FarmavitaR+

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

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.).

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.

Update - New applications for marketing authorisation with Hungary as Concerned Member State

In case of a new application for marketing authorisation applicant should submit the documentation to the National Institute of Pharmacy according to the following requirements: