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 Reporting requirements of Individual Case Safety Reports (ICSRs) applicable to marketing authorisation holders during the interim period
(Date: 07/12/2012 / Size: 85,51 Kb)
Questions and Answers to support the implementation of the Pharmacovigilance legislation - UPDATE, NOVEMBER 2012
(Date: 07/12/2012 / Size: 282,27 Kb)
New procedure for the issue/renewal of exceptional marketing authorizations
(Date: 14/08/2012 / Size: 372,72 Kb)
 LATEST LIST OF APPROVED DRUGS
(Date: 18/04/2012 / Size: 2465,15 Kb)
Amended procedure for the electronic reporting of adverse reactions (ICSRs) to the Cyprus Competent Authority
(Date: 11/04/2012 / Size: 90,82 Kb)
 Submission of data relating to the volume of sales of pharmaceutical products marketed in the Republic of Cyprus
(Date: 11/04/2012 / Size: 79,04 Kb)
[ APPLICATION FORM FOR PATIENTS WHO CARRY CONTROLLED DRUGS DURING THEIR HOLIDAY IN CYPRUS
(Date: 14/09/2011 / Size: 44,88 Kb)
Repeat Mutual Recognition Procedure (rMRP): Administrative (or Zero Days) Repeat MRP with Cyprus as the only CMS
(Date: 30/08/2011 / Size: 91,79 Kb)
Circular: Simplification of Renewal Procedure for National Medicinal Products that have Undergone at Least One 5year Renewal
(Date: 10/01/2011 / Size: 135,14 Kb)
Circular: Information for Medicinal Products Authorised through the Centralised Procedure
(Date: 10/01/2011 / Size: 96,89 Kb)
GUIDANCE FOR PROVIDING REGULATORY INFORMATION IN ELECTRONIC FORMAT SUBMISSIONS
(Date: 12/11/2009 / Size: 161,15 Kb)
Pharmacovigilance reporting requirements
(Date: 03/09/2008 / Size: 59,65 Kb)
NEW VERSION OF CHAPTER 7 - NOTICE TO APPLICANTS
(Date: 31/07/2007 / Size: 678,24 Kb)
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