Pharmaceutical specialty is the old name that was given in the 1990 Medicines Act of Spain to the drug of composition and information defined, in a pharmaceutical form and determined dosage, prepared for immediate medical use, arranged and conditioned for dispensing to the public, with uniform denomination, packaging, packaging and labeling and to which the pharmaceutical authority grants sanitary authorization and registers in the Register of pharmaceutical specialties. This term has been almost completely replaced with the new law of guarantees and rational use of the drug and health products (LGRUM) of 2006 with the term of medicine and is only maintained for the generic name.
Generic Pharmaceutical Specialty (GF), also known as generic medicine, is the specialty with the same pharmaceutical form and the same qualitative and quantitative composition in medicinal substances as another specialty (bioequivalence), whose efficacy and safety profile is sufficiently established by its continued clinical use.
Each registration number will relate only to one composition, one dosage form per unit of administration and one presentation for sale.
To obtain sanitary authorization, a pharmaceutical specialty must satisfy the following conditions:
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