Mexico removes plant requirements for selling vaccines
This article was originally published in Scrip
Companies looking to market certain medicinal products in Mexico, including vaccines, no longer have to have a plant there after changes to the law came into effect this month, says the health ministry.
Last August President Felipe Calder�n finally signed into law changes to articles 168 and 170 of regulations governing consumable healthcare products (Scrip Online, August 6th, 2008). These changes sought to gradually remove the requirements that obliged foreign companies marketing medicines in Mexico to have manufacturing facilities in the country.
On February 5th, six months after the decree's publication, the removal of the plant requirements for selling vaccines, vitamins, serums, haemo-derived products, antitoxins, homoeopathic medicines and herbal medicines came into effect. On August 5th, 2009, the requirement will be lifted for any other biological or biotech product. Six months after that the obligation will be removed for hypnotic and psychotropic medicines. And by August 10th, 2010, all types of medicines described by the general health law should be free of the requirement.
The amendments should considerably drive the growth of Mexico's pharmaceutical market, Antonio Prida, director for Europe at Proméxico Trade and Investment, told Scrip.
However, the overall aim of the decree was to improve access to lower-cost medicines by stimulating competition. The changes came into effect for the sale of antiretrovirals the day after it was published in the official journal, August 5th. The move was hailed by HIV/AIDS activists as it meant that more generic medicines would become available and drive down ARV prices.