Panama: New Decree implementing Law on medicines and other human health products

 

Panama has published a draft Draft Executive Decree implementing Law No. 1 of 10 January 2001 on medicines and other human health products.

The notified Executive Decree sets out the implementing regulations for Law No. 1 of 10 January 2001, which regulates all aspects relating to the functions of the National Pharmacy and Drugs Directorate; the charging of fees for the Directorate’s services; and all aspects relating to the registration of the following pharmaceutical products:

• Topical antiseptics
• Bactericides and disinfectants
• Biological and biotechnological products
• Cosmetics
• Herbal medicines
• Chemically synthesized medicines
• Homeopathic medicines
• Orphan medicines
• Pesticides for household and public health use
• Household and hospital cleaning products with antiseptic and fungicidal properties
• Radiopharmaceuticals
• Vitamin or dietary supplements

It also sets out implementing regulations for all aspects relating to the accelerated registration procedure; labelling; stability; interchangeability; manufacture, control and inspection and other provisions; marketing; prior and post- verification of pharmaceutical products; the National Pharmacovigilance System; pharmacotherapy; regulation and inspection of pharmaceutical establishments; good manufacturing practices for cosmetic, antiseptic and disinfectant products and household pesticides; registration requirements for raw materials, excipients and packaging inputs in industries producing medicines, cosmetics, disinfectants, pesticides and other products; product distribution; good pharmaceutical practices; prescriptions; and government procurement of human health products.

The full text of the Decree is available HERE

To find out more about the Decree, do not hesitate to contact the Product Compliance Institute.