18/07/2019
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 USD 99. Cannabinoid Drugs For the purposes of this topic shall mean any industrially produced medicinal product which contains cannabinoids. 1. Are Cannabinoid Drugs authorized in your country? Cannabinoid Drugs may be authorized in Spain on the basis of…
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 USD 99. 1. Are there proposals for reform or significant change to the healthcare system? At present, the main proposals for regulatory reform are referred to the Spanish regulations on: price and reimbursement of medicinal products and medical devices, advertising of 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 USD 99. 1. What are the basic requirements to obtain patent and trademark protection? The legal condition to obtain a patent or a trademark in Spain is to validly register it before the Spanish Patent and Trade Mark Office. In order to do so,…
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 USD 99. 1. What types of liability are recognized in your jurisdiction? The regime for product liability established in Spain is of a strict nature. It imposes strict liability upon the “producer” of a defective product. The producer will be liable for personal…
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 USD 99. 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 USD 99. 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…
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 USD 99. 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…
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, available to purchase here for USD 99. 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, Consumption and Welfare (‘Spanish Ministry of Health’), which is…
Preclinical & clinical trial requirements in Spain – a comprehensive…
Cannabinoid drugs, medicinal cannabis and opioid drugs in Spain –…
The legal framework for patents and trademarks in Spain. Prepared…
Key legal info on regulatory, pricing and reimbursement in Spain.…
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