Manufacturing/Import Licences from Third Countries
In accordance with the legislation, the complete or partial manufacture of pharmaceutical products, the procedures for portioning, packaging and appearance, are permitted only after a licence has been issued by the Drugs Council (manufacturing licence) following an application from the interested party in the format that is defined by the Drugs Council.
The manufacturing licence is required even if the pre-manufactured pharmaceutical products are intended for export.
Obtaining a manufacturing licence is not required in the following situations:
(a) for the manufacture, portioning, change of packaging or appearance which is undertaken by a pharmacist within a pharmacy and is intended solely for retail sale,
(b) for the performing of the above tasks by registered physicians or registered veterinarians or registered dentists for one of their own specific patients.
A manufacturing licence is also required for the importing of pharmaceutical products into the Republic of Cyprus which have a third country origin.
The manufacturing licence is issued if the applicant meets at least the following requirements:
(a) Has defined the product and the pharmaceutical forms to be manufactured as well as the location of where they are to be manufactured and tested,
(b) has suitable and sufficient premises, technical equipment, necessary personnel and the capabilities for the manufacture, control and storage of the product
(c) has at least one qualified person permanently and continuously available
The applicant must provide information in the application proving that they meet the above requirements.
The application for the issue of the manufacturing licence must be accompanied by the prescribed fees for the examination of the application and the inspection fees.
The Drugs Council issues the manufacturing licence following an inspection carried out by authorised inspectors and a positive recommendation from the inspectorate for the issuance of the licence.
The manufacturing licence is issued as soon as is possible and no later than 90 days from the date of which the complete application dossier has been received by the Drugs Council.
The manufacturing licence is applicable only for the areas, the pharmaceutical products and the pharmaceutical forms which are stated in the application.
In the case where a manufacturing licence holder submits an application for variation of the licence details, the variation application is examined within a period not exceeding 30 days. In exceptional circumstances this period may be extended up to 90 days.
The manufacturing licence is valid for a period of five (5) years and is renewable with the submission of the defined renewal fees.
The issuance of the manufacturing licence is published in the Official Gazette of the Republic of Cyprus along with a description summarising its contents.
Following the issue of the licence, inspections of pharmaceutical product manufacturers are performed periodically, at regular intervals, in accordance with the predefined programme so as to determine whether the Good Manufacturing Practice guidelines are being implemented and followed.