|Common package procedures|
Common Baltic package procedure
Three Baltic States face similar problems of medicines availability and stakeholders operating in three Baltic States experience similar difficulties then approving common Baltic packages.
To save resources of stakeholders, to make approval of the common Baltic packages easier, smoother, quicker and more transparent, medicines agencies of the Baltic States have agreed on common Baltic package procedure.
In order to have common Baltic labelling, Marketing Authorisation holders (MAH's) will never need to discuss it with each agency separately. During this procedure, MAH’s will communicate with only one agency (Reference Baltic State) acting on behalf of all three instead. An e-mail application (pdf format) with accompanying documents will be sufficient. The procedure will somehow resemble DCP.
Procedures will be coordinated by Estonian Agency of Medicines. Contact points are the following:
The common Baltic labelling should be prepared by MAH in accordance with common Baltic package guidance signed in May 2005 and updated in August 2009. We invite MAH's to use this procedure.
Common Polish - Lithuanian package procedure
In order to save resources of Marketing Authorisation holders (thereinafter referred to as MAH) and to make approval of the common Polish - Lithuanian packages easier, smoother, quicker and more transparent the Lithuanian State Medicines Control Agency (thereinafter referred to as Lithuanian Agency) and the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (thereinafter referred to as Polish Agency) have agreed on common Polish – Lithuanian package procedure.
In order to have common Polish – Lithuanian package MAH will not discuss about it with each Agency separately. During this procedure MAH will communicate with only one agency (Reference State) acting on behalf of all two instead. An e-mail application (PDF format) with accompanying documents will be sufficient.
|Last Update: 2015-11-10 14:52:43|