Update of § 76 of section 6(1) of the Medicinal Products Act, according to which the Agency of Medicines may revoke a marketing authorization if the medicinal product has not been available on the market for three consecutive years in Estonia, unless it is necessary to maintain the marketing authorization in the interests of public health. Upon issuance of the Marketing...
In order to facilitate the availability of information regarding the potential biological origin of medicines to healthcare professionals, as well as to allow other users of the Medicinal Product Register of Latvia to better orient themselves among the medicinal products included in the register, as well as to facilitate compliance with the regulation regarding the procedure for writing out prescriptions, the...
In Austria the AMVO (Austrian Medicines Verification Organisation) is responsible for the national implementation of verification of medicinal products which are subject to mandatory verification on the Austrian market according to EU Directive 2011/62/EU and delegated regulation (EU) 2016/161. On the respective homepage the Coding Rules for Austria have been published recently (http://www.amvo-medicines.at/presse-news/) in German and English....
The Estonian State Agency of Medicines and the Association of Pharmaceutical Manufacturers in Estonia are honoured to host the international Conference together with the Ministry of Social Affairs during the period Estonia is holding the presidency of the Council of the EU. The main focus of the Conference will be the implementation of safety features appearing on the packaging of medicinal...
From 01.11.2017 parts of the mutual recognition agreement (MRA) between USA and EU have entered into force (link) covering the mutual recognition of GMP inspections in order to help to make better use of inspection capacity and reduce duplication. EU and US regulators will rely on each other’s inspections in their own territories. In future, the need for an EU...
The 89th meeting of the Heads of Medicines Agencies (HMA) was held from 5th to 7th of September 2017 in Tallinn. The meeting was organised by the Estonian State Agency of Medicines during the EU Presidency of Estonia. Discussions were focused on: Availability of appropriately authorised medicines; Innovation and access to new medicines; Optimisation of the regulatory operations; Strengthen surveillance. For more...
On 1 July 2017, a new executive order on fees payable for medicinal products, pharmaceutical companies and clinical trials became effective. The new fees involve changes in a number of areas. Changes in relation to marketing authorisations and variations, etc. New obligation to inform DMA if the number of employees exceeds 500 at one location Obligation to inform DMA if...
Ministry of Health and Care Services has decided that The Norwegian Directorate of Health 's administrative tasks related to the area of medical equipment is to be transferred to The Norwegian Medicines Agency from 1 January 2018. The technological developments on the site have gone very fast since the EEA regulations were adopted at the beginning of the 1990s. This is...
Ivowen Limited hosts 2017 conference It was our pleasure to host the EuDRAcon conference for 2017 in Ireland on 1st and 2nd of June. We welcomed representatives from 21 Member States, including our new member from Cyprus, Nicolas Constantinou from Niconex Medical. EuDRAcon currently has participating members in 25 of the current 31 EEA member states, plus Switzerland, providing unrivalled EU/EEA...
There has been a change in receipt of aRMM at the Icelandic Medicines Agency (IMA). From 1 June 2017 IMA will take seven days to ensure that all relevant documents are enclosed in an application for aRMM evaluation. This is done to facilitate IMA’s review of the material that has been submitted. Link to information is here: https://www.ima.is/publications/news/nr/5246 For more information, please contact our...