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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.

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.

Falsified medicines: new legislation

Directive 2011/62/EU aimed at ighting against falsified medicines was transposed into Belgian law: the law of 20th June 2013 amending the Law of 25th March 1964 on medicines was published in the Belgian Official Journal on 26th June. Many of these provisions come into force on 1st and 2nd July 2013.

Validation des dossiers électroniques d’AMM des médicaments à usage humain : version « intermédiaire « du « checker ».

Le checker utilisé pour la validation technique des dossiers d’autorisation de mise sur le marché (AMM) des médicaments à usage humain a été adapté pour tenir compte des nouvelles règles de validation du NeeS (non eCTD electronic Submission) qui seront d’application à partir du 01/09/2013 . Une version « intermédiaire » (v.4) du checker a été développée. Les demandeurs qui le souhaitent peuvent appliquer les nouvelles règles à partir du 1er juillet 2013 et doivent alors utiliser cette version intermédiaire du checker.

Validation of the electronic MA files for medicines for human use: “Intermediate” version of the "checker".

The checker used for the technical validation of market authorization files (MA) for medicines for human use has been adapted to reflect the new validation rules NeeS (non-eCTD electronic Submission) that will apply to from 01/09/2013. An "intermediate" (v.4) version of the checker has been developed. Applicants may wish to apply the new rules from 1st July 2013 and must then use this intermediate version checker.

Survey of external satisfaction

The federal agency for medicines and health products (famhp) will soon launch a first satisfaction survey to assess the quality of its services and products. The results of this will be communicated at the end of 2013 and will be used to improve the delivery of FAMHP services.

Circular 596 on the production and distribution activities for experimental medicines

In circular 596 the famhp reminds the relevant health professionals about the requirements for production and distribution activities for experimental medicines and clarifies its position on the concepts of delivery, packaging and recovery of these medicines.

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