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[NL] MEB: App for over-the-counter medicine package leafletsUsing a special ‘App’ (application), package leaflets for over-the-counter medicines can be consulted on mobile telephones. Minister Ab Klink officially launched the app, designed by Neprofarm (umbrella organisation for over-the-counter medicines), during a special meeting. [EU] EMA: Standard operating procedure on processing of requests for fee reduction falling under paragraph 1 of Article 9 of Council Regulation (EC) No 297/95The European Medicines Agency have published: Standard operating procedure on processing of requests for fee reduction falling under paragraph 1 of Article 9 of Council Regulation (EC) No 297/95 [UK] MHRA: Labelling of medicines: Reminder – update to labelling to comply with Article 54(a), 54(e) and 56(a)UK legislation was amended in 2004 to implement the new medicines labelling provisions in Title V of Council Directive 2001/83/EC [as amended]. The transitional period for the labelling of medicines which were the subject of a granted marketing authorisation at the time the regulations came into force ends on 30 October 2010. [CH] Swissmedic: CL Formal Control – Incorporation of v1.1 Swiss Module 1 SpecificationsThe changes to Swiss Module 1 specifications for eCTD (v1.1) have been incorporated into the CL Formal Control. The forms Confirmation Substances from GMO, DMF for First Authorisation (and Variation), and Information on Product Quality (paragraph 13 TPA) have now been attributed their own entry number in the system (previously listed under Other forms). [NL] MEB: Changing enforcement term for changes to the legal status of supply for over-the-counter medicinesThe Medicines Evaluation Board, in consultation with the Netherlands Health Care Inspectorate (IGZ), has decided to expand the enforcement term from 6 to 12 months for changes made to the legal status of supply for self-care medicines. This term begins upon publication of the MEB ruling on changing the legal status of supply in the Government Gazette. [NL] MEB: Discussing the advantages and disadvantages of transparency: the ‘Transparent MEB’ meetingThe ‘Transparent MEB’ meeting that took place yesterday yielded a good overview of how the MEB deals with transparency. Speakers from the pharmaceutical industry, patient organisations, pharmacies, scientific fields, general practice and the MEB itself commented on their expectations for the MEB’s transparency policy. Global, European and national perspectives were also examined. [NL] MEB: Changes to the review committeeThe MEB decided to change the makeup of the review committee during its meeting of 28 January 2010. |
These European updates are some of the recent key regulatory news items we have noted, including those from the regulatory agencies and authorities in Europe. A two-letter code is used at the beginning of each item to indicate the country or region, according to the