MAVIS - Edition 20 - October 1996 - Veterinary Medicines Directorate

Medicines Act Veterinary Information Service October 1996TRANSFER OF CENTRALISEDMARKETING AUTHORISATIONSAt a meeting of the Standing Committee of Veterinary andHuman Medicinal Products in Brussels on 23 September,a draft Commission Regulation which sets down theprocedures for the transfer of a marketing authorisation,granted under the centralised procedure, to a new holderwas agreed. The text of the Commission Regulation,which is as yet unnumbered, will be published in theOfficial Journal of the European Community in due course.We do not yet know when the regulation will enter intoforce but it should be shortly after publication.REMINDER FOR APPLICANTSWhen applying for a national authorisation by applicationform, it would be most helpful if companies would continueto use the form MLA 201(vet)(Rev 10/93).Also, when submitting large quantities of data with anapplication, it would be helpful if companies could let usknow prior to dispatch so that appropriate arrangementscan be made if mechanical handling is required.For further information please contact Viv Saville (VMD,extension 3016).SUSPECTED ADVERSE REACTIONSURVEILLANCE SCHEMEThe definition of a Suspected Adverse Reaction (SAR) is taken from article 42b of the amended Directive 81/851/EEC:"adverse reaction means a reaction which is harmful and unintended and which occurs at doses normally used inanimals for the prophylaxis, diagnosis or the modifications of physiological function". In addition to this, the UK alsoinclude reports of suspected lack of efficacy, reports of non authorised use of veterinary medicines and reports ofhuman SARs.Quarterly ReportDuring the period 1 July to 30 September 1996, 289animal suspected adverse reaction reports were received.Of these, 19 reports related to unauthorised use, 10 casesinvolved unidentified, non authorised or non veterinaryproducts and 31 were considered unlikely to be productrelated. There were 2 cases related to Animal TestCertificate or Animal Test Exemption use and 17 cases ofsuspected lack of efficacy.The remaining 209 suspected adverse reaction reportswere associated with 116 authorised products.The 209 reports were divided by marketing categories asfollows:163 Prescription Only Medicine (POM)39 Pharmacists and Merchants List (PML)5 Pharmacists List (P)2 General Sales List (GSL)During the quarter 45 human suspected adverse reactionreports were received of which 7 related to OP sheep dipsand 2 related to non OP sheep dips. The balance of 38reports were associated with relatively minor incidents.All human incidents are considered by the Appraisal Panelfor Human Suspected Adverse Reactions to VeterinaryMedicines. The information thus accrued is analysed toidentify any trends or signals that need attention.5