9. MEC guidelines This Chapter represents a summary of the views of the TGA and the Medicines Evaluation Committee (MEC) with respect to OTC medicines (including new substances) at the time of publication and is intended to assist sponsors in submitting acceptable applications for registration of OTC medicines. Products are assessed according to the best clinical and scientific information at the time of evaluation. If you believe that a particular application warrants a departure from the Guidelines, a justification should be submitted with the application. The guidelines are not mandatory for existing products. However sponsors of existing products are encouraged to update labels to comply with the relevant guidelines when submitting label variation applications (refer to Chapter 11, , for information on changes to existing products). Suggested statements (for labelling purposes) are written in this chapter of the guideline as dot points and in italics. Comments relating to these suggested statements are in normal font and are not intended for inclusion on the labels. Allantoin The absence of convincing evidence that allantoin has a role as a wound healing agent precludes any claims being made for its efficacy in this regard. Alpha hydroxy acids There is evidence to suggest that the use of topical products containing alpha hydroxy acids (such as glycollic acid, lactic acid, citric acid and other fruit acids) may make users more sensitive to sunlight and especially to the ultraviolet (UV) radiation component of sunlight. UV exposure can damage the skin and at high doses, especially over a long period, can cause skin cancer (refer to the FDA Backgrounder Alpha Hydroxy Acids in Cosmetics, 3 July 1997). – The following statements should be included in the labelling of products containing hydroxy acids: This product may make your skin more sensitive to sunlight; • Sun exposure should be limited by using a sunscreen and by wearing protective clothing; • If you have sensitive skin, test this product on a area of skin before applying it to a large area; • Transient stinging or irritation may occur when using this product. If irritation persists, • discontinue use; and Not recommended for use on children or infants. • Anaesthetics, dermal All products containing local anaesthetics for dermal use must contain a statement such as: If irritation occurs, stop use immediately and seek medical advice. See also and
9. MEC guidelines This Chapter represents a summary of the views of the TGA and the Medicines Evaluation Committee (MEC) with respect to OTC medicines (including new substances) at the time of publication and is intended to assist sponsors in submitting acceptable applications for registration of OTC medicines. Products are assessed according to the best clinical and scientific information at the time of evaluation. If you believe that a particular application warrants a departure from the Guidelines, a justification should be submitted with the application. The guidelines are not mandatory for existing products. However sponsors of existing products are encouraged to update labels to comply with the relevant guidelines when submitting label variation applications (refer to Chapter 11, , for information on changes to existing products). Suggested statements (for labelling purposes) are written in this chapter of the guideline as dot points and in italics. Comments relating to these suggested statements are in normal font and are not intended for inclusion on the labels. Allantoin The absence of convincing evidence that allantoin has a role as a wound healing agent precludes any claims being made for its efficacy in this regard. Alpha hydroxy acids There is evidence to suggest that the use of topical products containing alpha hydroxy acids (such as glycollic acid, lactic acid, citric acid and other fruit acids) may make users more sensitive to sunlight and especially to the ultraviolet (UV) radiation component of sunlight. UV exposure can damage the skin and at high doses, especially over a long period, can cause skin cancer (refer to the FDA Backgrounder – Alpha Hydroxy Acids in Cosmetics, 3 July 1997). The following statements should be included in the labelling of products containing hydroxy acids: • This product may make your skin more sensitive to sunlight; • Sun exposure should be limited by using a sunscreen and by wearing protective clothing; • If you have sensitive skin, test this product on a area of skin before applying it to a large area; • Transient stinging or irritation may occur when using this product. If irritation persists, discontinue use; and • Not recommended for use on children or infants. Anaesthetics, dermal All products containing local anaesthetics for dermal use must contain a statement such as: If irritation occurs, stop use immediately and seek medical advice. See also and
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