New List Of Reimbursed Compounded Medicines

• Published date: 20 June 2023
• Subject Matter: Food, Drugs, Healthcare, Life Sciences, Food and Drugs Law, Biotechnology & Nanotechnology
• Law Firm: PLMJ
• Author: Mr Eduardo Nogueira Pinto, Ricardo Rocha and Tiago Linhares Carneiro

Ministerial Order 160/2023 of 12 June, which enters into force today, establishes the new list of reimbursed compounded medicines, with the addition of new reimbursed medicines to the list in force until now. This Ministerial Order also establishes the prescription and dispensing conditions on which the reimbursement of these medicines depends, as well as the conditions for the inclusion of new compounded medicines and the exclusion of compounded medicines from the reimbursement system.

A lista de medicamentos manipulados comparticipados é aprovada por portaria do membro do governo respons'vel pela 'rea da saúde, que determina igualmente a percentagem de comparticipaç'o.

Compounded medicines are classified as (i) magistral formulae if they are prepared in accordance with a medical prescription specifying the patient for whom the medicine is intended, or (ii) officinal formulae in the case of medicines prepared in accordance with the compendial indications of a pharmacopoeia or formulary. The list of reimbursed compounded medicines is approved by a ministerial order issued by the member of the government responsible for health. The order also establishes the reimbursement percentage.

Ministerial Order 160/2023 of 12 June stipulates that the reimbursement rate for compounded medicines included in the list published in the annex to the Ministerial Order is 30% of their price. This price is determined in accordance with the legislation in force¹. Access to the reimbursement also depends on compliance with the following prescription and dispensing conditions:

i) Prescriptions submitted electronically in accordance with the law must include the name of the compounded medicine and state the active ingredient and the pharmaceutical form in accordance with the annex to the above-mentioned Ministerial Order. They must also include the dosage, route of administration and quantity. The prescription may also contain a list of the excipients to be used and any other information necessary for the correct preparation of...