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Horizons 2023: Panelists discuss how European pharmaceutical companies can stay ahead of the game

We were pleased to welcome industry leaders to our Life Sciences and Health Care Horizons event in Zurich, where co-head of Hogan Lovells Life Sciences and Health Care sector Jane...

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Medical device advertising in Spain

The Ministry of Health takes steps to update the regulatory framework applicable to the advertising of medical devices.

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Advertising of medicinal products in Spain

The Ministry of Health launches the prior public consultation to update the regulatory framework applicable to the advertising of medicinal products. Until 1 May 2023, anyone...

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New Medical Devices Regulation in Spain

On 23 March 2023 the new Spanish Medical Devices Regulation (Spanish MDR) came into force. After a lengthy wait, the medical devices industry (and any other interested sector) finally has...

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Major regulatory changes in pharmaceutical laws and regulations in Spain for 2023

The Annual Regulatory Plan for 2023 recently released by the Spanish Government provides for important regulatory changes and developments in the area of medicinal products, including...

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New instructions from AEMPS on clinical investigations with medical devices in Spain

In order to comply with the provisions of the EU Medical Device Regulation (EU MDR) and the (coming) Spanish MDR, the Agencia Española de Medicamentos y Productos Sanitarios (Spanish ...

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Developments in Spain on promotion of authorized medicinal products pending pricing & reimbursement

The debate in Spain on the possibility of promoting medicinal products in the period between marketing authorization and pricing & reimbursement has recently taken on a special...

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Draft text of new Spanish regulation on medical devices is opened for contributions

The Spanish Ministry of Health has initiated the hearing and public information process for the new regulation on medical devices. The draft text will be available for contributions by 10...

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Spain’s AEMPS clarifies position on hydroxychloroquine, echoing statements of EMA and Lancet

The Spanish Agency for Medicinal Products and Medical Devices (AEMPS) stated that it will not take, for the time being, any regulatory action to temporarily suspend or halt the recruitment...

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