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European Union › European Parliament › Pharmaceutical Industry

The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of... more +
The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -
Hogan Lovells

Pharmacy compounding under the EU pharma law package

Hogan Lovells on

Pharmacy compounding is one of the topics in the EU Pharma Law Package that has perhaps received less attention compared to topics such as regulatory exclusivity rights, shortages, and sustainability. The EU Pharma Law...more

Goodwin

The European Parliament Adopts Position on the European Commission’s Proposal for the First Major Overhaul of the EU Medicines...

Goodwin on

In April 2023, we published an alert in relation to two European Commission legislative proposals: new Regulation 2023/0131 and new Directive 2023/0132, to replace the current EU regulatory framework for all medicines...more

Hogan Lovells

EU: New developments in the SPC manufacturing waiver legislative process

Hogan Lovells on

Following the European Commission’s draft proposal for implementing the so-called SPC manufacturing waiver the Committee on Legal Affairs of the European Parliament published a draft report on presenting its suggested...more

Hogan Lovells

The European Parliament adopted a report on the Commission Proposal for a Regulation on Health Technology Assessment

Hogan Lovells on

On 4 October 2018, the European Parliament adopted its Report on the Commission Proposal for a Regulation on Health Technology Assessment (HTA)....more

Hogan Lovells

Liability Challenges to the Medical Devices Industry

Hogan Lovells on

On 5 April 2017, despite uncertainties about the regulatory legal scope, the practical applicability of certain provisions, and the law's realizability within the given transition period, the European Parliament adopted the...more

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