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[UK] MHRA: Public consultation (MLX 371): Proposals to amend medicines legislation to allow student midwives access to the parenteral medicines which can be administered by registered midwivesMLX 371 seeks your views on proposals to allow student midwives access to the parenteral medicines which can currently be administered by registered midwives under an exemption in medicines legislation. [EU] EMA: Tenth EMA Human Scientific Committees' Working Party with Patients' and Consumers' Organisations (PCWP) meeting, London, UK, From: 16-Jun-2010, To: 16-Jun-2010The meeting covered the following topics: revision of the mandate and rules of procedure of the PCWP; the interaction between the Agency and health technology assessment bodies; the interaction between the Agency and patient & consumer organisations; direct reporting of adverse events by patients. [UK] MHRA: Variations legislation 2010 - details of experience to date, submissions audit and update to FAQsThe new Variations Regulation (EC/1234/2008) took effect on 1 January 2010. This immediately applied to variations to marketing authorisations covered by European procedures. However, the MHRA has also applied it to purely national variation applications since then. The system has now been in operation for six months (as at August 2010) and is still relatively new for some companies. Depending upon how many Type IA variations a company may have had to manage during this period, experience is still being gained. To help ensure that companies are submitting the new Type IA notifications correctly the MHRA have published details of experience to date and an audit of submissions made in June 2010. They have also updated the FAQs. [DK] Danish Medicines Agency: Report on the blood product area in 2009In 2009, 358,000 blood collections were made in Denmark. This is approximately 4,000 collections more than the previous year. You can read more in the annual blood product report. [SE] MPA: The MPA investigates reports of narcolepsy in patients vaccinated with PandemrixThe MPA has received six reports from health care professionals regarding narcolepsy as suspected adverse drug reaction following Pandemrix flu vaccination. The Agency will, in consultation with external experts, assess the possible relationship between the vaccination and the reported reactions. The MPA is in contact with other EU member states to get information if there are any reports in other countries. [CZ] SUKL: Sunset clause – A list of medicinal products - A list of medicinal products for which either no consumption has been reported or which do not comply with the requirements stipulated by the Decree.A list of medicinal products for which either no consumption has been reported or which do not comply with the requirements stipulated by the Decree. [CZ] SUKL: Question and answer - Sunset clause - frequently question and answer.Sunset clause - frequently question and answer. |
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