WE ARE INTO SHARING

Regulatory Intelligence

Stay Up To Date

Latest regulatory changes

Logistic change APB Recalls

Logistic change APB Recalls

Belgium Since May 2nd, 2024, APB has changed to CSP-Movianto as partner for handling their logistics related to recalls. This move allows them to streamline operations while maintaining quality and efficiency. Additionally, APB has a new RP (Responsible Person). Due...

read more
Dates GMH trainings 2024

Dates GMH trainings 2024

The Netherlands GMH organizes multiple trainings on the regulation of premiums and benefits with regard to medical devices. They offer two levels of training: a basic training and a more advanced training. These trainings will take up one half of a day (before noon)...

read more
Update FAQ additives and additives legislation

Update FAQ additives and additives legislation

Belgium On 5 February 2024, the Belgian authority has published an update of the FAQ on additives. The FAQ was extended from 27 to 41 pages with the addition of 20 new questions. Source: FAQ additieven | FOD Volksgezondheid (belgium.be)

read more
Circular 654 – Inspection on Full FMD Implementation

Circular 654 – Inspection on Full FMD Implementation

Belgium As previously announced, since 9th of Feb 2024, Belgium and Luxembourg switched to a full EU-FMD implementation. The Belgian NCA (FAGG / AFMPS / FAMHP) now published Circular 654 for the attention of the inspectors involved in the control of the distribution...

read more
Update Adverse Drug Reaction reporting details

Update Adverse Drug Reaction reporting details

Belgium On February 29th, EMA published the newest version (v29) of QRD Appendix V. In this version, the contact details for reporting adverse drug reactions in Belgium has been changed, since the authority has decided to abandon the use of a postal address and go...

read more
Amendment RD Plants

Amendment RD Plants

Belgium An amendment of the Belgian Royal Decree regarding the manufacture and trade of foodstuffs composed of, or containing, plants or plant preparations (RD August 31, 2021) has been published on 30 January 2024. The RD has come into force on 9 February 2024...

read more
NIHDI posts new FAQ on tenders for biologicals

NIHDI posts new FAQ on tenders for biologicals

Belgium Hospitals must, according to the Royal Decree of 13 September 2023, issue a tender for biological and biosimilar medicines within nine months after a first biosimilar pharmaceutical speciality, authorized in accordance with the law of March 25, 1964 on...

read more
Data basic training Keuringsraad

Data basic training Keuringsraad

The Netherlands Koag Kag/Keuringsraad has published the data for their basic training on the codes for promotion towards general public regarding medicinal products, medical devices and health products. This training takes place in Breukelen, The Netherlands, at...

read more
Update Adverse drug reaction reporting details

Update Adverse drug reaction reporting details

Luxembourg On January 17th, EMA published the newest version (v28) of QRD Appendix V. In this version, the contact details for reporting adverse drug reactions in Luxemburg has been changed, to include the German version of the address. Luxembourg/Luxemburg [French]...

read more
Want To Join

Our Current Open Vacancies

There are currently no open positions at IN2Pharma. But this may well change quickly at times, so we are always open to a spontaneous application.
Interested? Send your CV and job description to jobs@in2pharma.com 

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