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Register your Industry Single Point of Contact (i-SPOC) on supply and availability
Europe All Marketing authorisation holders (MAHs) should register their Industry Single Point of Contact (i-SPOC) who will inform EMA about the supply and availability of critical medicines identified in the context of a ‘public health emergency’ or a ‘major event’...
Update Commission Regulation regarding monacolins from red yeast rice
Europe The Commission Regulation (EU) 2022/860 amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards monacolins from red yeast rice has been published on 2nd June 2022. This Regulation entered into force on 22nd...
The FAMHP launches the Medicinal Product Management database
Belgium On 4th of July 2022, the FAMHP launches the Medicinal Product Management database, a new internal database for medicinal products. Due to the launch of the new database, existing databases will temporarily not be updated. As from 22nd June data will be...
Request to marketing authorisation holders to send the approved version of the risk management plan
Belgium The Vigilance Division of the FAMHP requests marketing authorisation holders to send the approved version of the risk management plan for medicinal products for human use with a national marketing authorisation.In order to have a better overview of the...
REMINDER: Medicines INDEXATION
Belgium We remind you that the honorary indexation of the Pharmacy distribution price in Belgium has an impact on the prices and this difference must be URGENTLY communicated to the Ministry of Social Security. Indeed, the Luxembourgish law imposes that the price of...
Electronic submission of notifications for food supplements in Luxembourg
Luxembourg Since 1st of May 2022 the notification of food supplements in Luxembourg should be done electronically. Since that date, the platform MyGuichet.lu is available without authentication and therefore accessible to all companies. No file submitted on paper or...
Update guidelines for (traditional) herbal medicinal products
Europe EMA published 2 updates of guidelines related to (traditional) herbal medicinal products: Specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products:...
Thematic audits at wholesalers by FAMHP
Belgium In the context of the transparency policy conducted by the FAMHP, the FAMHP announced thematic audits starting from March 2022 at wholesalers in medicines for human use. These inspections will be unannounced. The inspections will focus on the obligations of...
Revision of the PIC/S GMP Guide: Annex 13 and Annex 16
Europe At the end of January, EU Regulation 536/014 “Clinical trials” went into force. The entry into force of this Regulation resulted in the parallel updating of some international guidelines. In particular, a new version of the GMP Guide PE016 was...
News on the various Mutual Recognition Agreements (MRAs)
Europe On 19 April, the "Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2021" was published. This annual report of the GMP/GDP Inspectors Working Group (GMP/GDP IWG) gives a short but good overview of what was new in 2021....
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