LORENZ Group at International Conference on Good Documentation Practice in Regulatory Procedures

Lorenz Group has been developing innovative software solutions for Life Sciences for more than 20 years and is major e-CTD provider for the EU, Japan and U.S.

Malta as Reference Member State in the Decentralised Procedure

Since 2007 the Medicines Authority is accepting applications as Reference Member State in the Decentralised Procedure.

Until further notice, the applications considered will be those for solid oral dosage forms and oral solutions in accordance with article 10 of Directive 2001/83/EC, as amended.

To be able to consider such applications, some information is requested to enable the Medicines Authority to assess whether to accept the submission of an application for a Marketing Authorisation or not. The Request Form on the CMDh website should be filled in and sent to the Medicines Authority at least 6 months before the proposed submission date. The requests should be sent by e-mail directly to the CMDh (MRP/DCP) contact point with a copy to the e-mail address This e-mail address is being protected from spambots. You need JavaScript enabled to view it . 

The slots for the 20 procedures planned for 2010 are all booked. A few procedures are on the waiting list should slots become available in case of cancellation by the applicants.

Currently the Medicines Authority is filling in slots for 2011 - 2012. Please send in the pre-submission forms in due time for consideration, at least six months before proposed submission date. Once you are given a slot, you are requested to inform the Medicines Authority immediately should you not be able for any reason to submit in the agreed timeline. The Medicines Authority should be informed in good time about any problems encountered that may lead to postponement or cancellation of the slot that is granted.

Information and guidance documents on the decentralised procedure can be found on the CMDh website.

Public assessment reports of products authorised with procedures where Malta is RMS are being made available on http://www.medicinesauthority.gov.mt/par.html

Information source: www.medicinesauthority.gov.mt

Banishment of unlicensed herbal remedies in the UK

Thousands of patients in the UK facing the decision about the banning of more than 200 herbal products. For some, this decision is discriminatory and shameful. The same measures are planned for the rest of the EU in accordance with new directive from 2004 (part which concerns herbal products) - from 1 May 2011 all herbal products in the UK must be licensed or prescribed by a registered herb practitioner. This is connected with the concern over adverse events in these products.

PIM – innovative solution for ensuring consistent and high-quality  Product Information

EMA (ex EMEA) is performing a pilot phase of what is known as a Product Information Management system (PIM).

It is about interactive IT interface for the submission, review and corresponding update of the product information documents (SmPC, PIL and Labelling) in all 3 community procedures: Centralized, DCP and MRP and for the national procedure as well.