Russia: changes in pharmaceutical licencing


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