Estonia, Latvia and Lithuania are accepting Common Baltic Package. This is a voluntary procedure applicable to changes of the labeling referred to in the Article 61(3) of the Directive 2001/83/EC.
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 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:
Prerequisites:
- Summary of Product Characteristics does not contain any differences that preclude harmonization of the labeling.
- Name of the medicinal product is the same in all Baltic States.
- Labeling shall comply with relevant EU/EMA/QRD.
- There is no ongoing variation procedure that could affect labeling
- There is no renewal procedure ongoing
Reference: The Common Baltic Package Procedure
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