Regulatory Affairs - FarmavitaR - Regulatory affairs network

Regulatory Affairs

Act on Medical Products and Medical Devices

Wednesday, 12 August 2009 10:12 Martina Regulatory Affairs - Europe not-EU

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

Tuesday, 11 August 2009 15:20 Martina Regulatory Affairs - Europe not-EU

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

The Food Supplements Registration in Albania

Tuesday, 11 August 2009 13:21 FarmavitaR Regulatory Affairs - Europe not-EU

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.