Applying for a marketing authorisation for a new tobacco product

Issuing of an authorisation to place new tobacco products on the market.

Service channels

Procedure and requirements

Documentos and requirements

You must submit the following documents:

  • access code to the permanent certificate or, for legal entities, an up-to-date copy of the extract from the commercial register;
  • for sole proprietors, a copy of your declaration of commencement of activity;
  • a copy of the proof of payment of the fee referred to in Article 6(1), made by bank transfer;
  • evidence that the Directorate-General for Health (DGS) has been notified pursuant to Article 14b(1) of Law No 37/2007 of 14 August, including the date of submission of the new product by means of the common electronic access point provided for in Article 3 of Ministerial Implementing Order No 148?A/2016 of 23 May;
  • proposal for the packaging and labelling that the product will have when placed on the market.

Procedure

  • Applications for a marketing authorisation for a new tobacco product must be submitted to the Directorate-General for Economic Activities (DGAE) via the ePortugal portal. The application will then be sent to the DGS, which must issue an opinion within 4 months.
  • The DGS may request additional tests or the submission of additional items or information. Any such request will suspend the deadline for issuing the opinion until the manufacturer or importer submits the necessary items or information.
  • The DGAE will issue a reasoned decision, taking account of the DGS’s opinion, on the application for marketing authorisation for the new tobacco product. This decision will be issued within 30 days of receiving the opinion.

Time of issue/decision

The authorisation will cease to be valid in the event of a change in the product necessitating a new notification.

How much

EUR 2 738.99

Legislation, refusals, contests, claims

Legislation

Law No 37/2007 of 14 August, as amended by Law No 63/2017 of 3 August.

Ministerial Implementing Order No 284/2018 of 23 October.

Competent Entity

Direção-Geral das Atividades Económicas

Address: Avenida Visconde de Valmor n.º 72 1069-041 Lisboa

Phone number: 217 919 100

Email address: dgae@dgae.gov.pt

Web url: www.dgae.gov.pt

Operation hours

  • Dias úteis das 09:00h às 13:00h.
  • Dias úteis das 14:00h às 18:00h.