Official announcements
messages in brief
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29/09/2011
The BMF, BMI, BMG and BASG participated in this year's action week. The operation took place this year from 20.09. to 29.09.2011. A total of 84 countries participated in the organized action. The aim was to simultaneously and in a coordinated manner…
messages in brief
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28/09/2011
The World Health Organization (WHO) has recognized the EU Clinical Trials Register (CTR) as the primary registry for the International Clinical Trials Registry Platform (ICTRP), a web-based portal that contains information from a number of clinical…
messages in brief
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27/09/2011
Commission Regulation (EC) No. 1234/2008 of Nov. 24, 2008, concerning the examination of variations to the terms of marketing authorizations for medicinal products for human use and veterinary medicinal products (Variation-Regulation), governs…
messages in brief
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27/09/2011
Since 01.09.2011 the new harmonized validation criteria are in force. From now on, the validation of dossiers includes the following criteria: Pass/Fail (P/F) and Best Practice (BP). A dossier is considered valid if all Pass/Fail criteria have been…
Safety warnings
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messages in brief
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23/09/2011
The preparations Xenical and Alli Vimpat (active ingredient: orlistat) have been approved throughout Europe since 1998 and 2007, respectively, for weight reduction in adults with overweight (body mass index BMI≥28 kg/m2 in combination with a mildly…
Recall
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Medicines
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16/09/2011
The marketing authorization holder informed its supplied customers in a letter dated September 15, 2011, that crystalline particles may be present in the amino acid chamber of the three batches mentioned and that a recall is therefore being carried…
Recall
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Medicines
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15/09/2011
The marketing authorization holder, in agreement with the European Medicines Agency (EMA), has informed its supplied customers by fax dated September 14 that all batches of Vimpat Syrup are being recalled. The reason for this recall is precipitation…
messages in brief
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13/09/2011
The QRD (Quality Review of Documents) working group of the European Medicines Agency (EMA) published the new version of the QRD template for central procedures at the end of July 2011. The template for MR/DC or referral procedures followed at the end…
messages in brief
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12/09/2011
The proposals are intended to harmonize the pharmacovigilance system provided for in Regulation (EU) No. 1235/2010 and Directive 2010/84/EU. To this end, implementing measures have been developed by the European Commission in the following areas: the…
Replacement
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Medicines
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08/09/2011
The marketing authorization holder informed its supplied customers in a letter dated 07.09.2011 that due to individual reports of an unpleasant, moldy odor, a further batch must be recalled. This odor emanates from the primary packaging (plastic…
