Exemptions to labelling and package-leaflet obligations

HumanRegulatory and procedural guidanceProduct information

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:

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.

Guidance on labelling and package-leaflet exemptions

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

Reference Number: EMA/135540/2019 Rev.4Summary:

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

English (EN) (147.11 KB - PDF)

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Contact details of national competent authorities for requests of translation exemptions falling under Art. 63.3 of Directive 2001/83/EC and cases of shortages

Reference Number: EMA/670900/2020 Rev.18

English (EN) (128.15 KB - PDF)

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Table of decisions

Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group

Reference Number: EMA/934543/2022 Rev.5.1

English (EN) (967.37 KB - PDF)

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Labelling-exemption requests under Article 63 of Directive 2001/83/EC examined by the Quality Review of Documents group

Reference Number: EMA/828662/2017 Rev.4

English (EN) (377.19 KB - PDF)

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