Health-regulated establishments (H.R.E.) constitute a major category of the small and medium-sized enterprises (SME) in Greece, whose strengthening is inextricably linked to the promotion of entrepreneurship and productivity, as well as the reinforcement of employment. An establishment or enterprise or workshop or undertaking are defined as a “health-regulated establishment” when their operation is regulated under the Public Health Act.

Health-regulated establishments are regulated by the information regime, which is mandatory and according to which the interested party must inform the competent authority of the commencement of entrepreneurial activity, that they intend to engage in in a particular facility or establishment, without the need of a previous inspection of the property, in advance.

This notification is carried out using the new central system, called the “Integrated Information System for the Start of Entrepreneurial Activity and Control” (INS – SEAC), established bylaw and administered by the General Secretariat of Merchandise of the Ministry of Economy and Development. Prior to the activation of this system, notifications were made in municipalities or Citizen Services Centers, operating as Single Service Centers (SSC).

Prior to submitting a notification, the person concerned must ensure that the establishment can be set up in a particular location. For this purpose, the confirmation issued by the head of the competent authority of the municipality, where the establishment will be operating, is required, stating that this type of activity can be set up in this location. The authority responsible for issuing such a certificate examines the existing land use and other restrictions established by the current legislation or normative decisions of the municipality that have been issued before the application date for the certificate issuance and issues the certificate within fifteen (15) days from the date of application. If this time period expires, it is considered that the certificate was granted. The certificate is valid for five (5) months from the date of issue and during this time the person concerned must submit the notification.

Previous issuance of a certificate of commencement of entrepreneurial activity of the person concerned in a competent tax authority is prerequisite for starting the store activities.

The following documents are submitted to notify of the establishment and operation of a health-regulated establishment:

  1. Application – a solemn declaration of the interested party, notifying of the establishment and operation of the health-regulated establishment,

  2. Solemn declaration of a private engineer-supervisor, stating that all building conditions and duties have been met and rightfully fulfilled within the current norms of the store,

  3. Solemn declaration of the notifier stating the appointment of a person responsible for sanitary and economic matters of the store, and a solemn declaration of the latter that they accept this appointment

  4. Copy of a valid ID or another document (passport, driving license, personal health card) of the notifying natural person. If it is a company, the following documents are provided: a) certificate of a competent authority for keeping the registry of the administrative or judicial authority regarding the non-liquidation and non-bankruptcy of the company; b) certificate issued by a competent authority regarding the keeping of the archives of the administrative authority of the legal representation of the company and the representatives’ identification documents.

  5. Government fee