Argentina - Drug Information Association

Regulatory version: None
Language: French
GCC
GCC - Authorities / Organization: Gulf Central Committee For Drug Registration
(GCC-DR)
This document presents the organization and main objectives of the Gulf Central Committee For Drug Registration (GCC-
DR). It also explains it's responsibilities with details on the different centralised procedures. This includes the registration of
pharmaceutical companies and pharmaceutical products, GMP inspection, post-marketing surveillance... The document also
provide the main fees and practical details on tenders in the GCC.
Document date: Jan-2011
Type of text: Explanatory
Language: English
GCC - Circular No 327: Renewal of Centrally Registered Products, 18-Jan-2011
Circular number 327 dated on the 18th of Jan 2011 informs the companies to apply for renewals of centrally registered
products at least three (03) months before the expiry of the marketing authorisation license. The Marketing Authorisation
Holder (MAH) or the local representative should apply for the renewal and pay the fees for each concentration and
presentation. The marketing authorisation will be considered invalid if the renewal documents are not submitted and if the
reasons behind non submission are not presented at least 6 months prior to the expiry of the marketing authorisation
license.
Document date: 18-Jan-2011
Type of text: Circular
Regulatory version: None
Language: Arabic
Germany
Germany - BfArM Letter: Protection from Drug Risks - Stage II - Dexrazoxane-
Containing Medicinal Products –Increased Risk of Secondary Malignancies- 21-
Dec-2010
The BfArM wishes to inform that following the review of dexrazoxane-containing medicines initiated by the United Kingdom
and conducted under Article 31 of Directive 2001/83/EC regarding the potential increased risk of secondary malignancies,
pharmaceutical companies have the possibility to take position on the list of outstanding issues until 14-Feb-2011. The
BfArM plans to implement the final measures adopted by the EU Commission within the framework of a graduated plan
procedure at the end of the first quarter 2011.
Comment: This Letter has been published by the BfArM without its distribution list and annexes.
Document date: 21-Dec-2010
Type of text: BfArM Letter, Letter
Regulatory version: None
Language: German
Germany - BfArM & PEI Form: Report of Serious Adverse Events (SAE) in Clinical
Trials or Performance Evaluations by Sponsors & Investigators - Status: 26-Jan-
2011 (German & English Versions)
This form is available in a pdf ready-to-use format. This is the form to be used by sponsors and investigators for initial and
final reporting of serious adverse events (SAEs) occurring in clinical trials or performance evaluations with medical devices.
This form shall be sent to the Competent Authority, BfArM or PEI, depending on the type of medical device.
Document date: 26-Jan-2011
Type of text: Form
Regulatory version: None
Language: Multilingual
Germany - Red Hand Letter: DIANEAL, EXTRANEAL, NUTRINEAL – 24-Jan-2011
Product Name: DIANEAL, EXTRANEAL, NUTRINEAL Pharmaceutical Form: peritoneal dialysis solution Marketing
Authorization Holder: Baxter Deutschland GmbH Further to the Red Hand Letter of 17-Dec-2010 (118140) concerning the
potential presence of endotoxin in some batches of the peritoneal dialysis solutions DIANEAL, EXTRANEAL and NUTRINEAL
and an increased risk of peritonitis, Baxter Deutschland GmbH has provided the following update: Batches of DIANEAL,
EXTRANEAL and NUTRINEAL (manufactured in Castlebar, Ireland) considered potentially affected by the presence of
endotoxins remain on the market because there is currently not enough supply of unaffected products to meet patients
needs. However the risk of receiving a batch contaminated with endotoxin is very low, as only a small percentage of the