Article 31 referrals

Community interest referral (Article 31 referrals)

This procedure is triggered when the public health interest of the Community is involved, following concerns relating to the quality, safety or efficacy of a medicine. It is initiated by the EC, a Member State, or a MAH. This referral type has been used for norfloxacin and for colistin.

On 27. Oct. 2014 EMA completed the review of polymyxin-based medicines and issued recommendations for safe use in patients with serious infections resistant to standard antibiotics. The Committee recommended that doses should always be expressed in international units (IU) but because doses of colistimethate sodium can be expressed in different ways a conversion table should be included in the product information. Critically ill patients should be given a higher starting dose (loading dose) to provide an effective level of the antibiotic in the body more quickly. Although data were very limited, the Committee recommended doses for use in patients with kidney problems and in children, and provided guidance on dosage in adults when given directly into fluid surrounding the brain or spinal cord (intrathecal or intraventricular injection).

The CHMP opinion will now be forwarded to the European Commission, which will issue a final decision in due course.

The scientific opinion on the need to establish limits/ranges for the colisitimethate sodium subcomponents and on the adequacy of the Ph. Eur. Monograph and the control and bioassay methods described therein is still pending. See details

U. Theuretzbacher, JAC 2014: Product information for parenteral colistin varies substantially across Europe

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