El Salvador: New Pharmaceuticals And Cosmetics Law
Overhauls Standards And Procedures For Product Approval
On February 22, 2012, the Legislative Assembly of El Salvador unanimously passed Legislative Decree No. 1088, which contains the “Medicines Act” that substantially reforms the standards and procedures for approving pharmaceuticals, cosmetics and other types of drug products. The law was signed by the President of the Republic on March 2nd and will become effective 30 days after its publication in the Official Gazette.
The primary objectives of the law are to lower both branded and generic drug costs, improve quality control, regulate the registration of pharmaceuticals products and cosmetics, and the creation of the National Drugs Bureau as the governing body to oversee and enforce the Law
The most important provisions of the Act are:
- Creation of the National Drugs Division to be responsible for registration procedures and post-registration controls of pharmaceuticals, cosmetics and other drug products.
- The post-registration control will be carried out by choosing randomly one batch from any distribution center for verification at the National Drugs Division’s quality control laboratory that the chemical, quantitative and qualitative conditions of the product correspond to the same conditions that were approved.
- Registration of a pharmaceutical may be canceled by the National Drugs Division if the product is not commercialized within 5 years from date of registration or if the product is not in the market for 3 consecutive years after it has been commercialized.
- All products subject to the Act must comply with Good Manufacturing Practices, Distribution and Storage within one year from the effective date of the Act. “Good Practices” must be established in the corresponding regulations.
- The sale of drugs without prescription is prohibited and so is drug peddling.
- Drug stores are prohibited from having internal doctors and requesting them to write medical prescriptions.
- Prescriptions for pharmaceuticals must contain the preferred brand name of drug and its generic name.
- Reference prices of medicines must be in line with costs in Central America and Panama, so that the highest price market in El Salvador should not exceed the regional average price, which price shall be no greater than three to five times the international reference price set by the World Health Organization.
Commentary: Notwithstanding the effective date of the law, we believe that implementation of the Act will be delayed due to the creation of the National Drugs Division and the absence of regulations governing the various processes arising from this law.
In addition the Superior Council of Public Health (CSSP), previously responsible for health registrations, will be reorganized with its function reduced to monitoring health professionals, and authorizing and supervising health facilities.
For additional information, please feel free to contact Ms. Marcela Eugenia Mancia and/or Ms. Pamela Giraldo, in Romero Pineda’s Division of Health Registry at 503) 2505-5555 or email: firstname.lastname@example.org and email@example.com. They will be pleased to assist you.
Very truly yours,
ROMERO PINEDA & ASOCIADOS