Regulatory Affairs - FarmavitaR - Regulatory affairs network

Regulatory Affairs

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.

Business Networking

Thursday, 29 March 2007 11:15 Liz Rayan Regulatory Affairs - Other issues

coffee

Network Like an Entrepreneur

Are you a corporate type who is slow to network? Then take a clue from entrepreneurs and connectors who reap many benefits from contacts.

When it comes to networking, you guys need to wake up and smell the coffee! Entrepreneurs love to talk to people about their businesses— networking is typically their No. 1 or No. 2 channel for new clients.