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Out of stock for medicinal products in Luxembourg

Out of stock for medicinal products in Luxembourg

Luxembourg Le Ministère de la Santé of Luxembourg reminds all MAHs to notify to the Minister of Health in cases of temporary or permanent interruption of the placing on the market for the medicinal product no later than two months before this interruption and inform...

Brexit: Industry should keep Timelines for Batch Testing Facilities

Brexit: Industry should keep Timelines for Batch Testing Facilities

Europe In a reminder sent out to stakeholders the EMA points out that MAHs should use the remaining time to Brexit to complete all necessary preparations. This means that by 1 January 2020 all batch testing sites must be fully transferred to the remaining EU27 Member...

Cosmetic claims

Cosmetic claims

Europe The Technical Document on Cosmetic Claims came into effect on July 1st 2019. The Technical Document is a reference for the national competent authorities. The Technical Document is in fact a collection of 'best practice examples' and serves as a guidance for...

Serialisation: New Guidance for EU Inspectors

Serialisation: New Guidance for EU Inspectors

Europe The European Commission has published an Aide-Memoire to help both manufacturers and inspectors to verify compliance with the FMD regulation. Questions listed in the document focus for example on: Connection with hub and On-Boarding Partner (OBP) Data Flow...

New measures to limit unavailability of medicines – suspended

New measures to limit unavailability of medicines – suspended

Belgium Article 3, 2 °, of the Law of April 7th 2019 on unavailability was suspended by the Constitutional Court on July 18th 2019. This judgment means that wholesaler-distributors are no longer limited to the distribution of medicines to pharmacies and other Belgian...

Medicine shortages: improved reporting and communication?

Medicine shortages: improved reporting and communication?

Europe The European Union taskforce  has published two documents: 1) guidance for marketing authorisation holders on reporting of shortages in the EU. The document provides guidance to the pharmaceutical industry to facilitate the detection and early notification to...

Drug-device combinations

Drug-device combinations

Europe The European Medicines Agency has published a Draft guideline on the quality requirements for drug-device combinations. This guideline will provide guidance on the documentation expected for Drug-Device Combinations (DDCs) in the quality part of the dossier for...

Recognition of the FAMHP by FDA

Recognition of the FAMHP by FDA

Europe The FDA has recognized all 28 EU member states. This means that starting 11 July 2019, the US and the EU have fully implemented the mutual recognition agreement (MRA).  Every year, EU national authorities and the FDA inspect many production sites of...

EMA’s Annual Report on the EudraVigilance Database

Europe On 27 March 2019, the Annual Report 2018 on the European database for the collection of adverse reactions to medicinal products, Eudravigilance, was published by the EMA. It's a summary of the current status of the database. EudraVigilance is used to registrate...

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