Transcription of QRD Human PI Annotated Template v10.2 rev1
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QRD Human PI Annotated Template v10.2 rev1
Version rev. 1, 02/2021. ANNEX I. SUMMARY OF product CHARACTERISTICS. [NOTE: the following are those items of information required by Article 11 of Directive 2001/83/EC. and current practice in the centralised procedure. In the case of advanced therapy medicinal products, these items are listed in Annex II of Regulation (EC) 1394/2007. For the full information to be included in each section, please refer to the Guideline on Summary of product Characteristics as published on the website of the European Commission in the Notice to Applicants, Volume 2C: 2/ This guidance should also be read in conjunction with other relevant guidelines that can be found on the European Medicines Agency website ( QRD Convention to be followed for the EMA-QRD.)]
SUMMARY OF PRODUCT CHARACTERISTICS [NOTE: the following are those items of information required by Article 11 of Directive 2001/83/EC and current practice in the centralised procedure. In the case of advanced therapy medicinal products, these items are listed in Annex II of Regulation (EC) 1394/2007.
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