Europe – Recommendations for the implementation of the exemptions to the labelling and package leaflet obligations in the centralised procedure

Following the revision of the pharmacovigilance legislation in 2012 the scope of Article 63(3) of Directive 2001/83/EC has been expanded to cases where the product is not to be delivered directly to the patient or where there are availability issues:

‘Where the medicinal product is not intended to be delivered directly to the patient, or where there are severe problems in respect of the availability of the medicinal product, the competent authorities may, subject to measures they consider necessary to safeguard human health,

• grant an exemption to the obligation that certain particulars should appear on the labelling [immediate and/or outer] and in the package leaflet.
• They may also grant a full or partial exemption to the obligation that the labelling [immediate and/or outer] and the package leaflet must be in an official language or official languages of the Member State where the medicinal product is placed on the market, as specified, for the purposes of this Directive, by that Member State.’

Also, in accordance to recital 31 of Directive 2010/84/EU, it is possible to deviate from the
requirements for labelling and packaging in order to address severe availability problems related to the potential lack of:

• authorised medicinal products (e.g. centralised products not marketed in certain Member
States), or
• medicinal products placed on the market or shortages thereof (e.g. marketed products which become unavailable for a limited period of time due to manufacturing reasons).

*Rev.4 Changes since the last revision: Clarifications on which labelling components are covered by Art.63 (update of sections 2.1 and 2.2), moving of information from section 3.3 as well as information on shortage from section 3.1 to section 2.2 and addition of more flexibility with regards to omission of particulars requests under Art.63.3 affecting small MSs where multilingual packs are used.