Regulatory Affairs - FarmavitaR - Regulatory affairs network

Regulatory Affairs

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.

Administrative Fees - The Czech R.

Monday, 10 December 2007 22:33 FarmavitaR Regulatory Affairs - European Union

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.