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New nomenclature for incidents with medical devices

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...

Public consultations on labeling and naming policy

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

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

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...

GMP and GDP certificates no longer on paper

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

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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