Spain issues recommendations for distributors to detect and report misuse and unlawful diversion of human medicines

Patricia Carmona Botana

The Spanish medicines regulatory authority (AEMPS) recently issued recommendations to help distributors detect, audit and report unusual sales patterns of human medicinal products suspected of being misused or diverted into unlawful trade (Recommendations). The Recommendations supplement (i) the Spanish decree on the distribution of human medicines, which requires distributors to report any conduct or suspicion Read More

Portugal and Spain strengthen collaboration with pilot project for the joint procurement of medicines

Patricia Carmona Botana

Last week, the Health Ministers of Portugal and Spain signed a letter of intent that marks the beginning of a joint procurement, funding and price negotiation initiative for medicines and medical devices in the Iberian region.  The initiative seeks to enhance cooperation in order to improve patients’ safety, patient’s access to innovative treatments, as well Read More

Spain simplifies MA variation procedure for medicinal products

Marco de Morpurgo

With an informative note dated 20 April 2017, the Spanish Agency for Medicinal Products and Medical Devices (AEMPS) introduced measures to speed up the procedure for granting variations to the marketing authorisation (MA) of medicinal products. Under the former procedure, the grant of an MA variation authorisation required in certain cases (i) the confirmation or Read More

Competition Authority reviews regulation of wholesale distribution and marketing of medicines in Spain

Patricia Carmona Botana

The Spanish National Markets and Competition Commission (CNMC) recently launched a study on the regulation of the wholesale distribution and marketing of medicinal products in Spain.  Interested parties are invited to submit their comments to the CNMC at The study is triggered by the CNCM’s acknowledgment that, despite the specific characteristics of the pharmaceutical sector Read More

The Spanish Competition watchdog issues report on the proposed implementing provisions of the Patent Act

Patricia Carmona Botana

Yesterday, the Spanish Competition Authority (SCA) published a report on the draft Royal Decree authorising the Regulation implementing the Patent Act No. 24/2015 (Report). The Report includes indicators and statistics on the Spanish patent system such as the number of patents, costs and R&D&I data, and provides a comparison with other countries. According to the Read More