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13/12/13: deadline for the submission of dossiers for marketing authorisations

As the FAMHP will be closed between Christmas and New Year, we advise you to foresee December 13, 2013 as the final date for submitting requests for new marketing authorisations, variations, renewals and requests for parallel importation for medicines for human use or veterinary use. The validation of dossiers submitted after this date will only start on January 3, 2014.

Electronic submission of dossiers concerning marketing authorizations via CESP: update

The FAMHP has updated the list of dossier types for which it wishes to receive your submission via the «Common European Submission Platform » (CESP)

Electronic submissions for marketing applications for human medicinal products: new version of the checker

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.

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.

All codeine-containing medicines (or codeine derivatives) subject to medical prescription

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.

Antitussives and decongestants: judgement of the Council of State

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.

Pharmacovigilance: new circulars

Following the publication in the Belgian Official Journal of the Royal Decree of 28th May 2013 amending the Royal Decree of 14th December 2006 on medicinal products for human and veterinary use, the famhp wrote three circulars on the new legislation about pharmacovigilance. Circular 599 concerns their practical application. Circulars 600 and 601 specify the new requirements concerning the local persons responsible for pharmacovigilance for medicinal products for human use and for medicinal products for veterinary use respectively.

Intravenously administered iron-containing medicines: new recommendations

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.

Good distribution practices: new guidelines

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.

Combined hormonal contraceptives: current situation

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.

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