Dear [NAME]

Please, take a look at few regualtory affairs news from countries of southeast Europe.

First FarmavitaR+ / regulanet conference

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. Read more...

Administrative Fees - Romania

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). Read more...

Centralised Procedure - Turkey

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. Read more...

New RA Alliance

Breakthrough in global regulatory affairs projects:

FarmavitaR+ formed as a strategic alliance of regulanet® and Farmavita.Net

Farmavita.Net and regulanet® AG have established FarmavitaR+®, a joint venture company delivering high-quality regulatory affairs services to clients for pharmaceutical projects in Central, Eastern and Southern Europe.Read more...

Romania - specific requirements

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

Useful information abut specific requirements related to Romania are available.Read more...

Administrative Fees - The Czech R.

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. Read more...

Events & Conferences

Pharma & Biotech IP & Litigation
Protecting IP is a crucial issue in the Pharma industry. Successful pharma & biotech companies already understand that the IP and patenting practices are also essential in facilitating enhanced market exclusivity and revenue returns. Read more...

Patient Compliance

Patient Compliance & Communication Europe 2008

11-12 June 2008, London - Learn to achieve measurable RoI with higher sustainable revenue, stronger relationships with stakeholders and enhance your brands reputation. Read more...

DISSOLUTION TESTING

We would be pleased to announce our seminar entitled ‘DISSOLUTION TESTING’ which will be held on February 5th-6th, 2008 in Istanbul, Turkey.

The speaker of the seminar is Dr.Malcolm Ross (Pharmacist – Medicinal Chemist, Generapharm Pharmaceutical Consulting, SWITZERLAND.) Read more...

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