ARTICLE
9 June 2008

Changes In Pharmaceutical Licencing

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CMS Cameron McKenna Nabarro Olswang

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A number of changes to simplify licencing procedures for the pharmaceutical industry were introduced in July 2007.
Russian Federation Food, Drugs, Healthcare, Life Sciences

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 medicines.

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 medicines.

Law: amendments to the Regulations on the Licencing of Medicine Production, Regulations on the Licencing of Pharmaceutical Activity and the administrative rules of the licencing procedures

This article was written for Law-Now, CMS Cameron McKenna's free online information service. To register for Law-Now, please go to www.law-now.com/law-now/mondaq

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 developments.

The original publication date for this article was 02/08/2007.

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