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Maximum levels of citrinin in food supplements based on rice fermented with red yeast Monascus purpureus published
Europe A new Commission Regulation has been published ((EU) 2019/1901) amending Regulation (EC) No 1881/2006 regarding maximum levels of citrinin in food supplements based on rice fermented with red yeast Monascus Purpureus. The maximum level of citrinin has been set...
Change of consultation procedures related to the implementation of the Medical Device Regulation
The Netherlands Starting from 26 May 2020 the ‘College ter Beoordeling van Geneesmiddelen (CBG)’ will be giving advice according to the new Medical Device Regulation (MDR, EU 2017/745). Starting from 1 December 2019, the CBG only handles requests for consultation...
New nomenclature for incidents with medical devices
Belgium From January 2020 there is a new nomenclature applicable for manufacturers reporting an incident with a medical device to the FAMHP. The FAMHP advises manufacturers of medical devices to already change their internal codes to the new nomenclature codes. The...
Nitrosamines in medicinal products: report results of risk assessments for impurities
Belgium As a precaution, the European Medicines Agency (EMA) and European medicines authorities asked marketing authorisation holders in October 2019 to perform a risk assessment on the presence of nitrosamines. The Federal Agency for Medicines and Health Products...
Public consultations on labeling and naming policy
The Netherlands The Medicines Evaluation Board (MEB) invites interested parties and stakeholders to comment on 2 amended policy documents on the labeling of medicines for humans (MEB 6) and the naming of pharmaceutical products (MEB 13). The most important changes are...
Information session about PharmaStatus
Belgium Via the new online application ‘FarmaStatus’, marketing authorization holders can notify the FAMHP of unavailability and start or stop of commercialization of a medicinal product. Marketing authorization holders are invited to an information session on...
Steps to take to avoid nitrosamines in human medicines
Europe EMA’s human medicines committee (CHMP) is requesting as a matter of precaution that marketing authorization holders (MAHs) for human medicines containing chemically synthesized active substances review their medicines for the possible presence of nitrosamines...
Falsified Medicines Directive: end of transition period and beginning of monitoring activities
Belgium From 9 February 2019, all prescription and reimbursable medicines on the market must bear safety features. At each link in the distribution chain, the safety features must be checked so that the authenticity of the medicine upon delivery can be guaranteed....
GMP and GDP certificates no longer on paper
Belgium Certificates for Good Manufacturing Practice or Good Distribution Practice can be queried in the EudraGMDP database. The FAMHP will no longer automatically provide paper versions of these certificates, only upon request via this request procedure. Source:...
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...
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