Phamacovigilance/Regulatory

Prescribers and users of our medicines are encouraged to report any adverse effects that they suspect might be associated with a medicine, or product quality complaints that they fear may have an impact on patient safety. The objective of comprehensive reporting and monitoring is to ultimately lead to the safer use of medicines, while also helping to improve public health.

Reporting of adverse effects can be carried out by both health professionals and patients through three different routes:

To the Regulatory Affairs and Pharmacovigilance Department of Torrent Pharma (UK) Ltd:
A designated responsible person (either a physician or pharmacist) is appointed within this department to collect the first known points of information on adverse effects. Upon receiving this information, he forwards it to external pharmacovigilance service providers for assessment and reporting to MHRA, according to strict timeframes.

To Dr.Ebeling& Associates GmBH, Hamburg, Germany:
This is the external pharmacovigilance service provider employed by Torrent to carry out the assessment and reporting to MHRA of adverse effects to Torrent's products licensed in the UK and other EU countries.  Designated staff are appointed to collect full information on adverse effects and input into a global pharmacovigilance database, from which the reports for MHRA are generated.

To the Pharmacovigilance Department of Torrent Pharmaceuticals Limited:
The parent company of  Torrent Pharma (UK) Ltd. also acts as external pharmacovigilance service provider.  It maintains the global pharmacovigilance database, and can receive adverse effects from all parts of the world.

To report adverse effects during Office hours, please contact:-

RA / PV department, Torrent Pharma UK Ltd., Unit 4 Charlwood Court, County Oak Way, Crawley, West Sussex, RH11 7XA
Telephone: +44 (0) 1293574180
Mobile: +44 (0)7591 555940
Fax: +44 (0) 12935330003
Email: drugsafety@torrentpharma.co.uk

OR

Dr. Ebeling & Assoc. GmbH,

Isestrasse 5, D-20144 Hamburg, Germany
Telephone: +49 (0) 405480070
Fax: +49 (0) 40548007290

Email: PVTorrentUK@ebeling-assoc.com

To report adverse effects Out-of-Hours, please contact: -

Pharmacovigilance Department, Torrent Pharmaceuticals Limited

Telephone:  +44 (0)7591 555940

Adverse event or Product Complaint Intimation Form is provided at:http://www.torrentian.com/aer/complaintform/new_complaint_intimation_tp.aspx?Flag=T

 Please forward all product quality complaints to Torrent Pharma (UK) Ltd.

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Torrent Pharma (UK) Ltd

Aptil Pharma Ltd

Unit 4, Charlwood Court, County Oak Way, Crawley, West Sussex. RH11 7XA. United Kingdom

Telephone: +44 (0) 1293 574180 | Fax: +44 (0) 1293 533003 | Email: drugsafety@torrentpharma.co.uk

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