To the attention of Marketing Authorisation Holders
As regards medicinal products submitted for marketing authorisation renewal through national procedure, for which variations for harmonisation with QRD European templates have been approved, MAHs are encouraged to submit results of the consultations with target patient groups during conduct of the renewal procedure (not to be left for the final stage of the renewal process procedure).
Consultation results are submitted in accordance with provisions of Order of the Minister of Health No. 1205/2006.
Consultation results, submitted in electronic format on CD, are accompanied by the leaflet sample or mock-up on which the consultation has been achieved.