| Description: |
This authorisation procedure is being applied mainly to cover the public health need created by the lack of applications for Marketing Authorisations for products which were on the derogation list and for products which were authorised in the period between the publication of the derogation list and the date of accession. An authorisation is granted in accordance with Regulation 4(2) of the Medicines (Marketing Authorisation) Regulations (Subsidiary Legislation 458.34), under the Medicines Act, 2003 (Chapter 458 of the Laws of Malta). The authorisation is valid for 5 years. A renewal application should be submitted at least 6 months before the end of validity of the authorisation. |
