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Bosnia and Herzegovina
Written by Martina
Wednesday, 12 August 2009
Bosnia and Herzegovina-Act on Medical Products and Medical Devices
On May 1st 2009 the Agency for medical products and medical devices in Bosnia and Herzegovina has started with work. The Act on Medical Products and Medical Devices defines Agency's jurisdiction, how to apply for MA in Bosnia and Herzegovina, documentation for registration, pharmacovigilance, advertising...
The law is available for download at Downloads section of Farmavitar.Net. (in Bosnian!)
Variations to the terms of medicinal products registered in Albania
This file will explain you how to apply for variation to the trems of medical products and in short a procedure for revocation of marketing authorisation.
The whole 10 pages article is available for download at Downloads section of Farmavitar.Net
REGULATION FOR THE FOOD
SUPPLEMENTS REGISTRATION IN THE REPUBLIC OF ALBANIA
The Regulation for Food Supplements Registration
is implemented for the
food supplements which are introduced and marketed as alimentary products in the Republic of Albania.
FarmavitaR+ brings you a short description of the food supplements registration procedure.
The whole 8 pages article is available for download at Downloads section of Farmavitar.Net
Enforcement
of new pricing and reimbursement ordinance in Croatia
Croatian
Institute for Health Insurance (HZZO) has informed all marketing authorization
holders that 22nd August 2009 is deadline for adjustment of thier prices with "Low on
Medicines" (Narodne Novine 71/07) and with new "Ordinance about measures for
determination of prices of medicines and ways for reporting about wholesale
prices" (Narodne Novine no. 60/08).
Russia's Emerging OTC Market Holds Problems As Well As
Promise
Russia's
rapidly growing over-the-counter market offers pharmaceutical companies a
chance to expand their business, but its complex regulations and lengthy
registration timelines may hinder entry.
"Russia
is one of the biggest pearls," said Amra Pasovic, new and emerging markets
regulatory affairs director with Johnson & Johnson Group of Consumer
Companies in Russia.
Since readability testing became a necessity
for better patient understanding of leaflets, there has been a plethora of ways
to test a leaflet. To the outsider,
presenting a leaflet to a participant, asking a set of preset questions and
recording the responses could appear to be enough to gauge the user
friendliness of a Package Leaflet (PL).
However, a simple yes/no dichotomic approach quickly yields an
unforeseen variable which can aptly be demonstrated in the following
hypothetical situation.
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).
In collaboration with Regulanet network of regulatory affairs consultants throughout Europe and USA, we keep
daily contacts and communication with National Agencies for Medicines
and Medical Devices. Beside regulatory we also maintain understanding of the business, scientific and technical background of products.
FarmavitaR+ Journal 
