Over recent months, the CMDh has published paediatric assessment reports after completion of twelve Article 45 work-sharing procedures (external link) for the following active substances:


April 2012
Insulin (human)


June 2012
Silybi mariani fructus


July 2012


No regulatory action is required for Flecainide, Insulin (human), Silybi mariani fructus, Tamsulosin or Trimethoprim. The other reports include recommendations to update the product information.


Assessment reports have also been published following the completion of two Article 46 work-sharing procedures (external link).


June 2012
Humatrope (somatropin)


July 2012


No regulatory action is required for Humatrope (somatropin).


Marketing authorisation holders are asked to submit variations, where appropriate, for their products with UK marketing authorisations containing the above active substances in accordance with the recommendations in the work-sharing reports.


The relevant national or mutual recognition procedures should be followed. Type IB variations may be submitted in keeping with the new guideline on classifications introduced by the Variations Regulation which came into force on 1 January 2010.


Further guidance for submitting these applications to the MHRA was announced on 4 February 2011. In accordance with the CMDh Best Practice Guidance, these variations should be submitted with 90 days of the publication of the assessment report (external link). Any enquiries about submission of these variations should be addressed to specialpopulationsunit@mhra.gsi.gov.uk.


Posted on the UK MHRA website on 20 July 2012