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.

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.

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.

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.

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).


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