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The Medicines (Child Safety) Regulations 2003

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6.—(1) These Regulations shall not be applied in respect of relevant medicinal products consisting of or containing either paracetamol in oral liquid dosage form or more than 24mg of elemental iron if—

(a)in respect of those products, a United Kingdom marketing authorization was granted by the licensing authority before the coming into force of these Regulations;

(b)they were placed on the market before 1st October 2005; and

(c)their shelf life has not expired.

(2) Regulation 2(1) shall not be applied in respect of relevant medicinal products if—

(a)in respect of those products, a United Kingdom marketing authorization was granted by the licensing authority before the coming into force of these Regulations;

(b)they were placed on the market before 1st October 2005;

(c)their shelf life has not expired;

(d)they are in containers which are—

(i)in the form of sealed units consisting of sheet or strip material selected with a view to their resistance to opening by children; or

(ii)identical to containers which comply with the requirements of British Standard 6652 published on 30th September 1985, as amended and republished on 30th June 1989, and they—

(aa)have been certified by the British Standards Institution as complying with those requirements, or

(bb)are part of a series of containers in respect of which the licensing authority has been furnished with a report by the British Standards Institution to the effect that they comply with those requirements; and

(e)in the case of relevant medicinal products consisting of or containing aspirin or paracetamol, they are in containers which are opaque or dark tinted.

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