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May - June 2019, Key dates

May – June 2019, Dates to watch

Key dates to watch in Europe and World Wide for the months May – June 2019. May 2019 May 15: Presidential debate in the Brussels chamber. May 15: Implementing public procurement rules at a local and regional level: challenges and opportunities, Workshop May 21: EU Pharmaceutical Law Forum, EFPIA. May 23 – 26: Elections for the European Parliament in the EU Member States. May 26: Federal and regional elections: Federa
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ERP Guidance 2019

ERP Guidance, A year later

ERP stands for External Reference Pricing and is an instrument widely used in the last ten years in Europe for controlling pharmaceutical prices. The ERP Guidance document has only been released in July 2018, as Euripid Guidance Document on External Reference Pricing (ERP). It formulates and structures 12 guiding principles on how ERP should be applied in the context of the current environment and the available Eurip
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Pharma Brexit Brief Quick Facts

Pharma Brexit Brief

What is Pharma Brexit Brief? It is a living source of updated brief key points to watch for the pharmaceutical industry on Brexit, “deal” or “no-deal” resolution. Pharma Brexit Brief is a single source of information to refer to. Brexit´s Key Impact Aspects on Pharmaceutical Industry: Labor: UK is the third largest country in the EU (after Germany and Switzerland) to utilize pharmaceutical R&D funds of pharmaceut
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Can the new rules limit competition in the sector?

April 1, 2019 amendments to Regulation 10 concerning pharmaceutical product reimbursement were introduced. Can the new rules limit competition in the sector? New rules effective April 1, 2019, allow NHIF to charge pharmaceutical companies if their sales exceed sales (value) from previous periods. The sales numbers will be now monitored every quarter. As introduced, the current rules are expected to bear future revisi
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Understand Changes in Drug Pricing in Bulgaria

On April 1st, 2019, few regulation on drug pricing and inclusion in the positive drug list were updated and in force. Here is a brief summary of the rules that impact directly drug prices in Bulgaria
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Pharmaceutical Manufacturing Facilities in Bulgaria

Pharmaceutical Manufacturing Facilities in Bulgaria

The map of the Pharmaceutical Manufacturing Facilities in Bulgaria Project Work. This is an open source data which you can find on Google Maps. The current map of the Pharmaceutical Manufacturing Facilities in Bulgaria is under development and updates frequently. Note, that names for a few of the facilities may be changed due to the change in ownership (e.g. Actavis facility in Dupnitza is now part of TEVA; Actavis´
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Sustainable Joint Procurement

At the National level, Cross-border JP and Organizational experience, and why Europe does not lack organizational expertise.
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The new SPC waiver impact on the biosimilars market in Europe

On February 26, 2019, the Committee on Legal Affairs of the European Parliament approved the draft text of the regulation on a supplementary protection certificate SPC waiver. Earlier this year, the Legal Committee of the European Parliament (JURI) has voted in favor of the SPC manufacturing waiver. Read the full article on LinkedIn. With the introduction of SPC waiver for export and stockpiling, generic and biosimil
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Biosimilars landscape

Biosimilars landscape is evolving in Europe.
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Patent expiry

Patent Expiry of Biological Products in Europe 2018 – 2027

Expected Patent Expiry of Biological Products in Europe 2018 - 2027 and CAR-T entrants in 2018. Kinase inhibitor products patents expiry in Europe. Not exhaustive list of products. Brand names included.
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