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Regulatory Affairs

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.

Business Advertising Activity

Wednesday, 24 September 2008 15:27 FarmavitaR Regulatory Affairs - European Union

Business Advertising Activity

Hungarian National Institute of Pharmacy has published new guidelines in order to ensure the protection of consumer interests and sustain market competition which serves economic efficiency and social welfare, while recognizing the importance of professional self-regulation, the Parliament hereby passes the following Act to regulate business advertising activity for the purposes of achieving fair communication with consumers, protecting the interests of enterprises, observing the requirements of fair business practices, and facilitating the sale of goods and services.

CZECH - INFORMATION FOR M.A.H.

Friday, 12 September 2008 13:07 Eva Bolger Regulatory Affairs - Regulatory Affairs News

OTC Medicinal Products Subject to Sales Restriction - Implementation of a New Category

The State Institute for Drug Control (SÚKL) in Czech Republic has been preparing the implementation of a new category of supply of medicinal products, “OTC medicinal products subject to sales restriction” on the grounds of provisions of Section 39 (3) of the new Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts, asamended (“Act on Pharmaceuticals”).

Whole 8 pages article is availabel for download at Repository of Faramavita.Net

New tariffs for MA in Romania

Tuesday, 01 July 2008 10:15 FarmavitaR Regulatory Affairs - European Union

Romanian CA new fees

Starting with May 19^th 2008, the National Medicine Agency in Romania has increased the tariffs for evaluation of all types of applications (obtaining marketing authorizations via national procedure/ MRP and DCP, for variations, for renewals of MA, for clinical trials etc.).

Nanotubes

Wednesday, 11 June 2008 14:48 Martina Regulatory Affairs - General Gulielines

Are Nanotubes related to Mesothelioma?

Nanotechnology is the emerging scientific field which includes the study of small, thin, carbon-based materials known as nanotubes (also called CNTs), which are becoming widely used in a plethora of products ranging from technologically advanced items utilized by NASA to everyday items used in the home. These nanotubes are increasingly popular due to their light weight and supreme strength, which is said to be stronger than steel.

As the variety of uses for nanotubes increases, researchers continue to do studies and tests related to the consequences of nanotube use. Current research suggests that exposure to long multi-walled carbon-based nanotubes may lead to the development of mesothelioma, a deadly form of cancer that affects the lining of the lungs and has no known cure. Scientists claim that there is no cause for immediate concern, but that further testing related to nanotube exposure and the onset of mesothelioma is crucial.