Product-information templates

This page lists the templates for product information for use by applicants and marketing-authorisation holders. The European Medicines Agency's Working Group on Quality Review of Documents (QRD) develops, reviews and updates these templates.

Please note that:

• the Agency does not publish English templates for the annex A and annex I for referrals, because these annexes are prepared by the Agency. The translations of these annexes must be in line and consistent with the adopted English product information annexes of the product concerned;
• the information contained in these documents is non-exhaustive. Companies should refer to all relevant European Union legislation and guidelines when drawing up applications. It is the company’s responsibility to ensure that the product information complies with all such requirements;
• Maltese fonts are built in to Windows XP SP3 and higher;
• all Microsoft Office documents submitted to the European Medicines Agency must be in a format compatible with Microsoft Office 2003. Office 2007 and Office 2010 formats cannot currently be accepted.

Table of contents

• Centralised procedures
• Mutual-recognition, decentralised and referral procedures
• Appendices

Centralised procedures

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Mutual-recognition, decentralised and referral procedures

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Appendices

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