Malta as Reference Member State in the Decentralised Procedure

Since 2007 the Medicines Authority is accepting applications as Reference Member State in the Decentralised Procedure.

Until further notice, the applications considered will be those for solid oral dosage forms and oral solutions in accordance with article 10 of Directive 2001/83/EC, as amended.

Changes in Russian Regulatory Environment

Russia, as one of largest and most important pharmaceutical markets in the world underwent significant changes of its pharmaceutical regulatory laws. The new law went into effect in September 2010.

The main question remains: Are these changes going to facilitate registration procedure and at which price?


Introduction of Braille Script for Pharmaceuticals in Ukraine

20.05.2009 was introduced an amendment to the law of Ukraine “On medicines” (? 124/96?? of 4.04.96) which orders to use Braille script on packages. Changes came into force until 01.01.10. In Ukraine live approximately 45 000 of semi-blind people and 10 000 – 20 000 from this number are totally blind.

It’s important to pay attention for this question: for example EU producers had approximately 7 years preparation for new law concerning the Braille script.

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.

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

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.

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