Vaccines
Cuatrecasas / Portugal
Join industry executives in staying informed on the market access and HTA process in Portugal.
1. What is the definition of a vaccine in your country?
According to the Decree Law 176/2006, 30 August 2006 (Medicinal Products Act), vaccines are classified as immunological medicinal products.
2. What are the classifications of vaccines in your country?
Under the aforementioned Decree Law, vaccines may be bacterial, viral, and live.
3. Describe the pricing process for vaccines in your country (based on their classifications).
The NHS reimburses the cost of vaccines prescribed within the national Immunization program. Everyone in Portugal has access to free and safe vaccination: the national immunization program allows everyone to be vaccinated according to their age and at the competent health services.
The administration of vaccines which are not included in the national Immunization program vaccines is under the responsibility of the patients. In this case, these vaccines follow the pricing processes established for other medicinal products. Therefore, please refer to the previous answers.
4. Describe the reimbursement approval process for vaccines in your country (based on their classifications).
Vaccines follow the general rules on reimbursement of medicinal products. Therefore, please refer to the previous answers.
5. Other than the clinical studies required, do the data and studies required for the pricing and reimbursement of vaccines differ from that of other drugs?
Vaccines are classified as immunological medicinal products and follow the procedures already described for other medicinal products.