PL EN

MHRA: Code of practice for pack design for over the counter medicines

03.08.2009
Council Directive 2001/83/EC as amended, requires that marketing authorisation holders (MAH) inform the competent authority of all changes to the labelling which are not connected to changes to the Summary of Product Characteristics (SPC) [Article 61(3)]. Notwithstanding the need to notify the competent authority of the amendment, responsibility for the information presented on the packaging rests solely with the MAH.

kapitał ludzki

fundusz społeczny

Narodowe Centrum Badań i Rozwoju

innowacyjna gospodarka

rozwój regionalny