Exceptional Authorizations in Cyprus

As a member of the European Union (EU), the Republic of Cyprus, through the Department of Pharmaceutical Services, mandates that medicinal products for human use be submitted via the Common European Submission Platform (CESP).

CESP is an initiative that applies to all EU member states, applicants, and authorization holders for human and veterinary pharmaceuticals. It aims to establish a unified portal for electronic submissions related to European registration and post-approval procedures.

As part of their strategic goal to ensure the adequate availability of medicinal products in the Republic of Cyprus, the Pharmaceutical Services oversee various procedures for the licensing of medicinal products, including:

• Marketing authorization via National Procedure
• Mutual Authorization and Decentralised Procedures
• Centralized Procedure
• Special Marketing Authorisation (Article 126a of Directive 2001/83 / EC)
• Parallel Import Licence

Special Authorization

The special authorization procedure, under Article 126a of European Directive 2001/83 (which has been transposed into national legislation), allows the Drug Council to issue special licenses for medicinal products on justified public health grounds.

This type of special permit applies only to medicinal products that:

• Do not already have marketing authorization in Cyprus or a pending application with the Drug Council.
• Have a valid marketing authorization in a European Economic Area (EEA) Member State.

Additionally, the following requirements must be met:

• The competent authority of the EEA Member State where the medicinal product is authorized may be requested to provide copies of the assessment report and the marketing authorization in force.
• The marketing authorization holder (MAH) in the respective Member State must be notified.
• For medicinal products authorized under Article 126a, Appendix 1 of European Directive 2001/83 applies.
• The MAH must comply with all regulatory provisions, including:

• • Labeling requirements in Greek and English;

• • Appointment of a responsible person for pharmacovigilance;

• • Additional regulations on inspections and audits;

• • Specific regulations for immunological medicinal products and those derived from human blood or plasma.

Renewal of Special Marketing Authorization

Special marketing authorizations are valid for two years. If the holder wishes to renew the authorization, they must submit a renewal application at least three months before its expiration.

Issue of Special Marketing Authorizations

After contacting the receiving unit, the application form and required supporting documentation must be submitted in hard copy. The relevant application form (enclosed) must be completed and submitted.

For the application to be considered complete, the following are required:
1. A signed cover letter;
2. A signed application form;
3. All supporting documentation listed in the application;
4. A sample of the secondary packaging, including the patient information leaflet.