Regulatory Affairs - FarmavitaR - Regulatory affairs network

Regulatory Affairs

FDA Improves Generic Drug Access

Wednesday, 30 April 2008 22:20 Zdravko Mauko Regulatory Affairs - North America

FDA Announces Measures to Improve Generic Drug Access

The Food and Drug Administration (FDA) im March 2004 announced that it will provide more information to the public to help generic drug applicants determine if they are eligible for 180-day marketing exclusivity for their products. This period of marketing exclusivity is generally provided to the first generic drug that challenges a patent for the innovator product.

First FarmavitaR+ / regulanet conference

Saturday, 02 February 2008 22:08 Brad Clemmons Regulatory Affairs - Regulatory Affairs News

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.

Centralised Procedure - Turkey

Saturday, 02 February 2008 21:54 Zdravko Mauko Regulatory Affairs - Europe not-EU

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.

Administrative Fees - Romania

Tuesday, 22 January 2008 16:37 Mgr. Mihaela David Regulatory Affairs - European Union

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).

Development of International OTC Bradns

Tuesday, 08 January 2008 16:24 Zdravko Mauko Regulatory Affairs - Rx to OTC

Healthcare Brands International announces the acquisition of Antula Holdings AB

Healthcare Brands International (HBI) announces the completion of a major step towards its goal of building a new international Over-the-Counter (OTC) healthcare business with the acquisition of Antula Holdings AB, the privately-owned Scandinavian OTC healthcare business, and its subsidiaries.