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This section is about Pharmaceutical Regulatory Affairs.

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Bosnia and Herzegovina
Written by Martina   
Wednesday, 12 August 2009

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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!)

Last Updated ( Wednesday, 12 August 2009 )
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Albania
Written by Martina   
Tuesday, 11 August 2009
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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

Last Updated ( Tuesday, 11 August 2009 )
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Albania
Written by Martina   
Tuesday, 11 August 2009

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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  

Last Updated ( Tuesday, 11 August 2009 )
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Albania
Written by Martina   
Tuesday, 11 August 2009

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ON THE REGISTRATION OF THE HERBAL MEDICAL PRODUCTS IN THE REPUBLIC OF ALBANIA

FarmavitaR+ brings you a short description of herbal medical products registration procedure in the Republic of Albania.

The whole 4 pages article is available for download at Downloads  section of Farmavitar.Net

Last Updated ( Tuesday, 11 August 2009 )
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Albania
Written by Martina   
Thursday, 06 August 2009

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ON THE REGISTRATION OF THE DRUGS IN THE REPUBLIC OF ALBANIA

FarmavitaR+ brings you a short description of drugs registration procedure in the Republic of Albania.

The whole 12 pages article is available for download at Downloads section of Farmavitar.Net

Last Updated ( Tuesday, 11 August 2009 )
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Croatia
Written by Zdravko Mauko   
Tuesday, 21 July 2009

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). 

Last Updated ( Tuesday, 21 July 2009 )
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Russia
Friday, 05 June 2009

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.

Last Updated ( Tuesday, 21 July 2009 )
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Regulatory Affairs News
Tuesday, 05 May 2009

 

The Difficulty in Readability Testing

 

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. 

Last Updated ( Tuesday, 21 July 2009 )
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Romania
Tuesday, 21 April 2009

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  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).

Last Updated ( Saturday, 25 April 2009 )
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