Pharmaceutical Services

The legislation (following the amendment to Community Law - Article 126a) authorises the Medicines Council to issue Special Marketing Authorisations for reasons of public health. In order to be able to issue such marketing authorisations the following criteria must apply:

· A marketing authorisation issued by the Medicines Council for the specific medicinal product is not in force, nor is an application for the issuance of a marketing authorisation pending, and:

· The product has a marketing authorisation in another Member State in accordance with the provisions of Directive 2001/83 / EC

For medicinal products which will obtain a Special Marketing Authorisation the other provisions of the legislation still apply, as well as the obligations of the Marketing Authorisation Holder such as, the labelling in Greek and/or English, the appointment of responsible persons for scientific service and pharmacovigilance, the additional provisions concerning inspections and controls, provisions for immune products and products based on human blood or plasma, etc.

Special Marketing Authorisations are valid for 2 years and can be renewed upon request at least three months before their expiration. In order for a Special Marketing Authorisation to be renewed, all the conditions mentioned above must be met.