Regulatory Affairs - FarmavitaR - Regulatory affairs network

Regulatory Affairs

Counterfeit of medical products

Friday, 30 April 2010 09:23 EDQM Regulatory Affairs - EMEA

International Conference on counterfeit medical products paves the way to landmark convention aimed at protecting public health

Basel (Switzerland), 16.04.2010 - More than 140 participants, senior officials from health, law enforcement and judicial authorities from around 40 states, international organisations and institutions from around the world came together on 15 and 16 April 2010 in Basel to discuss the practical implementation of the future Council of Europe MEDICRIME Convention.

The event was organised under the aegis of the Swiss Chairmanship of the Council of Europe Committee of Ministers by Swissmedic, Swiss Agency for Therapeutic Products, and the Council of Europe. The Council of Europe has for a long time been involved in finding appropriate answers to the serious problems posed by counterfeiting of medical products and other threats to public health.

Introduction of Braille script for pharmaceuticals in Ukraine

Friday, 23 April 2010 10:14 Anna Grigorieva Regulatory Affairs - Europe not-EU

Braille script

20.05.2009 was introduced an amendment to the law of Ukraine “On medicines” (№ 124/96ВР 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.

Regulatory Updates - Free Webinar Series

Tuesday, 13 April 2010 14:11 Erin Riggs Regulatory Affairs - North America

Free Webinar Series

In order to fulfill dicentra’s mission to serve the natural health products industry as a source for education and trusted scientific and regulatory information, we offer free quarterly regulatory updates (every 3 months) through an online webinar.

These webinars are meant to keep you and all of your fellow coworkers up-to-date on the latest issues pertaining to scientific and regulatory affairs. The main focus of each webinar will be for anything important pertaining to natural health products and their regulations in Canada. Examples include a summary of the Natural Health Products Directorate’s status of submissions reports, the latest regulatory status of ingredients, new published monographs, and all other important issues. We will also cover major issues related to other product categories that may have an effect on natural health products.

All webinars are presented by a qualified member of our team and will last approximately 30 minutes. Please register by filling out the form below. Instructions on how to join will be sent to you a day prior to the webinar. Sit back and enjoy our interpretation and navigation to help propel your business forward at no cost.

To register, please visit http://www.dicentra.ca/updates/

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