News & Analysis as of

Life Sciences Spain

McDermott Will & Emery

Investing in Healthcare & Life Sciences - An International Guide to Regulatory and Transactional Issues Across the Sector -...

McDermott Will & Emery on

As macroeconomic forces and geopolitical dynamics continue to shape the M&A and investment climate globally, health and life sciences transactions continue to remain high priority sectors presenting both high growth and...more

Hogan Lovells

Advertising of medicinal products in Spain

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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 interested in this regulatory initiative may...more

Hogan Lovells

Medical device advertising in Spain

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The Ministry of Health takes steps to update the regulatory framework applicable to the advertising of medical devices. The Spanish Health Act gives the authorities control over health advertising. In particular, Article 102...more

Hogan Lovells

New Medical Devices Regulation in Spain

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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 access to the final text and knows...more

Hogan Lovells

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

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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 Agency for Medicinal Products and Medical...more

Hogan Lovells

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

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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 pricing and reimbursement or health...more

Hogan Lovells

Espacio Europeo de Datos Sanitarios: una revolución para la historias clínicas electrónicas

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Los prestadores de asistencia sanitaria almacenan y utilizan historias clínicas electrónicas ("HCE") en el contexto de la prestación de dichos servicios sanitarios. Sin embargo, la configuración de dichas HCE por parte de los...more

Hogan Lovells

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

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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 prominence. The Spanish market has been...more

Hogan Lovells

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

Hogan Lovells on

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 July 2021. The direct application of...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

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In Tuesday's Report: a panel discussion on the U.S. election, Americans warned of COVID-19 surge, Moderna files for FDA EUA, Hong Kong proposes corporate rescue bill, new Foreign Direct Investment rules in Spain, the EU moves...more

Hogan Lovells

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

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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 of patients for clinical trials to...more

Hogan Lovells

Combating COVID-19: Government powers for safeguarding supply of critical products and potential conversion of production – Italy,...

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The spread of COVID-19 is causing Europe to experience one of the greatest health crises in decades, the consequences of which are still unpredictable. Faced with this unprecedented situation, the governments of different...more

Hogan Lovells

Combating COVID-19: Government powers for safeguarding supply of critical products and potential conversion of production – Italy,...

Hogan Lovells on

The spread of COVID-19 is causing Europe to experience one of the greatest health crises in decades, the consequences of which are still unpredictable. Faced with this unprecedented situation, the governments of different...more

Hogan Lovells

Spain responds to COVID-19 with new reporting obligations, supply chain controls

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The Spanish Ministry of Health placed on manufacturers and marketing authorization holders (MAHs) – or their local representatives – new reporting, supply, and manufacturing obligations with respect to 347 medicinal products...more

Hogan Lovells

Impact of Spanish government's COVID-19 measures on life sciences companies operating in Spain

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With more than 17,000 people currently infected in Spain, the national government has granted the Ministry of Health far-reaching powers to contain the coronavirus, and has issued several orders to safeguard the economy....more

Hogan Lovells

Spain agrees to new economic regime for orphan medicinal products

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On 3 March 2020, the Spanish Council of Ministers, based on Article 3(3) of the Spanish Regulation on Medicinal Products (RDL 1/2015), agreed on a new economic regime for orphan medicinal products. ...more

Hogan Lovells

New medical device regulation in Spain opened for public consultation

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Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties....more

Hogan Lovells

A road map to life sciences M&A in Spain

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U.S.-based life sciences companies considering transactions in Europe may easily become overwhelmed with the complexity of Europe’s various jurisdictions. In this series, members of our European Life Sciences Transactions...more

Hogan Lovells

Relocation of the EU Medicines Agency – Spain

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"Spain is waiting for the EMA. Barcelona is ready". With this conviction, and with the conviction that everything is ready, the Spanish Minister for Health addressed the European Commissioner for Health & Food Safety, Mr...more

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