Questions and Answers to support the implementation of - European ...
Questions and Answers to support the implementation of - European ...
Questions and Answers to support the implementation of - European ...
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II for CAP) in order <strong>to</strong> avoid <strong>the</strong> need <strong>to</strong> submit variation when <strong>the</strong>re will be changes <strong>to</strong> <strong>the</strong> EURD list.For centrally authorised products, please refer <strong>the</strong> QRD templates updated in November 2012.In order <strong>to</strong> facilitate <strong>the</strong> <strong>implementation</strong> pending <strong>the</strong> publication <strong>of</strong> <strong>the</strong> final revised variationclassification guideline, <strong>the</strong> CMDh issued in accordance with Article 5 <strong>of</strong> Regulation (EC) No 1234/2008,a recommendation on classification <strong>of</strong> an unforeseen variation for change in <strong>the</strong> PSUR frequency ordate <strong>of</strong> submission, which can be found on <strong>the</strong> CMDh website. It is classified as a type IAIN variation.For centrally authorised products, an <strong>implementation</strong> plan has been published on <strong>the</strong> EMA websiteproviding fur<strong>the</strong>r details.5.16. When will <strong>the</strong> single EU assessment start?The procedure involving <strong>the</strong> PRAC for PSUR assessment for CAPs will start in July 2012. In contrast,<strong>the</strong> single assessment procedure involving only nationally authorised medicinal products will not startin 2012. The EMA will communicate fur<strong>the</strong>r information in 2013. Please see question 5.1.5.17. Does every PSUR assessed by PRAC need <strong>to</strong> go <strong>to</strong> CHMP or CMDh?(Update July 2012)In case <strong>of</strong> any regula<strong>to</strong>ry action i.e. variation, suspension or revocation <strong>of</strong> <strong>the</strong> marketing authorisation,<strong>the</strong> PRAC recommendation adopted in accordance with <strong>the</strong> new procedure for a single CAP or <strong>the</strong>single PSUR assessment procedure will be transmitted <strong>to</strong> <strong>the</strong> CHMP if it includes at least one CAP or <strong>to</strong><strong>the</strong> CMDh if it includes only NAPs.In case <strong>the</strong> PRAC adopts a recommendation on <strong>the</strong> maintenance <strong>of</strong> <strong>the</strong> marketing authorisation, <strong>the</strong>reis no requirement <strong>to</strong> transmit such recommendation <strong>to</strong> <strong>the</strong> CHMP or CMDh <strong>and</strong> <strong>the</strong> procedure endswith <strong>the</strong> adoption <strong>of</strong> <strong>the</strong> PRAC recommendation.5.18. Which PSUR cycle should my medicinal product follow for marketingauthorisations granted just after 2 / 21 July 2012? (New July 2012)Marketing authorisation holders covered by Article 107b <strong>of</strong> Directive 2001/83/EC or Article 28(2) <strong>of</strong>Regulation (EC) 726/2004 have <strong>to</strong> submit PSURs from <strong>the</strong> date <strong>of</strong> authorisation. As set in <strong>the</strong> newlegislation, <strong>the</strong> frequency with which <strong>the</strong> PSURs are <strong>to</strong> be submitted shall be specified in <strong>the</strong> marketingauthorisation.For medicinal products for which <strong>the</strong> application was submitted before 2/21 July 2012 but <strong>the</strong>marketing authorisation was granted in <strong>the</strong> months following <strong>the</strong> entry in<strong>to</strong> force <strong>of</strong> <strong>the</strong> newlegislation, <strong>the</strong> decision on <strong>the</strong> granting <strong>of</strong> <strong>the</strong> marketing authorisation may not yet specify <strong>the</strong> PSURcycle or include a cross-reference <strong>to</strong> <strong>the</strong> EURD list.The legislation provides rules only for those marketing authorisations which were granted before 2/21July (Article 107c (2) <strong>of</strong> Directive 2001/83/EC) <strong>and</strong> for which <strong>the</strong> frequency <strong>and</strong> dates <strong>of</strong> submission <strong>of</strong>PSURs are not laid down as a condition <strong>to</strong> <strong>the</strong> marketing authorisation. By analogy <strong>the</strong> same rulesshould apply for <strong>the</strong> PSUR cycle <strong>of</strong> marketing authorisation granted after 21 July 2012 but submittedbefore that date. Consequently, PSURs shall be submitted <strong>to</strong> <strong>the</strong> national competent authoritiesimmediately upon request or in accordance with <strong>the</strong> following frequency:• Where a medicinal product has not yet been placed on <strong>the</strong> market, at least every 6 monthsfollowing authorisation <strong>and</strong> until <strong>the</strong> placing on <strong>the</strong> market;<strong>Questions</strong> <strong>and</strong> <strong>Answers</strong> <strong>to</strong> <strong>support</strong> <strong>the</strong> <strong>implementation</strong> <strong>of</strong> <strong>the</strong> Pharmacovigilancelegislation - UPDATE, NOVEMBER 2012EMA/228816/2012 Page 21/29