Exemptions to labelling and package-leaflet obligations

Companies developing human medicines that are not delivered directly to patients or where there are availability issues may be exempt from some of the obligations for labelling or package leaflets. These include medicines that are authorised but not marketed and medicines that are being marketed but are temporarily out of stock.

The new pharmacovigilance legislation introduced these changes by expanding the scope of Article 63(3) of Directive 2001/83/EC.

Full details on the implementation of the exemptions are available in:

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

Translation exemptions

Companies should address requests for translation exemptions linked to the labelling or package leaflet (falling under Article 63(3)) directly to the national competent authorities concerned. Contact details for each Member State are available below.

Any requests for translation exemption for orphan medicines (falling under Article 63(1)) must be sent to qrd@ema.europa.eu. The Working Group on Quality Review of Documents (QRD) reviews and decides upon these requests.

Omission of particulars

Companies should send requests for omission of certain particulars to appear on the labelling and package leaflet for medicines administered by healthcare professionals only or in cases of severe lack of availability to qrd@ema.europa.eu.

Table of decisions

A table of decisions listing all requests reviewed by the Working Group on QRD and their outcomes is available below.