Regulatory Affairs - FarmavitaR - Regulatory affairs network

Regulatory Affairs

nCADREAC Agreement

Wednesday, 11 February 2009 15:48 FarmavitaR Regulatory Affairs - Europe not-EU

New Collaboration Agreement between Drug Regulatory Authorities in Central and Eastern European Countries

Having our common goal in mind, to protect public health in our countries by ensuring the use of medicinal products meeting international standards of quality, efficacy and safety as well as ensuring that relevant information is provided on such products,taking into account,

Czech Republic-yearly maintenance fees

Wednesday, 17 December 2008 11:11 FarmavitaR Regulatory Affairs - European Union

Czech Republic introduced yearly maintenance fees for medicinal products

With the new law on Pharmaceuticals 378/2007 Coll. valid from December 31st 2007 Czech Republic introduced yearly maintenance fees for registered medicinal products. However, related Decree was released on Decemer 15th 2008 stating the amount of these fees.

Update on e-CTD submission in Czech Republic

Monday, 06 October 2008 09:25 FarmavitaR Regulatory Affairs - European Union

Update on e-CTD submission in Czech Republic

„Special cases“ according to updated guideline REG-84- submission in eCTD format,

released 02.10.2008.

NMA of Romania News Flash

Thursday, 25 September 2008 10:30 FarmavitaR Regulatory Affairs - European Union

National Medicines Agency of Romania

NMA News Flash

To the attention of Marketing Authorisation Holders

In view of updating the National Medicines Agency’s (NMA) data base concerning representatives appointed by marketing authorisation holders (MAH) for relationships with the Agency,

NMA of Romania News Flash

Thursday, 25 September 2008 10:14 FarmavitaR Regulatory Affairs - European Union

National Medicines Agency of Romania

To the attention of Holders of Marketing Authorisations granted through centralised procedure

Even though notification of the National Medicines Agency (NMA) on placement of the market of medicinal products authorised through centralised procedure is not mandatory (notification being made to the EMEA), the NMA is however interested in ensuring Romanian patients’ access to this category of medicinal products as well. Therefore, we think it to the benefit of all parties involved that Marketing Authorisation Holders also notify the NMA on placement, discontinuation or temporary cessation on the Romanian market of such medicinal products. Thank you for your collaboration.