Principles and Practice of Pharmaceutical Medicine

The EMEA will validate the dossier within 10 working days. The project manager will consult with the Rapporteur or Co-rapporteur ...

in the EMEA opinion, then the decision-making procedure is suspended, and a new opinion is requested of the EMEA. A further Stan ...

been achieved on a particular product already submitted to a community procedure and a MS considers that a change/variation, sus ...

In case that an article 29 referral (mutual recogni- tion referral) relates to a product with MA in MS other than those involved ...

entitles the sponsor to the above listed incentives for development of the drug. Sponsors need to notify the EMEA of the intent ...

the generic applicant’s responsibility to define the impurity profile (if any), provide impurity levels, their characterization ...

scientific and regulatory challenge, insofar as the synthetic process takes place inside a living organ- ism. The synthetic proc ...

EU. The following definitions are from the Gui- dance CPMP/QWP/2820/00: 1.Herbal medicinal productsare medicinal pro- ducts cont ...

Traditional herbal medicinal products A MA for a herbal medicinal product may be submitted, as for any medicinal product, throug ...

of administration and any information necessary for the safe use of the traditional herbal medicinal product. Where an applicati ...

4.8 Undesirable effects. The precise wording pre- scribed for expression of frequencies of adverse effects is given in the guide ...

packages (addressing blister packs, ampoules, etc.). 34.13 Marketing authorization variations, renewals and reclassification Lic ...

active substance, can be applied for as a Type II variation. In the United Kingdom, variation applications are sent to the MHRA ...

License renewals MAs are granted for five years in the first instance, after which a renewal is necessary. This requires submiss ...

Complex applications require initial committee referral. Therefore, the procedure takes 180 days; a full fee is charged for revi ...

product complaints which need to be thoroughly investigated. In order to allow effective tracking of products, record keeping of ...

In clinical trials of IMPs without a MA, sponsors must report all serious unexpected suspected adverse drug reactions (SUSARs) w ...

Figure 34.4 illustrates the evaluation of a reported case for reportability. Clinical trial sponsors also have the obligation to ...

help to identify special issues or problems with a given drug. In later development, the profile of the product must be investig ...

Most companies elect to prepare six-monthly reports and when the reporting intervals to the RA prolong, to submit a number of re ...