Bulgaria

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J&J says it has “exhausted all current viable avenues” to get its antidepressant nasal spray Spravato reimbursed on England’s National Health Service, after NICE decided against re-appraising the drug following numerous funding rejections.

Belgium's Ceres Pharma has expanded its footprint in Eastern Europe by acquiring supplements and OTC device specialist ABOPharma.

The practice of telehealth got the impetus it had long needed during the pandemic, as experiences in Czechia and neighboring economies in eastern Europe show in a regional roundup by Kinstellar.

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

INFOGRAPHIC: An interactive timeline of HBW Insight's coverage of the blossoming European CBD market in 2019. The timeline covers the main events of the year beginning with the European Commission's decision to classify CBD as a novel food, and ending on the filing of the first application for a synthetic form of the cannabis-derived ingredient.

Bulgaria should remove clawback taxes for generics and biosimilars, avoid external reference-pricing mechanisms, adopt measures to drive up generic prescribing and adopt a “dynamic” biosimilars policy to encourage uptake, European off-patent industry association Medicines for Europe has urged. The industry body has also called on the new European Commission to offer the country its support in these areas.

Stada is set to snap up Czech Republic-based Walmark in its second major deal this year as it looks to make good on its promise to rapidly expand its OTC-focused Branded Products business. 

Medical Marijuana Inc. says claims that it has lost its licence to sell CBD as a food supplement in Bulgaria are incorrect. The firm tells HBW Insight it has in fact been granted additional approval to export CBD products from Bulgaria to Russia.

Bulgaria has granted US-based Medical Marijuana Inc. the right to sell CBD as a supplement in a first for an EU country. The move, which will see CBD regulated as a traditional food, puts Bulgaria directly at odds with the European Commission, which recently classified the cannabis plant extract as a novel food.