FAQs about Generic Drugs

 

1. What is a Generic Drug?
   A generic drug is a drug which has the same active substance, dosage and dosage form, and the same therapeutic indication compared to the original registered product that served as reference.
   
   
2. How to identify a Generic Drug?
   Generic drugs are identified by initials (MG), inserted into the outer packaging of the product.
   
   
3. What guarantees do we have of quality, safety and effectiveness of Generic Drugs?
   According to the Decree Law 176/2006 of August 30th, the application form for marketing of generic drugs follows the laws of other medications, excluding the submission of pre-clinical and clinical studies. This applies only if it is demonstrated the bioequivalence trial based on bioavailability studies, or if they are not suitable, therapeutic equivalence through appropriate clinical pharmacology studies (these tests strictly follow the provisions of the European Community rules) or other requests that may be made by INFARMED.
   
   
4. How are Generic Drugs prescribed?
   They are prescribed by ICD of active substances, followed by dosage and dosage form, having the physician either to add the name of the marketing authorization application´s holder, or the name of the brand itself.
   
   
5. Advantages of Generic Drugs?
   a) Drugs whose active substances have been already present on the market for several years;
   b) Same safety and efficacy of the reference drug, which is demonstrated through bioavailability studies (Decree-Law 72/91 of February 8th);
   c) A generic drug is 20 to 35% cheaper than the reference drug, while having the same dosage and the same dosage form. (Ordinance No. 577/2001, June 7th)
   In short, generic drugs have the same quality, efficacy and safety in comparison to the reference drug but at lower prices.
   
   
6. Can i ask my doctor to prescribe me a Generic Drug?
   It depends on the illness and on what treatment the doctor considers more appropriate. If you know that there are generic alternatives to the medication that your doctor has prescribed you, discuss it with him/her with the intent of changing to the generic drug.
   Do not take the initiative to make changes in medication without first asking  your doctor.
   
   
7. Are Generic Drugs always reimbursed?
   Yes, if they contain active substances belonging to the therapeutic class in which the reimbursement is authorized. These pharmacotherapeutic groups are defined by the National Government.
   
   
8. Why are Generic Drugs cheaper than the reference drug?
   In setting the price of a reference drug the financial effort made by the laboratory that developed the active substance and the entire research that is associated with it is taken into account. For a generic drug price that aspect is, obviously, not valued and the price of generic drugs is always substantially lower (20 to 35%) compared to the reference drug price.