Pharmaceutical Drug Product Registration in Greece

MOH

Ministry of Health

MOH Website

https://www.gov.gr/

Regulatory Authority

National Organization of Medicine  

Regulatory Website 

https://www.eof.gr/

Local Authorized Representative Required

Yes

Classification of Product

Prescription Medicinal Products

Prescription medications, sometimes known as legend drugs, need a prescription to be taken because it is thought that they could be hazardous if not used under a certified healthcare provider’s supervision. Extra controls are imposed on some prescription medications.

OTC Medicinal Products 

Over the counter (OTC) medicines are drugs you can buy without a prescription.

Drug Approval Process

In the context of the endeavor to expedite, for pragmatic reasons, the processes for the approval, modification, and renewal of the marketing authorization of pharmaceutical and biological products for human and veterinary use, the National Medicines Agency (NEMO).

Testing Authorization for Testing

Strict adherence to a certain prior authorization procedure is also required with regard to testing, namely, to carry out a clinical trial of the medication. 

As per the guidelines outlined in article 3 of Regulation (EU) No 536/2014 on Clinical Trials (and below under question 18 of Preclinical and Clinical Trial Requirements), clinical trials are subject to a specific review and authorization procedure carried out by E.O.F. in compliance with the provisions of Greek Interministerial Decision No. G5α/59676/Government Gazette B’ 4131/2016 on clinical trials conducted on humans.

Centralized Process

The “centralized procedure” for granting marketing authorizations permits the holder of the marketing authorization to promote the medication and distribute it to patients and medical professionals across the European Union using a single marketing license. 

The European Commission issues this license after the European Medicines Agency evaluates the application scientifically. Regulation (EC) No 726/2004 establishes the centralized procedure.

Mutual Recognition

Articles 45–46 of the Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013 specify this procedure. A pharmaceutical product must already have a marketing authorization in place in at least one EU nation to qualify for the mutual recognition process.

Decentralized Process

Directive 2004/27 established this procedure, which is covered by Interministerial Decision D.YG3α/G.P. 32221, articles 47 et seq. It makes it possible to evaluate an application jointly that is concurrently submitted to multiple Member States. As the reference Member State, one of the Member States will lead the evaluation of the application. 

The other (affected) Member States approve the Reference Member State’s recommended draft assessment report, SPC, labeling, and package leaflet at the conclusion of the process.

National Process 

Article 7 of Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013 states that permission to market a pharmaceutical product can also be acquired by applying to E.O.F., the national regulatory body.

Process 

1. Phase prior to submission

Market research: To better understand the market and the competitors, businesses frequently carry out market research prior to starting the registration procedure. Consultation with Regulatory Authorities: To learn about certain rules and regulations, it is advisable to have a consultation with the Greek regulatory authorities.

2. Compiling the dossier

A thorough drug dossier that includes all relevant product information, such as quality, safety, and efficacy data, must be prepared by companies.

The Common Technical Document (CTD) format, mandated by the European Medicines Agency, must be followed by the dossier.

3. Application Submission

The National Organization for Medicines (EOF) receives the drug registration application.

The format of the application must comply with the most recent regulatory requirements, and it contains all required documentation.

4. Verification

The submitted application is validated by the regulatory authorities to make sure it satisfies all requirements. The applicant can provide more information if there are any gaps or incomplete data.

5. Assessment

The regulatory bodies carry out a comprehensive assessment of the drug’s efficacy, safety, and quality. An examination of preclinical and clinical data and an evaluation of the manufacturing procedures may be part of this assessment.

6. Approval

The regulatory bodies authorize the drug for sale if it is found to be safe, effective, and of guaranteed quality. Depending on the evaluation, there could be requirements or limitations associated with the approval procedure.

7. Post-Marketing Surveillance

After approval, post-marketing surveillance ensures ongoing monitoring of the drug’s safety and effectiveness.