To the attention of Marketing Authorisation Holders for codeine-containing medicinal products
For implementation of the agreement adopted by the Coordination Group following the referral procedure concerning codeine-containing medicinal products, Marketing Authorisation Holders shall submit to the NAMMD until 1 October 2013 IAIN C.I.1a variations for medicinal products only containing codeine, namely IB C.I.1a variations for medicinal products containing codeine in association with other active substances, leaving one of the conditions in the Guideline on variations unmet in such cases.
The List of Marketing Authorisation Holders and the formulation agreed for the Summary of Product Characteristics and for the leaflet can be found in the annex attached to this announcement.
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