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Avanir Pharmaceuticals, Inc. Message Board

  • theefalcon theefalcon Mar 1, 2013 7:31 AM Flag

    EMA Post Authorisation Variations. Part 1

    Not having studied this in great detail, however there appears to be a route for add on variations available to the MAH following an approval of a product. As stated I’m not an expert on adding variations to a product that has been approved, however the following gives a means of doing just that. If AVNR settle for just ALS & MS at first glance there appears to be a pathway to add to the same. For full details which are extensive visit the EMA web site I shall bring the count down thread forward so you can get at it easily. When getting to the web site go to Human Medicines then the regulatory tab and select one of the Variation tabs.

    European Medicines Agency post-authorisation procedural advice for users of the centralised procedure

    This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency’s position on issues, which are typically addressed in discussions or meetings with MAHs in the post-authorisation phase.

    Commission Regulation (EC) No 1234/2008 (the Variations Regulation) and the Commission guideline on the details of the various categories of variations (the Classification Guideline) set out a list of changes to be considered as type-IA variations. Such minor variations have only a minimal impact, or no impact at all, on the quality, safety or efficacy of the medicinal product, and do not require prior approval before implementation ('do-and-tell' procedure). The Classification Guideline clarifies the conditions which must be met in order for a change to be considered a type-IA variation.
    Such minor variations are classified in two subcategories, which impact on their submission:
    Type-IA variations requiring immediate notification (‘IAIN’)
    The Classification Guideline specifies which type-IA variations must be notified (submitted) immediately to the national competent authorities or European Medicines Agency following implementation, in order to ensure the continuous supervision of the medicinal product.

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    • Most interesting.

      (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Nuedexta, 15 mg / 9 mg, 23 mg / 9 mg . Avanir have stated 30/10 and 20/10.

      Once again I have not studied this in depth as yet. However I have to give consideration to the possibilities that are apparent regarding the add on variations permissible by the EMA contained in this thread. The CHMP positive opinion expanded scope of the dosage range, some what ties in with current trials for example MS Pain.

      It is early days in respect of looking at this aspect, having said that I can see a possible speeding up of the process with the aid of the EMA variations. I will have to check but did it say that a variation add on may take around a year!

      Sr Falconi

      Sentiment: Hold

      • 2 Replies to theefalcon
      • I notice you have not replied to my post pointing out that Avanir said ( I think around early 2011) that they decided not to pursue approval in Canada because they did not want the cheaper priced Canadian Nuedexta to be obtained by US citizens.
        So Canadians with PBA, including the population that you brought up, veterans sufferring from TBI and PBA, can not have access to the drug because of that decision. I think that decision by Avanir stinks.
        As an extension of what you have posted on the subject, I assume you agree.

      • I don't know what that discrepancy in milligrams is about but it can not be that the EMA has approved an entirely different dose than the ones studied, ie. 30 dex/10 quin and 20 dex/10 quin.
        Most likely explanation is the Europeans are talking in terms of milliequivalents of dex and quin and not milligrams. If 30 milligrams of dex is equal to 23 milliequivalents of dex or if 10 mg of quinidine is equal to 9 milliequivalents of quinidine, there is the answer.
        Second most likely explanation is it is just a reporting mistake but this is less likely because
        (a) it would be unlikely such a major mistake would be made and
        (b) the higher approved dose of dex is 1.5 times higher than the lower dose approved, just like the relationship between 30mg dex and 20 mg dex.

    • Part 3
      Type 2 Variations
      The Variations Regulation and the classification guideline set out a list of changes to be considered as type-II variations. In addition, any other change that may have a significant impact on the quality, safety or efficacy of the medicinal product must be submitted as a type-II variation. Refer also to 'when will my variation application be considered a type-II variation or an extension application?' below.
      During validation of an ‘unforeseen’ variation, submitted by the MAH as a type-IB variation, the Agency may consider that the proposed variation may have a significant impact on the quality, safety or efficacy of the medicinal product. In such cases, the MAH will be requested to revise and supplement its variation application so that the requirements for a type-II variation application are met (see 'how shall my type-IB variations be handled (timetable)?').

      The co-rapporteur is normally not involved in the assessment of a type-II-variation application concerning quality, pre-clinical and most of the clinical summary-of-product-characteristic (SmPC) changes.
      The involvement of the co-rapporteur is however deemed necessary for new indications.
      The MAH should therefore inform the Agency of an upcoming type-II application for a new indication at least two months before submission, so that the Committee for Medicinal Products for Human Use (CHMP) can agree on the co-rapporteur’s involvement and be informed of the future submission.
      The involvement of the co-rapporteur in other type-II variations will be decided by the CHMP on a case-by-case basis. The Agency will inform the MAH accordingly.

      Best regards to all
      Sr Falconi

      Sentiment: Hold

    • Continued Part 2
      Type IA variations not requiring immediate notification (‘IA’)
      Variations that do not require immediate notification may be submitted by the marketing authorisation holder (MAH) within 12 months after implementation, or may be submitted earlier should this facilitate dossier life-cycle maintenance or when necessary, e.g. to ensure that the latest product information is reflected in Certificates of Pharmaceutical Products.
      The 12-month deadline to notify minor variations of type IA allows for an annual reporting for these variations, where a MAH submits several minor variations of type IA that have been implemented during the previous 12 months.
      Most of these type-IA variations do not have an impact on the product information. However, in case of an upcoming submission of a variation, extension or other regulatory procedure that will affect the product information, the MAH should also include any type-IA changes affecting the product information, in order to keep the product information up-to-date and to facilitate document management.
      There are no recommended submission dates for type-IA variations.. However, MAHs are encouraged to avoid submitting type-IA notifications shortly before or during the Agency holiday periods (e.g. the end of July and Christmas).
      Commission Regulation (EC) No 1234/2008 (the Variations Regulation) defines a major variation of type II as a variation that is not an extension and that may have a significant impact on the quality, safety or efficacy of a medicinal product.

      Sentiment: Hold