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Expansion disclosure Transfers of Value based on the GMH* code
The Netherlands As of February 1, data on financial relationships between suppliers and healthcare professionals can be submitted to the Transparency Register for Healthcare (“Transparantieregister Zorg” or TRZ) for the year 2021. Compared to previous years the...
FAMHP new Financing Law
Belgium On 03.02.2022, the Federal Parliament approved a law that adjusts the financing of the Federal Agency for Medicines and Health Products (FAMHP). This has been published in the Belgian Official Journal and will come into force soon. The law introduces new taxes...
EU: Strengthening the EMA
Europe A regulation strengthening the role of the EMA in crisis preparedness and management for medicinal products and medical devices has been published in the Official Journal of the EU (Regulation (EU) 2022/123 "on a reinforced role for the European Medicines...
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Are you looking for a challenging and varied job in the pharmaceutical industry? We carry out various projects for some 50 pharmaceutical companies in the areas of quality assurance, promotion & publicity, pharmacovigilance and regulatory affairs: plenty of...
EFPIA published 10 recommendations to ensure adequate procurement practices across the EU.
Europe EFPIA, representing the research-based pharmaceutical industry in Europe, releases the results of the in-depth survey it has carried out among its members to capture the state of play of the implementation of the 2014 EU Public Procurement Directive that ought...
APL will change names to IML: Innovative Medicines for Luxembourg
Luxembourg APL, the Association Pharmaceutique Luxembourgeoise, is a Luxembourg-based association founded in 2011. The APL's mission is to promote better healthcare by encouraging therapeutic innovation in the field of medicines for human use in Luxembourg. It does...
Amendment to the GMH Code as of 1 January 2022: cooperation Transparency Register
The Netherlands On 1 January 2022, a new provision will be added to the chapter in the GMH* Code regarding transparency. This provision relates to the clarifying note that the GMH foundation publishes annually at the time of publication of the reports by the...
New reporting process “Reporting Centre for drug shortages and defects”
The Netherlands Medicinal Product Quality Defects and Shortages on the Dutch Market should be reported through the “Meldpunt geneesmiddelentekorten en -defecten”. As of 01 January 2022, the Medicines Evaluation Board (MEB) and the Inspectorate (IGJ) have implemented...
Royal Decree of 29 November 2021 on transparency of the stock of medicines intended for public service obligations was published
Belgium On 10 December 2021, the Royal Decree (“RD”) of 29 November 2021 on transparency of the stock of medicines intended for public service obligations was published. This Royal Decree aims to implement a stock monitoring system for wholesaler-distributors as part...
MEB fee rate change as of January 2022
The Netherlands The Medicines Evaluation Board (MEB) increases the fee rates for authorisation applications, authorisation changes and the annual fees of human medicinal products. Fees for consultation procedures will also be increased. Fees for veterinary will remain...
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We are looking to expand our team with a Regulatory Affairs colleague who has the ambition and potential to grow in our organization. All projects within IN2Pharma are worked on in small teams of 2-5 people and for some projects, you also work on site at the clients’ offices for (max.) 1 or 2 days per week.
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