WE ARE INTO SHARING

Regulatory Intelligence

Stay Up To Date

Latest regulatory changes

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...

Amendments as a result of the new financing law of 2019

Amendments as a result of the new financing law of 2019

Belgium On 20 May 2019, a new law has been published in the Belgian Official Gazette. This new law changes provisions regarding the function and financing of the Federal Agency for Medicines and Health Products (FAMHP). The financing law of 2019 revises the financing...

Medicines for veterinary use

Medicines for veterinary use

Belgium As from 1 May 2019, new Belgian rules apply to the harmonisation of SPC, labelling and patient information leaflet. The FAMHP clarifies the rules for harmonisation of SPC’s, labelling and patient information leaflets (PIL) in different countries. Marketing...

Invoices replace advance payments

Invoices replace advance payments

Belgium The FAMHP has published a news item on their website concerning payments to the FAMHP. From now on, the FAMHP will send out invoices with structured message for most of its services. As a result, companies will no longer need to make advance payments (via an...

Want To Join

Our Current Open Vacancies

No Results Found

The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.

Stay Up To Date

In2Pharma News

Phone

+32 16 891 600

Location

Hof Ter Loonst
Terloonststraat 22
1910 Kampenhout
Belgium

Email

info@in2pharma.com

Social Media