• Regulatory Services in Hungary

    Overview

    Holding an established pharmaceutical market with a comprehensive Regulatory framework, Hungary stands a competitive market for foreign medicinal and medical devices manufacturers for investments in the region. To get the market access, manufacturers must comply with regulations of Hungary’s National Institute of Pharmacy and Nutrition (OGYEI). Not only the stringent regulations inclusive of language barriers, but also the complex Regulatory procedural challenges demand a special attention from manufacturers, who are willing to enter the region.

  • Regulatory Services in Greece

    Overview

    With an improved fiscal performance, and with a universal health care system, Greece offers good investment opportunities for medicine and medical device manufacturers. Accessing the market requires manufacturers to obtain necessary approvals from The National Organization for Medicines, an entity of Ministry of Health and Social Solidarity. Right from informing the Greek National Organization for Medicines (EOF), manufacturers might have to cope with other complex Regulatory procedures for registrations and licensing.

  • Regulatory Services in France

    Overview

    To gain access to France, foreign medicine and medical device manufacturers are obliged to get authorizations from the National Agency for Medicines and Health Products Safety (ANSM) under the Direction de l’évaluation des dispositifs médicaux. However, manufacturers need an authorized representative anywhere from the EU for obtaining registrations and gain market approvals. Navigating the time-critical approval processes and required Regulatory documentation, challenges market entrant’s compliance efforts.

  • Regulatory Services in Finland

    Overview

    Economy of Finland is highly industrialized and with the region’s substantial presence in biotechnology and life sciences sector, the Finish landscape has become the most sought after destination for medicine and medical device manufacturers for investments in the region. The Finnish Medicines Agency (FIMEA) looks after the market authorizations and registrations in the region. Though the market seems to be attractive for investments, navigating through the established Regulatory regime might pose a challenge for foreign manufacturers for successful compliance.

  • Regulatory Services in Estonia

    Overview

    The progressing economy coupled with growing opportunities for R&D and innovation in life sciences sector makes the Republic of Estonia a haven for medicines and medical devices manufacturers to invest in the region. To enter the Estonian market, manufacturers however must obtain market authorizations from the State Agency of Medicines controlled by Ministry of Health. Navigating the Estonian life sciences Regulatory market might stand a challenging aspect for foreign manufacturers while approaching for necessary registrations and approvals.

  • Regulatory Services in Denmark

    Overview

    For many years, Denmark has been a promising location offering good scope for medicine and medical devices investments. To obtain the market access, manufacturers must obtain approvals from The Danish Health and Medicines Authority (DHMA), an agency oversees the registrations and licenses across the region. Right from holding an authorized representative anywhere from the EU region, foreign entrants must go through many complex Regulatory procedural challenges, failing in any of which might affect compliance efforts.

  • Regulatory Services in Czech Republic

    Overview

    In order to gain access to the Czech Republic, foreign manufacturers are obliged to get authorizations from the State Institute for Drug Control (SUKL). Apart from obtaining must-to-have CE marking for medical devices, manufacturers need an authorized representative for obtaining registrations and gain market approvals. To do so, the challenge lies with procedural complexities that a foreign manufacturer may find difficult to handle.

  • Regulatory Services in Cyprus

    Overview

    With a prosperous economy, Cyprus has become the most sought after destination for medicine and medical device manufacturers for investments in the region. To enter the region, manufacturers must obtain market authorizations from The Ministry of Health Pharmaceutical Services, an authority overseeing the registrations and licensing of the medicinal products in the region.

  • Regulatory Services in Bulgaria

    Overview

    With recent reforms in health system, Bulgaria stands a good bet for medicine and medical device investments. To obtain market access, manufacturers must get authorizations from the Bulgarian Drug Agency, under the supervision of Ministry of Health, Bulgaria. An authorized representative anywhere from the EU region is required to enter the region and without the updated Bulgarian Regulatory knowledgebase navigating through the complex Regulatory procedures might be an uphill task for new market entrants.

  • Regulatory Services in Austria

    Overview

    With its universal healthcare system, Austria offers a good fortune for Medicinal product and Medical Device manufacturers across the globe. To enter the region, however, manufacturers must obtain market authorizations from The Austrian Agency for Health and Food Safety (AGES), an agency looks after the registrations and licensing in the region.

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