Regulatory Affairs - FarmavitaR - Regulatory affairs network

Regulatory Affairs

Change of Access

Tuesday, 21 April 2009 14:26 FarmavitaR Regulatory Affairs - European Union

Romania - Notice on change of access to information on centrally authorised medicinal products

The NMA hereby informs you on replacement of PDF files in the “Useful Information” section of the main menu, containing the Romanian version of the Summary of Product Characteristics (SPC) of centrally authorised medicinal products, with a table in Excel format including the following data: name of centrally authorised medicinal products, medicinal product registration number in the Community Register of centrally authorised medicinal products and the marketing authorisation holder (MAH).

NMA of Romania News Flash

Tuesday, 21 April 2009 14:23 FarmavitaR Regulatory Affairs - European Union

Important notice to the attention of Marketing Authorisation Holders

The NMA hereby informs you on certain issues of importance in the CMD(h) Press Release on the Report from the CMD(h) meeting held on 16th 17th February 2009 (http://www.hma.eu/186.html)

NMA of Romania News Flash

Tuesday, 21 April 2009 14:16 FarmavitaR Regulatory Affairs - European Union

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Romania - Important notice to the attention of Marketing Authorisation Holders

The NMA hereby informs you on certain issues of importance in the CMD(h) Press Release on the Report from the CMD(h) meeting held on 19th and 20th January 2009 (http://www.hma.eu/186.html)

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NMA of Romania News Flash

Tuesday, 21 April 2009 13:03 FarmavitaR Regulatory Affairs - European Union

Romania - Important notice to the attention of Marketing Authorisation Holders

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- Name of the medicinal product;
- International Non-Proprietary Name (INN) of the active substance contained in the respective medicinal product;

News-Bulgarian Drug Agency

Wednesday, 11 February 2009 16:32 FarmavitaR Regulatory Affairs - European Union

Bulgaria Will be a reference Member State

BDA triggers a timetable definition in order to prepare slots for assessment of the marketing authorization applications in MRP and DCP procedures for which Bulgaria is to be a reference Member State under Art. 76 (1) and (3) of LMPHM.