The European medicines Agency (EMEA) reaffirms efficacy and safety of A/H1N1v pandemic vaccines and notably of Pandemrix used in Belgium.
The customs authority and the FAMHP wish to provide some clarification concerning the Belga communiqué of Sunday 15th November 2009 in which Oxfam Solidarity challenged the seizure of some drugs.
The firm GlaxoSmithKline has warned the Federal Agency for Medicines and Health Products (FAMHP) about supply shortages of the vaccine Infanrix Hexa. After evaluation of the dossier by the Advisory Commission, the FAMHP has authorized temporary importation of vaccines from another Member State. So the vaccine Infanrix Hexa should be available again in ONE centers and "Kind & Gezin" in the coming days.
Due to a supply shortage of Cerezyme, treatment recommendations for patients with Gaucher’s disease have been issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA ) and published in the communiqué of the FAMHP dated 18/08/2009. The situation returns to normal at the manufacturing site of Cerezyme. The recommendations have therefore been updated.
The first implementation decrees of the Law of 19th December 2008 on human body material were published on Friday 23rd October 2009 in the “Moniteur belge”. In particular the result was that the law came into effect on 1st December 2009. Specific provisions contained in the Law of 13th June 1986 on the removal and transplantation of organs and the Royal Decree of 15th April 1988 were repealed on the same date.
The Federal Agency for Medicines and Health Products (FAMHP) is launching its first major public information campaign with the support of Laurette Onkelinx, Vice-Prime Minister and Minister of Public Health: "Medicines via the internet? Don’t surf with your health! ".
The supply shortage of Cerezyme mentioned in the communiqué of 06/07/2009 is worse than expected. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued new recommendations for the prescription of this medicine.
Following an European referral, it appears that the medicines WinRho SDF 1500 IU and WinRho 5000 IU have an unfavorable benefit / risk ratio for the "treatment of immune thrombocytopenic purpura (ITP)”. The Marketing Authorization (MA) of these medicines has been withdrawn at the request of the MA holder (Cangene Europe Ltd). The distribution of these medicines has been stopped and batches still on the market have been recalled.
The legislation foresees that the applicant or holder of a marketing authorization (MA) or registration of a medicinal product adapts the proposed PIL on the basis of results of consultation with target patient groups who judge the readability, clarity and ease of use of the PIL. The Federal Agency for Medicines and Health Products (FAMHP) gives holders/ applicants for marketing authorizations or registrations of medicines instructions so that the user tests meet the objective of the patient information leaflets allowing appropriate use of the medicines.
Circular 547 of the Federal Agency for Medicines and Health Products (FAMHP) reminds MA holders of medicines of the obligation to notify the FAMHP the date when they are placed on the market or are withdrawn. Circular 547 provides guidance on how data on the status of marketing in Belgium of medicines authorized by the European Commission (centralized procedure for obtaining an MA) must be communicated to the AFMPS.