Templates and Translations of Standard Sentences

Templates for product information for use by applicants and marketing-authorisation holders.

On this site it's possible to find documents with Icelandic translations on standard sentences.

Appendix I, statements for use in section 4.6 'pregnancy and lacation of the SmPC.

Appendix II, Medical Dictionary for Regulatory Activities, terminology to be used in section 4.8 'undesirable effects' of the SmPC.

Appendix III to the Quality Review of Documents templates for human medicinal products.

Appendix IV, Terms for batch number and expiry date to be used on outer and / or inner labeling.

Appendix V, Adverse-drug-reaction reporting details.


Additional requirements for the labelling that apply to products via National, Mutual Recognition or Decentralised Procedure only

"Blue box" requirements