Marketing  Authorisation for Medicines via Centralised Procedure in Turkey

Marketing authorisation could be laso granted for Turkey to comapnies on-going cantalised procedure by EMEA, according to investigation of  FarmavitaR+ consultant from Istanbul, Turkey. 

Romania - Tariffs for products authorised through mutual recognition procedure or decentralised procedure

 Ther Framavita.Net members and visitors please be informed that in Romania for registration of medicinal product two separate fees should be paid:

 -one is called tax for evaluation and is in amount of 1000 euros, no matter the type of registration

-the other one is a fee for registration which depends on the type of the application (registration, variation by national procedure/ MRP/ DCP).

New Guidelines about Administrative fees in the Czech Republic 

As of December 1 2007 this new guideline for admistraive fees supersedes guideline UST 29 published in January 2007.

Please, contact us for regulatory affairs support in Czech R., Slovak R., Hungary, Croatia, Serbia, Montenegro, Macednia, Albania, Bulgaria, Romania and Turkey.

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. 

The Hub of the Wheel

Pharmaceutical companies' regulatory affairs units are more vital than ever, but, traditionally, they have not been known for their flexibility. Peter Lassoff explains why this image is outdated, and how working more co-operatively with your regulatory department will help to maximize your success in the market place.

 Readability (QRD) Testing of Patinet Information Leaflet (PIL)

Since 2005, marketing authorization holders of medicines are required to have the patient information leafets for their products readability tested. The European Directive 2004/27/EC (a revision of Directive 2001/83/EC) defines it as follows: 'The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use' .

National Medicines Agency of Romania has published country specific requirements for MRP and DCP 

Useful  information abut specific requirements related to Romania are available.