Pharmaceutical specialty

Tables

Pharmaceutical specialty is the old name given in the Spanish Medication Law of 1990 to medicines with a defined composition and information, pharmaceutical form and specific dosage, prepared for immediate medicinal use, ready and conditioned for dispensing to the public, with uniform denomination, packaging, container and labeling and to which the pharmaceutical authority grants health authorization and registers in the Register of pharmaceutical specialties. This term has been almost completely replaced with the new law on guarantees and rational use of medicines and health products (LGRUM) of 2006 with the term medicine and it is only maintained for the name of the generic medicine.

The Generic Pharmaceutical Specialty (EFG), also known as generic medication, is the specialty with the same pharmaceutical form and the same qualitative and quantitative composition of medicinal substances as another reference specialty (bioequivalence), whose efficacy and safety profile is sufficiently established due to its continued clinical use.

Each registration number will refer only to a composition, a pharmaceutical form, a dose per administration unit and a presentation for sale.

To obtain sanitary authorization, a pharmaceutical specialty must satisfy the following conditions:

• Being Safe., that is, when in normal conditions of use it does not produce toxic or undesirable effects disproportionate to the benefit it seeks, for which they will be subjected to toxicological studies.

• Being effective in the therapeutic indications for which it is offered. The effectiveness of the medications for each of its therapeutic indications should be established through the previous clinical trials controlled by sufficiently qualified individuals.

• Reach the requirements quality and purity to be established and stable (conditions of conservation).