Health, Pharmacy and Biotech

As a rapidly expanding area, PRA offers specialized services in Health, Pharmacy and Biotech Law, based on solid specific education and over ten years of experience in the area.

PRA, through this unit, intends to provide its clients with a highly specialized consultancy service, designed in light of the specificities of each business, and which allows providing the client with all the tools to guarantee compliance with legality, optimization of resources and of means of production, and a prominent position in the market in which it operates.

PRA provides judicial and extrajudicial support, namely in terms of:

Regulation, licensing and conventions

▪ Regulatory compliance;

▪ Licensing of health establishments and pharmacies, including their transfer and all the matters associated with their regular operation;

▪ Licensing of entities holding authorizations for the wholesale distribution of medicines, distributors of medical devices and manufacturers of medical devices;

▪ Health Conventions (SNS, ADSE, etc.);

▪ Development and application of internal standards.

Pharmaceutical Industry

▪ Pharmaceutical distribution, community pharmacies, public and private hospital establishments, other operators in the pharmaceutical sector;

▪ Marketing authorization for reference medicines, generic medicines and medicines based on the cannabis plant;

▪ Import and export of medicines;

▪ Licensing of activities relating to medical cannabis – cultivation, manufacture, wholesale, import and export of medicinal products, preparations and substances based on the cannabis plant for medicinal purposes;

▪ Clinical trials;

▪ State contribution to the price of medicines;

▪ Food suplements;

▪ Cosmetic products.

Health and Pharmacy offenses

▪ Administrative offenses committed by health establishments, pharmacies and entities holding authorizations for the wholesale distribution of medicines (ERS, ARS, DGAS, INFARMED, etc.).

Medical malpractice and malpractice

▪ Civil, Criminal and Disciplinary Liability of Health Professionals – doctors, nurses, hospital managers, pharmacists, medical assistants;

▪ Civil liability of health establishments, pharmacies and entities holding authorizations for the wholesale distribution of medicines;

▪ Civil and Criminal Liability in the provision of non-conventional health techniques;

▪ Civil and Criminal Liability in the provision of health care by unqualified personnel.

Medical devices

▪ Registration of medical devices;

▪ Protection of intellectual property related to the development of medical devices;

▪ Confidentiality and exclusivity agreements.

Labor law of health professionals

Health data protection

Health care contracts

Advice on public procurement in the Health and Pharmacy area

Support in the institutional relationships of professionals, healthcare providers and pharmacies, including with:

▪ Professional associations;

▪ ACSS, ERS, ARS, INFARMED.

Other questions:

▪ Living will;

▪ Advertising in health and in the pharmaceutical sector;

▪ Registration of trademarks and patents;

▪ Compulsive internment;

▪ “Maior acompanhado” regime.