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The Human Medicines Regulations 2012
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27. Clinical particulars in relation to the medicinal product, covering—
(a)therapeutic indications;
(b)posology and method of administration for adults and, where necessary, for children;
(c)contra-indications;
(d)special warnings and precautions for use and, in the case of immunological medicinal products any special precautions to be taken by persons handling such products and administering them to patients, together with any precautions to be taken by the patient;
(e)interaction with other medicinal products and other forms of interactions;
(f)use during pregnancy and lactation;
(g)effects on ability to drive and to use machines;
(h)other undesirable effects; and
(i)information on overdose (including symptoms, emergency procedures and antidotes).
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