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Spain, Poland, Italy, Hungary Pharma Companies Gain Equal Access to Vietnam Market

  • A circular that came into force in Vietnam earlier this month brings Vietnam's market entry requirements for pharmaceuticals from Spain, Poland, Italy, and Hungary into line with their EU counterparts

  • The circular removed discrimination against the regulatory bodies of the member states of the EU, specifically Spain, Poland, Italy, and Hungary, which were previously designated as "Stringent Regulatory Authorities" (SRAs) instead of "Reference Regulatory Authorities" (RRAs)

  • The new regulations will group all 27 members of the EU together in the eyes of Vietnam's Ministry of Health

  • The European-Vietnam Free Trade Agreement (EVFTA) came into force on August 1, 2020 and has already reduced tariffs on pharmaceutical products with most set to be eliminated by 2027

  • The EVFTA also allows EU pharmaceutical companies to establish their own companies in Vietnam and gain greater access to public procurement contracts, with the percentage of contracts reserved for domestic companies progressively reduced to 50% over 15 years

  • The EU exported about €1.5 billion worth of pharmaceutical products to Vietnam in 2021, accounting for about 14% of the EU's total exports to the country

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