Amending an application for a marketing authorisation for a new tobacco product

Any changes in the identification details of the manufacturer or importer or of the person responsible for the application compared to the details in the application for authorisation, must be notified to the Directorate-General for Economic Activities (DGAE) within 10 days of the change being confirmed.

Service channels

Procedure and requirements

Documentos and requirements

You must contact the Directorate-General for Economic Activities to find out which documents you need to submit, as the documents vary depending on the change you need to report.

Procedure

  • Applications for a marketing authorisation for a new tobacco product must be submitted to the DGAE via the ePortugal portal. The application will then be sent to the Directorate-General for Health (DGS), which must issue an opinion within 4 months.
  • The DGS may request additional tests or ask you to submit 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 a marketing authorisation for the new tobacco product. This decision will be issued within 30 days of the DGAE receiving the opinion from the DGS.

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

It is free of charge.

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.