In order to start a business for the sale of pharmaceutical goods on the Spanish market, local and foreign investors have to observe the applicable legislation in the field. Companies selling pharmaceutical products have to comply with certain licensing requirements, which vary based on the nature of the goods traded on the local market.
Provided that we refer to drugs and other similar products that can be sold by pharmaceutical companies, it is necessary to obtain an approval issued by the Spanish Medicinal Products and Medical Devices Agency (AEMPS) or from the European Medicines Agency. The pharmaceutical company also needs to be registered with this institution. It is important to know that pharmaceutical goods that are considered drugs can be sold on the Spanish market only with the proper authorization; wholesalers must also be licensed in order to sell products here.
Our team of lawyers in Spain can provide legal representation when starting a pharmaceutical company in this country and can also advise on the regulations that have to be followed when selling pharmaceutical goods (drugs or medical devices); investors can also request from our team of Spanish lawyers in-depth information on the manner in which the licenses are issued.
How can a Spanish pharmaceutical company obtain a license?
The issuance of the license is mandatory in order to sell pharmaceutical products in Spain. In order to obtain the license, the regulations of the Royal Decree 1345/2007 must be followed. This regulation provides the legal framework applicable to those selling medicines and the issuance of the license is bound by a set of factors, such as:
- • pharmaceutical companies must submit an application containing detailed information on the medicine;
- • relevant data that must be offered refer to the results of the preclinical investigations;
- • other data refer to clinical trials and pharmaceutical investigations and such companies must also provide reports signed by experts in the field;
- • the file is then analyzed by the AEMPS and the institution has the right to request additional information, provided that it considers that the application is incomplete;
- • the AEMPS will then take a decision on the matter in a period of 210 days since the application was made (calculated from the date since the complete application was registered with the institution).
What are the regulations concerning the price of pharmaceutical goods in Spain?
When selling pharmaceutical goods in Spain, investors should know that the prices at which pharmaceutical goods can be sold on the local market are subjected to specific regulatory control. As a general rule, the manufacturers of pharmaceutical goods are free to establish the price at which their products can be bought, but when referring to pharmaceutical goods that are reimbursed by the country’s National Health System (NHS), the Spanish government has the right to determine the maximum price at which the goods can be sold.
As long as the respective medicines can be reimbursed by the National Health System through a prescription, the Spanish authorities are entitled to participate in establishing the price of the products. In the case of all other pharmaceutical goods, including those which are prescribed through a private prescription and which are not part of the NHS, the companies can freely determine the price; our team of lawyers in Spain can provide more information on the policies available for the sale of pharmaceutical goods.
What are the statistics on the Spanish pharmaceutical industry?
The pharmaceutical industry in Spain is a very solid field of activity, as it is in other European countries; thus, it can provide relevant investment opportunities. It is necessary to know that specific types of medicines can also be purchased from online sellers; our law firm in Spain can provide more details on the regulations for starting an online company here. Investors must consider the following:
- • in 2016, Spain invested EUR 1,085 million in research and development related to pharmaceutical products;
- • in 2016, the total pharmaceutical production in Spain had a value of EUR 15,144 million;
- • the employment in the pharmaceutical sector accounted for 41,102 employees in 2016;
- • in 2018, the value added tax applicable to pharmaceutical products was of 21%;
- • in 2016, the export of pharmaceutical products from Spain accounted for EUR 10,497 million.
Businessmen are invited to contact our law firm in Spain for more details on how to enter the pharmaceutical industry; our team of Spanish lawyers remains at your disposal for personalized advice on any inquiry related to the legislation and tax regulations applicable to local pharmaceutical businesses.