July 28, 2010
Marketing authorisation holders for medicines for which the marketing authorisation was granted before 30 October 2005 had a 5 years transitional period to amend the labelling to comply with Articles 54(a), 54(e) and 56(a). The MHRA has reminded MAHs to submit their applications by the 1 August 2010 to ensure compliance by 30 October 2010. The [...]
July 28, 2010
The MHRA has reminded marketing and manufacturing authorisation holders to keep all API manufaturing sites named on approved marketing authorisations actively maintained as approved suppliers in line with European GMP expectations. If Companies do not want to maintain back up API manufacturers to GMP requeirement, they should remove them from the MA by submission of a [...]
July 28, 2010
The applications under Article 61(3) are notifications regarding minor changes to the label and the PL, that are not associated with a change to the SmPC, and are not subject to the variation application. However, submission of the results of user testing is considered outside the scope of the article 61(3) notification procedure. This includes [...]
July 19, 2010
The requirements on electronic submissions (NeeS and eCTD) and paper documentation have been updated on the CMDh website. Most NCAs are ready to receive electronic-only documentation and this mode of submission is strongly promoted even when the NCA still accepts paper submissions. No NCA request full paper copy anymore, however some modules might be required [...]
July 19, 2010
An updated list of contact email addresses for submision of electronic response documents for applications for marketing authorisations, variations and renewals in mutual recognition procedures and DCP is available on the CMDh website.
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