Regulatory Affairs Network - FarmavitaR - Regulatory affairs network

Regulatory Affairs Network

Paediatric Medicines

Friday, 26 January 2007 16:04 Zdravko Mauko Regulatory Affairs - General Gulielines

New Legislation for Pediatric Medicines

On 23 October 2006, the Council of the European Union approved all the compromise amendments to the proposal for a Regulation on Medicinal Products for Paediatric Use which were agreed at its second Parliamentary reading. The Regulation was officially published on 27 December 2006 and will enter into force on 26 January 2007.

Open Source Pharmaceuticals - New Business Model

Friday, 12 January 2007 23:43 Regulatory Affairs - Other issues

Open Source Pharmaceuticals - New Business Model

"Open source" as applied to culture defines a culture in which intellectual property is made generally available. Participants in such a culture are able to improve and modify those products and redistribute them back into the community. Farmavita.Net is now inviting proposals for "open source pharmaceutical projects". Web 2.0 based software available at www.farmavita.net is allowing knowledge sharing and management of complex international, multi-center projects.

CEE Sourcing

Monday, 17 July 2006 23:49 Zdravko Mauko Regulatory Affairs - Europe not-EU

Central European markets to source drugs from India

GIREESH CHANDRA PRASAD; TIMES NEWS NETWORK [ MONDAY, JULY 17, 2006 01:57:27 AM]

NEW DELHI: Central European countries with relatively smaller pharmaceutical markets are now courting Indian drug makers to cut down the huge subsidies they provide to their healthcare system.

CEFTA

Sunday, 12 March 2006 23:58 Zdravko Mauko Regulatory Affairs - Europe not-EU

Central European Free Trade Agreement

The Central European Free Trade Agreement (CEFTA) is a trade agreement between Romania, Bulgaria, Croatia and the Republic of Macedonia. Former members are Poland, the Czech Republic, Slovakia, Hungary and Slovenia.

Patent Expiry Dates

Wednesday, 01 March 2006 03:03 Jesse Tale Regulatory Affairs - Other issues

How to Calculate Standard Patent Expiry Dates and Data Exclusivity in Key Territories

Use this handy guide to navigate the calculation of patent expiry dates in US, Canada, Germany, Spain, France, United Kingdom and Australia, and also data exclusivity in the US, Canada, Europe and Australia.

Evergreening

Thursday, 23 February 2006 21:41 Regulatory Affairs - Other issues

Evergreening through Patent Strategies

One form of evergreening occurs when the originator manufacturer “stockpiles” patent protection by obtaining separate 20-year patents on multiple attributes of a single product. But many other evergreening strategies exist ...

Information provided by European Generic Association.

DMF project

Tuesday, 03 January 2006 11:43 Regulatory Affairs - General Gulielines

Timeframe for DMF development

Timeframe to development and submission of DMF is 8 to 9 months. In some cases when you have an experienced project team and when you are in a hurry timeframe could be squeezed to 4 months.

Data Exclusivity

Thursday, 29 December 2005 01:28 Regulatory Affairs - General Gulielines

New legal framework for harmonisation of the data exclusivity

The new periods of data exclusivity will only take effect for reference products applying for marketing authorisation after the new law is fully in effect (around November 2005). Therefore, the first generics applications under the 8+2+1-year data exclusivity period will not occur until late 2013.

New CADREAC

Friday, 16 December 2005 22:26 Regulatory Affairs - General Gulielines

Simplified MRP procedure for EU candidates

For the Czech R., Slovak R., Hungary, Croatia, Romania and Bulgaria there is simplified MRP procedure, also known as CADREAC prcedure. Because of simplicity of CADREAC procedure we suggest you to use this procedure for this countries, in cases when you have MA in RMS. Details about procedure could be submitted by Farmavita.

Please take a look at the official nCADREAC web site http://www.newcadreac.org/cadreac.html