Portugal
| Topic | Details |
| Relevant statutory law(s) |
Decree-Law 176/2006 of 30 August (as amended) on the legal framework of medicinal products for human use, available here. Decree-Law 145/2009 of 17 June (as amended) on the rules to which research, manufacture, marketing, putting into service, survellaince and advertising of medical devices and their accessories must conform, available here. Decree-Law 5/2017 of 6 January on general principles of medicinal products and medical devices advertising, available here. Order 1542/2017 issued by the Secretary of State for Health, available here. Order 5657/2017 issued by the Secretary of State for Health, available here. |
| Industry code(s) of conduct |
APIFARMA’s Code of Ethics for promotion practices of the pharmaceutical industry and interaction with healthcare professionals and health organizations, available here. APIFARMA’s Code of Conduct governing the relations between the pharmaceutical industry and patients’ associations, patients advocates, patients experts, patients and caregivers, available here. APIFARMA’s Communication and Public Relations in the Pharmaceutical Industry - Code of Good Practice for Communication, available here. APORMED’s Code of Good Commercial Practices, available here. |
| Other | INFARMED's Information Circulars |
Please also see European Union.
Portugal
| Topic | Details |
| Competent authority/authorities enforcing the above statutory law(s) |
National Authority for Medicine and Health Products (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P. – INFARMED) |
| Competent authority/authorities enforcing the above code(s) of conduct |
Portuguese Association of the Pharmaceutical Industry (Associação Portuguesa da Indústria Farmacêutica – APIFARMA) Portuguese Association of Medical Devices Companies (Associação Portuguesa das Empresas de Dispositivos Médicos – APORMED) |
| Competent authorities enforcing any other provisions indicated above | Not applicable |
Please also see European Union.
Portugal
| Topic | Detail |
| Restrictions on event locations (e.g., events abroad, touristic locations, mountain or beach locations during winter/summer season, etc) | Please refer to our answer below. |
Please also see European Union.
Portugal
| Topic | Details |
| Restrictions or requirements regarding event venues (e.g., resorts, castles, SPAs, proximity to transport connections or centers with relevant medical expertise, etc) |
The places selected should be appropriate from a professional, operational, and economic standpoint in view of the purpose of the event. The programme of the event (a) should be directly related to the professional activity of the participating healthcare professionals or to be relevant enough to justify their attendance (b) may include as lunches and dinners that take place during the event; and (c) cannot include entertainment activities (for example, leisure, recreation or sports). No event may be held in venues renowned for their leisure, entertainment, sport, or luxury and extravagance facilities. Particularly, the following venues are likely not to be permitted:
The events should be held in Portugal, unless it is logistically more reasonable to hold the event in another country (a) taking into account the home countries of most of the participants; or (b) taking into account the location of the relevant resources or knowledge which are the object or topic of the event. |
Please also see European Union.
Portugal
| Topic | Details |
| Restrictions or requirements regarding accommodation provided to HCPs (e.g. five star hotels, maximum number of nights, minimum duration of events, etc.) | Accommodation provided to HCPs may not exceed the period between the day prior to the beginning of the event and the day after the end of the event. Hotel must not exceed that of four stars. Resorts and hotels offering sports activities (e.g. golf clubs) should be avoided. |
Please also see European Union.
Portugal
| Topic | Detail |
| Restrictions on air travel (e.g. economy class only; minimum flight duration for business class) | The most direct route should be booked, without the allowance of more time at the destination than is reasonably justified to enable the HCP to effectively participate in the event/s. Economy-class air travel only. Exceptionally, business class tickets may be offered following assessment on a case-by-case basis, particularly considering flight duration (more than five hours). |
| Restriction on train transportation (class; duration; etc.) | Please refer to the answer above. |
| Other restrictions regarding travel | Travel expenses must be directly paid by travel agencies appointed by the pharmaceutical companies. |
Please also see European Union.
Portugal
| Topic | Details |
| Limitation on providing meals (e.g. only refreshment for events lasting for half a day or more) | No specific rules |
| Maximum value for meals (e.g., EUR 60) – please specify by meal (breakfast, lunch, dinner) where applicable | EUR60 maximum per meal in the national territory and EUR90 in international events (unless the country in which the event takes place has a different Code of Ethics or national legislation, in which case such different amount shall apply, even if it is higher). |
| Restrictions on where meals can be provided? (e.g. no Michelin-starred restaurant) | Luxury restaurants or similar excessive venues should be avoided. Hospitality granted in connection with the events should be of a reasonable level and not exceed what healthcare professionals participating in the event would be willing to pay for themselves. |
| Other restriction (e.g. no alcohol may be offered) | Not applicable |
Please also see European Union.
Portugal
| Topic | Details |
| Rules applicable to family members travelling together with HCPs to the event location. | “Support may only be granted to the individual HCP(s) who is (are) genuinely participating in the related event. |
Please also see European Union.
Portugal
| Topic | Details |
| Rules originally designed for traditional events (described in previous points) but applicable also to online conferences | There are no specific rules applicable to online conferences. Rules applicable to the traditional events apply with the necessary adjustments. |
| Additional rules applicable specifically to online conferences (incl. communication / advertising rules in relation to events attended by multinational audience) |
There are no specific rules applicable to online conferences. Rules applicable to the traditional events apply with the necessary adjustments. Events conducted exclusively by virtual means are exempted from check for a positive evaluation on the e4ethics online event preassessment platform (when applicable). |
Please also see European Union.
Portugal
| Topic | Details |
| Specific rules applicable to promotional events organized by/on behalf of MAH in comparison to independent scientific events described in previous points (incl. event location, venue, accommodation, transport, meals, family members, online conferences | Rules applicable to scientific and professional events also apply to promotional events organized by/on behalf of MAH. |
Please also see European Union.
Portugal
| Topic | Details |
| Specific rules on engaging or interacting with HCPs in regard of medical devices |
Please refer to our answers above, which are applicable to medical devices in general terms. Please find below some further specific information although not exhaustive. Regarding virtual events, APORMED’s Code of Good Commercial Practices states that the associated companies may provide financial or in-kind support to virtual events. The location and space of the events should not be the main attraction and the events and shall take place in or near cities that are a recognized scientific or business centre, appropriate for the organization of the event. The choice of location and venue should always consider the following:
Entertainment includes, among other, programmes where dancing or live music are the main attraction, sightseeing tours, excursions such as trips to the theatre, sporting events such as skiing, golf or football matches, and other recreational and leisure programmes. No payments and reimbursements of accommodation costs in top-end or luxury hotels are allowed (nor shall be accepted that HCP’s pay the difference to a reasonable tariff). Promotional meetings for sales and other commercial purposes (i) shall take place, as general rule, within the place where the HCP performs its activity or nearby; (ii) supporting transportation and accommodations costs is not allowed except if necessary for purposes of demonstration of non-portable equipment. |
Please also see European Union.
Portugal
