The National Directorate of Pharmacy and Drugs of the Ministry of Health (MINSA) approved the procedure for the sanitary registration of allergenic products in accordance with Law 1 of January 10, 2001.
The regulation indicates that allergenic extracts will be approved for health registration purposes, through a health registration process, either individually or by family by the National Directorate of Pharmacy and Drugs.
Allergenic products are important for in vivo diagnosis and treatment of allergic diseases and their availability and good use is vital to obtain the expected result from them in order to promote people’s health.
The registration of allergenic products will be individual or by family, requested by the importer of medicines with a valid operating license in Panama, issued by the National Directorate of Pharmacy and Drugs. For the traceability of the products, said importer must present the list of suitable health professionals who will administer these products.
Among the requirements is the responsibility of both the importer and the health professional who administers the allergenic product, they are jointly and severally responsible for compliance with the regulations, as well as the storage and distribution conditions required by the National Directorate of Pharmacy and Drugs.
Finally, an allergen is defined as a molecule capable of inducing an IgE response and/or a Type I allergic reaction, and can be described as follows: Recombinant allergens, Allergoids, Major/minor allergens, Relevant and conjugated allergens.
