CHAPTER VIIMARKET SURVEILLANCE

Article 23Communication of serious undesirable effects

1.

In the event of serious undesirable effects, the responsible person and distributors shall without delay notify the following to the F1Secretary of State F2...:

(a)

all serious undesirable effects which are known to F3the responsible person or the distributor or which may reasonably be expected to be known to F4that responsible person or distributor;

(b)

the name of the cosmetic product concerned, enabling its specific identification;

(c)

the corrective measures taken by F5that responsible person or distributor, if any.

F62.

The Secretary of State must immediately inform all other competent authorities of any information notified to the Secretary of State under paragraph 1.

F73.

Where a distributor reports serious undesirable effects of a cosmetic product to the Secretary of State, the Secretary of State must immediately inform the responsible person.

F84.

Where end users or health professionals report serious undesirable effects of a cosmetic product to any competent authority that is not the Secretary of State, that competent authority must immediately inform the Secretary of State who must then immediately inform the responsible person.

Where end users or health professionals report serious undesirable effects of a cosmetic product to the Secretary of State, the Secretary of State must immediately inform all other competent authorities and the responsible person.

5.

Competent authorities may use the information referred to in this Article for the purposes of in-market surveillance, market analysis, evaluation and consumer information in the context of Articles 25, 26 and 27.