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Romania - Important notice to the attention of Marketing Authorisation Holders
The NMA hereby informs you on certain issues of importance in the CMD(h) Press Release on the Report from the CMD(h) meeting held on 19th and 20th January 2009 (http://www.hma.eu/186.html)
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Question and Answer – Article 5 of Regulation (EC) No 1234/2008
The CMD(h) has agreed a Q&A (http://www.hma.eu/120.html) to clarify that Article 5 of Regulation (EC) No 1234/2008, applicable as of 1st January 2009, can only be used to request the provision of a recommendation on the classification of a variation according to Commission Regulation (EC) No 1234/2008 and not according to the Commission Regulation (EC) No 1084/2003, in force until 31st December 2009.
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The NMA hereby informs you on certain issues of importance in the CMD(h) Press Release on the Report from the CMD(h) meeting held on 19th and 20th January 2009 (http://www.hma.eu/186.html)
Question and Answer – Article 5 of Regulation (EC) No 1234/2008
The CMD(h) has agreed a Q&A (http://www.hma.eu/120.html) to clarify that Article 5 of Regulation (EC) No 1234/2008, applicable as of 1st January 2009, can only be used to request the provision of a recommendation on the classification of a variation according to Commission Regulation (EC) No 1234/2008 and not according to the Commission Regulation (EC) No 1084/2003, in force until 31st December 2009.
Cover letter for Variation applications in MRP
The CMD(h) has agreed on a template for a cover letter for variation applications submitted through MRP, prepared by the Working group on Validation issues/National requirements. The CMD(h) has agreed that the use of the template for the cover letter is voluntary and it is published on the CMD(h) website
(http://www.hma.eu/uploads/media/Cover_Letter_Variations_2009_01_Rev0.doc).
Number of application forms for registration of homeopathic medicinal products
The CMD(h) has agreed to accept the submission of one application form for several dilutions of a homeopathic stock for a pharmaceutical form. This agreement is reflected in a Q&A, which is published on the CMD(h) website, under Questions & Answers, Homeopathics (http://www.hma.eu/214.html).
Request for Marketing Authorisation Holders for medicinal products presented as pressurised metered dose inhalers (pMDI)
Marketing Authorisation Holders are requested to review dossiers to ensure that storage orientation studies have been performed and the results of these studies are included in the registered dossier. If the results of the storage orientation studies show that there is a possibility for dose decrease/increase after storage in certain positions, an appropriate recommendation for storage orientation and/or re-priming of the product should be included in the product information.
If MAHs establish that their dossiers need to be updated with respect to either of the above points, an appropriate variation application should be submitted.
Marketing Authorisation Holders are requested to carry out the review of their dossiers and submit any necessary variation applications as soon as possible and not later than 30th June 2010.
A letter detailing this request is published on the CMD(h) website:
(http://www.hma.eu/uploads/media/MAHs_storage_orientation_issue.pdf)
Reflection paper on advice to Applicants/Sponsors/CROs of Bioequivalence Studies
The CMD(h) would like to bring to the attention of Applicants/Sponsors/CROs of Bioequivalence Studies, the publication on the EMEA website, under Inspections – Good Clinical Practices (http://www.emea.europa.eu/Inspections/GCPproc.html) of the reflection paper on advice to Applicants/Sponsors/CROs of Bioequivalence Studies.
This advisory document has been developed in order to underline the responsibilities of the parties involved, clarify expectations and reinforce steps taken by the applicants, sponsors and CROs themselves to ensure the quality of bioequivalence trials submitted in marketing authorisation dossiers.
