“Cannabis Law” for Medicinal Purposes, Decree-Law no. 8/2019
Translation of the Portugues cannabis law
Summary Regulates the use of cannabis medicines, preparations and plant-based substances for medicinal purposes
Decree-Law No. 8/2019 of January 15
Law No. 33/2018, of July 18, provides the legal framework for the use of medicines, preparations and substances based on the cannabis plant for medicinal purposes, namely their prescription and dispensing in pharmacies (the “Cannabis Law for Medicinal Purposes”).
In this legal framework, the principles and objectives regarding prescription, dispensing in pharmacy, detention and transport, scientific research, information for professionals, as well as regulation and supervision of activities related to the use of the cannabis plant for medicinal purposes were established.
Thus, it is important to set and frame the activities of cultivation, production, extraction and manufacturing, wholesale trade, import and export, transit, acquisition, sale and delivery of medicines, as well as the placing on the market of medicines and preparations and substances based on the cannabis plant intended for human use for medicinal purposes.
With regard to cannabis-based medicines, although they are medicines for human use, thus being applicable to the respective legal framework, namely Decree-Law No. 176/2006, of 30 August, in its current version, Decree-Law No. 97/2015, of 1 June, in its current version, and Decree-Law No. 282/95, of 26 October, in its current version, it is important to intensify and list the additional obligations arising from the Cannabis Law for Medicinal Purposes, specifically with regard to the rules applicable to prescription and dispensing.
With regard to cannabis-based preparations and substances, the specific rules relating to their use, in particular as regards their placing on the market, prescription, and dispensing, shall be implemented, without prejudice to the application of the existing general regime for narcotic and psychotropic substances.
The medicinal uses of cannabis-based preparations and substances are established and publicized as a result of controlled clinical trials, observational studies, systematic reviews, and meta-analyses of indexed international literature, these being the basis of the scientific evidence that has so far been produced regarding the medicinal use of cannabis.
In compliance with international drug control treaties, which stipulate that signatory countries allowing the medical use of cannabis and other drugs under control shall have structures directed at the control, production, and supply of cannabis for medical use, and in the light of Article 9(4) of the Cannabis Law for Medicinal Purposes, it is planned to create a specific office regarding medicinal cannabis with INFARMED – National Authority of Medicines and Health Products, I. P.
Also, and having regard to the provisions of Article 4 of the Cannabis Law for Medicinal Purposes, which provides that the Military Laboratory of Chemical and Pharmaceutical Products (LMPQ) can contribute to the production of medicines, preparations, and substances based on the cannabis plant, are established in accordance specifics of the application of the legal framework now introduced by this Decree-Law.
In this context, it was considered necessary to make changes to the Implementing Decree No. 61/94, of October 12, in order to adjust the existing regime for the narcotic and psychotropic substances, in order to allow for a better implementation of the regime introduced by the Cannabis Law for Medicinal Purposes, namely, by entering specificities in relation to the instruction of applications and procedures related to the granting of licences for the activities related to the cultivation, manufacturing, wholesale trade, import, export and transit of these specific substances.
The Association of Pharmaceutical Distributors, the Association of Portuguese Pharmacies, the National Association of Pharmacies, the Portuguese Association of the Pharmaceutical Industry, the Portuguese Association of Generic and Biogeneric Medicines, the Portuguese Pharmacists Association, and the Portuguese Doctors Association were heard.
The hearing of the Association of Wholesalers of Chemical and Pharmaceutical Products and NORQUIFAR – National Association of Importers/Storekeepers and Retailers of Chemical and Pharmaceutical Products was promoted.
So:
In accordance with Article 12 of Law No. 33/2018, of July 18, and of Article 198(1)(a) of the Constitution, the Government shall decree the following:
General provisions
Article 1
Object
1 – This Decree-Law regulates Law No. 33/2018, of July 18, which establishes the legal framework for the use of medicines, preparations, and substances based on the cannabis plant for medicinal purposes.
2 – This Decree-Law also makes the fourth amendment to Implementing Decree No. 61/94, of October 12, as amended by Implementing Decrees No. 23/99, of October 22, 19/2004, of April 30, and 28/2009, of October 12.
Article 2
Definitions
For the purposes of this Decree-Law, it is understood that:
(a) “Cannabis plant-based medicinal product” means a medicinal product which has exclusively as active substances (I) one or more substances derived from the cannabis plant; (ii) one or more cannabis plant-based preparations; or (iii) one or more cannabis plant-based substances in association with one or more cannabis plant-based preparations;
(b) “Cannabis plant-based preparations” means preparations obtained by subjecting substances derived from the cannabis plant to treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation, such as powdered or powdered cannabis plant-based substances, tinctures, extracts, essential oils, squeezed juices or processed exudates;
(c) “Cannabis plant-based substances ” means cannabis plants, or parts thereof, whether Whole, fragmented or cut, as well as exudates not subject to a specific treatment, or other substances defined by part of the cannabis plant used and the Botanical taxonomy, including the species, variety, and author.
CHAPTER I
General provisions
Article 1
Object
1 – This Decree-Law regulates Law No. 33/2018, of July 18, which establishes the legal framework for the use of medicines, preparations and substances based on the cannabis plant for medicinal purposes.
2 – This Decree-Law also makes the fourth amendment to Implementing Decree No. 61/94, of October 12, as amended by Implementing Decrees No. 23/99, of October 22, 19/2004, of April 30, and 28/2009, of October 12.
Article 2
Definitions
For the purposes of this Decree-Law, it is understood that:
(a) “Cannabis plant-based medicinal product” means a medicinal product which has exclusively as active substances (I) one or more substances derived from the cannabis plant; (ii) one or more cannabis plant-based preparations; or (iii) one or more cannabis plant-based substances in association with one or more cannabis plant-based preparations;
(b) “Cannabis plant-based preparations” means preparations obtained by subjecting substances derived from the cannabis plant to treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation, such as powdered or powdered cannabis plant-based substances, tinctures, extracts, essential oils, squeezed juices or processed exudates;
(c) “Cannabis plant-based substances ” means cannabis plants, or parts thereof, whether Whole, fragmented or cut, as well as exudates not subject to a specific treatment, or other substances defined by part of the cannabis plant used and the Botanical taxonomy, including the species, variety, and author.
CHAPTER II
Cultivation, manufacturing, wholesale trade, import, export, and transit
Article 3
Authorization for the exercise of activities
1 – The activities of cultivation, manufacturing, wholesale trade, import, export and transit of medicines, preparations or substances based on the cannabis plant for medicinal purposes, do not require authorization, in accordance with Article 4 of Decree-Law No. 15/93, of January 22, in its current version, and the exercise of these activities must observe the regime provided for in this decree, as well as in Implementing Decree No. 61/94, of October 12, in the wording introduced by this Decree-Law, and its regulations, without prejudice to the provisions of the following number.
2 – The exercise of the activities of manufacturing, wholesale trade, import and export of medicines, preparations, or substances based on the cannabis plant for medicinal purposes also observes the provisions of Chapters iii and Section iv of Chapter iv of Decree-Law No. 176/2006, of August 30, in its current version, with the necessary adaptations.
3 – The entities that obtain the authorization provided for in Paragraph 1 require, annually, its maintenance, adding for this purpose all the updates of the information contained in the initial authorization request, under penalty of expiration of the authorization.
4 – The applications referred to in the preceding paragraphs must be submitted on the website of INFARMED – National Authority of Medicines and Health Products, I. P. (INFARMED, I. P.), on the Internet.
5 – The activities referred to in Paragraph 1 are not authorized for their own use.
Article 4
System of good practices of cultivation, manufacturing, and distribution
The exercise of the activities of cultivation, manufacturing, wholesale trade, import, export, and transit of medicines, preparations, or substances based on the cannabis plant for medicinal purposes also obeys, depending on the activity developed, the following requirements:
a) Good agricultural and harvesting practices – Guideline on Good Agricultural and Collection Practice (GACP), published by the European Medicines Agency;
(B) Good manufacturing practices for active substances intended for medicinal products for human use, approved by the Commission’s Delegated Regulation (EU) No. 1252/2014 of May 28, 2014, that complements Directive 2001/83/EC of the European Parliament and of the Council, as regards the principles and guidelines for good manufacturing practices for active substances intended for medicinal products for human use;
c) Good manufacturing practices of medicines, provided for in Decree-Law No. 176/2006, of August 30, in its current version, which establishes the legal regime of medicines for human use, with the appropriate adaptations;
(d) Good practices for the distribution of active substances and medicinal products, established within the framework of the European Union.
CHAPTER III
Introduction and placing on the market
SECTION I
Marketing
Article 5
Marketing authorisation
The marketing of cannabis plant-based medicines for medicinal purposes is subject to a marketing authorization (AIM), provided for and regulated in Decree-Law No. 176/2006, of August 30, in its current version.
SECTION II
Placing on the market
Article 6
Placing on the market authorization
1 – The placing on the market of cannabis plant-based preparations or substances for medicinal purposes is subject to a placing on the market authorization (PMA).
2 – The granting of a PMA does not prejudice the possible liability, civil or criminal, of its holder.
Article 7
Investigation and admission of the application for placing on the market authorization
1 – In the application for the granting of PMA, addressed to the president of the highest body of INFARMED, I. P., it should be stated:
a) Name or firm;
B) Domicile or head office, in Portugal or in another member state of the European Union;
(c) Taxpayer identification number or legal person identification number, unless the applicant has his head office, domicile or principal place of business in another member state of the European Union, in which case he must indicate the equivalent national identification number;
(d) Proposed name for the cannabis plant-based preparation or substance;
e) Proof of payment of the fee due.
2 – The request is also instructed with the elements, information and documents provided for in Annex I of this Decree-Law and of which it is an integral part.
3 – The form for the application for the grant of the PMA is available on the website of INFARMED, I. P., on the Internet.
4 – The request is subject to preliminary rejection when it does not comply with the provisions of the preceding paragraphs.
5 – INFARMED, I. P., must, within 10 days, assess the regularity of the request.
6 – After the period foreseen in the previous number has elapsed without the INFARMED, I. P., notifying the applicant of the respective preliminary refusal, the application is admitted, being analyzed in accordance with the following article.
Article 8
Analysis and decision of the marketing authorization application
1 – INFARMED, I. P., decides on the application for the PMA within 90 days, counted from the date of admission of the application.
2 – When INFARMED, I. P., notifies the applicant to provide, within a period fixed for that purpose, the necessary elements, clarifications, and transmission of documents, the period referred to in the preceding paragraph shall be suspended until the date on which the applications are satisfied.
3 – In the analysis of the PMA request, INFARMED, I. P., considers the safety of the use of the plant-based preparation or substance of cannabis, namely its pharmaceutical form, route of administration, and current technical and scientific knowledge.
4 – Without prejudice to the provisions of the preceding paragraph, INFARMED, I. P., rejects the application for the request authorization whenever it concludes that:
a) The documents submitted are not in conformity;
b) The qualitative or quantitative composition does not correspond to that declared;
c) Pharmaceutical quality is not properly demonstrated; or
d) The cannabis plant-based preparation or substance does not guarantee the safety of its use.
5 – The decision of the PMA request is notified to the applicant and published on the website of INFARMED, I. P., on the Internet.
6 – It is assigned by INFARMED, I. P., a registration number for cannabis plant-based preparations and substances for medicinal purposes which are authorised under the terms of this article.
7 – INFARMED, I. P., provides an up-to-date list of the substances and preparations possessing a PMA on its website.
8 – After notification of the decision granting the request, the holder communicates to INFARMED, I. P., the price to be charged for the cannabis plant-based preparation or substance for medicinal purposes, in accordance with the price regime provided for in an ordinance to be approved by the member of the government responsible for health.
Article 9
Validity of the marketing authorisation
1 – The PMA is valid for a period of five years, subject to renewal in accordance with the following article.
2 – After the first renewal, the PMA is considered valid for an indefinite period, without prejudice to the provisions of the following paragraph.
3 – INFARMED, I. P., may, for pharmacovigilance-related reasons, determine that the renewal of the PMA is only valid for a period of five years.
Article 10
Renewal of the marketing authorization
1 – The application for renewal is submitted at least 9 months in advance of the expiration of the PMA’s validity period, accompanied by all information, elements, and documents relating to any changes introduced since the granting of the initial PMA, namely updated complementary documentation demonstrating the adaptation to the technical and scientific progress of the authorized preparation or substance.
2 – With the application for renewal, the applicant shall also provide the draft summary of the characteristics of the preparation or substance, labeling and instructions for use, duly updated, as well as a description of the situation with regard to pharmacovigilance data.
3 – The request is subject to preliminary rejection when it does not comply with the provisions of the preceding paragraphs.
4 – INFARMED, I. P., must, within 10 days, assess the regularity of the request.
5 – After the period provided for in the preceding paragraph has elapsed without INFARMED, I. P., notifying the applicant of the respective preliminary refusal, the application for renewal is considered admitted, being analyzed in the following paragraphs.
6 – INFARMED, I. P., decides on the application for renewal of the PMA within 60 days from the date of admission of the application, based on the criteria provided for in Article 8
7 – When INFARMED, I. P., notifies the applicant to provide, within a period fixed for this purpose, the necessary elements or clarifications, the period referred to in the preceding paragraph shall be suspended until the date on which such elements or clarification are provided.
8 – The decision on the application for renewal of PMA is notified to the applicant, being published on the website of INFARMED, I. P., on the Internet.
9 – If the application for renewal is not submitted within the fixed period, is not admitted, or is the object of rejection, the PMA expires at the end of the established validity period or at the end of the period determined in the decision of rejection, as the case may be.
Article 11
Amendments to the marketing authorization
The changing of the terms of a PMA depends on the authorization of INFARMED, I. P., following the respective procedure, with the necessary adaptations, the provisions of Articles 7.º and 8.º
Article 12
Obligations of the marketing authorization holder
The holder of the PMA must:
a) Marketing cannabis plant-based preparations or substances for medicinal purposes, assuming all legal responsibilities for their placing on the market;
B) Ensure the monitoring of scientific and technical progress, submitting to INFARMED, I. P., the respective change requests, where necessary;
c) Submit to INFARMED, I. P., the preparations, substances, raw materials, intermediate products, and other components, whenever required, namely for the purpose of proving the quality of cannabis plant-based preparations and substances;
d) Ensure, within the limits of their responsibilities, in conjunction with wholesale distributors, the adequate and continuous supply of cannabis plant-based preparations and substances in the relevant geographic market, in order to meet the needs of patients;
e) Notify INFARMED, I. P., of the beginning of the marketing, as well as of any interruption thereof, whether temporary or permanent, accompanied by the respective rationale;
F) To transmit to INFARMED, I. P., when requested for this purpose, any information relating to cannabis plant-based preparations and substances, as well as to the protection of public health, namely data relating to the market supply;
g) Comply with the rules governing advertising, labeling, and instructions for use relating to cannabis plant-based preparations and substances, in accordance with Annex ii of this Decree-Law, which is an integral part thereof;
h) Comply with the pharmacovigilance obligations laid down in Article 15;
i) Ensure compliance with the system for the prevention and collection of cannabis plant-based preparations and substances, in accordance with Article 178 of Decree-Law No. 176/2006, of August 30, in its current version.
Article 13
Suspension or revocation
1 – INFARMED, I. P., can reasonably decide to suspend, for a period fixed in the respective decision, or to revoke the PMA, when there are objective reasons to consider that the conditions on which the respective authorization was based are no longer fulfilled or that there is a risk to health.
2 – The suspension or revocation of the PMA may entail the withdrawal from the market of the cannabis plant-based preparation or substance, within the terms and for the period fixed in the respective decision.
Article 14
Advertising
The advertising arrangements for medicinal products provided for in articles 150 to 165 of Decree-Law No. 176/2006, of August 30, in its current version, is applicable, with the necessary adaptations, to preparations and substances based on the cannabis plant.
Article 15
Monitoring and security
1 – INFARMED, I. P., monitors the safety of the uses of cannabis plant-based preparations and substances, through the critical and contextualized evaluation of the reports of suspected adverse reactions potentially associated with their use.
2 – Reports of suspected adverse reactions should be made to INFARMED, I. P., by health professionals, PMA holders, and users of cannabis plant-based preparations and substances.
3 – The PMA holders must have a technical officer and the appropriate means to analyze all suspected adverse reactions that they are aware of, and that may result from the use of their cannabis plant-based preparations or substances.
4 – Suspicious adverse reaction detected by the user of cannabis plant-based preparations or substances must be previously communicated by himself to a health professional, preferably to the doctor responsible for the prescription.
5 – INFARMED, I. P., defines and approves, in its own regulation, the necessary requirements for the implementation of the provisions of this article.
Article 16
Rates
1 – The following acts are subject to the payment of fees, to be charged by INFARMED, I. P.:
a) PMA request – (euro) 1,800.00;
b) Application for renewal of the PMA – (euro) 1,000.00;
c) Request for amendment to the PMA – (euro) 500.00.
2 – The payment of the fees referred to in the preceding paragraph is a condition for the continuation of the requests to which they relate.
3 – The marketing of preparations or substances based on the cannabis plant is subject to the payment of the marketing fee, as well as the respective regime, provided for in Decree-Law No. 282/95, of October 26, in its current version, with the necessary adaptations.
4 – The proceeds of the fees referred to in the preceding paragraphs constitute INFARMED’s own revenue, I. P.
5 – The Military Laboratory of Chemical and Pharmaceutical Products (LMPQ) is exempt from paying the fees referred to in this article.
6 – It is the duty of the Tax and Customs Administration, in accordance with the Code of Procedure and Tax Procedure, to promote the coercive collection of debts arising from the non-payment of the marketing fee applicable to preparations or substances based on the cannabis plant, serving as an executive title the certificate passed for this purpose by INFARMED, I. P.
CHAPTER IV
Prescription and dispensing
Article 17
Prescription
1 – The prescription of cannabis plant-based medicinal products, preparations and substances for medicinal purposes is only allowed in cases where it is determined that conventional treatments with authorized drugs are not producing the expected effects or cause relevant adverse effects.
2 – INFARMED, I. P., defines, through a deliberation of the directive board published on its website, the list of therapeutic indications considered appropriate for the prescription of cannabis plant-based preparations and substances for medicinal purposes.
3 – The list referred to in the preceding paragraph is periodically revised, according to the evolution of technical and scientific knowledge.
4 – The prescription is also limited to the list of medicines, preparations and substances authorized by INFARMED, I. P., and made available on its website.
5 – The prescription is carried out electronically, in accordance with the rules relating to the prescription of medicines and health products, and must be adapted according to the provisions of this Decree-Law.
6 – The prescription of medicines, preparations and substances based on the cannabis plant for medicinal purposes also observes the provisions of Article 5 of Law No. 33/2018, of July 18, as well as the rules established in Decree-Law No. 176/2006, of August 30, in its current version, in Decree-Law No. 15/93, of January 22, in its current version, and other legislation applicable to medicines for human use.
Article 18
Dispensing
1 – Medicines, preparations, and substances based on the cannabis plant prescribed for medicinal purposes are dispensed in a pharmacy, upon presentation of the medical prescription referred to in the previous article, and upon verification of the identity of the acquirer.
2 – If the prescription is intended for minors or adults accompanied, plant-based medicines, preparations, and substances for medicinal purposes should be dispensed only to those who hold and prove the exercise of their parental responsibilities, the bond of guardianship or adult’s supervision, as applicable.
3 – In the act of dispensing, the necessary instructions for the correct use of cannabis plant-based medications, preparations, and substances are made available to the patient.
4 – The dispensing of cannabis plant-based medicines, preparations, and substances for medicinal purposes also observes the provisions of Article 6 of Law No. 33/2018, of July 18, as well as the rules provided for in Decree-Law No. 176/2006, of August 30, in its current version, in Decree-Law No. 15/93, of January 22, in its current version, and other legislation applicable to medicines for human use.
CHAPTER V
Inspection, violations and penalties
Article 19
Inspection
For the purposes of exercising the supervisory powers of INFARMED, I. P., the provisions of Decree-Law No. 15/93, of January 22, in its current version, in articles 176 to 179 of Decree-Law No. 176/2006, of August 30, in its current version, and Implementing Decree No. 61/94, of October 12, in the wording introduced by this Decree-Law, with the necessary adaptations, are applicable.
Article 20
Violations, fines, and additional penalties
1 – The violation of the following obligations constitutes an offense:
- a) The placing on the market of cannabis plant-based preparations and substances for medicinal purposes without the respective PMA;
- B) Failure to comply with the obligations of the holder of the PMA provided for in Article 12;
(c) Violation of the advertising regime provided for in Article 14;
(d) Failure to comply with the prescription and dispensing obligations provided for in Articles 17 and 18
2 – The offenses provided for in the preceding paragraph are punished with a fine in the amount of:
- a) (euro) 1,500.00 to (euro) 3,740.98 in the case of natural persons; and
- b) (euro) 3,000.00 to (euro) 44,891.81 in the case of legal persons.
3 – Negligence and attempt are punishable, with the minimum and maximum amounts of the fine being reduced to half the amounts set in the preceding paragraph.
4 – Whenever the seriousness of the violation and the fault of the agent justifies it, INFARMED, I. P., may, in addition to imposing the fines to which it applies, proceed to apply the following additional penalties:
- a) Loss in favor of the State of illicit objects, equipment, and devices;
- b) Prohibition of the exercise of the respective activity, up to a maximum of two years;
- c) Deprivation of the right to participate in public tenders, up to a maximum of two years;
- d) Suspension of authorizations, licenses, or other entitlements, up to a maximum of two years.
5 – The provisions of the preceding paragraphs are applicable without prejudice to the administrative offenses regime provided for in Decree-Law No. 15/93, of January 22, in its current version, in Decree-Law No. 176/2006, of August 30, in its current version, and in Implementing Decree No. 61/94, of October 12, in the wording introduced by this Decree-Law.
CHAPTER VI
Final and transitional provisions
Article 21
Technical rules on prescription and dispensing
The technical standards regarding the prescription and dispensing of medicines and health products are reviewed by INFARMED, I. P., in accordance with the provisions set out in this Decree-Law for the prescription and dispensing of cannabis plant-based preparations and substances for medicinal purposes.
Article 22
Amendment to Implementing Decree No. 61/94, of October 12
Articles 13, 22, and 43 of Implementing Decree No. 61/94, of October 12, in its current version, are replaced by the following:
“Article 13
[…]
1 – […].
2 – […].
3 – […].
4 – […].
5 – The holder of the authorization for cultivation must keep up-to-date records of all the inputs and outputs of the plant species included in Tables I and ii, which ensure the traceability of the product resulting from the activity and compliance with the provisions of Articles 31 et seq.
Article 22
[…]
1 – […].
2 – […].
3 – INFARMED, I. P., for public health reasons or in view of the international commitments undertaken and in accordance with the rules arising from the United Nations conventions, may set limits on the quantities of substances and preparations mentioned in Tables I, ii, and iv to be the object of cultivation, manufacturing, wholesale trade, import or export activities.
Article 43
[…]
1 – […]:
- a) For cultivation – (euro) 3,000.00;
- b) For manufacturing – (euro) 3,000.00;
- c) […];
- d) […];
- e) For import – (euro) 1,200.00;
- f) For export – (euro) 1,200.00;
- g) For wholesale trade, including transport and circulation – (euro) 1,000.00.
2 – […].
3 – […].
4 – […].»
Article 23
Amendment to Implementing Decree No. 61/94 of October 12
Articles 6(A) and 36(A) are added to Implementing Decree No. 61/94, of October 12, with the following wording:
«Article 6(A)
Requirements
The appraisal of requests and procedures related to the granting of authorizations for the exercise of activities related to the cultivation, manufacturing, wholesale trade, transit, import, and export of cannabis plant-based medicines, preparations, and substances for medicinal, medical-veterinary, or scientific research purposes, as well as authorizations to exercise the activity of cultivation of the cannabis plant for other purposes, namely industrial, as well as the security measures to be taken, are defined by an ordinance of the members of the Government in charge of finance, internal administration, justice, health, economy, and agriculture areas.
Article 36(A)
Security measures
1 – The security measures to be established in the ordinance provided for in Article 6(a) observe the technical characteristics enshrined in Ordinance No. 273/2013, of August 20, in its current version.
2-entities wishing to carry out the cultivation and manufacturing activities provided for in the previous paragraph must also have a safety officer who meets the requirements of the category of safety director provided for in Article 22 of Law No. 34/2013, of May 16.»
Article 24
Subsidiary legislation
The use of cannabis plant-based medicines, preparations, and substances for medicinal purposes must also observe, with the necessary adaptations, the provisions of the following diplomas:
- a) Law No. 33/2018, of July 18;
- b) Decree-Law No. 15/93, of January 22, in its current version;
- c) Decree-Law No. 176/2006, of August 30, in its current version,
- d) Decree-Law No. 97/2015, of June 1, in its current version;
- e) Implementing Decree No. 61/94, of October 12, in the wording introduced by this Decree-Law;
- f) Other legislation applicable to medicines for human use.
Article 25
Military Laboratory of Chemical and Pharmaceutical Products
1 – The LMPQ is legally authorized to produce medicines, preparations, and substances based on the cannabis plant, under the provisions of Article 4 of Law No. 33/2018, of July 18, being exempt from the request for authorization and obtaining the respective authorization provided for in the first part of Article 3(1).
2 – Without prejudice to the provisions of the preceding paragraph, the LMPQ, in the exercise of the activity of the production of medicinal preparations and other substances on the base of the plant of cannabis, says the arrangements provided for in this decree-law, in addition to the provisions of Decree-Law No. 15/93, of January 22, in its current version, on chapter III of Decree-Law No. 176/2006, of August 30, in its current version and with the necessary adaptations, and the Implementing Decree No. 61/94, on October 12, the writing was introduced to it by this decree-law.
3 – LMPQ communicates to INFARMED, I. P., the start of the activity of producing cannabis plant-based medicines, preparations, and substances, and can only start it after confirming compliance with the legal standards applicable to the exercise of the same, and registering of this activity by INFARMED, I. P., duly notified to the LMPQ.
4 – For the purposes of the provisions of the preceding paragraph, LMPQ provides INFARMED, I. P., with all necessary information.
5 – LMPQ is exempt from paying the fees provided for in Implementing Decree n.º 61/94, of October 12, in the wording introduced by this Decree-Law.
Article 26
Transitional provision
Entities holding an authorization for the cultivation, manufacturing, and wholesale distribution of medicines containing narcotic and psychotropic substances, granted under the provisions of Decree-Law No. 176/2006 of August 30, as currently drafted, and Decree-Law No. 15/93 of January 22, as currently drafted, shall adopt the security measures provided for in Article 36(A) of Implementing Decree No. 61/94, of October 12, in the wording introduced by this Decree-Law, within 90 days from the date of entry into force of the ordinance provided for in Article 6(A) of the same Implementing Decree, under penalty of expiration of the authorization.
Article 27
Entry into force
This Decree-Law shall enter into force on the first day of the month following its publication.
Seen and approved in the Council of Ministers on December 13, 2018. – Augusto Ernesto Santos Silva – Ricardo Emanuel Martins Mourinho Félix – Helena Maria Mesquita Ribeiro – Pedro Gramaxo de Carvalho Siza Vieira – Marta Alexandra Fartura Braga Temido de Almeida Simões – Luís Manuel Capoulas Santos.
Promulgated on December 26, 2018.
Shall be published.
The President of the Republic, Marcelo Rebelo de Sousa.
Referendum on January 7, 2019.
The Prime Minister, António Luís Santos da Costa.
ANNEX I
(referred to in Article 7(2))
1 – Identification of cannabis plant-based preparation/substance:
- a) Name;
- b) Type of preparation/substance;
- c) Statement of composition and content;
- d) Pharmaceutical form;
- e) Route of administration;
- f) Packaging;
- g) Packaging size;
- h) Shelf life and storage conditions;
(i) Labelling;
- j) Instructions necessary for proper use.
2 – Identification of stakeholders in the cannabis plant-based preparation/substance production chain:
- a) Plant supplier;
- b) Manufacturer of the plant-based preparation/substance;
- c) Distributor/importer.
3 – Documents to be submitted:
- a) Copies of the manufacturing authorizations and the certificate of Good Manufacturing Practices for Medicinal Products;
- b) Declaration by the plant supplier of compliance with Good Agricultural and Harvesting Practices (GACP);
- c) Proof of compliance by the plant supplier with the legislation in force in the country of origin for the cultivation of the cannabis plant;
(d) Proof that the manufacturing of the preparation/substance complies with the rules of the country of origin, in the case of imported preparations/substances;
- e) Documentation demonstrating the quality of the cannabis plant-based substance/preparation for medicinal use, in accordance with the specific guidelines for herbal medicines and preparations, published on the European Medicines Agency (EMA) website.
ANNEX II
(referred to in Article 12(g)]
1 – The labeling must be written in Portuguese and contain the following mentions:
Product’s name
Type of preparation/substance
Statement of composition and content
Pharmaceutical form
Shelf life
Storage conditions
Indication for use
Manufacturing batch number
Authorization registration number
2 – The instructions for use in Portuguese must contain the form of preparation and/or administration of the cannabis plant-based preparation/substance for medicinal purposes, accompanied by a brief clear, and objective description, in Portuguese, and written in a simple and accessible way to the user. The instructions for use that may be approved for each preparation should contain all the information necessary for its correct use/prescription, warning of possible side effects and the risk of developing addiction, and it should also be stressed that any treatment should be started with minimum doses to be indicated by the doctor, and this minimum dose should be adjusted according to the pharmacological effects obtained and any side effects that may occur.
3 – The instructions for use are approved by INFARMED, I. P., and made available, in an appropriate place, on the INFARMED website, I. P.
Frequently Asked Questions
Most frequent questions and answers
You can apply for medical cannabis license at the INFARMED
Infarmed is the National Authority of Medicines and Health Products.
You can apllay for medical cannabis cultivation license at the Infarmed website?