Pharmaceutical companies in Spain have as a main activity the production and distribution of authorized medicaments on the territory of Spain; such companies can also deal with the marketing of its brand medicaments or medical equipment. Foreign investors who are interested in opening a pharmaceutical company in Spain must comply with a set of regulations imposed by the Spanish legislation. Our company formation agents in Spain can provide you with assistance in obtaining the permits and licenses mandatory for such a company, as well as the marketing authorizations which are necessary in order to sell the products on the Spanish market.
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Marketing authorization for pharmaceutical companies
According to the Spanish legislation, all pharmaceutical companies with operation on the territory of Spain have to obtain an authorization available under the Law 29/2006, which grants the right to market the medicaments, supplements and medical equipment on the Spanish territory. Under the European Legislation 726/2004, pharmaceutical companies in Spain can obtain a marketing authorization which is available for the European Union space.
The following video offers a short presentation on the registration of a Spanish pharmaceutical company:
Special medication, such as those recommended for the treatment of HIV/AIDS, cancer, diabetes and neurodegenerative diseases, must receive a marketing authorization, which is done through a centralized procedure that respects the European legislation; our company formation specialists can provide you with in-depth information on the provisions of the harmonized EU’s legislation on this topic.
Regulatory bodies on pharmaceutical industry in Spain
The authorizations issued for pharmaceutical companies in Spain are done under the supervision of The Spanish Agency for Medicines and Medical Devices, which evaluates, issues and controls the distribution of the medicines; the main regulatory body under which the pharmaceutical companies function is the Ministry of Health, Social Services and Equality, which offers the legal framework under which healthcare products are manufactured and promoted on the Spanish market.
Pharmaceutical companies can produce medicaments, medical devices, cosmetic products and food supplements, all being regulated by specific laws; you can request information on these laws from our company formation specialists, who can offer you in-depth details.
If you need further information on the legal framework which regulates the operations of a pharmaceutical company in Spain, please contact our Spanish company formation agents.