Clarification Paper for Joint Labelling between IE and UK
11 October 2011
The joint labelling procedure is applicable for products authorised via a European procedure (a mutual recognition procedure or decentralised procedure) in which Ireland and the UK are both involved. The procedure involves co-ordination of approval of the products final colour mock-ups.
The joint labelling procedure is dealt with during the national phase of the European procedure when the assessment of the mock-ups is co-ordinated between the two countries. No technical assessment is carried out as part of this procedure as the Summary of Product Characteristics and label text will have been agreed during the European procedure and no additional fees are incurred in using the procedure.
Further information about the use of the procedure is available from the Clarification Paper on Joint Labelling between IE and UK.