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Introduction

The Evaluation of Pharmaceutical Products Section is staffed with trained Pharmacists who assess applications for marketing authorizations for medicinal products for human use before as well as after their circulation to the Cyprus market.

The control of medicinal products for human use that are imported or manufactured in Cyprus performed according to national law, Medicines for Human Use (Control of Quality, Supply and Prices) law No. 70(Ι), 2001 as amended and other regulations enacted on the basis on the national law.

The main activities of the Evaluation of Pharmaceutical Products Section are:

1. Evaluation of applications for marketing authorization
2. Evaluation of applications for renewal of marketing authorization
3. Evaluation of applications for variation of marketing authorization
4. Check the precision of the translations in the Greek language of the mock-ups, the labeling and the Patient Information Leaflet of the medicinal products
5. Review medicinal products ingredients for of animal origin substances that hold the risk of causing spongiform encephalopathy.
6. Evaluate the documents submitted by the Marketing Authorisation Holders for upgrading the medicine dossier

1. Assessment of applications for marketing authorization
The assessment of applications for marketing authorization is performed by the sector´s trained Pharmacists. After all application documents accompanied the application are evaluated, they are submitted to a Subcommittee of the Drug Council, together with an assessment report, for further evaluation concerning the medicinal product efficacy, safety and quality. The subcommittee prepares recommendations for the Drug Council, which has the authority to approve or to reject an application.

Procedures for obtaining a Marketing Authorisation

National Application for Marketing Authorisation

It concerns a marketing authorization for a medicinal product issued by the Drug Council and is valid only for Cyprus. National Authorisation is applicable for medicinal product that do not have a marketing authorization in the Community (ie. Local manufacturers) and line extensions of medicinal products (ie. different strength, route of administration, dosage form) that have national authorisarion. The existing national marketing authorisations will remain as such and will be renewed according to legislation.

Mutual Recognition Procedure/Decentralised Procedure):

When a medicinal product has been granted a national marketing authorization in at least one Member State of EEA, the applicant can submit an application for marketing authorization at the same time in a number of MS via the mutual recognition procedure (MRP).

In addition, in the case that the applicant wishes to apply at the same time for marketing authorization in more than one MS for a medicinal product that does not have marketing authorization in any country of the EEA, the applicant submits the medicinal product dossier to all member states concerned and requests from one of the MS to act as a Reference MS (Decentralised Procedure).

The CMS are called to approve the RMS assessment report, the summary of product characteristics, the labeling and the package leaflet as approved by the RMS. A CMS may refuse to approve any of the above based on the grounds of potential serious risk to public health. It shall give a detailed exposition of the reasons for its position to the reference Member State, to the other Member States concerned and to the applicant. The points of disagreement shall be forthwith referred to the coordination group of the MRP. If Member States have adopted divergent decisions concerning the authorisation of the medicinal product or its suspension or revocation, a Member State, the Commission or the applicant or the marketing authorisation holder may refer the matter to the Committee for Medicinal Products for Human Use (CHMP). The European Commission issues the final decision after receiving the CHMP letter of opinion.

Medicinal products that obtained a marketing authorization in Cyprus before 1 May 2004, remain nationally authorized and are renewed under the national marketing authorization procedure.

MRP products may extend their authorisation to other Member States by following a repeat MR procedure.

CAP - Centralized Authorization Procedure

An application to the European Medicine Agency (EMA) is submitted by the applicant. The application for CAP is assessed EMA personnel and by the Committee for Human Medicinal Products (CHMP) which is consisted by one representative and its substitute from each MS. This procedure applies only to high-technology medicinal products, particularly those resulting from biotechnical processes, and products that contain new active substances and have therapeutic indications HIV, cancer, neurodegerative diseases and diabetes. The marketing authorization is issued by the European Commission upon positive recommendation of the EMA.

Special Authorisation

The current procedure falls under article 126a of the European Directive 2001/83 (which has been transposed to national legislation) allows the Drug Council to issue Special licenses for medicinal products for justified public health reasons.

This type of medicinal product special permit is applicable only to products that do not already have a marketing authorization in the Republic of Cyprus or a pending application to the Drug Council. In addition they shall fulfill the following requirements:

· the medicinal product has marketing authorization in a EEA MS
· the competent authority in that Member State, may be requested, to submit copies of the assessment report and of the marketing authorisation in force in respect of the medicinal product concerned
· the marketing authorisation holder in the Member State in which the medicinal product concerned is authorized, is notified
For medicinal products which will be licensed under article 126a Apendix 1 of the European Directive 2001/83, the Marketing Authorisation Holder should comply with all provisions such as Greek and English language, labeling, appointment of a Pharmacovigilance responsible person, additional regulations on inspections and audits, regulations on immunological medicinal products or medicinal products derived from human blood or plasma.

Legal types of application for marketing authorization and documents to be submitted

The legal types of applications are the following:

1. Full application
2. Bibliographical applications
For applications based upon Article 10a of Directive 2001/83/EC, non-clinical/clinical overviews/summaries should demonstrate that the constituent(s) of the medicinal product have a well-established use, with an acceptable level of safety and/or efficacy, as outlined in Annex I to Directive 2001/83/EC

3. Generic medicinal products (essentially similar medicinal products)
4. Hybrid application:
For products whose application is based on the dossier of a reference medicinal product (different strength, pharmaceutical form etc.)

5. Consent from the marketing authorization holder
For applications based upon Article 10c of Directive 2001/83/EC, expert reports or quality/non-clinical/clinical overviews/summaries of the original marketing authorization holder may be referred to.

6. Application for a fixed combination
7. Biosimilar medicinal products (product that use biological products as reference medicinal products)
8. Traditional medicinal products of herbal origin

electronic Common Technical Document (eCTD)

The electronic Common Technical Document (eCTD) is an interface for the pharmaceutical industry to agency transfer of regulatory information (2003/63/EC). The content is based on the Common Technical Document (CTD) format.

The eCTD has five modules:

Module 1: Administrative Information and Prescribing Information
Module 2: Common Technical Document Summaries
Module 3: Quality
Module 4: Nonclinical Study Reports
Module 5: Clinical Study Reports
More information regarding eCTD can be found at:

http://ec.europa.eu/enterprise/pharmaceuticals/index_en.htm

2. Renewal Applications
The Regulatory Sector examines Renewal Applications submitted by the Marketing Authorisation Holder to the Drugs Council at least 9 months before the expiration of the current Marketing Authorisation (5 years). After the first renewal, the marketing authorization is considered to be granted for an indefinite time unless the Drug Council with its decision renews the licence for a period of 5 years based on Pharmacovigilace concerns.

If a medicinal product is not marketed within 3 years from the time its marketing authorization is issued, the license automatically ceases to be in force.

3. Variation Applications
In the case that one or more data or documents are subject to change, the Marketing Authorization Holder should submit a variation application to the Drug Council and enclose all required documents according to Regulation (EC) 1234/2008. The pharmacists (Assessors) of the Regulatory Sector are responsible for reviewing these applications and forwarding their resolution to the Drug Council. The Drug Council decides whether to approve or reject the variation application taking into account the assessors’ report.

4. Linguistic Review in the Greek Language of the Labeling [ie. Summary of Product Characteristics (SmPC) and, Patient information Leaflet (PL) - Quality Review of Documents
The linguistic review of the GreekSmPC, Patient information Leaflet and of the Greek Labeling is conducted by the Drug Regulatory Sector Assessors (Pharmacists). The Assessors also actively contribute to the linguistic review of the Greek translation of medicinal products subject to centralized authorization procedure throughout participation to the Quality Review of Documents Group of the European Medicine Agency (EMA).

5. Control of Pharmaceutical Products with Animal Origin components to reduce the risk of transmission of Transmissible Spongiform Encephalopathie (TSE)
The control of Pharmaceutical Products with animal origin excipients is conducted by the Pharmacists (Assessors) of the Regulatory Sector. The Marketing Authorisation Holder is responsible for submitting the Certificate of Suitability of the European Pharmacopeia (CEP) for all raw materials of animal origin which are subject to examination by the Drug Regulatory Sector Assessors.




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