim­i­nal penal­ties ap­ply­ing for non­com­pli­ance.

To ac­cess the new doc­u­ment visit tga.gov.au.

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