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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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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