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Medicine shortages in Austria are published currently on the Federal Office for Safety in Health Care (BASG) website in the “Shortages catalogue”. The obligation of the authorization holder (and all other authorized bodies) to secure the supply is regulated in § 57a (1) AMG (Austrian Medicinal Products Act). Notifications for medicine shortages due to manufacturing or GMP problems acc. to §34...

Initial situation In an arbitration process, the Federal Office for Safety in Health Care (BASG) was obliged according to § 14 of the Federal Disability Equality Act (BGStG) to request Holders of a Marketing authorization/Registration/Parallel import license to provide their Package Leaflets (PL) in an accessible format corresponding to the standard PDF-UA until 31.12.2020. The arbitration process was triggered due to the...

In the end of February 2019, the European Commission (EC) produced a letter concerning the withdrawal of the United Kingdom from the perspective of the EU rules for batch testing of medicinal products. The EC communication addressed the option that exemptions could be granted by the competent authorities on case by case basis, allowing marketing authorisation holders, for a limited...

Luxembourg national legislation on FMD has been published. For more information concerning the application of the European Falsified Medicines Directive (Directive 2011/62/EU) in Luxembourg, please refer to the Luxembourg Medicines Verification Organisation (LMVO) website. Consultant: www.farmaconsult.be...

On February 9, 2019, the European Falsified Medicines Directive (Directive 2011/62/EU) came into effect. The Belgian Federal Agency for Medicines and Health Products (FAMHP) has bundled some practical guidelines for dealing with problems in the start-up phase into a circular letter and has decided to set a transitional period. From 9 February 2019, most prescription and reimbursable medicines placed on the...

After February 9th 2019 the EU drug verification system (established by the Falsified Medicines Directive (Directive 2011/62/EU) and further detailed by Commission Delegated Regulation (EU) 2016/161) became applicable. The Bulgarian Drug Agency (BDA) and the Bulgarian Medicines Verification Organisation (BGMVO) published the first Guidelines for managing alerts during verification and decommissioning of medicines. The document has been coordinated with the national...

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...