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Data sheets

Abstract

Regulations made under the Medicines Act 1968 require pharmaceutical companies to send doctors complete prescribing information for all products to be promoted by representatives or direct mail after 1st March, 1973. This information is to be provided on data sheets of specified form (loose sheets measuring 203 by 127 mm, or if part of a data sheet compendium, A5 paper), and printed in a standard way. The contents must be arranged under specified headings, which include presentation, uses, dosage and administration, contra-indications and warnings, pharmaceutical precautions, legal category, package quantities, further information which the manufacturer considers necessary, and the date of preparation of the data sheet. These requirements become absolute on January 1st 1974; until then data sheets of somewhat different specifications are in certain circumstances permitted. It will be difficult to file data sheets adequately before 1974; perhaps one might expect some help with this problem from the Department of Health before then.

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