Decreto-Lei n.º 8/2019
- Emissor:Presidência do Conselho de Ministros
- Entidade Proponente:Saúde
- Tipo de Diploma:Decreto-Lei
- Páginas:184 - 191
Summary in plain english (Without legal value)
What is it?
This decree-law regulates the Law of Cannabis for Medical Use, establishing the rules for its usage.
What is going to change?
The existing rules for the concession of licenses for the exercise of activities regarding cannabis, for medicine and mixtures/substances are created and framed
The cultivation, production, wholesale trade, import and export of medicine and the mixtures and substances may only be carried out after duly authorized by INFARMED, which license must be annually updated.
The submission of the license request is established by a decree.
These activities must also obey to a good practices and safety rules system, regarding the cultivation, production and distribution of medicine, mixtures and substances.
Specific rules on the placing on the market, prescription and provision of mixtures/substances are created
For the mixtures/substances to be made available on the market, a placing on the market license (ACM) is necessary.
Proceedings to obtain a license:
- Request submitted to INFARMED with all the necessary elements and information, namely within the scope of the quality and safety guarantee of the cannabis mixture/substance.
- INFARMED analyses the request within 90 days, considering the mixture/substance’s usage safety for human use.
- If the request is accepted, INFARMED grants a registry number to the mixture/substance and publishes online an updated list of the substances and mixtures with an ACM.
The ACM is valid for five years and renewable. The amendments to the ACM also depend on the INFARMED’s consent.
The person authorized to place the cannabis mixtures/substances on the market must:
- communicate the price assigned to the mixture;
- sell the mixtures/substances, taking all the responsibilities for its placing on the market;
- collaborate with INFARMED, namely by notifying it of the beginning of the sales and submitting the mixtures for quality control, whenever required, among others;
- keep the registries updated with all the inputs and outputs regarding the cultivation, production, distribution and provision activities.
The mixtures/substances with the cannabis plant for medical use may only be prescribed if the conventional medicine do not show the desired effects and according to a list of therapeutic indications deemed appropriate by INFARMED.
The pharmacy may only sell the cannabis mixtures/substances upon submission of the medical prescription, informing the patient of its correct use.
What advantages does it bring?
This decree-law aims to enable the patients’ access to therapies with the use of cannabis mixtures and substances, which before was not legally accepted.
When does it enter into force?
This decree-law enters into force on the first day of the month following its publication.