A number of changes to simplify licencing procedures for the
pharmaceutical industry were introduced in July 2007.
On 13 July, the Federal Service of Supervision in Public
Health and Social Development (Roszdravnadzor) clarified that
pharma manufacturers only need to apply for an addition to
their licence when introducing medicine in a new form (eg in
solution as opposed to tablet form) and not, as previously,
when producing a new medicine (ie with a new name).
Roszdravnadzor envisages that the changes will not weaken
government control of medicine production. Since the new
approach will reduce the number of applications, it will give
Roszdravnadzor more time to undertake day-to-day control
measures. It may also stimulate local manufacturing of foreign
On 19 July, the Government of the Russian Federation made
the Federal Service of Veterinary and Phytosanitary Supervision
responsible for licencing the production of animal medicines
and for all pharmaceutical activity involving such
Law: amendments to the Regulations on the Licencing
of Medicine Production, Regulations on the Licencing of
Pharmaceutical Activity and the administrative rules of the
This article was written for Law-Now, CMS Cameron
McKenna's free online information service. To register
for Law-Now, please go to
Law-Now information is for general purposes and guidance
only. The information and opinions expressed in all Law-Now
articles are not necessarily comprehensive and do not purport
to give professional or legal advice. All Law-Now information
relates to circumstances prevailing at the date of its original
publication and may not have been updated to reflect subsequent
The original publication date for this article was
To print this article, all you need is to be registered on Mondaq.com.
Click to Login as an existing user or Register so you can print this article.
Inquests are something which affect a vast range of NHS and private organisations, as well as individual clinicians, and so we provide a brief overview of recent developments as well as a couple of key potential changes to come.
Le 28 janvier dernier, le Président du Tribunal de grande instance de Nanterre, statuant en référé, a accordé des dommages et intérêts au titre du préjudice d'anxiété à certaines victimes du Mediator dans trois jugements.
The Turkish Competition Board has launched an investigation into the alleged blocking by the Turkish Pharmacists Union of "named patient sales" by pharmaceutical warehouses.
Some comments from our readers… “The articles are extremely timely and highly applicable” “I often find critical information not available elsewhere” “As in-house counsel, Mondaq’s service is of great value”
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).