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)
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.
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.
Register yourself to FarmavitaR+ and post your PR, professional articles, comments about articles. Participate in discussions at message board and network with other pharmaceutical professionals.
FarmavitaR+ Journal 
