News

Starting in February 2018, the Bulgarian Drug Agency (BDA) applies additional requirements to the applicants when presenting proof of payment. These regard the fees paid for the administrative procedures managed by the BDA: marketing authorisations (MA) or registrations, variations, renewals of MA, transfer of MA, line-extensions, notification for changes in product information, parallel import, annual maintenance fees or withdrawals of...

Following the withdrawal of Great Britain from the European Union ("Brexit"), the United Kingdom's licensing authority is no longer available for EU approval procedures and for regulatory pharmacovigilance activities. So far Great Britain played an important role. While it may depend on the outcome of the negotiations, what the implications of Brexit for the UK and the EU Member States...

From 2018, a new system will be valid for the compensation of medicinal products on prescription. Additional compensation of medicinal products on prescription is intended to improve the availability of medicines for people with high costs for medicinal products. There will be additional compensation for medicines costs over 100 euros. It is planned to pay an additional compensation 50% if...

Patient information leaflets of more commonly used registered medicinal products on prescription will be available in English and Russian by 15th of December 2017. These are 10 active substances ramipril, amlodipine, rosuvastatin, omeprazole, metoprolol, telmisartan, nebivolol, metformin, atorvastatin, sodium levotyroxin. From May 1, 2017, 388 leaflets of non‐prescription medicines marketed in Estonia are available in Russian and English. The translations...

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...