Regulatory Affairs - FarmavitaR - Regulatory affairs network

Regulatory Affairs

Strategic RA Consulting

Thursday, 20 September 2007 09:06 Peter Lassoff Regulatory Affairs - Regulatory Affairs News

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 Peter Lassoff explains why this image is outdated, and how working more co-operatively with your regulatory department will help to maximize your success in the market place.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

Monday, 04 June 2007 01:14 Zdravko Mauko Regulatory Affairs - General Gulielines

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' .

World's largest patent database now online

Friday, 04 May 2007 22:38 Zdravko Mauko Regulatory Affairs - Other issues

World's largest patent database is now online

More than 63 million patent documents from 80 patent organisations worldwide can be searched via the International Patent Documentation Data Base, (INPADOCDB). It was created by merging and revising two existing databases of the European Patent Office (EPO).

Romania - specific requirements

Thursday, 19 April 2007 16:28 Zdravko Mauko Regulatory Affairs - European Union

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

Useful information abut specific requirements related to Romania are available.

Bulgaria - RA News

Tuesday, 17 April 2007 17:50 Zdravko Mauko Regulatory Affairs - European Union

Bulgarian Drugs Agency continues accepting applications for marketing authorizations

As of 1 January 2007 BDA has stoped accepting applications for marketing authorizations, renewed and variations made of medicinal products until Pharmaceuticals and pharmacies serving human Medicine Act (PPSHMA) enters into force.

Bugarian office of Farmavita.Net has confirmed that BDA continues accepting applications after new Human Medicines Law has bee adopted in Apirl 2007.