It refers to a Marketing Autorization (MA) valid exclusively in the Republic of Cyprus. The procedure for issuing a National MA can be followed for pharmaceutical products that are not marketed in other member states (mainly applications for generics or well-established use medicinal products), as well as linear extensions of pharmaceutical products (e.g. different strength, route of administration, pharmaceutical form, etc.) that have been approved through a national procedure.
The main types of applications are as follows:
Generic application Article 10(1) according to “The Medicines for Human Use (Quality, Supply and Price Control) Law of 2001
Hybrid application, Article 10(3), “The Medicines for Human Use (Quality, Supply and Price Control) Law of 2001
Well-established use application, Article 10a, “The Medicines for Human Use (Quality, Supply and Price Control) Law of 2001
Extension application, “The Medicines for Human Use (Quality, Supply and Price Control) Law of 2001
More information you can find in “The Medicines for Human Use (Quality, Supply and Price Control) Law of 2001
The application for granting a marketing authorisation shall be accompanied by the medicinal product dossier. The applicant shall submit the dossier in Greek or English, prepared in the electronic form of the Common Technical Document (eCTD).
The parts of the eCTD are the following:
- Module 1: Administrative data and product information
- Module 2: Summaries
- Module 3: Quality
- Module 4: Non-clinical reports
- Module 5: Clinical study reports
For all new MA applications, the eCTD format is mandatory. This is also applicable to ASMF submissions.
It is noted that for generic applications equivalence between generic and reference product must be demonstrated in order to allow bridging (exemption from submission) preclinical and clinical studies (Sections 4 and 5), while for well-established use applications Sections 4 and 5 include bibliography review of studies that have been published in authoritative scientific journals.
In addition to the dossier, the marketing authorization holder shall submit a cover letter for application for a marketing authorization , signed by the applicant's responsible/ authorised person and an Electronic Application form for marketing authorisation, signed by applicant's responsible/ authorised person.
EU electronic Application form (eAF) for marketing authorisation is available under the link e Submisson/EU Electronic Application Forms.
The annexes, listed in the eAF (in section Annexed documents/where appropriate of eAF) shall be enclosed, as applicable to the application.
A separate eAF should be submitted for each pharmaceutical form and strength.
All parts of Modules 1, 2, 3, 4 and 5 shall be submitted with the application.
The content of the individual Module may vary depending on the legal basis of the application and the specific requirements related to the pharmaceutical form of the medicinal product.
The application for a marketing authorisation, the medicinal product dossier and all other attachments/ documents shall be submitted electronically, via the common European Union application portal Common European Submission Portal/CESP.
The marketing authorization of pharmaceutical products for human use requires a thorough scientific evaluation of their quality, safety and effectiveness by appropriately qualified pharmacists-experts of the Pharmaceutical Services.
When the requested additional documentation has been submitted and assessed, the procedure is finalised by granting or rejecting a marketing authorisation.
If, after finalization of the assessment, a positive opinion is reached on the benefit/ risk balance, the Drug Council after the suggestion of the Subcommittee of New National Products, will issue a decision on granting the marketing authorisation with the approved SmPC, PL, labelling and mock-ups of the medicinal product and the medicinal product will be placed on the Cypriot market.
Variations
After obtaining a marketing authorisation, the marketing authorisation holder shall throughout the medicinal product life cycle, submit/ notify all variations to the initially approved medicinal product dossier. EU electronic Application form for Variations is available under the link e Submisson/EU Electronic Application Forms.
Renewal
Five years after the marketing authorisation has been granted, the benefit/risk balance of the authorised medicinal product is once again re-evaluated in the renewal procedure. The application for the renewal of marketing authorisation has to be submitted by the marketing authorisation holder. EU electronic Application form for Renewals is available under the link e Submisson/EU Electronic Application Forms.