Transcription of SAFETY FEATURES FOR MEDICINAL PRODUCTS FOR HUMAN …
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Commission europ enne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGI - Tel. +32 22991111 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Health systems and PRODUCTS Medical PRODUCTS quality, SAFETY and innovation SAFETY FEATURES FOR MEDICINAL PRODUCTS FOR HUMAN USE QUESTIONS AND ANSWERS - VERSION 19 (Submitted for discussion to the Member State expert group on the SAFETY features1) Document history: Date of submission of draft to the Member State expert group on the SAFETY FEATURES : November 2021 Date of publication: December 2021 Supersedes.
Regulation (EU) 2016/161, while the list of medicinal products not subject to prescription which shall bear the safety features are set out in Annex II of the same Regulation. 1.5. Question: Do the rules on the safety features also apply to veterinary medicinal products? Answer: No. The rules apply only to medicinal products for human use.
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