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The FAMHP launches the Medicinal Product Management database

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...

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REMINDER: Medicines INDEXATION

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...

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Update guidelines for (traditional) herbal medicinal products

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:...

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Thematic audits at wholesalers by FAMHP

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...

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Revision of the PIC/S GMP Guide: Annex 13 and Annex 16

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...

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News on the various Mutual Recognition Agreements (MRAs)

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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