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La rivista farmaceutica online

Informazioni Sanitarie

Italian Regulatory Affairs News

Time extension – Adaptation of the patient leaflet of medicines authorized by national procedure to the format drafted by the Working Group on Quality Review of Documents (15/05/2015)

Information for the Pharmaceutical companies


Considering the difficulties expressed by several MA Holder in the performance of readibility testing and consequentely in the submission of the relevant type IB variation - C.I.z (Submission of results of assessments carried out on target patient groups in order to comply with Article 59(3) of Directive 2001/83/EC and any resulting change to the Package Leaflet) within the deadline established in the communication dated 23.07.2013, please be informed that for the medicinal products under letter a) of this communication, the deadline for the submission of the above mentioned variation has been postponed to 01.12.2015.

The Saudi Arabian competent authority has published a new guideline on the requirements for the labelling of medical devices.

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Updates to the existing rules concerning cosmetics in Brazil. The national regulatory agency ANVISA has adopted new legislation according to which cosmetics will be exempt from registration and will be subject to a simple notification before sale.

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The CMDh of the EMA has approved new recommendations for updating the product information for  medicinal expectorants based on ambroxol and bromhexine to include safety information regarding the risk of severe allergic reactions and allergic skin reactions.

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News for the disposal methods of inventory stocks of phytosanitary products laid down by the ministerial decree contained in the note of 7th September, 2010, which provided directions for disposal of withdrawn plant protection products.

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