Life Sciences Newsletter No. 2/2021

New European regulation on medical devices comes into force

Last 26 May, Regulation (EU) 2017/745, of 5 April, came into force, establishing the rules applicable to the placing on the market, making available on the market or putting into service of all medical devices intended for human use, as well as accessories for such devices, with the sole exception of medical devices intended for in vitro diagnosis.

Some of the most relevant changes resulting from this legislative change are:

  • Broadening of the scope of application of the concept of medical device, to include, namely, software whose use has a medical purpose and implants, among others.
  • Manufacturers of implantable medical devices will now have to ensure that such devices are accompanied by an implant card, which must contain information allowing the device to be identified, including its designation and serial number, among others.
  • Institution of a unique device identification system, which will allow the identification of devices placed on the market, facilitating their traceability, working by assigning a unique identification number to each medical device, which will allow the tracking of the device throughout the entire commercial route to the end user.

Cannabis: Detailed rules for licensing in Portugal

Administrative Rule no. 83/2021, of 15 April, comes within the scope of Decree Law no. 15/93, of 22 January, which defines the legal regime applicable to the trafficking and consumption of narcotics and psychotropic substances, and of Regulatory Decree no. 61/94, of 12 October, which establishes the rules regarding the control of the legal market for narcotics and psychotropic substances.

This Administrative Rule defines the requirements and procedures for granting authorizations for activities related to the cultivation, manufacture, wholesale trade, transport, circulation, importation and exportation of medicines, preparations and substances based on the cannabis plant, for medicinal, medical-veterinary, and scientific research purposes.

The authorizations for cultivating the cannabis plant for other purposes, namely industrial purposes, as well as the respective safety measures to be adopted are also defined in this Administrative Rule.

Its main objective is to specify the rules that must be complied with for the licensing of activities related to that plant, thus constituting a relevant development in the legal regulation of this matter in Portugal.

Prohibition of advertising of discounts on the price of medicines in Portugal

On 19 May Decree-Law no. 36/2021 was published, adding to the ban on advertising of medicines, the ban on advertising of discounts on the price of medicines.

This prohibition covers all forms of advertising and is essentially justified on two grounds: the protection of public health & consumer interests, and the harm that could be caused to competition between pharmacies.

Thus, it was understood that discounts on medicines could lead to their inopportune and irrational consumption, jeopardizing an efficient and safe use of medicines.

In addition, discounts on medicines are seen as potentially aggravating the inequality of access to medicines, depending on whether patients live in more densely populated areas where there is greater competition between pharmacies or in less densely populated areas with less competition.

In this sense, discounts on the price of medicines whose advertising is prohibited will continue to be allowed, but the advertising of such discounts will be expressly prohibited whenever they are made on the prices of medicines subject to medical prescription, containing substances defined as narcotic or psychotropic, or which are co-paid by the Portuguese National Health System.

Legislative proposal for EU health technology assessment

On 24 March 2021, after more than three years of negotiation, the Council of the European Union agreed on a mandate to open negotiations with the European Parliament on a legislative proposal concerning joint work on health technology assessment.

Health technologies include medicinal products, medical devices or medical and surgical procedures, as well as measures for the prevention, diagnosis or treatment of illnesses used in healthcare.

This legislation provides, in particular, for the setting up of a coordination group including national health authorities whose work will mainly consist of clinical evaluation and joint scientific consultation on health technologies.

This proposal should benefit the Member States, the developers of health technologies and essentially the patients, by making these technologies more accessible to them.

Finally, this legislation aims to cut the red tape associated with companies’ procedures for placing health technologies on the market.

Simplified recognition of qualifications for health professionals in Portugal

Law 31/2021 was published on 24 May, amending Law 9/2009 of 4 March, which transposes into Portuguese law Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications.

This Law simplifies the procedures associated with the recognition of professional qualifications, namely for health professionals, such as doctors, nurses responsible for general care, dentists, midwives, pharmacists, and veterinary doctors.

As regards these professions, the new rules cover the recognition of qualifications obtained outside the European Union by a national of a Member State, allowing subsequent recognition of a qualification already recognized in another Member State based on certified professional experience of at least three years, or, in the case of nurses responsible for general care, allowing automatic initial recognition whenever certain requirements are met.

The Law also adds rules regarding the prior declaration concerning professional movement within the national territory, determining that the mere presentation of the declaration allows access to and exercise of the profession in the whole national territory, regardless of the authority to which it is presented.


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