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.

Fibromyalgia - Regulatory caution threatens EU market expansion

Until regulatory hurdles in the EU are overcome, the US offers the greatest commercial potential and will be the primary growth market for all current and future brands indicated for fibromyalgia. Datamonitor forecasts the fibromyalgia market to more than double in value from 2008 to total $2.5 billion by 2018 across the seven major regions.

OTC Medicinal Products Subject to Sales Restriction - Implementation of a New Category

The State Institute for Drug Control (SÚKL) in Czech Republic has been preparing the implementation of a new category of supply of medicinal products, “OTC medicinal products subject to sales restriction” on the grounds of provisions of Section 39 (3) of the new Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts, asamended (“Act on Pharmaceuticals”).

Whole 8 pages article is availabel for download at Repository of Faramavita.Net

First FarmavitaR+ / regulanet conference

More than 25 participants met recently in Zagreb to explore and prepare for collaborations with the associates of FarmavitaR+ (FvR+) in Central, Eastern and South-eastern Europe.

Regulatory about cosmetic ingredients

Many of the ingredients used in the cosmetic products are actually industrial strength chemicals, solvents and petroleum by-products. This is even true for many of the most expensive products available and products being promoted as "natural". The truth is that many of the ingredients used widely by cosmetic industry , reason of being used is not that  they are good for your skin.

Breakthrough in global regulatory affairs projects:

FarmavitaR+ formed as a strategic alliance of regulanet® and Farmavita.Net

Farmavita.Net and regulanet® AG have established FarmavitaR+®, a joint venture company delivering high-quality regulatory affairs services to clients for pharmaceutical projects in Central, Eastern and Southern Europe.