This is the second article in a series on the use of substances and preparations based on the cannabis plant for medicinal purposes in Portugal.(1)

How are cannabis-based medicinal preparations and substances placed on the market?

Those who wish to place cannabis-based medicinal preparations and substances on the market must obtain a marketing placement authorisation (MPA) from the National Authority for Medicines and Healthcare Products (INFARMED). This is a different authorisation to that which is required for medicines.

MPA applications must be accompanied by various information, including the following:

  • the identification of the preparation or substance;
  • the identification of those involved in the production chain of the preparation or substance;
  • the authorisations that have already been granted; and
  • proof of compliance with good practice or the applicable legislation (eg, copies of manufacturing authorisations and the Good Manufacturing Practice for Medicinal Products certificate).

To determine the outcome of the application, INFARMED will consider the preparation or substance's safety, including:

  • its pharmaceutical form;
  • its administration route; and
  • relevant technical and scientific knowledge.

INFARMED will reject applications if:

  • the documents submitted do not comply with the requirements;
  • the preparation or substance's qualitative or quantitative composition does not correspond to that which was declared;
  • the preparation or substance's pharmaceutical quality has not been properly demonstrated; or
  • the preparation or substance's safety is not guaranteed.

INFARMED publishes a list of preparations and substances to which it has granted an MPA on its website.

Medicinal products have specific legal rules which determine the need for a marketing authorisation.

How long does it take to obtain an MPA?

According to the applicable legislation, it takes approximately 100 days from the submission of the application to obtain an MPA.

Where INFARMED requests additional documents or clarification, the procedure is suspended until they have been submitted. This may lengthen the overall time required.

For how long are MPAs valid?

MPAs are valid for five years, although they can be renewed. After its first renewal, an MPA is considered valid for an indefinite period, unless INFARMED determines that it is valid for only a further five years for pharmacovigilance reasons.

How can applicants renew an MPA?

Applicants must submit MPA renewal applications at least nine months before the MPA expires. Renewal applications must detail any changes that have occurred since the first MPA was granted, including:

  • any updated complementary documentation that evidences the preparation or substance's adaptation to technical and scientific progress;
  • a summary of the preparation or substance's characteristics;
  • the preparation or substance's updated labelling and usage instructions; and
  • a description of the situation regarding the preparation or substance's pharmacovigilance data.

How much does it cost to obtain, renew or amend an MPA?

Initial MPA applications cost €1,800. MPA renewal or variation applications cost €1,000 and €500, respectively.

How is the price of cannabis-based medicinal preparations and substances determined?

Following the grant of an MPA, the MPA holder proposes a price for its preparation or substance to INFARMED. This price includes:

  • the trade margins, which are defined by agreement between those that operate in the production and distribution sectors; and
  • the legally applicable fees and taxes.

Within 15 business days of receiving the price proposal, INFARMED may object to the proposed price if it is disproportionate to that which is charged on the international market where the preparation or substance in question is already being sold. If INFARMED objects, MPA holders must submit a new price. If INFARMED does not object during the 15-business-day period, the proposed price is deemed to be accepted.

MPA holders may revise the preparation or substance's price at any time by following the same procedure.

Where can cannabis-based medicinal preparations or substances be sold and under what conditions?

Medicinal preparations or substances based on the cannabis plant may be sold in pharmacies subject to medical prescription.

They may be prescribed only:

  • if conventional treatments with authorised medicines have not produced the expected effects or have caused significant adverse effects; and
  • for the following therapeutic indications:
    • spasticity associated with multiple sclerosis or spinal cord injuries;
    • nausea or vomiting resulting from chemotherapy, radiotherapy or combined HIV and hepatitis C medication;
    • appetite stimulation in palliative care of patients undergoing cancer or AIDS treatment;
    • chronic pain associated with cancer or diseases of the nervous system (eg, in case of neuropathic pain caused by nerve damage, phantom limb pain or trigeminal neuralgia or after shingles);
    • Tourette's syndrome;
    • epilepsy and severe seizure disorders in childhood (eg, Dravet syndrome or Lennox-Gastaut syndrome); and
    • glaucoma that is resistant to therapy.

The list of approved therapeutic indications is reviewed periodically according to scientific and technical developments.

Endnotes

(1) For the first article in the series, please see "Cannabis for medicinal purposes: licensing FAQs".