The Norwegian Medicines Agency has recently announced a need for more suppliers or alternatives on the market in Norway for the active substances ivermectin and erythromycin, and want to get in contact with possible suppliers. The Norwegian Medicines Agency’s announcement list are applicable for medicinal products deemed as critical to the market, with regard to public health. Possible reasons for shortage...
New magazine (published 4 times a year) is being added to the list of magazines where healthcare professional advertising is allowed: „Psichiatrijos žinios“ You find more information here...
News issued by the State Agency of Medicines: EU regulators established two documents to better address potential problems with medicines’ supply and to develop and coordinate actions to facilitate the prevention, identification, management of and communication about shortages. You will find more information here. ...
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...
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...