From the 1st September 2013 the new NeeS validation criteria (v4.0) need to be used regarding the technical validation of marketing applications for human medicinal products. The NeeS checker v4.0 (September 2013 release) is therefore adapted.
Electronic submissions for marketing applications for human medicinal products: new version of the checker
Narcotics used for the treatment of pain: a new version of the document on the size and type of packaging
The strategy document of famhp aimed at limitingb the sizes and types of packaging of narcotic medicines used for the treatment of pain, available in pharmacies open to the public, has been updated. Version 4.3 is now available.
For the entry into force of the Royal Decree (RD) of 17th June 2013 all medicines containing codeine or codeine derivatives (dihydrocodeine, ethylmorphine, thebacon), whether pharmaceutical products or magistral and officinal preparations, can only be delivered on prescription.
In its judgments of 4th July 2013 the Council of State cancelled the decisions of 21st December 2011 of famhp leading to the modification of the marketing authorizations (MA) of antitussives and decongestants held by Medgenix, Qualiphar and Novartis.
The Committee for Medicinal Products for Human Use of the European Medicines Agency has reassessed the benefit / risk balance of injectable iron-containing medicines for intravenous administration. This Committee believes that their benefits outweigh their risks provided that adequate measures are taken to minimize the occurrence of allergic reactions.
The new guidelines on good distribution practices come into force on 8th September 2013. They must be implemented by the distribution authorization holders and by the manufacturing authorization holders that operate distribution activities. In order to prepare a "FAQ" (Frequently Asked Questions) document the famhp asks all those concerned to send any questions about it before 31st August 2013.
The EMA has published an information file on combined hormonal contraceptives (CHC). This file refers to the ongoing reassessment of 3rd and 4th generation CHC’s for which the recommendations of the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency is expected in October 2013. This file also traces the history of the hormonal contraceptives and subsequent revaluations.
The European Medicines Agency (EMA: European Medicines Agency) has initiated a procedure of reassessment of zolpidem-containing medicines, used for the symptomatic treatment of insomnia (sleeping difficulty). This review has been made in response to concerns related to the onset in some patients of drowsiness and slow reactions the day after taking the medicine, and a potential increased risk of accidents during activities requiring alertness (e.g. when diving).
In June 2013 the PRAC adopted recommendations on HES solutions under Article 31 of Directive 2001/83/EC. A number of marketing authorization holders called for a review of these recommendations. Following the suspension of the use of these medicines in the United Kingdom since 27th June, the EMA has launched a new "urgent" reassessment procedure in accordance with Article 107i of Directive 2001/83/EC. Pending the outcome of these procedures, the recommendations of the PRAC still apply (see press release of 18th June 2013).
Tetrazepam-containing medicines: suspension of the marketing authorization and withdrawal from the market
The famhp sent to the firms concerned the decision of the European Commission of 29th May 2013 to suspend the marketing authorizations (MA) of the tetrazepam-containing medicines throughout the European Union. A recall of all batches of the involved medicines marketed in Belgium (EPSIPAM, MYOLASTAN and TETRAZEPAM EG) must be made by 1st September 2013.