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Sunshine Act – disclosure

Sunshine Act – disclosure

Belgium On June 30, the transfers of value from the pharmaceutical and medical device industry to the healthcare industry have been disclosed on betransparent.be. This is already the third disclosure of collaborations under the legal framework of the Sunshine Act. A...

New Deadline for Risk Assessment on Nitrosamines

New Deadline for Risk Assessment on Nitrosamines

Europe Marketing authorisation holders (MAHs) are asked to take precautionary measures to mitigate the risk of nitrosamine formation or presence during the manufacture of all medicines containing chemically synthesised active substances. The MAHs were obliged to...

Closure of the MEB Portal

Closure of the MEB Portal

The Netherlands For safety reasons, the Medicines Evaluation Board portal was provisionally taken offline in January this year and unfortunately the MEB made the decision to close down the portal permanently. Due to the closure of the portal, the following services...

Amended policy on DHPCs: addition of photos

Amended policy on DHPCs: addition of photos

The Netherlands The Medicines Evaluation Board (MEB) has amended its policy on Direct Healthcare Professional Communications (DHPCs) for medicinal products for human use. The update includes the following: “The marketing authorisation holder must attach one (or more)...

Declaration on sold packages: new submission method and new deadline

Declaration on sold packages: new submission method and new deadline

Belgium According to the financing law of FAMHP, a declaration of the number of packages of medicines sold on the Belgian market must be submitted annually to define the yearly contributions. Up to now, every marketing authorization holder and wholesaler of medicines...

Changes to product information policy

Changes to product information policy

The Netherlands The Medicines Evaluation Board (MEB) recently revised 2 policy documents relating to the requirements for product information: “labelling of pharmaceutical products” and “Nomenclature of pharmaceutical products”. The revision only applies to medicinal...

Suspension of ranitidine medicines in the EU

Suspension of ranitidine medicines in the EU

Europe The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recommended the suspension of all ranitidine medicines in the European Union due to the presence of low levels of an impurity called N-nitrosodimethylamine (NDMA)....

Regulation on the mutual recognition of goods

Regulation on the mutual recognition of goods

Europe An updated regulation (2019/515) on the mutual recognition of goods lawfully marketed in another Member State is applied as of 19 April 2020. The mutual recognition principle ensures market access for goods that are not, or are only partly subject to EU...

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