18/10/2022
Cannabinoid drugs, medicinal cannabis and opioid drugs in Spain – a legal guide. Prepared in association with Faus Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for GBP 119. Cannabinoid Drugs For the purposes of this Chapter 8: Cannabinoid Drugs, Cannabinoid Drugs shall mean any industrially produced medicinal product which contains cannabinoids. 1. Are Cannabinoid Drugs authorized in your country? Cannabinoid Drugs may be authorized in…
Want to know more about regulatory reforms in Spain? Read on! Prepared in association with Faus Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for GBP 119. 1. Are there proposals for reform or significant change to the healthcare system? In July 2022, the Ministry of Health opened a public consultation on the first draft of the law that will amend the current Spanish Law on Medicinal…
The legal framework for patents and trademarks in Spain. Prepared in association with Faus Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for GBP 119. 1. What are the basic requirements to obtain patent and trademark protection? Pursuant to Law 24/2015 on patents, the basic legal requirements to obtain a patent are: (i) to have a new invention in any field of technology; (ii) that such invention…
The low-down on the situation regarding product liability in Spain. Prepared in association with Faus Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for GBP 119. 1. What types of liability are recognized in your jurisdiction? The Spanish regime for product liability is a strict liability regime. Such regime imposes strict liability to the “producer” of a defective product. The producer will be liable for personal injury…
A brief overview of the situation regarding traditional medicines and OTC products in Spain. Prepared in association with Faus Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for GBP 119. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Plants traditionally used in Spain for medicinal purposes can be sold to the public without the need for a marketing authorization issued…
All about marketing, manufacturing, packaging & labeling, advertising in Spain. Prepared in association with Faus Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for GBP 119. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? The AEMPS is the authority in charge of granting marketing authorizations in Spain, whether they result from a…
Preclinical & clinical trial requirements in Spain – a comprehensive legal overview. Prepared in association with Faus Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for GBP 119. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trial may be conducted abroad. For those cases whenever clinical trials are conducted outside the European Union,…
Key legal info on regulatory, pricing and reimbursement in Spain. Prepared in association with Faus Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain. The guide is available to purchase here for GBP 119. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The main regulatory authorities in Spain are: The Spanish Ministry of Health (‘Spanish Ministry of Health’), which is…
The low-down on the situation regarding product liability in Spain.…
Want to know more about regulatory reforms in Spain? Read…
Preclinical & clinical trial requirements in Spain – a comprehensive…
All about marketing, manufacturing, packaging & labeling, advertising in Spain.…
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